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Clinical Evaluation of ImageChecker CT CAD Software for Lung Nodule Detection

The ImageChecker CT Computer-Aided Detection (CAD) software system, presented by William Sacks, PhD, MD, is designed to assist in the detection of solid lung nodules in chest CT scans. It aims to enhance clinical sensitivity by marking candidate nodules for review after an initial unaided assessment by radiologists. This PMA outlines the clinical utility, operational instructions, and key issues surrounding the software, including definitions of actionable nodules, sensitivity, specificity, and endpoint assessments based on expert panel evaluations.

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Clinical Evaluation of ImageChecker CT CAD Software for Lung Nodule Detection

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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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