Determining the sample size required to establish whether a medical device is non-inferior to an external benchmark

<strong>Objectives:</strong> The use of benchmarks to assess the performance of implants such as those used in arthroplasty surgery is a widespread practice. It provides surgeons, patients and regulatory authorities with the reassurance that implants used are safe and effective. However,...

Full description

Bibliographic Details
Main Authors: Sayers, A, Crowther, MJ, Judge, AD, Whitehouse, MR, Blom, A
Format: Journal article
Published: BMJ Publishing Group 2017