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The Mariner Biomedical, Inc. ADVANCED CARE™ Sterile Wound Dressing is intended for use in the local management of surgical incisions, trauma inflicted wounds, abrasions, superficial burns, secondary dressing for packed wounds and donor sites. The dressing is also appropriate for pressure, diabetic and venous stasis ulcers. It is intended to be used to protect skin from potential irritation, maceration, and to manage exudate.

The ADVANCED CARETM Hydrophilic Wound Dressings will be manufactured from hydrophilic polyurethane foam in various thicknesses and configurations in sizes up to 25" by 25" squares, and thicknesses from 100 mil to 0.05".

The dressings will be offered as sterile stand alone polyurethane dressings individually packaged.

This 510(k) summary describes a wound dressing, not an AI/ML powered device. Therefore, the requested information regarding acceptance criteria, study details, and AI/ML specific elements (like sample sizes for test and training sets, ground truth establishment, MRMC studies, standalone performance, and expert involvement) is not applicable to this document.

The document states:
"The ADVANCED CARETM Hydrophilic Wound Dressings will be manufactured from hydrophilic polyurethane foam in various thicknesses and configurations... Physical characteristics of the ADVANCED CARET Wound Dressing are identical to those of the predicate device [Rynel Medical Epitech HPF-L00562 Sterile Wound Dressing]."

This indicates that the device's acceptance is based on its physical characteristics being substantially equivalent to a predicate device, as per traditional medical device regulatory pathways, not on performance metrics derived from a study involving AI/ML.

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