Which of the following is not indicative of a device being 'substantially equivalent'?

In the context of determining whether a medical device is 'substantially equivalent' to a legally marketed device, the concept primarily revolves around demonstrating that the new device has similar characteristics or performance to an existing device that is already on the market. Substantial equivalence is assessed by evaluating aspects such as safety, effectiveness, and intended use.

Choosing higher performance metrics as a criterion for substantial equivalence is not appropriate because the emphasis is on similarity, rather than superiority. A device can be considered substantially equivalent even if it does not outperform the predicate device in all aspects. The primary focus should be on ensuring that there are no new questions regarding safety or effectiveness compared to the predicate device.

The other factors, such as similar safety profiles, comparison with a legally marketed device, and effectiveness, are all essential components of the substantial equivalence evaluation process. They help establish that the new device functions in a manner that is at least as safe and effective as its predicate, fulfilling the regulatory requirements established by the FDA and other regulatory bodies.