(27 days)
TenderWet® active and TenderWet® active Cavity are for the wet management of dry, light and moderately exudating partial and full thickness wounds such as minor burns, superficial injuries, laccrations, cuts, abrasions, incisions/surgical wounds, and skin tears. TenderWet active may also be used under the direction of a health care professional for chronic wounds such as pressure uleers, lower extremity ulcers, venous ulcers, arterial ulcers, diabetic ulcers, and ulcers of mixed etiology.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a device called "TenderWet® Active." This type of document is for a medical device that demonstrates substantial equivalence to a legally marketed predicate device, rather than a novel AI/software device that requires extensive performance studies against acceptance criteria in the manner you've outlined.
Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be found in this document.
This document solely confirms that the FDA has reviewed the submission (K040517) for the TenderWet® Active device and determined it is substantially equivalent to existing devices, allowing it to be marketed. It does not contain primary study data or performance metrics against specific acceptance criteria.
N/A