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The Miro3D 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 Reprise Miro3D 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 to defined sizes. The Miro3D porous scaffold provides a protective environment for wound healing. The device is packaged dry, terminally sterilized in its packaging by e-beam irradiation and is rehydrated with sterile saline or lactated Ringer's solution prior to use. The Miro3D Wound Matrix is provided in four sizes that may be cut to fit a wound size prior to application.

This document describes the regulatory submission for the Miro3D Wound Matrix, a medical device. The submission aims to demonstrate substantial equivalence to a previously cleared predicate device.

The provided text does not contain information related to an AI/ML powered device, nor does it present acceptance criteria or a study proving device performance in the context of an AI/ML algorithm.

Instead, this document is a 510(k) summary for a biomedical device (wound matrix) that is based on animal-derived tissue. The key points from the provided text are:

• Device: Miro3D Wound Matrix (a sterile, single-use, non-crosslinked acellular wound dressing derived from porcine liver tissue).
• Purpose of Submission (K223257): To add MR Safe information and symbols to the labeling of the existing Miro3D Wound Matrix.
• Predicate Device: Miro3D Wound Matrix (K221520), which is explicitly stated to be the identical product to the subject device, with the only difference being the labeling for MR Safe information.
• Performance Data: The performance data provided are specifically related to MR (Magnetic Resonance) testing to support the "MR Safe" claim. This includes adherence to ASTM standards for MR image artifacts, magnetically induced displacement force, magnetically induced torque, radio frequency induced heating, and marking for safety in the MR environment.
• No AI/ML Component: There is no mention of any AI or machine learning component in the device or its intended use. The performance data and acceptance criteria relate solely to the physical and material properties of the wound matrix, particularly its compatibility with MRI.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves an AI/ML device meets the acceptance criteria, as the input document is not about an AI/ML device.

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