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MicroMatrix® is intended for the management of wounds including; partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunnel/undermined wounds (donor sites/grafts, post-Mohs surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and draining wounds. The device is intended for one-time use.

MicroMatrix® is composed of a resorbable, porcine-derived, extracellular matrix scaffold containing epithelial basement membrane, specifically known as Urinary Bladder Matrix ("UBM"). The devices are supplied as a dry, absorbent, white to off-white particulate with two particle distributions, specifically <500um and <1000µm. The particulate is packaged in an amber glass vial with butyl stopper and crimp sealed. The device vial is then packaged in a peel-open outer pouch that is terminally sterilized using electron beam irradiation. MicroMatrix® can be applied to a wound either in the dry state or pre-hydrated with sterile saline, and can be used in conjunction with other sheet based extracellular matrix derived scaffolds indicated for wound management. MicroMatrix is composed of resorbable extracellular matrix particles comprised of UBM. Submitted in vitro and in vivo studies suggest that the product will be sloughed from the skin during the normal wound healing process or will be incorporated (remodeled) into the wound bed via enzymatic degradation, cellular infiltration, capillary growth, and/or integration by the surrounding host tissue. The device is intended for one time use.

The provided document is a 510(k) premarket notification for a medical device called MicroMatrix®. It describes the device, its intended use, and its comparison to a predicate device. However, it does not contain the specific detailed information typically found in a study proving a device meets acceptance criteria, such as a table of acceptance criteria and reported device performance, sample sizes for test sets, expert details for ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set sample sizes and ground truth methods.

This document primarily focuses on establishing substantial equivalence to a legally marketed predicate device, rather than presenting a performance study with detailed acceptance criteria and results. The "PERFORMANCE DATA" section states: "Packaging validation, LAL endotoxin, and shelf life studies were submitted in support of the modifications to MicroMatrix® described in this 510(k)." This indicates that performance data related to these specific aspects were provided, but the document does not elaborate on their acceptance criteria or detailed results in a format that would fulfill the request.

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

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