(28 days)
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.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Suture retention strain meets design specifications | Testing performed; functioned as intended; results as expected. |
| Tensile strain meets design specifications | Testing performed; functioned as intended; results as expected. |
| Hydration uptake meets design specifications | Testing performed; functioned as intended; results as expected. |
| Dimensional analysis meets design specifications | Testing performed; functioned as intended; results as expected. |
| Packaging performance meets design specifications | Testing performed; functioned as intended; results as expected. |
| Clinician feedback is positive | Design validation completed via clinician feedback; functioned as intended; results as expected. |
| Simulated use testing is successful | Design validation completed via simulated use testing; functioned as intended; results as expected. |
| No new issues of safety or effectiveness | Performance data demonstrates the larger Cytal Wound Matrix 3-Layer is as safe and effective as the cleared Cytal Wound Matrix. |
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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