Outline: The purpose of this one-day short course is to provide a comprehensive account of statistical methods for design and analysis of therapeutic and diagnostic medical devices, including sample size calculations, estimation of the clinical performance of a medical device, comparison of clinical performance of competing medical devices, and regression analysis of medical device data. Additionally, some recently developed methods for correction of verification bias and imperfect reference bias methods will be discussed.

Part of this short course will be based on the one instructor's textbook entitled ''Statistical Methods in Diagnostic Medicine'', Second Edition, 2012 (Wiley & Sons).

The following topics will be covered in the course:

1. Introduction to Medical Devices—Definition and the World of Medical Devices (GC and AZ)

2. Development of Medical Devices (GC)

3. Types of Studies to Demonstrate a Device is Safe and Effective (GC)

4. Pivotal Clinical Study Design and Sample Size Calculation for Non-Diagnostic Devices (GC)

5. Regulation of Medical Devices (GC)

6. Pivotal Clinical Study Design for Diagnostic Devices (GC)

7. Measures of the Accuracy of Diagnostic Tests (AZ)

8. Design and Sample Size Calculation of Diagnostic Accuracy Studies (AZ)

9. Estimation and Comparison of Relative Diagnostic Accuracy in Two-samples (AZ)

10. Regression Analysis of ROC curves (AZ)

11. Methods for Correcting Verification Bias (AZ)

12. Methods for Correcting Imperfect Gold Standard Bias (AZ)

13. Multi-reader Multi-case Studies (MRMC) (AZ)

14. Innovative Statistical Issues and Examples of Recent Diagnostic Medical Devices (GC)