Comparator

The choice of comparator decides what a study can conclude. A comparator that does not reflect current practice can make a device look better or worse than it would in real use.

medical device (3.34), therapy (e.g., active treatment, normal clinical practice), placebo or no treatment, used in the control group (3.15) in a clinical investigation (3.8)

ISO 14155:2020, clause 3.12

A procedure or another medical product that serves to assess the level of performance of the investigational device. Often the comparator is another medical device.

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