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MITRAFLEX Pigmented Wound Dressings are intended for use in the management of: Venous stasis ulcers, Diabetic ulcers, Pressure sores, Donor sites, Blisters, Incisions, Severe sunburn, Poison Ivy, Dermabrasions and other dermatologic procedures, Partial-thickness wounds, Superficial burns, Abrasions and lacerations, Full-thickness wounds, Skin tears, Dermal lesions, Minor chemical burns, Thermal burns, Facelifts and other plastic surgery procedures (e.g. laser resurfacing)

MITRAFLEX Pigmented Wound Dressings are sterile, absorptive dressings. MITRAFLEX combines the moist wound environment properties of film dressings with the absorptive qualities of traditional therapies in a structure which is both adhesive and conformable. MITRAFLEX dressings are constructed of three layers, each specifically engineered to give MITRAFLEX its unique blend of "ease of use" features while providing a microenvironment conducive to moist wound healing. The wound contact surface of MITRAFLEX is a porous adhesive which facilitates ease of application to the wound site. A second layer consisting of a microporous polyurethane membrane absorbs and acts as a reservoir for wound exudate. This layer is also moisture vapor permeable which facilitates the reduction of exudate while maintaining a moist environment to promote optimal wound repair. MITRAFLEX is impermeable to microorganisms and liquids.

The provided text is a 510(k) summary for a medical device called MITRAFLEX Pigmented Wound Dressing. It describes the device, its intended use, and its substantial equivalence to other existing devices.

However, the document does NOT contain any information regarding: acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. This 510(k) summary focuses on device description and substantial equivalence, not detailed performance studies or their associated metrics.

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