Search Results

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.

Ask a specific question about this device