Technical Assessment
Contents
1. Change viewing direction of shown 1 image set e g to View from Head On selection the Image Set Information under the images shows changes parameters for Orientation e g L PF gt R P in red and for Viewing direction here inverted in red Press button under media tree Confirm image set parameters in dialog with OK Click directly on 2 image set in media content tree for selection and preview Change viewing direction of shown 2 image set e g to View from Head On selection the Image Set Information under the images shows changes parameters for Orientation e g L PF gt R P in red but for Viewing direction the parameter remains as is This indicates that the viewing direction change has NOT been processed correctly for the an image set Press Import button under media tree Confirm image set parameters in dialog with OK stryker Image Set Information 4 T2 AX 3D 320 x 316 0 665rmm Image Set Information Series No 5 Description Orientation FE3D AXI as is as is tay Aaah Ps 0 430mm The image orientation of the 2 image set has not been changed correctly as required for a viewing direction change it has been stored on disk with wrong image orientation labels and will be loaded flipped as soon as it is loaded from disk again e g after application restart If the sequence above is repeated the image orientation of e2. Protocol refer to 3 lists safety measures including a Verify image orientation and scan quality no motion artifacts b Safety Information refer to 1 2 contains In order to prevent the import of mirrored images we recommend to mark the patient s right side on the acquired images 2 Image Import same task page in all products under examination a Safety Information refer to 1 2 Check the orientation of the patient with respect to the images Verify that the orientation labels L Left R Right A Anterior P Posterior H Head F Feet within the system are correct b System to show image set information multi planar reconstruction and 3D visualization during image import INQF 11 1 Rev None Effective August 1 2008 Page 9 of 14 stryker Technical Assessment c System to report changed image parameters e g Orientation Viewing direction in red on image set status information d System to ask for confirmation of image parameters that have been changed import dialog summary 3 Image correlation a Safety Information refer to 1 2 When using image set correlation ensure and confirm that the image sets are correlated correctly and accurately with each other For navigation accuracy visually verify the accuracy of the image correlation by using well known landmarks and the image fusion function b Safety Information refer to 1 2 Note that navigation on correlated i
3. potential harm of the identified limitations listed above the applications built in and described safety measures have been reviewed All hazardous situations are mitigated by safety measures Every image set correlation must be confirmed by the user check box to be active for navigational use Prior to navigation the registration step prompts the user to touch well known landmarks for accuracy confirmation According to the safety instructions refer to 1 2 the user is required to perform landmark checks by comparing the visualization of the actual tool tip relative to the patient s anatomy on the screen INQF 11 1 Rev None Effective August 1 2008 Page 5 of 14 stryker Technical Assessment The hazardous situations and the potential harms are summarized in the table below Precondition Two image set are imported consecutively For both image sets the viewing direction is changed by the user Surgeon plans to register on the 1 image set and to navigate on the 2 image set Hazardous situation 1 Navigation is to be used for intra medullary tumor removal located asymmetric in the spinal cord A confirmed correlation between the first and second image set is available and the surgeon switches to the 2 image set after registration of the 1 image set The system will show the mirrored image data of the 2 set because the application has been restarted Hazardous situation 2 Navigation is to be used for pe
4. registration accuracy b Use of intra operative 3D C arm scan function for navigation c Use of intra operative ultrasound for spinal cord tumor tissue localization If the information of the 2 set is missing for navigation a surgeon can use an intra operative C arm for guidance on bony structures or an intra operative ultrasound imaging device for soft tissue guidance refer to 7 4 User Awareness Is the discrepancy obvious to the user Surgical navigation is used in the OR to execute a treatment plan that is result of surgical planning Surgical planning starts with conventional diagnostic imaging to diagnose the patient a The human spine or bones are rarely 100 symmetric and navigation displays and quantifies asymmetries INQF 11 1 Rev None Effective August 1 2008 Page 10 of 14 stryker Technical Assessment b During image correlation the system makes use of overlay colors to help in judging correlation accuracy The system requires a checked Confirmed box to accept and use an image correlation for planning and navigation c Registration patient fixation and patient tracking are critical for navigation accuracy Therefore landmark checks during surgery and prior to use of navigational information are routinely applied d For lateral lesions patient positioning is optimized based on the diagnosis Any deviation to the other side if indicated by navigation would raise concerns regarding navigation data integrit
5. set because the application has been restarted ere Navigation is to be used Opening of the pedicle at the Lei Faas for pedicle screw treatment site might take longer Two image including image placement The because the navigational Seis are eorr lation andis correlation accuracy information does not match the imported restarted prior to confirmation and the z anatomical and tactile feedback consecutively the navigated landmark check on the 2 during surgery The surgeon while tae both teatment image set are accepted realizes the mismatch and 2 seis the Registration ig because the displayed 23 continues treatment of the viewing performed on 1 anatomical position is correct side using the first direction is image set rated accurate The image set or the re imported changed by navigation is surgeon starts locating the second image set or C arm Gas went performed on treatment site based on vision to finish the required i correlated 2 the flipped anatomical treatment This may result in an image set information of the 2 OR time extension of less than image set 30 minutes Two image The application is The image correlation The surgeon does not accept sets are used for planning uses the stored orientation the automatic correlation result 3 imported including image labels from the 2nd image 31 and uses manual or no consecutively correlation and is set on disk and tries to correlation Therefore the while for both restarted prior to correlate the 1st
6. the 2 image set gets loaded with the wrong orientation labels resulting in a mirrored visualization Since sections of the spinal column are curved the image correlation of the non mirrored and mirrored dataset looks obviously wrong refer to Figure 3 amp smwer Leene Age oooy ay 2 X Patient 3 Planning 4 Registration Planning CTM Recon 3 L Spine CT02 Recon 3 L Spine Image Correlations D A Screws m amp Annotation Points Screenshots eate v D image Corretation Eul automatis matching andma 7 7 Identity matching indrect comelation Mult Planar Image Set CTOT Curent 2082 16 56 21 00 Figure 3 Image correlation view after restart of the application using the correlation result that has been calculated after image import prior to the restart of the application Since the a image set is now mirrored the curvature of the spine obviously does not fit to the 1 image set anymore If a confirmed correlation between the first and second image set is available and if the surgeon switches to the 2 image set after registration of the 1 image set the system will show the mirrored image data of the 2 set if the application has been restarted Since the spinal column is rarely exactly centered and aligned in the scanned volume and due to the curvature of the spine the mirrored 2 image set deviates significantly from the correlated 1 image set In these cases navigation can not be used on t
7. a deviation from the initial surgical plan because the 2 image set information can not be used for navigation 1 1 2 1 3 1 Harm Identification Table Complete the Harm Identification Table below for the event issue being analyzed Describe The Hazard i e the potential source of harm created by the issue event non conformance Note For all hazardous situations all potential harms shall be identified and described For each Hazard the corresponding Foreseeable sequence of events i e circumstance which leads the Hazard to become a Hazardous situation For each Hazard the corresponding Hazardous situations i e circumstance in which people property or the environment are exposed to one or more hazard s INQF 11 1 Rev None Effective August 1 2008 Page 6 of 14 Technical Assessment stryker All Potential Harms i e physical injury or damage to the health of people or damage to property or the environment Each potential harm is numbered to correspond to the related hazard For example hazard 1 may have three harms which would be numbered as 1 1 1 2 and 1 3 Refer to Appendix A in INQP 11 Health Hazard procedure for an example Harm Identification Table When completing the HIT the following tips may be useful a Remember that one hazard can result in more than one harm and that more than one sequence of events can give rise to a hazardous situation Be sure to discuss
8. all possible hazardous situations and harms that can result from a hazard b Refer to ISO 14971 Annex D Risk concepts applied to medical devices to provide additional guidance on overall risk management concepts and additional information that will help complete the table c Refer to ISO 14971 Annex E Examples of hazards foreseeable sequences of events and hazardous situations for additional information Harm Identification Table HIT Hazard Hazard Foreseeable Nbr Description sequence of Hazardous situation Potential Harm s events Navigation is to be used The application is for intra medullary tumor used for planning removal located Two image including image asymmetric in the spinal sets are correlation and is cord A confirmed Ii ail lei image imported restarted prior to correlation between the set e g MRI series to open consecutively the navigated first and second image set gone y f the wrong side of the spinal 1 while for both treatment is available and the 4 4 card inorder to remove an sets the Registration is surgeon switches to the i intramedullary tumor The viewing performed on 1 2nd image set after hie adi idr Mei ea direction is image set registration of the 1st eg the cut causes a potentiall changed by navigation is image set The system will irreversible neurological lee the user performed on show the mirrored image i correlated 2 data of the 2nd set image
9. and diameter Image based annotation point placement and visualization e g to support repositioning of bony anatomic points during surgery Surgical Navigation Procedures Intra operative visualization of volume image data including visualization of pre planned volumes of interest relative to the tracked instrument supporting navigated excision of user defined bony structures Intra operative visualization of resection planes relative to the tracked instrument on bony structures assisting bony resections Intra operative creation and visualization of annotation points supporting recording of landmarks on bony anatomy e g to assist oncology replacement prosthesis repositioning leg length and rotation assessment or navigated implant placement Navigated intra operative screw placement based on pre planned or intra operative virtual screw definition Neither the SpineMap 3D nor the OrthoMap 3D Navigation system does sustain or support life The Planning versions of the affected products listed above are considered as potentially being part of the chain of events but since these products are not used for treatment in the OR any potential harm can only occur while using the Navigation applications in the OR INQF 11 1 Rev None Effective August 1 2008 Page 2 of 14 stryker Technical Assessment a Technical Assessment of Risk to Health List and describe all the known or foreseeable hazards to the patient or us
10. atient s bony anatomy under treatment is highly symmetric Incorrect or inaccurate image correlation during navigation is rated severe in the current risk analysis refer to Risk Analysis Project 10326 Restoration Rev H Do any of the affected products Risk Management documents require updating If so add the necessary update to the existing CAPA related to the issue non conformance to ensure it is tracked to completion Yes the risk analysis documents of the products under examination have to be updated 3 Risk Mitigation Factors Are there any design or process factors that might mitigate risk Are there specific factors that could contribute to the risk Surgical navigation accuracy depends on several factors that are potentially prone to human error Starting with patient preparation and image data acquisition in radiology patient positioning and fixation in the OR and finally the surgeon using the navigation system for planning and navigation each step will contribute to the final accuracy reached during patient treatment Knowing this the system has been designed with built in status displays and confirmation steps that help to detect potential accuracy issues Furthermore safety information refer to 1 2 and imaging protocols refer to 3 are shipped with each product to guide the user to avoid safety issues 1 Patient preparation and image acquisition process creation of the patient s image data Imaging
11. d order during the import of two image sets consecutively changes the image orientation of the second image set The issue does NOT occur if 1 Only one image set is used OR the viewing direction is kept unchanged OR multiple image sets are imported in separate sessions OR the viewing direction is only changed for the 1 image set OR the viewing direction is only changed for the 2 image set OR oar wh any other image set is selected for preview prior to the viewing direction change and import of a an image set Image Set Task Page Viewing Home 1 Image Sets i direction selection View from feet xz Select media Browse STRYKER L SPINE 7 ws BSIRY KER LESPINE W y Date Images Description Zoom E y EA ic STRYKER L SPINE Age 000Y b Selected image set Axial CT 01 Zoom 120 Media content tree Import ination for impo 3 STRYKER L SPINE Age OO0Y Patient Image Set List LightSpeed16 E CT01 Recon 3 L S E CT02 Recon 3 LS 0 264mm Image Set cTot Current 8 00 28 00 21 97 INQF 11 1 Rev None Effective August 1 2008 Page 13 of 14 Technical Assessment Sequence of events that will lead to the observed event Import of 2 image sets during one session Startup of software package create a new patient or select an existing patient record Change to Image Set task page and select click on media content tree for preview 1 image set from On Image Set task page
12. dicle screw placement A confirmed correlation between the first and second image set is available and the surgeon switches to the 2 image set after registration of the 1 image set The system will show the mirrored image data of the 2 set because the application has been restarted Hazardous situation 3 The image correlation uses the stored orientation labels from the 2 image set on disk and tries to correlate the 1 image set to the mirrored 2 image set Based on the asymmetry of the spine the orientation error leads to a bad correlation result refer to Figure 3 after application restart Potential harm 1 The surgeon uses the information of the 2 image set e g MRI series to open the wrong side of the spinal cord in order to remove an intra medullary tumor The tumor is not found on that side but the cut causes a potentially irreversible neurological deficit refer to 7 Potential harm 2 Opening of the pedicle at the treatment site might take longer because the navigational information does not match the anatomical and tactile feedback during surgery The surgeon realizes the mismatch and continues treatment of the correct side using the first image set or the re imported second image set or C arm vision to finish the required treatment Potential harm 3 The surgeon does not accept the automatic correlation result and uses manual or no correlation Therefore the situation might cause
13. equiring requiring medical ea erie oe E im customer medical or surgical intervention not impair any bodily function i i fan rson intervention of any perso INQF 11 1 Rev None Effective August 1 2008 Page 8 of 14 stryker Technical Assessment 2 Review of Risk Management Plan Was this Hazard Harm identified in the original Design or Process Risk Analysis and if so what was the likelihood and severity Image orientation No the situation is not covered in the current risk assessment In the systemic error under examination the first image set is always orientated correctly while the issue can only occur if a second image set is used The risk assessment covers only image orientation errors which are related to image data acquired with a wrong orientation by the radiology department and loaded into the system Using images with wrong image file parameters like pixel size slice position or image orientation during navigation is rated severe in the current risk analysis refer to Risk Analysis Project 10326 Restoration Rev H Image correlation No the situation is not covered in the current risk assessment The risk assessment for the image correlation function assumes correlation of correctly oriented image set In the worst case scenario under examination a successful image correlation of the first and second image set can only be performed and accidentally confirmed to be accurate if the p
14. er that may result from the identified discrepancy attaching supporting testing technical reports complaint analysis etc When ever possible discuss the probability of occurrence for each Hazard and resulting Harm providing objective evidence to support conclusions A reported event occurred with the iNtellect Cranial Software 6000 651 000 used for neurosurgery refer to 6 Because the SpineMap 3D and OrthoMap 3D Software package contain the same affected function and were built on the same software code base this technical assessment is performed Initial investigation showed that the symptoms as described in the reported event are based on a systematic software issue The issue can only occur when importing a minimum of two patient image sets into the navigation system consecutively and changing the viewing direction of each imported set If the user imports two image sets consecutively and changes the viewing direction for both the bug only occurs for the 2nd image set Instead of changing the viewing direction of the 2 image set the application accidentally mirrors the i image set and stores the mirrored volume on disk The image set orientation of the 2 image set remains correct in system memory until the application is restarted and the data is read from disk refer to Attachment A for detailed description of the work flow Two limitations have been identified to be significant if this error scenario occurs 1 During plannin
15. es and long bones INQF 11 1 Rev None Effective August 1 2008 Page 1 of 14 stryker Technical Assessment Stryker Navigation System OrthoMap 3D Module Intended Use The Stryker Navigation System OrthoMap 3D Module is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery The system is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate The system can be used for intra operative guidance where a reference to a rigid anatomical structure can be identified Indications for Use The system should be operated only by trained personnel such as surgeons and clinic staff The Stryker Navigation System OrthoMap 3D Module supports but is not limited to the following surgical procedures Orthopedic Oncology Procedures Surgical Planning Procedures Segmentation to define volumes of interest using correlated multi modality image data e g to assist outlining and visualizing bony structures such as aberrant pathology Image based distance and angular measurement tools e g to define and maintain safety margins to outlined bony structures e Image based resection plane planning to define resections relative to identified structures e g to support limb salvage surgery taking safety margins into account Virtual screw placement planning in the image data with variable screw length head length
16. g the image correlation function used to overlay two image sets automatically for image fusion is affected if the bug occurs even if the application has not been restarted Since the image correlation uses the stored orientation labels from the 2 image set on disk the image correlation tries to correlate the 1 image set to the mirrored 2 image set If the imaged section of the spine is highly symmetric and the section is in the center and well aligned within the image volume the automatic correlation might match the image sets accurately For spinal structure this scenario is negligible Especially the curvature of the spine makes the mirrored spine look obviously different compared or overlaid on the non mirrored counterpart A close look to the matching result shown on the right Figure 1 shows that the Figure 1 mirrored red bony structure of a lumbar spine does not really match original image green The Automatic correlation of a lumbar spine CT 3D and also the sectional images show a segment L1 L5 with its mirrored CT segment significant deviation refer to Figure 2 This is a same image set correlation result that would not be confirmed by a surgeon to be accurate Figure 2 A closer look to the result identifies significant deviations The spinal processes do not match at all INQF 11 1 Rev None Effective August 1 2008 Page 3 of 14 stryker Technical Assessment 2 Ifthe application is restarted
17. he 2 image set For spinal and orthopedic oncology navigation the likelihood of occurrence of the upper described limitations is rated negligible because 1 For pedicle screw placement which is the primary application of the spinal navigation system there is no medical indication to use multiple image sets The bony structures of the vertebra to be treated show up well in a single CT scan For tumor treatments e g intra medullary tumors of the spinal cord and other orthopedic oncology procedures the use of a second MRI series to also show the oncological soft tissue situation is feasible The intended use of the oncology application limits the navigational use to rigid bony structures INQF 11 1 Rev None Effective August 1 2008 Page 4 of 14 stryker Technical Assessment 2 For both applications there is no medical indication or need to change the viewing direction of the image data since the surgeons viewing direction during treatment is from the patient s side The Spine and OrthoMap 3D software inherited the functionality to import multiple set and to change the viewing direction from the Neuro software package these image based packages are built on the same software code base For orthopedic surgery this functionality is not used since the standard default viewing direction for radiology acquisition of images and for the orthopedic and spine surgeon to view the patient is view from feet refer to Figure 4 Neu
18. image set situation might cause a sets the the navigated to the mirrored 2nd image deviation from the initial INQF 11 1 Rev None Effective August 1 2008 Page 7 of 14 stryker Technical Assessment viewing treatment set Based on the surgical plan because the 2nd direction is asymmetry of the spine image set information can not changed by the orientation error leads be used for navigation This the user to a bad correlation result may result in an OR time refer to Figure 2 after extension of less than 30 application restart minutes Note Depending on the number of Hazards and or Potential Harms identified the initiating site may need to add additional rows to the above table Since there is no medical indication in pedicle screw placement procedures to use multiple image sets and there is no medical indication to change the viewing direction in any spinal and orthopedic oncology applications the likelihood that this issue will occur in spinal or orthopedic oncology surgery is negligible refer also to 7 Based on an analysis of all received complaints for the SpineMap 3D and OrthoMap 3D product as of today there has been no reported issue that relates to the systemic error described Therefore the likelihood of the related hazardous situations is estimated to be negligible even if the product is not contained b Harm Analysis Tool Estimate the likelihood and severity of each of the above Har
19. mage sets adds the possible correlation error to the registration error c If two uncorrelated image sets are available while entering the planning page the system automatically pops up the image correlation dialog d The system requires confirmation of the correlated image set pairs before it can be used for visualization e g during planning and navigation 4 Registration planning a Safety Information refer to 1 2 For adequate registration ensure that the reference points are distributed asymmetrically on anatomically distinctive areas including points close to the target of the surgery Avoid symmetrical distributions like lines circles or cylinders Select points on rigid connected structures only If there is a moveable joint or a fracture select the reference points on the side where the patient tracker will be fixed We recommend to use a minimum of at least four reference points 5 Registration a Safety Information refer to 1 2 Use well known landmarks touch them on the patient and check their match on the displayed images Adequate registration results are required for navigation accuracy during surgery b Touch well known landmarks to verify registration accuracy and compare them with the displayed images Registration confirmation step 6 Navigation a Safety Information refer to 1 2 After registration perform continuous landmark reassessment periodically during the surgery to verify the
20. ms identified in the Harm Identification Tool and plot them on the Harm Analysis Tool risk table below Refer to ISO 14971 Annex D Risk concepts applied to medical devices to provide additional guidance on overall risk management concepts and additional information that will help complete the table For any conclusions drawn from the Harm Analysis Tool provide relevant back up data to support your conclusions Attach extra pages or reference other reports by formal report names numbers Refer to Appendix B in INQP 11 Health Hazard procedure for an example Hazard Analysis Tool Harm Analysis Tool HAT Refer to Appendix B of INQP 11 for Completion Instructions Intolerable As low as reasonably possible Acceptable Severity Ratings 3 Likelihood Probability Reference Reference ii Definition Negligible Moderate Serious Severe Occurrence 2 High almost inevitable Occurrence 4 Moderate likely Occurrence 3 a possible Occurrence unlikely 2 Remote Product 1 Negligible contained Serious Severe Negligible Minimal Moderate Any failure Any failure Se a A Anytalre suing Any tale ae ea resulting in no transient self resulting in or damage ia a j r Sas injury example limiting illness or reversible injuries fad oak annoyance to the injury not r
21. nt necessary Yes or No YES refer to 7 f Yes Arrange for completion of Medical Assessment form CQF PMS 002 01 B f No provide rationale INQF 11 1 Rev None Effective August 1 2008 Page 11 of 14 stryker Technical Assessment 7 References 1 Safety Information SpineMap 3D Navigation TD6002650700 Rev B 2 Safety Information OrthoMap 3D Navigation TD6005650700 Rev D 3 CT MRI Imaging Protocol SpineMap amp OrthoMap 3D Navigation 6002 650 730 Rev F 4 User Manual SpineMap 3D Navigation TD6002650740 Rev C PDF part of software 5 User Manual OrthoMap 3D Navigation TD6005650740 Rev B PDF part of software 6 Technical Assessment Cranial HHA 10 021 RARE 2010 187 7 Medical Opinion 09 29 2010 _CQF PMS 002 01 B Medical Assesement_Dr_Hubbe_Spine pdf 8 Review Complete and Approve Technical Assessment Prepared by P Signature OA y Date November 3 2010 INQF 11 1 Rev None Effective August 1 2008 Page 12 of 14 stryker Technical Assessment Attachment A The software packages under examination make use of 3D medical T data CT MR etc that is loaded into the software during an import step on the Image Sets task page The software offers an optional feature to change the viewing direction on the images based on user preference either to view from head or view from feet It was observed that changing the viewing direction twice in a well define
22. rosurgeon s Point of View Spine Surgeon s Point of View Radiology Point of View Spine Surgeon s Point of View Figure 4 For orthopedic applications like spine and orthopedic oncology surgery the surgeon is either on the patient s left or right side In contrast to the neurosurgeon there is no reason for the orthopedic surgeon to change the standard viewing direction which is View from feet The Spine and OrthoMap 3D applications can be extended by license to integrate with a C arm providing 3D volumetric image data intra operatively The integration of a 3D C arm includes an automatic transfer of the acquired 3D volume via network using the DICOM standard The image transfer is triggered automatically by the system and the user has no options to change the orientation of the incoming data Therefore the reported issue does not affect navigation based on intra operative 3D C arm data For orthopedic applications the use of a 2D c arm to determine e g the correct surgical level spine or location oncology is commonly used and mitigates the risk if navigational guidance appears inaccurate or can not be used The intra operative use of C arms allows the surgeon to visualize the surgical instrument s position relative to the patient s bony anatomy intermittently and in real time single shot and fluoroscopy mode Therefore the use of a C arm can be used as an alternative guidance if navigation can not be used To rate the
23. stryker Technical Assessment HHA Number HHA 10 027 RARE Number 2010 214 Technical Assessment Name Viewing Direction Change using Multiple Image Sets Part Number Product family SpineMap 3D Version 1 0 Products 6002 650 000 100 300 005 6002 651 000 81 80045 OrthoMap 3D Version 1 0 Products 6005 650 000 300 005 6005 651 000 81 80044 PER Number s 201475 Requestor E Boettger Investigator s U Buhner 1 Product Overview Provide a brief synopsis of the device and its intended use including indications for use e g patient population and whether the device sustains or supports life Stryker Navigation System SpineMap 3D Module Intended Use The Stryker Navigation System SpineMap 3D is intended as a planning and intra operative guidance system to enable open or percutaneous computer assisted surgery The system is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate The system can be used for intra operative guidance where a reference to a rigid anatomical structure can be identified Indications for Use The Stryker Navigation system Spine Map 3D supports but is not limited to the following surgical procedures e Pedicle screw placement e Navigation e Precisely positioning instruments or implants during orthopedic surgery such as operations performed with spinal structure hip and bones in the upper and lower extremiti
24. very second image set would be affected INQF 11 1 Rev None Effective August 1 2008 Page 14 of 14
25. y 5 Impact During Surgery What might the surgeon do if the hazardous situation occurs during surgery NOTE If answer is not known for this question obtain a Medical Assessment 1 For treatment of bony structures surgeon uses conventional surgery including 2D 3D C arm guidance if patient cannot be treated using navigation refer to 7 2 For localization of intra medullary tumors intra operative ultrasound is used instead of navigation refer to 7 Lesion side is marked in OR plan usage of direct pre surgical timeout refer to 7 If the user can not find a lesion on the shown side the user would reconfirm the correct side either using pre operative or intra operative images ultrasound Using this correct information the operation is finished on the correct side refer to 7 6 Medical Assessment Medical Assessments shall be obtained if any of the following conditions exist a The initiating site determines that no Product Field Action is required b The Product Field Action is determined to be non reportable to the site s home Regulatory Agency An initiating site should also consider obtaining a Medical Assessment when the following situations exist c When evaluating potential hazards for the first time d To assist in risk vs benefits analyses Do the results of the Medical Assessment require an update to Technical Assessment f Yes Update Technical Assessment form accordingly Is a Medical Assessme
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