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Dermaphylyx Film Wound Dressings are self-adhesive and semi-occlusive. They are intended for use in the management of a variety of partial and full-thickness wounds.

The following Indications are for Prescription Use or under the direction of a health care professional:
Dermal Ulcers
Donor Sites
Incisions
Superficial Burns
Abrasions and lacerations
IV Catheter Sites

The following Indications are for Over-the-Counter Use:
Abrasions
Minor Burns
Minor Cuts
Minor Lacerations
Blisters
As a Cover for gauze and gel bandages.

Dermaphylyx Film Wound Dressings are self-adhesive and semi-occlusive. The wound contact surface is composed of a porous adhesive. A second layer consists of a polyurethane film which is waterproof and dirt proof while maintaining breathability.

The provided document is a 510(k) summary for the Dermaphylyx Film Wound Dressing. It describes the product, its intended use, and states that it is substantially equivalent to predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or answer the specific questions about study details from this input. The 510(k) summary is a declaration of substantial equivalence, not a detailed report of clinical or performance testing with specific metrics and methodologies.

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