(47 days)
Mepilex is designed for a wide range of shallow wounds, which have low to moderate levels of exudate, e.g., leg ulcers, pressure ulcers and skin lesions.
The Mepilex is a sterile, absorbent silicone-coated dressing designed for a wide range of shallow wounds, which have low to moderate levels of exudate, e.g., leg ulcers, pressure ulcers and skin lesions.
This document is a 510(k) premarket notification for a medical device called Mepilex™, a sterile, absorbent silicone-coated wound dressing. The submission aims to demonstrate substantial equivalence to a predicate device, the Cutinova® Foam Dressing.
The document does not describe a study involving acceptance criteria and device performance in the context of an AI/ML algorithm or software. Instead, it focuses on the substantial equivalence of and biological safety of a wound dressing. Therefore, most of the requested information regarding AI/ML study details (e.g., sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies) is not applicable.
Here's an analysis based on the provided text, focusing on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not contain a table of acceptance criteria in the sense of specific performance metrics for a device, nor does it report specific device performance data for Mepilex™ in a quantitative manner. The acceptance for this submission is based on substantial equivalence to an existing predicate device and biological safety testing.
| Acceptance Criteria Category | Description from Document | Performance/Outcome |
|---|---|---|
| Substantial Equivalence | "Mepilex is substantially equivalent in composition, function and intended use to the Beiersdorf AG Cutinova® Foam Dressing." | Met: The FDA reviewed the 510(k) and determined the device is substantially equivalent, allowing it to be marketed. |
| Biological Safety | "Mepilex have been found to be non-toxic and non-irritating when tested by the above biological tests in accordance with the ISO 10993 Part I, 'Biological Evaluation of Medical Devices' with FDA modified matrix (Guidance effective July 1, 1995)." | Met: Device demonstrated non-toxicity and non-irritation as per ISO 10993 Part I and FDA guidance. |
| Intended Use | "Mepilex is designed for a wide range of shallow wounds, which have low to moderate levels of exudate, e.g., leg ulcers, pressure ulcers and skin lesions." | Met: The indications for use were accepted by the FDA. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not applicable as the document describes a wound dressing and focuses on substantial equivalence and biocompatibility, not an AI/ML or software device requiring a test set of data. The biological tests performed for ISO 10993 Part I typically involve in vitro and in vivo (animal) studies, not a "test set" of clinical data in the context of AI.
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. Ground truth for a test set is relevant for AI/ML device validation, which is not the subject of this 510(k) submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable for the same reasons as above.
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
An MRMC study is not applicable as this submission is for a physical wound dressing, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable in the context of AI/ML ground truth. For biological safety testing, the "ground truth" would be the observed biological response to the material as interpreted by toxicologists or biocompatibility experts against established standards (ISO 10993). For substantial equivalence, the "ground truth" is the established characteristics and performance of the predicate device.
8. The sample size for the training set
This information is not applicable as this is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI/ML device.
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