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Meso Wound Matrix is a resorbable porcine mesothelium derived product intended for the management of topical wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns and skin tears), and draining wounds.

The device is intended for one time use.

Meso Wound Matrix is composed of porcine collagen from peritoneum tissue. It is an absorbent, white to off- white material supplied as sheet. The device is packaged sterile in a double-layer package.

The provided text is a 510(k) summary for the Meso Wound Matrix and an FDA letter confirming substantial equivalence. It does not present a study or acceptance criteria for device performance as typically understood for AI/software-as-a-medical-device (SaMD) products. Instead, it focuses on the device's technological characteristics, biocompatibility, and substantial equivalence to a predicate device based on regulatory requirements for a wound dressing.

Therefore, many of the requested items, such as acceptance criteria table with reported performance, sample sizes for test/training sets, expert adjudication methods, MRMC studies, or standalone performance, are not applicable or available in this document. This document is related to a traditional medical device (wound dressing), not an AI/SaMD product.

However, I can extract information relevant to the regulatory approval process as much as possible:

1. Table of Acceptance Criteria and Reported Device Performance: This document does not describe specific acceptance criteria (e.g., sensitivity, specificity, accuracy) or quantitative performance metrics for the device's efficacy in terms of wound healing. The "performance data" section rather lists types of tests conducted for regulatory compliance.

   Acceptance Criteria Category	Reported Device Performance (Summary)
   Biocompatibility	Passed tests according to ISO 10993-1:2003
   	- Cytotoxicity
   	- Sensitization
   	- Systemic Toxicity
   	- Sub-Chronic Toxicity
   	- Genotoxicity
   	- Implantation
   	- Pyrogenicity
   	- Hemocompatibility
   Hydration	Testing conducted; no specific results or criteria provided
   Animal Testing	Testing conducted; no specific results or criteria provided
   Viral Inactivation	Testing conducted; no specific results or criteria provided
   Technological Characteristics	"Technologically identical to the cleared KN ECM Surgical Patch (K094061)"
   Material	Composed of porcine collagen from peritoneum tissue
   Sterility	Packaged sterile

2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/SaMD product with a "test set" in the context of algorithm evaluation. The document mentions "animal testing" but does not specify sample sizes or provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm's performance is not relevant for this type of device submission. Regulatory decisions are based on the demonstrated characteristics and equivalence to predicate devices, assessed by FDA reviewers.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set requiring expert adjudication is described.

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. This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the "Performance Data" sections (biocompatibility, hydration, animal, viral inactivation), the "ground truth" would be the established scientific and regulatory standards for each test type (e.g., specific endpoints for biocompatibility, histological findings in animal studies, viral load reduction for inactivation studies). No single "ground truth" like pathology or outcomes data is explicitly detailed here for a classification task. The primary ground for approval is Substantial Equivalence to a legally marketed predicate device, based on material, intended use, and technological characteristics.

8. The sample size for the training set: Not applicable. This is not an AI/ML product that uses a "training set."

9. How the ground truth for the training set was established: Not applicable. No training set is involved.

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