Performance goal

A performance goal is used for single-arm studies when a concurrent control is not practical. It is less established than an objective performance criterion and needs to be justified and agreed with FDA, often through a Pre-Submission.

A numerical value that is considered sufficient by FDA for use as a comparison of the pivotal study results with a safety endpoint, an effectiveness endpoint, or, in a diagnostic clinical performance study, a diagnostic performance measure.

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