Superiority study

A superiority claim needs a study designed and powered for it, and failing to show superiority does not prove the devices are equivalent. When the aim is to show the device is not unacceptably worse, a non-inferiority design is used instead.

Study designed to demonstrate that the safety or effectiveness of the investigational device is superior to that of the comparator.

FDA guidance: Design Considerations for Pivotal Clinical Investigations for Medical Devices (November 2013), Section 11, Glossary