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For Over The Counter use, Aquacel Hydrofiber Wound Dressing may be used for: abrasions, minor cuts and minor scalds and burns. Under the supervision of a health care professional, Aquacel may be used for wounds such as: leg ulcers, pressure ulcers (Stages I-IV), and diabetic ulcers; surgical wounds (post-operative, donor sites, dermatological), burns (first and second degree); management of surgical or traumatic wounds that have been left to heal by secondary intention; local management of wounds that are prone to bleeding such as wounds that have been mechanically or surgically debrided, donor sites, and traumatic wounds.

Aquacel Hydrofiber Wound Dressing is a non-absorbable wound dressing.

The provided text is a 510(k) premarket notification for the AQUACEL™ Hydrofiber™ Wound Dressing. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics.

Instead, it states: "Data/information supporting the safety of Aquacel Hydrofiber Wound Dressing was presented in Premarket Notification K943258. All testing was performed in accordance with Good Laboratory Practice Regulations." This indicates that safety data was submitted previously and is referenced here, but the specifics of that data or any performance criteria are not included in this document.

Therefore, I cannot provide the requested information from the given text. The text focuses on regulatory approval based on substantial equivalence rather than detailed performance study results against specific acceptance criteria.

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