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Over-the-counter use of L.A.M. IPM Wound Gel is suitable for minor abrasions and minor cuts. Under the supervision of a healtheare professional. L.A.M. IPM Wound Gel is suitable for oxuding wounds such as leg ulcers, pressure ulcers, diabetic ulcers, and for the managemont of mechanically or surgically debrided wounds.

L...A.M. IPM™ Wound Gel is a clear viscous, odorless, aqueous gel composed principally of sodium hyaluronate, a derivative salt of Hyaluronic acid. Over-the-counter use of I.A.M. IPM™ Wound Gel is suitable for minor abrasions and minor cuts. Under the supervision of a healtheare professional, J.A.M. IPM™ Wound Gol is suitable for exuding wounds such as log ulcers, pressure ulcers, diabetic ulcers, and for the management of mechanically or surgically debrided wounds.

The provided text is insufficient to answer the request. The document is a 510(k) summary for a wound gel and primarily discusses regulatory approval based on substantial equivalence to existing predicate devices. It mentions biocompatibility testing and "Clinical experience in 27 patients" but does not provide details about acceptance criteria, specific performance metrics, the design of a study to prove these criteria, sample sizes for test or training sets, ground truth establishment methods, or the involvement of experts, MRMC studies, or standalone algorithm performance.

Therefore, I cannot extract the requested information from the given text.

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