(30 days)
The Miro3D Fibers Wound Matrix is intended for the management of wounds including:
· Partial and full thickness wounds
- · Pressure ulcers
- · Venous ulcers
- · Chronic vascular ulcers
- · Diabetic ulcers
- · Tunneled, undermined wounds
- · Trauma wounds (abrasions, lacerations, partial thickness burns, and skin tears)
- · Draining wounds
- · Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence)
The Miro3D Fibers Wound Matrix is a sterile, single use, non-crosslinked acellular wound dressing that is derived from porcine liver tissue. The liver is perfusion decellularized resulting in a collagen matrix that is dried and cut into fibers. The device is packaged dry and terminally sterilized in its packaging by e-beam irradiation. The Miro3D Fibers Wound Matrix may be used dry or rehydrated and is provided in four sizes by weight.
The provided text is a 510(k) summary for the Miro3D Fibers Wound Matrix. It describes the device, its intended use, a comparison to a predicate device, and the performance data submitted to the FDA to demonstrate substantial equivalence.
However, there is no information within this document about acceptance criteria or a study proving the device meets those criteria, specifically concerning AI/software performance.
The document solely focuses on the physical and biological characteristics of a wound matrix, which is a physical medical device (a collagen matrix derived from porcine liver). It is not an AI or software-driven device.
Therefore, I cannot extract the information required to answer your prompt, as the prompt's questions pertain to AI/software performance, ground truth, expert adjudication, and MRMC studies, none of which are relevant to a physical wound matrix device in this context.
To answer your request, I would need a document describing the regulatory submission for an AI/software medical device.
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