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

ABSTRACT:

Objectives

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, it is not currently clear how or how many implants should be statistically compared with a benchmark to assess whether or not that implant is superior, equivalent, non-inferior or inferior to the performance benchmark of interest.We aim to describe the methods and sample size required to conduct a one-sample non-inferiority study of a medical device for the purposes of benchmarking.

Design

Simulation study.

Setting

Simulation study of a national register of medical devices.

Methods

We simulated

SUBMITTER: Sayers A 

PROVIDER: S-EPMC5652499 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature