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