(78 days)
Management of venous cuts, for example, cuts resulting from any shape objects and abrasions, other superficial injuries, superficial wounds, burns (1st and 2nd degree) donor sites, post operative wound.
vitop® Dressing
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies proving the device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for a device called "Vitop® Dressing," indicating that the device is substantially equivalent to legally marketed predicate devices.
The letter does not contain details about specific acceptance criteria testing, study designs, sample sizes, ground truth establishment, or expert involvement as requested in your prompt. It focuses solely on the regulatory approval.
N/A