Objective performance criterion (OPC)

An OPC lets a single-arm study be judged against an accepted benchmark instead of a concurrent control. It works only when the historical data are relevant to the new device and population, so it suits device types with a long, well-documented track record.

A numerical target value derived from historical data from clinical studies and/or registries and may be used by FDA for the comparison of safety or effectiveness endpoints.

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