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Cytal® Wound Matrix is intended for the management of wounds including: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunnel/undermined wounds (donor sites/grafts, post-Mohs 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.

Cytal® Burn Matrix is intended for the management of wounds including: second-degree burns, partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, tunnel/undermined woundermined wounds, surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, and skin tears), and draining wounds. The device is intended for one-time use.

The UBM devices are composed of a resorbable porcine-derived extracellular matrix (ECM) scaffolds, containing epithelial basement membrane, known as urinary bladder matrix (UBM). Cytal devices are supplied in single or multi-layer sheet configurations (1 to 6 layers) in sizes up to 10 cm x 15 cm (1-, 2, and 6-Layer, K152721) or 16 x 35 cm (3-Layer, K192725). Cytal sheets are provided with fenestrations in both lyophilized (1- and 2-Layer) and vacuum pressed (3- and 6-Layer) configurations. The devices are packaged in double peel-open pouches. The devices are terminally sterilized using electron beam irradiation and are intended for one-time use. UBM devices are pre-hydrated with sterile saline and applied to the wound. The devices can be cut to size and/or used in conjunction with other extracellular matrix derived scaffolds indicated for wound management, such as MicroMatrix® UBM Particulate. The devices are sloughed from the skin during the normal wound healing process or are incorporated (remodeled) into the wound bed via enzymatic degradation, cellular infiltration, capillary growth, and/or integration by the surrounding host tissue.

The provided text is a 510(k) summary for ACell, Inc.'s Cytal® Wound Matrix and Cytal® Burn Matrix devices. It describes modifications to an existing device rather than a new device requiring extensive clinical trials to prove effectiveness. Therefore, the information about acceptance criteria and studies largely focuses on bench testing to demonstrate that the modified device remains substantially equivalent to its predicates.

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 numerical acceptance criteria for each test. Instead, it provides a general "Meets Acceptance Criteria" for each performance benchmark.

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

The document does not specify the sample size used for each bench test. Given that these are bench tests for product modification, the data provenance is assumed to be from ACell, Inc.'s internal testing labs, likely in the US, and is prospective, as it's conducted to support a new submission.

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 information is not applicable. The studies mentioned are bench tests evaluating physical and material properties of the device, not clinical performance requiring expert ground truth or assessment.

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

This information is not applicable, as there is no mention of a test set requiring adjudication in a clinical or diagnostic context.

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 MRMC comparative effectiveness study was done. The document explicitly states: "No clinical studies were required as appropriate verification of the subject devices was achieved based on the comparison to the predicate devices and from the results of the bench testing and engineering analysis."

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

No standalone performance study of an algorithm was done. This device is a physical medical device (wound matrix), not an AI/software as a medical device.

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

This information is not applicable in the context of the bench tests performed. The "ground truth" for these tests would be established by validated measurement standards and physical/chemical analytical methods, not clinical expert consensus, pathology, or outcomes data.

8. The sample size for the training set

The concept of a "training set" is not applicable here as the device is not an AI/ML algorithm.

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

This information is not applicable.

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