Check this out, very interestingFrom Crusader post :
"It's specifically a "clinical PERFORMANCE study", which is about usage and device performance, not about clinical data. It's the FDA wanting to see it in use at US point of care clinics to verify ease of use. That's it.
"Clinical Performance Studies
The purpose of clinical performance studies is to establish or confirm aspects of device performance which cannot be determined by analytical performance studies, literature and/or previous experience gained by routine diagnostic testing. This information is used to demonstrate compliance with the relevant general safety and performance requirements with respect to clinical performance."