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For the management of dry to low/moderate exuding wounds such as:

Stage I-IV pressure ulcers Diabetic & foot ulcers Partial and full thickness wounds Graft and donor sites Post-operative surgical wounds Trauma wounds (dermal lesions, trauma injuries and incisions) 1 & 2nd degree burns Abrasions and lacerations

Prescription Use Only (Part 21 CFR 801 Subpart D)

The product is a spreadable amorphous water based wound gel comprising a synthetic clay as the thickening agent. The gel provides for optimal moisture management of the wound bed by donating/absorbing water that in turns aids in wound healing. The presence of active silver compounds within the gel provides preservative action and acts as an effective barrier to microbial penetration by inhibiting the growth of microorganisms within the dressing. The gel is clear to hazy and will not stain tissue when used over a period of 3 days though its potential to stain skin beyond 3 day use is not known.

Even with silver content at 550ppm, the gel is not discolored by incidental exposure to intense light such sunlight or to elevated environment temperatures.

The device is packaged primarily in tamperproof tubes (43g) with screw caps though it may be available in other sizes and containers. The tube is contained in a cardboard box with product insert.

I am sorry, but the provided text describes a medical device, specifically an antimicrobial silver wound gel (MTR550). It does not contain information about the acceptance criteria and study design for an AI/ML powered medical device. Therefore, I cannot extract the information required to answer your request.

The text focuses on:

• Regulatory information: FDA 510(k) clearance, substantial equivalence to predicate devices, and general controls.
• Device description: Composition, packaging, and specific properties of the wound gel.
• Indications for Use and Contraindications.
• Manufacturing and Biocompatibility testing.
• Performance data: Antimicrobial efficacy (preservative challenge test, in vitro assays against microorganisms), animal studies (rat, porcine), non-staining property, and stability.
• Comparison with predicate devices.

There is no mention of AI/ML, test sets, training sets, ground truth establishment by experts, adjudication methods, or MRMC studies.

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