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XenoMem™ Wound Matrix is indicated for the management of wounds including:

• · Partial and full-thickness wounds;
• · Pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers;
• · Tunnelled/undermined wounds
• · Surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound deliscence),
• · Trauma wounds (abrasions, lacerations, second-degree burns, skin tears);
• Draining wounds.

XenoMem™ Wound Matrix is an acellular, porcine peritoneal matrix, supplied sterile to maintain and support an environment for wound management. It consists of an extracellular tissue matrix, derived from porcine peritoneum. XenoMem™ Wound Matrix porcine peritoneal membrane provides a robust biological matrix that allows for easier handling during preparation and application of the wound dressing. The membrane has undergone a decellularisation, viral inactivation and a freeze-drying process in order to remove donor genetic material, in a non-destructive manner, so as to maintain the structure and function of the tissue. XenoMem is sterilized via gamma irradiation and sold for prescription only.

The provided text describes the 510(k) summary for the XenoMem™ Wound Matrix device, focusing on its substantial equivalence to predicate devices rather than a study proving the device meets specific performance acceptance criteria for a new clinical claim. This document is a regulatory submission for market clearance based on comparing the new device to existing legally marketed devices.

Therefore, the information requested in your prompt regarding acceptance criteria for a new clinical claim, a study that proves it, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC effectiveness studies is not available in the provided text.

The closest information available is a "Summary of Testing and Results Supporting Substantial Equivalence," which describes various bench and analytical tests performed to show that the XenoMem™ Wound Matrix is comparable to its predicate device (Oasis® Wound Matrix).

Here's the information that can be extracted from the provided text, reformatted to align with your request, and highlighting the missing elements:

1. A table of acceptance criteria and the reported device performance

Important Note: These are not performance acceptance criteria for a clinical claim in the traditional sense, but rather a list of tests conducted to support the claim of substantial equivalence to a predicate device for regulatory clearance. The "met requirements" indicates the device performed comparably to the predicate or within predefined industry standards for these specific properties.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not available. The document does not describe specific "test sets" or clinical studies with human participants that would typically have sample sizes and data provenance details. The tests listed are primarily bench (in vitro) and analytical.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not available. No ground truth establishment by external experts is described for these bench and analytical tests. The "ground truth" for these tests would be the established scientific methods and acceptable ranges for each parameter.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not available. No adjudication method is described as this document pertains to laboratory and analytical testing for substantial equivalence, not a clinical study requiring human interpretation or consensus.

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/Not available. This device is a wound matrix, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance is not relevant or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable/Not available. As above, this is a physical medical device (wound matrix), not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the tests listed (tensile strength, thickness, residual DNA, sterility, biocompatibility, DSC, etc.), the "ground truth" would be established scientific and engineering standards, ISO standards, and relevant FDA guidance documents for medical device materials and manufacturing. This is not "expert consensus" or clinical outcomes data in the context of diagnostic performance.

8. The sample size for the training set

• Not applicable/Not available. No "training set" is described as this is not a machine learning or AI device.

9. How the ground truth for the training set was established

• Not applicable/Not available. No training set is described.

In summary, the provided document is an FDA 510(k) clearance letter and summary for a physical medical device (wound matrix). It demonstrates substantial equivalence based on material properties, manufacturing processes, and safety testing, as opposed to a clinical study proving new diagnostic or treatment efficacy claims with specific acceptance criteria that would involve human experts, large test sets, or AI performance metrics.

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