平成 23 年度経済産業省委託事業 平成23年度戦略的技術開発委託費
Contents
1. CAD B 3 3 A B 2 O 3 1 5 5 WG 12. CADx CADx 3 1 1 2 1 3
3. 3 7 1 CADx Retrospective Study 2 3 CADx
4. JIRA CADx R gt A CADx X CT MR UCS gt CAD gt CAD A B C B 83 1
5. CADe Computer Aided Detection CADx Computer Aided Diagnosis CADx 2 CADx Computer Aided Diagnosis 3 CADx
6. CADe 2 CADx 30 i SOUP SOUP SOUP
7. amp CAD WG WG WG
8. CAD SE ORMILEBBRLTIS CAD X X CT USI MRI PET CT CAD WG CAD CAD
9. 2 ii i a d a b c d iil 1 a a b 2 d c X 1 ij 2
10. i SOUP SOUP SOUP SOUP 2 4 1 22 2
11. 2 4 1 2 19 3 CADx
12. IEC62304 16 1 2 1 9 16 GHTF 0331012
13. 13 CAD DICOM For processing NNN IHS CT NR SEI oe CAD CAD me E 3
14. CAD 1 2 CAD 3
15. 1 1 GCP Good Clinical Practice GCP 21 4 1 415 14
16. PMDA gt gt 1 4 CADx gt ick CADx nea gt
17. B CAD CAD DB DB DB s DB 10 DB DB DB CAD CAD DB
18. 1 2 w 18 3
19. CAD 2 2 CAD CADe CADx ee 3 CAD 2
20. 3 IEC62304 IEC62304 IEC62304 IEC62304 XXX YYYYYY 1 B SU ALBEE ERAR meld 4 IEC623O4 J 4 1 AAA QMS amp QMS 4 2 BBB RV 5 5 1 planning oe E ee CT Ta La Do ce 514 sm C 1 5 1 5 Tooo a e ae Socom
21. 5 10 3 2 4 EN
22. CADx gt CADx FDA gt gt 2 5 CADx gt DB
23. HR 7 15 4 1 Computer Aided Diagnosis CAD X CAD CAD CAD
24. CADx CADx CADx CADx CADx CADx CADx CADx CADx
25. ee DICOM For processing 3 2 2 CAD CAD
26. 1 3 CADx p lt 0 05 EA ROC ROC Receiver Operating Characteristics ROC LM 1 p lt 0 05 LROC Localized response ROC FROC Free response RO
27. Appendix 4 CADx CADx 2 1 CADx 2 CADx CAD 5 CADx HS CADx 1 2 2
28. ROC 2 ROC Receiver Operating Characteristics ROC multiclass ROC ROC 1 1 2 ROC 23 3 CADx CADx 2 CADx 2 2
29. e CADe CADx Decision Support O FDA CADx I 83 5 SOUP OS MS Word Excel CADx 7 3 6 11 A 3 7 sCADx CADe CADe CADe 3 8
30. 3 2 1 CADx 2 CADx 3 CAD 4 CADx wa 1
31. WG CAD 10 CAD 2 1998 FDA CAD Computer Aided Detection Diagnosis 1 CAD CAD FDA CAD CAD
32. CADx Computer Aided Diagnosis CADx CADx CADx CADx CADx
33. X 1998 computer aided detection diagnosis CAD CAD FDA Food and Drug Administration 10 3800 CAD 1 CAD X CT CT MR MR FDA CAD 3
34. CAD s s B DB CAD 1 DB A DB
35. roo 24 24 DB CADx 2 23 CAD i sam B VJbUr reece eRe C 22 24 CADe OVE SHI HS C 23 CAD COE a ABSE 2 3 4 1 Medical Devices Medical Device Data Systems Docket No FDA 2008 N 0106 URL http www aami org hottopics mdds FDA 2011_02_15_FederalRegister pdf 2 Identifying an MDDS URL http www fda gov MedicalDevices ProductsandMedicalProcedures GeneralHospital DevicesandSupplies MedicalDeviceDataSystems ucm25 1906 htm 3 Qu
36. CAD CPU OS iv we v
37. CAD 3 CADx 5 10 26 11 24 12 22 1 26 2 23 CADx CADe Computer Aided Detection CADx Computer Aided Diagnosis CAD CADe CADx 3 1
38. 24 CADx CPU OS
39. 1 CADx CADx 4 CADx 1 3 CADx
40. 2 34 2 IEC62304 CAD CAD 9 12 IEC62304 IEC62304 IEC62304 IEC62304
41. CA 100 CAD CAD 2009 10 FDA CAD CAD
42. CADx 3 11 12 WG CAD DB a lene Sh Oe eae ae WG 5 2 WG 11 24 16 00 18 00 3 WG 12 22 A 16 30 18 30 3 1 2 2 WG 1 23 11 24 A A 16 00 18 15 2 2 1 23
43. CAD 10 2010 12 CAD 100 2000 1 31 CAD 2007 4 9 CAD 2007 12 4 2010 3 17 ARV 2010 5 21 CAD CAD 2011 3 CAD CAD 3
44. CADx 20 1 CADx 2 1 2 5 RR E EW CE 4 CADx 1 2 CADx 2 ROC Receiver Operatorating Characteristic CADx
45. HS 7 A 3 2 S 3 3 B O 4 CADx D CADx 3 2 3 2 1 MA 7 CAD 12
46. A Appendix O
47. IEC1348 ISO14971 IEC62304 2006 Medical device software Software lifecycle processes IEC TR80002 1 Medical device software Part 1 Guidance on the application of ISO 14971 to medical device software 1 ISO14971 26 4 O GCP 21 3 31 68 O 14
48. 6 3 3 2 1 3 4 1 CADx IEC62304 1
49. 2011 R 4 3 4 4 23 CAD WG 4 1 3 AM RR A HA RAL BA 4 3 4 2 2 5 23 FE CAD WG A sS 2
50. A BRIEC B IEC62304 2 IEC62304 JIS Q 13485 i CAD CADe CADx li CAD fil FAD Focal Asymmetric Density CADe
51. CAD w CADe CADx 8 ii CAD CAD CADx R A 3 2 2011 i 1 CADx or ii 3 CADx
52. TEL FAX 029 861 7840 E Mail human ws m aist go jp
53. CADx IEC62304 Software Of Unknown Provenance off the shelf 25 3 5 CADx IEC 7 i EMC ii ii IEC60950 1 IEC 60601 1 2 ISO 13485 ISO 14971 4
54. SOUP ii FAD CADe CADx iii Bl CADe CADx iv CADe CADx v 4 IEC62304 So
55. ii i Bl i 32 i SOUP ii SOUP
56. 2 3 4 CT 5 6 6 CAD RS 14 3 3 3 CAD CADe Computer Aided Detection
57. gt CADx E 3 4 3 5 3 6 3 7 gt gt gt E gt CADx CADe CADx 2012 1 20 4 WG 24 1 26 3 1 4 4 WG 1 24 1 26 A 17 00 19 20 2 4 1 3 WG R 4 2
58. 3 4 1cm reference standard RS RS gold standard truth CAD RS CAD CAD RS 1
59. CAD CADx CADx CAD CAD
60. e 1207 1 e JIRA PMDA CADx R CADx CADx 1 CAD CAD CAD
61. gt gt Dr Petrick Nick Dr H P Chen gt 3 WG 23 12 22 A 16 00 18 00 gt 4 WG 24 1 3 1 3 3 WG 1 23 12 22 A 16 00 18 15 2 3 1 2 WG 3 2 2011 R 3 3 3 RAL EE RI BAL 4 gt 4 2 CAD
62. i li CAD 5 1 4 CAD IEC62304 2 4 6
63. 17 3 3 1 CADx CADx 2 CADx 7 21 a 1 415 BLT
64. CADx ii 3 1 IEC62304 4 3 a A B C 2 3 CAD 29 iv i li ii
65. e F 3 1 83 2 83 4 A CADx CADx CHS CADx B CADe CADx
66. 2 2 2 2 1 2 1 fil 2 Ste Ooo pe eee 4 1 21 2
67. 1 WG 23 10 26 2 WG 23 11 24 3 WG 23 12 22 4 WG 24 1 26 5 WG 24 2 23 A A kk 1 2 kk 2 3 DA A IO he Ba es oa a a a N EO 3 WG 3 2 3 3 ko PA FDA ZDR Bee CE POO asta ews heated elie Ree cater tae hana macho haa 16 TAYE a A RRR EOIR kk 16 2011 R kk 28 OO 37 a e OAREN E E E T AAT E E E EE EI 40 1 CAD 2 3 4 1960
68. CADx gt C 3 2 gt gt gt D 3 3 gt
69. M IEC62304 Medical device software Software life cycle processes JIS Q 13485 JIS T 14971 33 Appendix 1 122 IEC62304
70. 3 GCP O 80 FO 2 2 3 4 3 O 40 1 5 14 3 O 274 O JISC 60950 1 1 O JIS T 0601 1 2 1 2 JIS Q 13485 JIS T 14971 2010 R 2010 OOOOO
71. 3 1 CADx X X CT MRI CADx 16 CADx CADx
72. sS3 sS4 85 23 B A 11 3 9 10 eo 5 B A 2011 i ii CAD CADe CADx
73. 23 2 3 WG 2 4 3 23 WG en BLIALA
74. 24 2 23 A 10 00 13 00 2 5 1 4 WG R 5 2 2011 R 5 3 1207 1 5 4 5 5 23 FE CAD WG R 3 ZE 4 F DB A CAD s
75. CAD 9 1 IEC62304
76. 1 2 2 WG 11 24 2 3 8 2 4 CADx 2 5 CADx 2 1 21 WG 3 AM RR BG BA 4 gt 2 3 8 4 IT gt
77. CAD 3 2 3 CAD ie aS CAD EE NE IO CAD CT X 2
78. 1 CADe CADx IEC62304 Medical device software Software life cycle processes KU JIS Q 13485 28 2 CAD IEC62304 4 1 CAD CAD
79. 27 2011 R 1 CADe Computer Aided Detection CADx Computer Aided Diagnosis CAD IEC TEC62304 Medical device software Software life cycle processes CAD
80. a12 821 an S2 a an2 n ain az an Sn aint nn S1 aint ain SI1 a21 a2n S1 anit a nn SS a11 ann 2 ii i aii az a S ii i i 1 n ai Si X 1 j 2
81. i ms E 5 2 521 EEE A C 35 4 PC HY CAD QMS ISO1348 JISTO601 1 PC QMS ISO9001 JISC6930 1
82. 36 23 14 CADx CADx 37 1 CAD 2 3 4 38 1 CAD CAD
83. C AFROC Alternative FROC JAFROC Jackknife AFROC CADx 22 ROC CADx RI 1 2 n 1 ail 821 an S a11 an1 2
84. WG 3 1 1 1 WG 1 23 10 26 K 17 00 19 30 2 1 1 WG 1 2 1 3 CAD 1 4 WG 1 5 CADx R 3 weZ EH RI HH eS 4 CADx R
85. ality System QS Regulation Medical Device Good Manufacturing Practices URL http www fda gov MedicalDevices DeviceRegulationandGuidance PostmarketRequi rements QualitySystemsRegulations default htm 4 iEC TC62 Scope URL http www iec ch dyn www f p 103 7 0 FSP_ORG ID FSP LANG ID 1245 25 5 4 1 22 2 2 3 2 3 WG 100 8901 1 3 1 03 3501 1562 FAX 03 3501 0315 URL http www meti go jp T 305 8564 1 1 1
86. ftware Of Unknown Provenance off the shelf 31 vi vii CADe CADx i 2 ii
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