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Mepilex Ag Dressing is indicated for the management of low to moderately exuding wounds such as leg and foot ulcers, pressure ulcers and partial thickness burns. Silver sulphate present in the dressing helps reduce microbial colonization on the dressing.

Mepilex Ag is an anti-microbial, absorbent soft silicone dressing consisting of a flexible, absorbent polvurethane foam pad with added silver and activated charcoal, which is coated with a silicone wound contact layer and a wrinkled water vapor permeable polyurethane film backing. The silicone layer is covered with a polyethylene release film.

The provided 510(k) summary for the Mepilex Ag Dressing indicates that no clinical data was submitted as part of this specific submission. The submission is a "Special 510(k)," which often signifies that no changes were made to the currently marketed device or its indications for use. Instead, the submission focuses on demonstrating substantial equivalence to a previously marketed device (K061554) based on a comparison of technological characteristics and non-clinical data (shelf life).

Therefore, I cannot provide a detailed answer to your request regarding acceptance criteria and studies that prove the device meets them, as the relevant information is explicitly stated as "Not applicable" for clinical data in this document.

Here's what can be extracted from the document regarding the information you requested, based on the absence of clinical data:

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

   • No acceptance criteria for device performance in clinical settings are mentioned, as no clinical studies were performed for this submission.
   • The "performance" documented relates to non-clinical data: "The data provided in this submission substantiate a 24 month shelf life." No specific acceptance criteria for shelf-life are given.

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

   • Not applicable, as no clinical test set was used for this 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):

   • Not applicable, as no clinical test set requiring expert ground truth was used.

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

   • Not applicable, as no clinical test set requiring adjudication was used.

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, as this device is a medical dressing, not an AI-assisted diagnostic tool, and no clinical studies were performed.

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

   • Not applicable, as this is a medical dressing, not an algorithm.

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

   • Not applicable, as no clinical studies requiring ground truth for device performance were conducted for this submission.

8. The sample size for the training set:

   • Not applicable, as no machine learning algorithm was developed for this device in this submission.

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

   • Not applicable, as no machine learning algorithm was developed for this device in this submission.

In summary: This 510(k) submission is specifically a "Special 510(k)" relying on demonstrating substantial equivalence to a predicate device without new clinical data. The information you're requesting primarily relates to clinical performance studies, which were not part of this specific regulatory filing for the Mepilex Ag Dressing.

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