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Cytal® Wound Matrix 3-Layer 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, surgical wounds (donor sites/grafts, post-Mohs 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.

Cytal® Wound Matrix 3-Layer is composed of a resorbable, porcine-derived, extracellular matrix (ECM) scaffold containing epithelial basement membrane, specifically known as urinary bladder matrix (UBM). The devices are supplied in fenestrated sheet configurations up to 16 cm x 35 cm and packaged in double peel-open pouches. The devices are terminally sterilized using electron beam irradiation. Cytal Wound Matrix 3-Layer is pre-hydrated with sterile saline and applied to the wound. The device can be cut to different sizes. The device is intended for one time use.

The document provides information on the Cytal® Wound Matrix 3-Layer and its substantial equivalence to a predicate device. However, it does not describe acceptance criteria or a study proving that the device meets those criteria in the typical sense of a diagnostic or AI device performance study.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (ACell, Inc. Cytal® Wound Matrix (K152721)) for regulatory clearance. This involves showing that the new device has "the same intended uses and similar indications, technological characteristics, and principles of operation" and that minor differences "raise no new issues of safety or effectiveness."

Therefore, many of the requested categories for a diagnostic or AI device study are not applicable or not explicitly detailed in this type of submission.

Here's a breakdown based on the provided text, addressing your questions where information is available and noting where it is not:

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

The document does not explicitly state "acceptance criteria" for clinical performance in the way one might for a diagnostic device (e.g., sensitivity, specificity thresholds). Instead, the performance testing aimed to show that the device "met the clinically relevant user needs, design inputs, and specifications" and functioned "as intended," demonstrating substantial equivalence.

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

• Sample size: Not specified. The document refers to "bench testing" and "design validation testing" (clinician feedback and simulated use) but does not provide specific sample sizes for these tests.
• Data provenance: Not applicable in the context of clinical data for performance; this was bench and simulated use testing.

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)

• The document mentions "clinician feedback" for design validation. The number and qualifications of these clinicians are not specified.

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

• None specified. The document briefly mentions "clinician feedback" but does not detail any adjudication method for potential discrepancies or consensus building.

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, an MRMC study was NOT done. This type of study (comparative effectiveness, human readers, AI assistance) is relevant for diagnostic AI devices. The Cytal® Wound Matrix 3-Layer is a wound dressing, not an AI or diagnostic device, so this type of study is not applicable or performed in this context.

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

• Not applicable. As a wound matrix, there is no "algorithm only" performance to evaluate. The device's performance is inherent in its material properties and interaction with biological systems.

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

• For the technical performance aspects (suture retention, tensile, hydration, etc.), the "ground truth" would be established by engineering and material science standards and specifications.
• For "design validation" via clinician feedback and simulated use, the "ground truth" is implied to be clinician judgment regarding the device functioning as intended and meeting user needs. This is not equivalent to a clinical ground truth like pathology or patient outcomes.

8. The sample size for the training set

• Not applicable. Since this is not an AI/machine learning device, there is no "training set."

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

• Not applicable. There is no training set for this type of medical device.

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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, 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.

Cytal" Wound Matrix is composed of porcine-derived extracellular matrix scaffolds, specifically known as urinary bladder matrix. The devices are supplied in single and multi-layer sheet configurations (1 to 8 layers) in sizes up to 10 cm x 15 cm, and can be provided with or without fenestrations in both Ivophilized and vacuum pressed configurations. The device is packaged in double peel-open pouches. The devices are terminally sterilized using electron beam irradiation. The device is intended for one time use.

The technical specifications for the Cytal" Wound Matrix are as follows, depending upon whether the device is fenestrated or unfenestrated:

• . If fenestrated: Device will be provided dry in sheet sizes up to 10 x 15 cm in double sterile barrier packaging. Device will be fenestrated appropriately according to size with parallel slits along the long axis.
• . If unfenestrated: Device will be provided dry in sheet sizes up to 10 x 15 cm in double sterile barrier packaging.

This document is a 510(k) Premarket Notification for the Cytal® Wound Matrix, a medical device. This type of FDA submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through extensive clinical trials as one might see for novel technologies or pharmacuetical products. Therefore, the information provided focuses on comparative testing rather than detailed clinical performance against predefined metrics.

Here's a breakdown of the requested information based on the provided text, recognizing the nature of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" are typically framed in terms of demonstrating substantial equivalence to a predicate device, often through mechanical, biocompatibility, and sometimes functional comparison, rather than specific clinical performance metrics. The reported "device performance" then describes how the device compares to the predicate or meets general safety standards.

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 describes material-level testing rather than human clinical test sets in the typical sense for performance evaluation in a 510(k).

• Sample Size for Test Set: Not explicitly stated for each test, but standard for material testing (e.g., n=3 or n=5 per batch for mechanical or biocompatibility tests). These are material samples, not patient samples.
• Data Provenance: The tests are likely performed by contracted labs based on industry standards (ISO), not specified by country or whether retrospective/prospective in a clinical context. These are laboratory-based tests.

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 is not applicable for this 510(k) submission. "Ground truth" in this context refers to laboratory and material science standards and the results of the specific tests (e.g., measuring suture retention strength, cell viability in cytotoxicity tests), not clinical expert consensus. The results are objective measurements from scientific testing.

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

Not applicable. The tests performed are objective, quantitative measurements (e.g., chemical assays, physical strength tests), not subjective interpretations requiring adjudication among experts.

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 a medical device for wound management, not an AI or imaging device involving human readers or interpretation.

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

Not applicable. This is a physical medical device, not an algorithm or AI.

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

The "ground truth" for the tests described is based on:

• Standardized Test Methods: Adherence to established international standards (e.g., ISO-10993-1 for biocompatibility). The "truth" is whether the material successfully passes the criteria defined within those standards.
• Objective Measurements: Laboratory measurements of physical properties (e.g., suture retention strength) and biological responses (e.g., cytotoxicity levels).

There is no mention of pathology, expert consensus, or clinical outcomes data for defining "ground truth" in this 510(k) filing.

8. The sample size for the training set

Not applicable. This is a physical medical device undergoing material and biocompatibility testing, not an AI or machine learning model that requires a training set.

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

Not applicable, as no training set is involved.

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