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Cytal® Wound Particulate 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 onetime use.

Cytal® Wound Particulate is composed of a resorbable, porcine-derived, extracellular matrix scaffold containing epithelial basement membrane, specifically known as Urinary Bladder Matrix (UBM). The devices are supplied as a dry, absorbent, white to off-white particulate sized

Here's a breakdown of the acceptance criteria and study information for the Cytal Wound Particulate, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a discrete table of acceptance criteria with specific numerical targets. Instead, it describes "performance testing" to address a size change and demonstrate substantial equivalence to a predicate device. The general acceptance criterion implied is that the device "functioned as intended and the results observed were as expected" for each test.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample sizes used for the "Performance Data" tests (Particle Size Characterization, Dispensing, Sterilization Validation, Endotoxin).

Data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data mentioned. Given the nature of these tests (characterization, deployability, sterilization, endotoxin), they are typically conducted as part of the manufacturing and quality control process, likely at the manufacturer's facilities.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The tests described (e.g., particle size, endotoxin) are objective laboratory measurements, not typically requiring expert consensus for ground truth establishment in the same way clinical or diagnostic studies would.

4. Adjudication Method for the Test Set

This information is not applicable as the tests performed are objective laboratory measurements rather than assessments that would require adjudication among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes performance testing related to product characteristics and manufacturing, not a clinical study involving human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device, Cytal Wound Particulate, is a medical device product (an animal-derived extracellular matrix scaffold for wound management), not an algorithm or AI system.

7. The Type of Ground Truth Used

For the described "Performance Data" (Particle Size Characterization, Dispensing, Sterilization Validation, Endotoxin), the "ground truth" would be objective laboratory measurements against established specifications or industry standards for each test. For example, for endotoxin, the ground truth would be the quantitative endotoxin level measured against a defined acceptable limit.

8. The Sample Size for the Training Set

This question is not applicable as the device is not an AI/ML-based system requiring a training set.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as the device is not an AI/ML-based system.

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