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The MiroDry 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 MiroDry 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 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 MiroDry Wound Matrix is provided in six sizes that may be cut to fit a wound size prior to application.

This document is a 510(k) Premarket Notification from the FDA regarding the "MiroDry Wound Matrix." It indicates that the device is substantially equivalent to a previously marketed predicate device ("Miro3D Wound Matrix").

The request asks for information about the acceptance criteria and the study proving the device meets these criteria. However, the provided text explicitly states:

"No performance testing was completed as prior testing of Miro3D was leveraged for MiroDry based on identical material and processing equivalence."

This means that Reprise Biomedical, Inc. did not conduct new performance studies or establish new acceptance criteria for the MiroDry Wound Matrix because they are claiming "substantial equivalence" to their predicate device, Miro3D Wound Matrix (K223257), due to "identical material and processing equivalence." The FDA's 510(k) clearance process often allows for this, especially for devices that are very similar to already cleared ones.

Therefore, I cannot provide the detailed information requested in the prompt based on the provided document, as no new performance studies with their own acceptance criteria were performed for the MiroDry Wound Matrix. The substantial equivalence argument relies on the prior performance data and acceptance criteria met by the predicate device, Miro3D Wound Matrix.

To answer your specific questions:

1. A table of acceptance criteria and the reported device performance: Not applicable. No new performance testing was conducted for MiroDry. Its equivalence is based on the predicate.
2. Sample size used for the test set and the data provenance: Not applicable. No new test set data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device is a wound matrix, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is a wound matrix, not an algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable. The device is not based on a machine learning model.
9. How the ground truth for the training set was established: Not applicable.

The document focuses on establishing substantial equivalence by comparing the technological characteristics of the MiroDry Wound Matrix to its predicate, Miro3D Wound Matrix. The critical points for substantial equivalence are highlighted in "Table 1: Subject vs. Predicate Wound Matrix Comparison":

• Identical Intended Use and Indications for Use: Both are for wound management, including various types of wounds.
• Identical Material: Both are perfusion-decellularized porcine liver.
• Identical Manufacturing Process: Perfusion decellularize, dry, cut to size.
• Identical Preparation: Rehydration with sterile saline or Lactated Ringer's solution.
• Identical Sterilization Method and SAL: Electron beam irradiation at 10^-6.
• Identical Packaging, MR Compatibility, Shelf Life (initial), and Storage Conditions.

The only stated difference is the "Wound Matrix Configuration and Sizes," where the MiroDry is a "collagen sheet scaffold...0.6cm thick" with six sizes, and the Miro3D is a "Three-dimensional collagen scaffold...2cm thick" with four sizes. The document argues that this change "does not change the Intended Use or fundamental scientific technology of the collagen matrix for wound management."

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