(108 days)
Mepilex® Transfer Ag dressing is indicated for the management of a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers, partial thickness burns, traumatic and surgical wounds. Mepilex® Transfer Ag can also be used under compression bandaging.
Mepilex® Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound environment and has antimicrobial properties. A moist wound environment is shown to be beneficial for wound healing. Mepilex® Transfer Ag contains silver sulphate which acts as a preservative to reduce or minimize growth of microorganisms within the dressing. Mepilex® Transfer Ag has been shown to inactivate microorganisms for up to 14 days in vitro. Mepilex® Transfer Ag consists of: a Safetac® adhesive layer which is a unique and a patented adhesive technology; a compressed polyurethane foam containing silver sulphate and activated carbon.
This document describes the Mepilex® Transfer Ag wound and burn dressing. Here's an analysis of the provided text regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Testing) | Reported Device Performance |
|---|---|
| Antimicrobial effect against 16 strains | "All areas performed as expected to provide a level of efficacy deemed necessary for the intended use of this device." |
| Antimicrobial effect inside the dressing against P.a, S.a and C.a | "All areas performed as expected to provide a level of efficacy deemed necessary for the intended use of this device." |
| Preservation to reduce or minimize growth of microorganisms within the dressing | "Mepilex® Transfer Ag has been shown to inactivate microorganisms for up to 14 days in vitro." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Antimicrobial effect against 16 strains" and "Antimicrobial effect inside the dressing against P.a, S.a and C.a." However, it does not specify the sample sizes (e.g., number of dressings, replicates, or experiments) used for these in vitro tests.
The data provenance is in vitro (laboratory-based) testing. The country of origin of the data is not specified. It is inherently retrospective as the tests were completed before the 510(k) submission.
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 "ground truth" for the in vitro antimicrobial tests would be established by the testing methodology and controls used in the laboratory experiments, rather than expert consensus on data interpretation.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable to the type of in vitro testing performed. Adjudication methods are typically used in clinical studies or image-based diagnostic evaluations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
No, an MRMC comparative effectiveness study was not done. This device is a wound dressing, not an AI-powered diagnostic tool, so such a study would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone algorithm performance study was not done. This device is a medical product, not a software algorithm.
7. The Type of Ground Truth Used
The ground truth used for the performance evaluation was based on in vitro antimicrobial testing standards and methodologies. This involves observing and quantifying the reduction or inactivation of specific microorganisms under controlled laboratory conditions.
8. The Sample Size for the Training Set
This is not applicable. The Mepilex® Transfer Ag is a physical medical device (wound dressing), not an AI model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
This is not applicable, as there is no training set for this type of device.
N/A