SecondLook Digital Radiologist Manual
Contents
1. CAD Never stop looking SecondLook Digital User s Manual for Siemens 2009 iCAD Inc All Rights Reserved iCAD the iCAD logo Never Stop Looking and SecondLook are registered trademarks of 1CAD Inc Other company product and service names may be trademarks or service marks of others DTMO019 Rev F SLD Siemens Users Manual for Siemens Rev F This page intentionally left blank DTM019 iCAD Inc Page 2 of 24 SLD Siemens Users Manual for Siemens Rev F CAD Never stop looking 98 Spit Brook Rd Suite 100 Nashua NH 03062 USA 603 882 5200 The European Representative for iCAD Inc is MDSS GmbH Schiffgraben 41 30175 Hannover Germany DTM019 iCAD Inc Page 3 of 24 SLD Siemens Users Manual for Siemens Rev F This page intentionally left blank DTM019 iCAD Inc Page 4 of 24 SLD Siemens Users Manual for Siemens Rev F TABLE OF CONTENTS ies 1 EE EE ER EE ER EE 1 1 OVERVIEW OF MANUAL ME OR EE EE EE 7 2 SECONDLOOK DIGITAL IN BREAST CANCER DETECTION eene 7 2 1 e ele EE ER RE EE EE 7 2 2 DESCRIPTION OF SECONDLOOK Dora 7 3 SECONDLOOKO9 DIGITAL DEVICE LABELING ee ese ee esse ee ea ee ee gee ee ge ee Rae ek Re ee ER Ee ee RE nnne nnne Re ee RE Ee 9 3 1 BRIEF DEVICE DESCRIPTION dns edi ses Haut de ee eek ie adie E Re ED ee ge N Ee se een Tee ae 9 3 2 INDICATIONS FOR USE N RR R2. Operating Points allows users to trade off sensitivity and false positive rate to achieve the desired CAD performance DTM019 iCAD Inc Page 23 of 24 SLD Siemens Users Manual for Siemens Rev F 6 4 Alternate Marking of Detection Secondary Graphical Representation Version 7 2 software of the SecondLook Digital system populates Mammography CAD Structured Report with the centroid and the perimeters coordinates of a detection allowing the workstation to display alternate style CAD markers For example individual calcifications or the contour of a mass could be outlined Additionally users could selectively toggle between standard CAD marks ellipses and rectangles and the alternate CAD style marks 6 5 Certainty of finding only available outside of the USA Certainty of finding provides an indication of how certain CAD is of a specific detection This enables workstations to offer users the ability to dynamically vary the number of CAD marks displayed for a given exam or to set a user defined threshold Functionality to vary the number of CAD marks displayed based upon certainty of finding is not available in the USA 7 Summary of Radiologist Use of SecondLook Digital The radiologist uses the SecondLook Digital CAD marks with mammography according to the following steps 1 The radiologist first reviews the Siemens full field digital mammograms without viewing the CAD marks following her or his existing procedures of clin
3. per image Lesion metrics are provided for microcalcification clusters and densities All metrics are defined in the DICOM standard and the information is contained in the Mammography CAD Structured Report 6 1 1 Micro Calcification Area Measurement This metric is the area measurement of a microcalcification cluster in square millimeters mm 6 1 2 Microcalcification Cluster Summary This metric is the total number of microcalcifications within an individual cluster 6 1 3 Density Longest Axis Measurement This metric is the longest axis of an individual density in millimeters mm 6 1 4 Density Area Measurement This metric is the area measurement of individual density detections in square millimeters mm 6 2 Nipple Skin Line and Pectoral Muscle Detections Version 7 2 software of the SecondLook Digital system detects the nipple position and populates the Mammography CAD Structured Report with the nipple coordinates Version 7 2 software also segments breast tissue and populates the Structured Report with the skin line and pectoral muscle coordinates enabling review workstations to calculate distances to lesions and enhance correlation between views 6 3 Dynamic Operating Points Version 7 2 software of the SecondLook Digital system provides CAD results for both Operating Points in the Mammography CAD Structured Report enabling review workstations to provide dynamic switching between the Operating Points on the fly Changing
4. practice The radiologist would make an initial determination if a work up were indicated for the patient prior to turning on and viewing the CAD marks with the softcopy review workstation 2 The second page contains printed versions of the mammograms with CAD marks turned on During clinical use the radiologist would take a SecondLook at the mammograms corresponding to any CAD marks From this re evaluation of the mammograms the radiologist would determine if any additional work up was required If there were no CAD marks no re evaluation of the mammograms would be necessary Work up decisions are not based solely upon the CAD marks All work up decisions are based upon review of the mammograms supporting clinical information and CAD marks by the radiologist 3 The third page then presents a summary of the case which includes the case history the mammographic findings and the resulting pathology An arrow points to the location of the tumor in printed versions of the mammograms DTM019 iCAD Inc Page 19 of 24 SLD Siemens Users Manual for Siemens Rev F 5 2 Sample Cases 5 2 1 Case 1 Case History and Mammograms Case 1 History 62 yo female with palpable mass in upper outer quadrant of right breast No family history of breast cancer DURING CLINICAL USE THE INITIAL MAMMOGRAPHY REVIEW AND ig INITIAL WORK UP DECISION WOULD BE ACCOMPLISHED is DTM019 iCAD Inc Page 20 of 24 SLD Siemens User
5. procedures Therefore the radiologist s work up decision should not be altered if the system fails to mark an area that the radiologist has detected on the initial image review and has already decided requires further work up Nor should the decision be affected if the system marks an area that the radiologist decides is not suspicious enough to warrant further work up whether the area is detected by the radiologist on initial image review or only after being marked by the system DTM019 iCAD Inc Page 10 of 24 SLD Siemens Users Manual for Siemens Rev F Effectiveness and safety have not been established for non standard mammographic views e g magnification compression views or non displaced implant views Therefore any CAD marks in these views should not be used by the radiologist in evaluating the patient Warnings System Operation The system should not be used if it is suspected that any electrical component is defective or inoperable Do not place any liquids on or near SecondLook If a liquid is accidentally spilled on electrical components immediately turn off the Uninterruptible Power Supply UPS which will automatically shut down the system to prevent any potential electrical shock Contact your authorized SecondLook service provider for further instructions Ensure that the system is connected to a properly wired and grounded power receptacle Confirm that the voltage and current requirements are within sy
6. proprietary measures as well as a feature selection process to determine the most likely locations to be cancer 3 The most likely locations are evaluated in the context of the patient and highlighted with CAD marks displayed overlying the mammograms on the review workstation used by the radiologist for softcopy reading It is important to remember that SecondLook Digital will not necessarily mark what a radiologist would work up This is an important consideration as every radiologist works up different areas based on her or his own criteria SecondLook Digital does not function on its own but always with a radiologist Therefore if SecondLook Digital highlights a mass or microcalcifications in one view only the radiologist can look for it in the other view to determine if there is a lesion that warrants work up A SecondLook Digital Device Labeling 3 1 Brief Device Description SecondLook is a mammographic computer aided detection CAD system that identifies and highlights potential areas of concern to assist radiologists in breast cancer detection The CAD algorithms used in the SecondLook computer system include image processing feature computations and pattern recognition technology to detect mammographic features indicative of malignancies Areas of concern identified include suspicious clusters of microcalcifications spiculated and non spiculated masses architectural distortions and focal asymmetric densities S
7. studies a description of the principles of operation for the computer aided detection CAD algorithms a list of conformance to standards and how the system is supplied e The procedures for a radiologist using the SecondLook Digital CAD marks are described in Section 4 e Sample cases are provided in Section 5 to familiarize the radiologist with the SecondLook Digital system prior to clinical use e Section 6 summarizes a radiologist s use of SecondLook Digital SecondLook Digital in Breast Cancer Detection Background SecondLook a computer aided detection CAD system for mammography has been developed by iCAD Inc to identify and mark regions of interest on screening and diagnostic mammograms to bring them to the attention of radiologists after the initial reading has been completed Thus the system assists the radiologist in minimizing observational oversights by identifying areas on the original mammogram that may warrant a second review The SecondLook system was first developed for use with screen film mammography SFM For SecondLook to process full field digital mammography FFDM from the Siemens a new optional system component has been developed SecondLook Digital SecondLook Digital can be configured as a stand alone system that only processes FFDM Description of SecondLook Digital SecondLook Digital is a mammographic CAD system that identifies and highlights potential areas of concern to assi
8. the Siemens full field digital mammography images within the softcopy review workstation or on a paper printout The CAD marks are used by the radiologist as an additional tool in breast cancer detection An overview of the SecondLook CAD algorithms is shown in Figure 1 Standard Mammography Films Y v MicroCalc Density Algorithm Algorithm Calc Image Density Image Enhancement Enhancement MicroCalc Density Detector Detector Region Clustering Growing MicroCalc Density Classifier Classifier Y Context Based Patient Evaluation Areas of Concern Highlighted by CAD Marks Figure 1 SecondLook CAD Algorithms Overview DTM019 iCAD Inc Page 14 of 24 SLD Siemens Users Manual for Siemens Rev F The CAD algorithms begin with image enhancement of the digitized mammographic images to accentuate all areas that could be individual microcalcifications and densities The microcalcification and density detectors then identify the areas that are most likely to be individual microcalcifications and densities based on an initial analysis of Siemens data and intensity measurements The types of densities detected are depicted in Figure 2 and include spiculated and non spiculated masses architectural distortions and focal asymmetric densities Circumscribed Masses Round Oval Lobular Microlobulated Mass Obscured Ma
9. 5 of 24 SLD Siemens Users Manual for Siemens Rev F 6 1 1 Micro Calcification Area Measurement sss esent 23 6 1 2 Microcalcification Cluster Summer 23 6 1 3 Density Longest Axis Measurement sss AA AR ee AA AR ee AA Ge ee ke Ge ee ke ee ee ee 23 6 1 4 Density Area Measurement se dd es Re des GE ed GE ee das ann Ad es GRA AA Re AG GE ee Ge GR ee eie 23 6 2 NIPPLE SKIN LINE AND PECTORAL MUSCLE DETECTIONS iese esse ee ee ee ee ee ee ee ee ee ee Ge Re ee ee ee ee ee ee 23 6 3 DYNAMIC OPERATING POINTS EE SEE e tte RED EOD bud Ee Ed b oe hee 23 6 4 ALTERNATE MARKING OF DETECTION SECONDARY GRAPHICAL REPRESENTATION sesse esse ee 24 6 5 CERTAINTY OF FINDING ONLY AVAILABLE OUTSIDE OF THE USA 24 7 SUMMARY OF RADIOLOGIST USE OF SECONDLOOK DIGITAL eene 24 DTM019 iCAD Inc Page 6 of 24 SLD Siemens Users Manual for Siemens Rev F 2 2 1 2 2 Overview of Manual This manual is intended to describe the SecondLook Digital computer aided detection algorithms and provide training to radiologists using the SecondLook Digital system in breast cancer detection e Section 2 gives an overview of the role of SecondLook Digital in breast cancer detection e The SecondLook Digital Device Labeling is included in section 3 which provides a brief description of the system indications for use contraindications warnings and precautions adverse effects summary of clinical
10. E EE Reds 9 3 3 CONTRAINDICATIONS n sssseekeeekt tettette ttrt ttrt Artt ESE ESEESE ESEEESNEESNEESNEESSEENSEES SEANSEN SENSE ES SESSE ennnen anen 10 3 4 FL Mcr EE ME RE ee 10 3 5 ae dale ER N RE OR 12 3 6 ADVERSE EFFECTS idi e EE EE EE OE OE EE nl eA ae 12 3 7 SUMMARY OF CLINICAL STUDIES esse ee ee ee ee ee ee ke ee ee ee ee ee GR Re enne enne nnn sn ee ee ennt nen Re n nnn ee ee nn 12 3 8 PRINCIPLES OF OPERATION RA RE a EA EE N OE N EA 14 3 9 CONFORMANCE TO STANDARDS iese ee ee ee tettetett tett ee Re ee GRA ee GR Re ee ee RR ee GR rs nennen nennen nnns ee de ee ee en 17 3 10 HOW SUPPLIED tien iss EE ee ee Ee aed ate ene pte ented e e eke LL EE e eda 17 4 RADIOLOGIST USE OF SECONDLOOK DIGITAL nee ee Re ee RE Re AR RR ER nennen RR Rae EE ee 17 4 1 RADIOLOGIST REVIEW PRIOR TO VIEWING CAD Mapks ee ee ee ee ee ee ke ee ee ee ee Re ee ee Re ee ee ee ee ee 17 4 2 RADIOLOGIST REVIEW WITH CAD Mapks ee ee ee ee ee ee ee Re ee GR Re ee ee RR enr ee ee ee Re ee ee Re ee nnn ee ee ee 18 5 RADIOLOGIST TRAINING WITH SAMPLE CASES se ee ee se ee ke ek Raak RE Ee ee KERR ek Rae ek Rae ee nnns 19 5 1 TRAINING INSTRUCTIONS siste 19 5 2 EAST EE EE OE EE N EO EE 20 MERO EE EE EE EE EE ET 20 6 WORKFLOW FEATURES iret sede sl se eek eke ee Ese Eg ekke ese ee ee Gn kase vb n ee He ekke eed ees ee Ee Ee bk ee Se eke Das 23 6 1 LESION iium 23 DTM019 iCAD Inc Page
11. O SecondLook Digital assists radiologists with these mammographic views and full breast diagnostic views On occasion other views are obtained for screening or diagnostic purposes such as left and right exaggerated craniocaudal projections rotated laterally L XCCL and R XCCL and left and right straight mediolateral projections L ML and R ML When additional screening or diagnostic views are taken SecondLook Digital may process more than 4 views for each patient SecondLook Digital is not used to assist the radiologist in evaluating magnification compression views or specimen radiography For patients with breast implants SecondLook Digital is used with implant displaced views only When SecondLook Digital processes magnification compression views specimen radiography or non displaced implant views any resulting CAD marks should not be used by the radiologist in evaluating the patient SecondLook Digital is intended to be used by a radiologist as follows The radiologist must first review the mammogram in the normal manner and only afterward consult the CAD marks to determine if SecondLook Digital has marked any areas of concern that were not observed on the initial review To view the CAD marks prior to the initial unassisted review of the mammogram risks the so called satisfaction of search error in which the radiologist s vigilance for other areas on the mammogram may be lowered by virtue of seeing one or more areas highligh
12. SecondLook system assists in breast cancer detection not interpretation or diagnosis Upon re evaluation of the Siemens full field digital mammography images at the locations of the CAD marks the radiologist uses interpretive skills to determine if the area should be worked up based on its mammographic appearance The initial unassisted review of Siemens full field digital mammography images is critical because the system will not highlight all areas that the radiologist may detect and using the system before finishing the unassisted conventional image review runs the risk of inducing a so called satisfaction of search error in which the radiologist fails to examine the unmarked areas of the images with adequate vigilance e The system is not designed to highlight interval change between mammographic exams e The system is not designed to highlight asymmetric breast tissue tubular density solitary dilated duct skin thickening or nipple retraction The SecondLook system will highlight areas that a radiologist determines do not require work up Thus the work up is determined by the radiologist and the presence of a CAD mark should not influence the decision that would have been made had the area been noted in the first place e The radiologist must still use diagnostic skills to differentiate benign from malignant lesions by working up the area which may include magnification spot mammography ultrasound or interventional
13. atical features are then computed to describe each detected cluster of microcalcifications and density For example the variability in size and shape of the calcifications in a cluster are good features to describe clusters of microcalcifications These features are used by microcalcifications and density classifiers which are specifically designed to select the areas most likely to be cancer Further analysis uses the context of all areas selected for the patient For example there is a maximum total number of SecondLook CAD marks each 4 image case can include Simultaneous analysis of all areas of concern detected in the patient allows the locations most likely to be cancer to be highlighted by the CAD marks DTM019 iCAD Inc Page 16 of 24 SLD Siemens Users Manual for Siemens Rev F Figure 4 Region Growing to Determine Shape of Density 3 9 Conformance to Standards Refer to the SecondLook Digital Service Manual for the CE Declaration of Conformity 3 10 How Supplied The SecondLook system includes the following components e Uninterruptible Power Supply e Computer 4 Radiologist Use of SecondLook Digital 4 1 Radiologist Review Prior to Viewing CAD Marks The radiologist first reviews the Siemens full field digital mammograms without viewing the SecondLook Digital CAD marks following her or his existing procedures of clinical practice The radiologist will make an initial determination if a work up is indicat
14. ded to 17 2 95 Cl 16 0 18 4 aided by the system The sensitivity of SecondLook Digital with input from the Siemens full field digital mammography system was statistically no different than the sensitivity of SecondLook Analog medium with input from screen film mammography The false positive rate of SecondLook Digital with input from the Siemens full field digital mammography system was statistically no different than the false positive rate of SecondLook Analog medium with input from screen film mammography The study with SecondLook Digital did not assess the impact of this system on reduction in missed cancers percent of women who could have had their cancers discovered earlier and work up rate In summary the SecondLook system will enhance a radiologist s effectiveness in detecting breast cancer DTM019 iCAD Inc Page 13 of 24 SLD Siemens Users Manual for Siemens Rev F 3 8 Principles of Operation SecondLook uses computer aided detection CAD algorithms to identify suspicious lesions in mammograms The Siemens full field digital mammography system creates digital mammographic images that are input to SecondLook and these CAD algorithms use advanced image processing feature computations and pattern recognition technology to analyze the images for potential areas of concern These potential areas of concern are displayed for the radiologist by overlying CAD marks at the appropriate locations of
15. e and Humidity Warning SecondLook system operations must be performed within the following temperature and humidity ranges e Temperature 50 95 Fahrenheit 10 35 Celsius e Humidity 20 80 DTM019 iCAD Inc Page 11 of 24 SLD Siemens Users Manual for Siemens Rev F 3 5 Precautions Precautions System Operation e The SecondLook system is protected by an Uninterruptible Power Source UPS When power is lost the unit beeps constantly for five minutes and the SecondLook system will automatically shut down The beep indicates that the power source is protecting the equipment after a loss of power e To prevent damage to the system maintain equipment in a well ventilated air conditioned environment e Only images from a Siemens full field digital mammography system that is maintained in accordance with MQSA standards should be used e Effectiveness and safety in patients with breast implants has not been established for views that include the implant When implant displaced views are analyzed by the system any resulting CAD marks should not be used by the radiologist in evaluating the patient e Effectiveness and safety have not been established for non standard mammographic views e g magnification compression views When these views are analyzed by the system any resulting CAD marks should not be used by the radiologist in evaluating the patient Precautions Installation and Maintenance e This product c
16. econdLook is intended to be used by a radiologist as follows The radiologist must first review the mammogram in the normal manner and only afterward consult the CAD marks to determine if SecondLook has marked any areas of concern that were not observed on the initial review SecondLook amp is designed to mark areas with the mammographic appearance of cancer however many of the marked areas will not contain a malignancy and it is up to the radiologist to decide using conventional clinical judgment and reviewing the mammogram itself if the area is suspicious enough to warrant further work up SecondLook is not a diagnostic device as the CAD marks are intended to be used to assist only in detection and not in interpretation 3 2 Indications for Use The SecondLook Digital computer aided detection system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from the Siemens full field digital mammography system to bring them to the attention of the radiologist after the initial reading has been completed Thus the system assists the DTM019 iCAD Inc Page 9 of 24 SLD Siemens Users Manual for Siemens Rev F radiologist in minimizing observational oversights by identifying areas on the original mammogram that may warrant a second review 3 3 Contraindications There are no contraindications for use of this device 3 4 Warnings Warnings Radiological Interpretation The
17. ed for the patient prior to turning on and viewing the CAD marks with the softcopy review workstation DTM019 iCAD Inc Page 17 of 24 SLD Siemens Users Manual for Siemens Rev F 4 2 Radiologist Review with CAD Marks The radiologist turns on and views the SecondLook Digital CAD marks with the softcopy review workstation after determining whether or not a work up is indicated from her or his initial review of the patient mammograms The radiologist will take a SecondLook at the mammograms corresponding to any CAD marks From this re evaluation of the mammograms the radiologist determines if any additional work up is required If there are no CAD marks no re evaluation of the mammograms is necessary Work up decisions are not based solely upon the CAD marks All work up decisions are based upon review of the mammograms supporting clinical information and CAD marks by the radiologist Areas of concern marked by SecondLook Digital include suspicious clusters of microcalcifications spiculated and non spiculated masses architectural distortions and focal asymmetric densities Below is the recommended case review process with SecondLook Digital 1 Review patient history and evaluate Siemens full field digital mammograms prior to turning on and viewing CAD marks with softcopy review workstation 2 Make initial interpretation 3 Turn on and view CAD marks with softcopy review workstation and identify potential areas of co
18. ical practice The radiologist will make an initial determination if a work up is indicated for the patient prior to turning on and viewing the CAD marks with the softcopy review workstation 2 The radiologist turns on and views the CAD marks with the softcopy review workstation after determining whether or not a work up is indicated from her or his initial review of the patient mammograms During the review of the CAD marks the radiologist could also review the lesion metrics and vary the number of CAD marks displayed based upon the certainty of finding or by switching Operating Points 3 The radiologist will take a SecondLook at the mammograms corresponding to any CAD marks From this re evaluation of the mammograms the radiologist determines if any additional work up is required If there are no CAD marks no re evaluation of the mammograms is necessary Work up decisions are not based solely upon the CAD marks All work up decisions are based upon review of the mammograms supporting clinical information and CAD marks by the radiologist DTM019 iCAD Inc Page 24 of 24
19. ncern 4 Review mammograms re evaluating areas of concern highlighted by CAD marks with softcopy review workstation 5 Render decision It is very important to remember that it is the radiologist who makes the final decision about a case When a radiologist decides to work up a case the CAD marks must not change the decision however the CAD marks can identify locations for further work up that were initially undetected by the radiologist DTM019 iCAD Inc Page 18 of 24 SLD Siemens Users Manual for Siemens Rev F 5 Radiologist Training with Sample Cases 5 1 Training Instructions One sample case demonstrates the use of SecondLook Digital for the radiologist prior to clinical use This case is intended to familiarize the radiologist with the procedures for using the SecondLook Digital CAD marks The case review procedures are emphasized Therefore the training is accomplished by following the case presentation in Section 5 2 of this manual without requiring use of the softcopy review station For the example case in the manual the procedures for using SecondLook Digital CAD marks are demonstrated to the radiologist with the following steps 1 The first page will provide the case history and printed versions of the Siemens full field digital mammograms without CAD marks During clinical use the radiologist would first review the mammograms without viewing the CAD marks following her or his existing procedures of clinical
20. ontains no independently user serviceable parts To prevent damage to the system do not attempt to install or repair the SecondLook system Only trained personnel are qualified to install or repair the system For service training contact iCAD Inc at 1 866 280 2239 e Disconnect power cord before moving or servicing 3 6 Adverse Effects The use of SecondLook adds no known additional risks to mammography There is no direct contact with the patient 3 7 Summary of Clinical Studies A variety of studies have been performed in order to achieve regulatory approval Below is a summary of the studies More information can be obtained by contacting iCAD Conclusions drawn from the studies DTM019 iCAD Inc Page 12 of 24 SLD Siemens Users Manual for Siemens Rev F The use of the SecondLook Analog medium system led to a clinically significant reduction in missed cancers of at least 27 1 95 Cl 22 196 32 0 A retrospective study of 374 cancer cases showed that 21 996 9596 CI 17 996 25 9 of women diagnosed with breast cancer who had prior screening mammograms within 9 24 months of diagnosis could have had their cancers discovered earlier by an average of 15 1 months with the use of SecondLook Analog medium The use of the SecondLook amp Analog system led to an insignificant increase in the number of work ups recommended by radiologists reading screening mammograms from 16 6 95 Cl 15 5 17 8 unai
21. s Manual for Siemens Rev F Mammograms with CAD Marks Case 1 Note The softcopy review workstation may use symbols other than rectangles calcifications and ellipses masses for the CAD marks DURING CLINICAL USE THE AREAS OF CONCERN HIGHLIGHTED BY THE CAD MARKS WOULD BE RE EVALUATED USING THE SOFTCOPY eee A REVIEW WORKSTATION FROM THIS RE EVALUATION OF THE Tt MAMMOGRAMS THE RADIOLOGIST MAKES THE FINAL WORK UP G DECISION Tum DTM019 iCAD Inc Page 21 of 24 SLD Siemens Users Manual for Siemens Rev F Case Summary Case 1 History 62 yo female with palpable mass in upper outer quadrant of right breast No family history of breast cancer Mammographic findings 3 cm circumscribed mass with partially obscured borders in the right breast at 10 o clock shown to be a cyst on ultrasound Linear distribution of pleomorphic calcifications in the right breast at 2 o clock posteriorly Pathology Ductal carcinoma in situ arrows show location DTM019 iCAD Inc Page 22 of 24 SLD Siemens Users Manual for Siemens Rev F 6 Workflow Features 6 1 Lesion Metrics Version 7 2 software of the SecondLook Digital system computes basic metrics for detected lesions enabling review workstations to present this information to users in a variety of ways The iCAD software version number is plainly visible on the review workstation typically near the text indicating the number of CAD marks
22. ss Irregular Mass with Indistinct Margins SC EI Spiculated Mass Architectural Distortion y IZ aas Se S N NOTE Focal asymmetric densities are difficult to depict pictorially but are detected by SecondLook Figure 2 Densities Detected by SecondLook Further analysis of detected areas is accomplished by clustering individual microcalcifications and region growing densities Clusters include 3 or more individual microcalcifications that are each no more than 4 1 millimeters apart Figure 3 depicts portions of three different Siemens full field digital mammography images showing how the SecondLook system would highlight microcalcifications clusters in these examples These examples use CAD marks that are rectangular and correspond to the approximate DTM019 iCAD Inc Page 15 of 24 SLD Siemens Users Manual for Siemens Rev F size of the microcalcifications although alternative symbols for the CAD marks may be used Region growing determines the shape of potential densities as shown in Figure 4 Figure 3 CalcMarks Highlighting Microcalcifications Clusters with a The minimum number of calcifications b The extent of the CalcMark enclosing all calcifications considered as part of the cluster C Overlapping CalcMarks are distinctly highlighted even when clusters are close to each other After clustering for microcalcifications analysis and region growing for density analysis clinically relevant and mathem
23. st radiologists in breast cancer detection The CAD algorithms used in the SecondLook Digital computer system include image processing feature computations and pattern recognition technology to detect mammographic features indicative of malignancies Areas of concern marked include suspicious clusters of microcalcifications spiculated and non spiculated masses architectural distortions DTM019 iCAD Inc Page 7 of 24 SLD Siemens Users Manual for Siemens Rev F and focal asymmetric densities SecondLook Digital does not distinguish between benign and malignant processes and may highlight technical artifacts SecondLook Digital integrates with the Siemens FFDM system to process FFDM images The resulting CAD marks are typically displayed overlying the appropriate locations of the mammogram on the review workstation used by the radiologist for softcopy reading When the CAD marks are displayed within the review workstation the radiologist can turn on or off the display of CAD marks overlying the mammogram Although the remainder of this manual is written with the assumption that the CAD marks are viewed on a review workstation a paper printout of the CAD marks is another possible option The radiologist using a paper printout follows similar procedures Typical screening mammography includes four mammographic views left and right craniocaudal projections L CC and R CC and left and right mediolateral oblique projections L MLO and R ML
24. stem specifications to avoid bodily injury from electrical shock or fire hazard Warnings Installation and Maintenance Modem Warning The modem is to be used by service personnel only in case the system requires remote servicing EMC Warning This SecondLook system has been tested and found to comply with EN 60601 1 2 Compliance with EN 60601 1 2 shows the system is reasonably protected against harmful interference in a typical medical installation However this system generates uses and can radiate radio frequency energy and if not installed and used in accordance with instructions may cause or be subject to harmful interference with other devices in the vicinity If the SecondLook system appears to cause or be subject to harmful interference try the following steps to correct the problem e Reorient or relocate the SecondLook system or the interfering device e Increase the separation between the SecondLook system and the interfering device e Plug the SecondLook system into an outlet on a different circuit from the interfering device e Contact your authorized SecondLook field service provider for further instructions Uninterruptible Power Supply Warning Persons performing troubleshooting or maintenance on the equipment should be aware and cautioned that the Uninterruptible Power Supply UPS continues to provide electrical energy during power failures and when disconnected from the main power Temperatur
25. ted by SecondLook Digital The absence of a CAD mark at a lesion initially detected without the assistance of SecondLook Digital should not be used by the radiologist to override the decision to further evaluate the lesion SecondLook Digital is designed to mark areas with the mammographic appearance of cancer however many of the marked areas will not contain a malignancy and it is up to the radiologist to decide using conventional clinical judgment and reviewing the mammogram itself if the area is suspicious enough to warrant further work up SecondLook Digital is not a diagnostic device as the CAD marks are intended to be used to assist only in detection and not in interpretation Therefore SecondLook Digital can assist a radiologist in detecting areas of concern that would have been missed without its use but used properly it cannot cause a radiologist to miss areas of concern that would have been detected without SecondLook Digital SecondLook Digital was developed by leaders in the fields of image processing and artificial intelligence Below is a description of how SecondLook Digital s computer aided detection CAD works DTM019 iCAD Inc Page 8 of 24 SLD Siemens Users Manual for Siemens Rev F 1 The Siemens full field digital mammograms are processed by the system Image processing is used to identify all the potential cancerous locations in the image 2 These locations are analyzed using radiologic and
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