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Foundation DRS Solo is indicated for the management of wounds including:

• · Full thickness and partial thickness wounds
• Pressure ulcers
• Venous ulcers
• · Ulcers caused by mixed vascular etiologies
• · Diabetic ulcers
• · First degree burns
• · Partial thickness burns (superficial second-degree burns)
• · Donor sites and other bleeding surface wounds
• · Abrasions
• · Trauma wounds (abrations, lacerations, skin tears)
• · Dehisced wounds
• · Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)

Foundation DRS Solo may be cut to size.

Foundation DRS Solo is a highly conformable, advanced wound care device comprising a porous matrix of chitosan derived from shellfish and sodium chondroitin sulfate, a glycosaminoglycan. The chitosan- glycosaminoglycan biodegradable, porous matrix provides a scaffold for cellular invasion and capillary growth. The device is applied on the surface of the wound, and provides a moist wound environment. The dressing may be replaced or may remain in place, acting as a scaffold to promote cellular infiltration and capillary growth as the dressing degrades.

This document, a 510(k) Premarket Notification summary for the Foundation Dermal Regeneration Scaffold (DRS) Solo, does not describe an AI/ML powered medical device or a study involving human readers and AI assistance for diagnostic purposes.

Instead, this document pertains to a medical device that is a dermal regeneration scaffold for wound management. The "acceptance criteria" discussed are related to the safety and performance of this physical wound dressing, not the accuracy or performance of an AI algorithm.

Therefore, I cannot provide the requested information about acceptance criteria for an AI device, sample size for test sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the device described in the provided text.

The "Summary of Nonclinical Testing" section (page 4-5) lists the studies conducted to demonstrate the safety and performance of the Foundation DRS Solo. These include biocompatibility tests, bacterial endotoxins testing, chemical characterization, sterilization validation, packaging validation, and a Wound Healing Study in a Porcine Model. The document states that "All tests found the device to meet study endpoints and meet acceptance criteria," but it does not specify what those exact acceptance criteria were for each test.

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