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For Over-The Counter Use, DuoDERM Hydroactive Gel Wound Dressing may be used for abrasions, lacerations, minor cuts, minor scalds and burns, and skin tears. Under the supervision of a healthcare professional, DuoDERM Hydroactive Gel may be used for the hydration and management of partial and full-thickness wounds, such as pressure sores, leg ulcers, diabetic ulcers and skin conditions resulting from radiation dermatitis.

DuoDERM Hydroactive Gel Wound Dressing is substantially equivalent to Carrasyn Hydrogel Wound Dressing. The products are equivalent in intended use and function. Both products provide a moist wound healing environment. DuoDERM Hydroactive Gel Wound Dressing is also capable of absorbing exudate.

The provided text is related to a 510(k) Premarket Notification for a wound dressing and does not contain information about acceptance criteria or a study that proves the device meets such criteria.

The document primarily focuses on establishing "substantial equivalence" of the DuoDERM® Hydroactive® Gel Wound Dressing to a predicate device (Carrasyn® Hydrogel Wound Dressing) for regulatory approval. This is a common pathway for medical devices where a new device is compared to an already legally marketed device, demonstrating that it is as safe and effective.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document does not describe performance metrics, statistical analysis, sample sizes for test or training sets, expert qualifications, or details of a study designed to prove specific acceptance criteria.

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