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34 * ! Mon, 8/3/2020, 10:00 AM - 11:50 AM Virtual
Current and Future Challenges in Diagnostic Device Evaluation — Topic Contributed Papers
Section on Medical Devices and Diagnostics
Organizer(s): Bipasa Biswas, Center for Devices and Radiological Health, FDA; Manasi Sheth, Food and Drug Administration
Chair(s): Chava Zibman, Food and Drug Administration
10:05 AM Proper and Improper Summary Measures of Classification Performance
Andriy Bandos, University of Pittsburgh
10:25 AM Comparative Evaluations of Diagnostic Tests in Studies with Extreme Verification Bias
Gene Pennello, Food and Drug Administration; Qin Li, Food and Drug Administration
10:45 AM Statistical Considerations in Artificial Intelligence Related Diagnostic Devices
Manasi Sheth, Food and Drug Administration; Daniel Erchul, Food and Drug Administration
11:05 AM Artificial Intelligence for Risk Prediction and/or Stratification
Bipasa Biswas, Center for Devices and Radiological Health, FDA
11:25 AM Designing Studies of Tests for Biomarkers Using Banked Specimens
Alicia Toledano, Biostatistics Consulting, LLC
11:45 AM Floor Discussion