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Over the counter: Aleo BME Liquid Bandage is intended to cover and protect the skin from outside dirt and microbial penetration in minor cuts, scrapes, burns, skin irritations and abrasions.

Prescription Use: Aleo BME Liquid Bandage is intended to cover and protect the skin from outside dirt and microbial penetration for minor cuts, scrapes, burns, irritations and abrasions, as well as closed surgical incisions and excisions.

ALEO liquid bandage is a tough elastic skin protectant for covering minor skin cuts, scrapes, abrasions and cracks. When applied, it rapidly forms water-proof, breathable and transparent protection that forms an effective barrier to prevent microbial penetration from the external environment while the polymeric film remains intact.

The provided text is a 510(k) summary for the Aleo BME Liquid Bandage. It details the device's intended use, regulatory classification, and comparisons to predicate devices. However, it does not contain specific acceptance criteria or the details of a study with reported device performance metrics in the format requested.

It states that "Physical, mechanical and preservative effectiveness testing results confirm that the Aleo BME Liquid Bandage meets the product design specifications" and that "performance testing of the Aleo BME Liquid Bandage was compared to the predicate devices," but it does not provide the actual criteria or results of these tests.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide details on sample size, ground truth, expert qualifications, or MRMC studies, as this information is not present in the provided document.

The document focuses on the regulatory submission for substantial equivalence based on the device's design, function, and intended use being similar to existing legally marketed devices, rather than a detailed presentation of performance data against specific acceptance criteria.

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