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MatriDerm is indicated for the management of wounds including:

• Full thickness and partial thickness wounds
• Chronic wounds (e.g. pressure ulcers, venous ulcers, diabetic ulcers, chronic ulcers)
• Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
• Partial thickness burns
• Trauma wounds (abrasions, lacerations and skin tears)
• Draining wounds

MatriDerm is a single-use three-dimensional acellular dermal matrix composed of bovine collagen fibers and bovine elastin. The device is supplied sterile and is available in different sizes providing flexibility of choice based on the treatment protocol, wound location, size and depth. The device can be cut to fit the wound.

This document describes the MatriDerm device, a collagen-elastin wound matrix, and its substantial equivalence to a predicate device (PriMatrix Dermal Repair Scaffold). The information provided focuses on the device's characteristics and safety testing rather than a comparative effectiveness study with AI assistance.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner with specific numerical thresholds for performance metrics. Instead, it demonstrates substantial equivalence by comparing the MatriDerm device to a legally marketed predicate device (PriMatrix Dermal Repair Scaffold) and referencing successful completion of standard biological and bench tests.

However, based on the Performance Test Data section, we can infer some criteria and reported performance:

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

• Biocompatibility: The text states "recommended tests were successfully performed/evaluated on final, finished and sterile subject device." It does not specify sample sizes for each individual biocompatibility test (e.g., cytotoxicity, implantation), nor the provenance of the data.
• Clinical (HRIPT): 60 subjects.
• Clinical (SPT): 22 subjects.
• Data Provenance: The document does not specify the country of origin for the clinical study data or if it was retrospective or prospective. It is implied to be prospective for HRIPT and SPT as these are typically conducted specifically for regulatory submissions.

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)

This section is not applicable. The evaluations for MatriDerm are primarily based on laboratory testing (biocompatibility, bench tests) and human clinical tests (HRIPT, SPT) that assess biological responses or physical properties, not expert interpretations of images or clinical cases that require "ground truth" establishment in the context of diagnostic AI.

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

This section is not applicable as the studies described (biocompatibility, bench, and clinical skin tests) do not involve expert adjudication methods typically used in diagnostic assessment studies.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a wound dressing, not a diagnostic AI system, and therefore does not involve human readers or AI assistance in diagnostic interpretation.

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

This question is not applicable as MatriDerm is a medical device (wound matrix) and not an algorithm or AI system.

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

The concept of "ground truth" as typically defined for diagnostic device evaluation (e.g., pathology for cancer diagnosis) is not directly applicable here. For MatriDerm, the "truth" is established by:

• Biocompatibility: Adherence to ISO standards and FDA guidance, with confirmation through specific biological tests.
• Bench tests: Measurements against material specifications and validated test methods.
• Clinical (HRIPT/SPT): Direct physiological responses in human subjects (e.g., presence/absence of irritation, wheal formation), observed and documented by qualified personnel (not specified in detail, but standard for such clinical tests).

8. The sample size for the training set

This question is not applicable as MatriDerm is a physical medical device, not a machine learning algorithm that requires a training set.

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

This question is not applicable as MatriDerm is a physical medical device, not a machine learning algorithm.

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