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2/3/04Sacks1 Clinical Description William Sacks, PhD, MD—ODE/CDRH Clinical Description William Sacks, PhD, MD—ODE/CDRH R2 Technology, Inc. ImageChecker.

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Presentation on theme: "2/3/04Sacks1 Clinical Description William Sacks, PhD, MD—ODE/CDRH Clinical Description William Sacks, PhD, MD—ODE/CDRH R2 Technology, Inc. ImageChecker."— Presentation transcript:

1 2/3/04Sacks1 Clinical Description William Sacks, PhD, MD—ODE/CDRH Clinical Description William Sacks, PhD, MD—ODE/CDRH R2 Technology, Inc. ImageChecker CT CAD Software System P030012 ImageChecker CT CAD Software System P030012 Radiological Devices Advisory Panel February 3, 2004 R2 Technology, Inc. ImageChecker CT CAD Software System P030012 ImageChecker CT CAD Software System P030012 Radiological Devices Advisory Panel February 3, 2004

2 2/3/04Sacks2 Outline Outline Character of device Clinical utility Instructions for use Issues new to this PMA Outline Outline Character of device Clinical utility Instructions for use Issues new to this PMA

3 2/3/04Sacks3 Character of device Character of device For chest CT scans For chest CT scans For CTs done for any indication For CTs done for any indication Detects solid lung nodules Detects solid lung nodules  E.g., not ground glass opacities ( GGOs) Nodules between 4-30 mm Nodules between 4-30 mm Computer-Aided Detection (CAD) Computer-Aided Detection (CAD) Character of device Character of device For chest CT scans For chest CT scans For CTs done for any indication For CTs done for any indication Detects solid lung nodules Detects solid lung nodules  E.g., not ground glass opacities ( GGOs) Nodules between 4-30 mm Nodules between 4-30 mm Computer-Aided Detection (CAD) Computer-Aided Detection (CAD)

4 2/3/04Sacks4 Computer-Aided Detection(CAD)/Diagnosis(CADx) CAD CADx DetectionDiscrimination Scans entire image Scans only portion selected by user Marks images Gives level of suspicion

5 2/3/04Sacks5 Clinical Utility Clinical Utility Many nodules missed in clinical practice:  other pathology distracts  hundreds of images per exam CAD intended to reduce missed nodules; i.e., intended to increase user’s SENSITIVITY to detecting lung nodules CAD intended to reduce missed nodules; i.e., intended to increase user’s SENSITIVITY to detecting lung nodules Clinical Utility Clinical Utility Many nodules missed in clinical practice:  other pathology distracts  hundreds of images per exam CAD intended to reduce missed nodules; i.e., intended to increase user’s SENSITIVITY to detecting lung nodules CAD intended to reduce missed nodules; i.e., intended to increase user’s SENSITIVITY to detecting lung nodules

6 2/3/04Sacks6 Instructions for Use Instructions for Use Reader reviews films unaided first Reader reviews films unaided first CAD marks candidate nodules CAD marks candidate nodules Reader looks again in vicinity of marks Reader looks again in vicinity of marks If CAD fails to mark a nodule judged actionable on unaided review, reader should retain initial judgment If CAD fails to mark a nodule judged actionable on unaided review, reader should retain initial judgment Instructions for Use Instructions for Use Reader reviews films unaided first Reader reviews films unaided first CAD marks candidate nodules CAD marks candidate nodules Reader looks again in vicinity of marks Reader looks again in vicinity of marks If CAD fails to mark a nodule judged actionable on unaided review, reader should retain initial judgment If CAD fails to mark a nodule judged actionable on unaided review, reader should retain initial judgment

7 2/3/04Sacks7 Issues new to this PMA CAD target Definition of “truth” Definition of “truth” Unit of analysis Unit of analysis Endpoints Endpoints Issues new to this PMA CAD target Definition of “truth” Definition of “truth” Unit of analysis Unit of analysis Endpoints Endpoints

8 2/3/04Sacks8 CAD TARGET Not malignant nodule but Actionable nodule CAD TARGET Not malignant nodule but Actionable nodule

9 2/3/04Sacks9 DEFINITION OF “TRUTH” Not biopsy (tissue histology) but Expert panel DEFINITION OF “TRUTH” Not biopsy (tissue histology) but Expert panel

10 2/3/04Sacks10 UNIT OF ANALYSIS UNIT OF ANALYSIS Statistical unit = person further broken down into Lung quadrant UNIT OF ANALYSIS UNIT OF ANALYSIS Statistical unit = person further broken down into Lung quadrant

11 2/3/04Sacks11 ENDPOINTS ENDPOINTS Sensitivity and specificity (or FPF) of action recommendation and/or ENDPOINTS ENDPOINTS Sensitivity and specificity (or FPF) of action recommendation and/or ROC

12 2/3/04Sacks12 CLINICAL STUDY 3 expert radiologists on panel to determine “truth” for each nodule 15 other radiologists with range of experience, called “the readers” 15 other radiologists with range of experience, called “the readers” 90 subjects ( 360 lung quadrants) 90 subjects ( 360 lung quadrants) 15 readers used 100-point scale for confidence-in-actionability of each case 15 readers used 100-point scale for confidence-in-actionability of each case CLINICAL STUDY 3 expert radiologists on panel to determine “truth” for each nodule 15 other radiologists with range of experience, called “the readers” 15 other radiologists with range of experience, called “the readers” 90 subjects ( 360 lung quadrants) 90 subjects ( 360 lung quadrants) 15 readers used 100-point scale for confidence-in-actionability of each case 15 readers used 100-point scale for confidence-in-actionability of each case

13 2/3/04Sacks13 CLINICAL STUDY Presentation by Nicholas Petrick, Ph.D. OST/CDRH CLINICAL STUDY Presentation by Nicholas Petrick, Ph.D. OST/CDRH

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