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Clinical Description William Sacks, PhD, MD—ODE/CDRH

R2 Technology, Inc. ImageChecker CT CAD Software System P030012 Radiological Devices Advisory Panel February 3, 2004. Clinical Description William Sacks, PhD, MD—ODE/CDRH. Outline Character of device Clinical utility Instructions for use Issues new to this PMA.

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Clinical Description William Sacks, PhD, MD—ODE/CDRH

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  1. R2 Technology, Inc. ImageChecker CT CAD Software SystemP030012 Radiological Devices Advisory Panel February 3, 2004 Clinical Description William Sacks, PhD, MD—ODE/CDRH Sacks

  2. Outline • Character of device • Clinical utility • Instructions for use • Issues new to this PMA Sacks

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

  4. Computer-Aided Detection(CAD)/Diagnosis(CADx) CAD CADx Sacks

  5. 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 Sacks

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

  7. Issues new to this PMA • CAD target • Definition of “truth” • Unit of analysis • Endpoints Sacks

  8. CAD TARGET • Not malignant nodule • but • Actionable nodule Sacks

  9. DEFINITION OF “TRUTH” • Not biopsy (tissue histology) • but • Expert panel Sacks

  10. UNIT OF ANALYSIS • Statistical unit = person • further broken down into • Lung quadrant Sacks

  11. ENDPOINTS • Sensitivity and specificity (or FPF) of action recommendationand/or ROC Sacks

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

  13. CLINICAL STUDY • Presentation by • Nicholas Petrick, Ph.D. • OST/CDRH Sacks

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