Sample performance testing for a software-only medical device

[SSchoepel]

What exactly (or as close as possible) is supposed to go into the performance testing section of a 510k submission?

It isn't performance of the product to it's own speed requirements (that's V&V).

I've been advised it's testing of adherence to claimed/required standards, but also told it's testing against the predicate devices (whether actually obtained physically or a comparison using as much literature as necessary to make the case).

If someone has a sample or knows of a very specific guidance, please send it.

Thank you,
S. Schoepel

 

[yodon]

The guidance part is easy: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085281.htm

Think in terms of verification (confirmation that the requirements are met) and validation (confirmation that the user needs are met). If you are claiming substantial equivalence to a predicate device (software), you would need to demonstrate that.