Sample performance testing for a software-only medical device

SSchoepel

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#1
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
 
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