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Wound Matrix TF is intended for the management of wounds including:

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

The device is supplied sterile and is intended for one-time use.

Wound Matrix TF is an animal-sourced, acellular wound dressing that is derived from porcine liver tissue. The liver tissue undergoes perfusion decellularization and the resulting wound dressing is comprised primarily of collagen type I. The device is intended for use in the management of wounds. Wound Matrix TF is terminally sterilized in its packaging and is hydrated, moist and flexible when its packaging is opened. The dressing is available in sizes ranging from 1 cm x 2 cm to 10 cm x 25 cm, and may be trimmed or cut as required.

The provided text does not describe acceptance criteria or a study proving that the device meets acceptance criteria in the way typically expected for a medical device's performance claims (e.g., accuracy, diagnostic sensitivity/specificity).

Instead, this document is a 510(k) summary for a wound matrix (Wound Matrix TF), which is a type of medical device generally used for wound management, not a diagnostic AI device or a device with quantifiable performance metrics like sensitivity/specificity. The "Performance Data" section specifically states: "Verification and validation testing was conducted to confirm that bioburden, endotoxin and device dimensions were within the specified values in accordance with the risk assessment."

Therefore, it's impossible to create the requested table and answer many of the questions as they pertain to AI/diagnostic performance. However, I can extract the relevant information regarding the device itself and its "performance data" as described.

Here's the information based on the provided document, addressing the prompts where applicable and noting where the information is not present or not relevant:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and data provenance

• Sample size: Not specified. The document mentions "Verification and validation testing" but does not give specific sample sizes for bioburden, endotoxin, or dimensional testing.
• Data provenance: Not applicable in the context of diagnostic/AI data. The tests are laboratory/manufacturing quality control tests on the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of experts: Not applicable. The "ground truth" for bioburden, endotoxin, and dimensions would be established by scientific/engineering standards and measurements, not by expert consensus in the diagnostic sense.
• Qualifications of experts: Not applicable.

4. Adjudication method for the test set

• Adjudication method: Not applicable. This is not a diagnostic device involving human interpretation or adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• MRMC study: No, not applicable. This is not an AI diagnostic device.

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

• Standalone study: No, not applicable. This is not an AI algorithm.

7. The type of ground truth used

• Type of ground truth: Laboratory measurements and engineering specifications for bioburden, endotoxin, and physical dimensions.

8. The sample size for the training set

• Sample size for training set: Not applicable. This is not an AI device.

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

• How ground truth was established: Not applicable. This is not an AI device.

Summary of Device and its "Performance Data" Context:

The device, "Wound Matrix TF," is an animal-sourced, acellular wound dressing derived from porcine liver tissue. The 510(k) summary focuses on demonstrating "substantial equivalence" to a predicate device (Miromatrix Wound Matrix, K140510) and a reference device (Cook Biotech Oasis® Wound Matrix, K061711).

The "performance data" provided refers to verification and validation testing conducted to confirm manufacturing and material quality attributes such as bioburden, endotoxin levels, and device dimensions. The primary change from its previous clearance (K140510) was the addition of fenestrations and a reduction in minimum thickness. These changes were assessed via a risk assessment to confirm continued substantial equivalence to the predicate device, rather than through a clinical performance study with human-subject outcomes or diagnostic accuracy metrics.

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