1. JSM 2011 Good Statistical Practice for Medical Device Trial Submission Huyuan Yang † , Matthew Rousseau* , H. Terry Liao * P , and Peter Lam* † Millennium Pharmaceutical * Boston Scientific Corporation P Presenter The view points of this presentation are from the authors and not from the companies we represent

6. Estimate Sample Size Range JSM 2011 N per group using a 2-sided 5% alpha and 90% power Test Rate Control Rate 10% 10.25% 10.5% 10.75% 11% 5% 582 535 495 460 428 5.25% 654 599 552 510 473 5.5% 740 674 617 568 524 5.75% 842 762 694 635 583 6% 965 867 784 713 652

7. Estimate Power Range JSM 2011 Assessing power using a fixed N of 617/group Test Rate Control Rate 10% 10.25% 10.5% 10.75% 11% 5% 91% 93% 95% 96% 97% 5.25% 89% 90% 92% 94% 95% 5.5% 84% 87% 90% 92% 94% 5.75% 79% 83% 86% 89% 91% 6% 73% 78% 82% 85% 88%

9. Estimate Power Range JSM 2011 Assessing power using a fixed N of 592 per group with a NI margin of 7.5% Control Rate Test Rate 24% 25% 26% 27% 28% 24% 91% 83% 70% 55% 39% 25% 96% 90% 82% 69% 54% 26% 98% 95% 90% 81% 68% 27% 99% 98% 95% 89% 80% 28% 99% 99% 97% 94% 89%