Search Results

PolyFIT+ High Hydrating Antimicrobial Dressings are intended as effective barriers to inhibit microbial proliferation within the dressing and reduce microbial penetration through the dressing. PolyFIT+ High Hydrating Antimicrobial Dressings are indicated for use under a healthcare professional's orders as adjunctive treatment to maintain a moist wound environment in the management of dry wounds or wounds with minimal to no exudate, in the care of partial or full-thickness wounds, such as pressure ulcers (Stages II-IV), lower extremity ulcers (venous or arterial), diabetic foot ulcers, surgical or traumatic wounds (including those left open to heal by secondary intention). They are not intended for wounds with exposed tendon or bone and for 3rd degree byrns.

Not Found

The provided text is related to an FDA 510(k) clearance for a medical device called "PolyFIT+ High Hydrating Antimicrobial Dressings." It does not contain any information about acceptance criteria, study details, or performance metrics in the context of an AI/ML device.

The document is a clearance letter and an indications for use statement for a wound dressing. It declares the device substantially equivalent to legally marketed predicate devices.

Therefore, I cannot fulfill your request for information about acceptance criteria and a study proving device performance, as the provided text does not contain this type of data.

Ask a specific question about this device