(247 days)
PolyFIT+ Absorbing Antimicrobial Dressings are intended as effective barriers to inhibit microbial proliferation within the dressing and reduce microbial penetration through the dressing. PolyFIT+ Absorbing Antimicrobial Dressings are for use under a healthcare professional's orders as adjunctive treatment in the management of exudating wounds, partial and 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, for 310 degree burns or for dry wounds.
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This document is a 510(k) clearance letter from the FDA for a medical device called "PolyFIT™+ Absorbing Antimicrobial Dressings and PolyFIT™+ High Absorbing Antimicrobial Dressings."
The letter acknowledges that the device is substantially equivalent to legally marketed predicate devices. However, this type of document (a 510(k) clearance letter) does not contain acceptance criteria or the details of a study proving the device meets those criteria.
510(k) clearance is based on demonstrating substantial equivalence to a predicate device, usually through performance testing, material characterization, and sometimes limited clinical data summarized in the 510(k) submission. The FDA letter itself is the final communication of that decision, not the submission document.
Therefore, I cannot provide the requested information based solely on the provided text. The information regarding acceptance criteria, study details, sample sizes, ground truth, and expert qualifications would be found in the original 510(k) submission filed by Poly Remedy, Inc., not in this clearance letter.
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