(401 days)
Mepitel® Ag is intended for the management of a wide range of exuding wounds such as skin abrasions, sutured/surgical wounds, partial thickness burns, partial and full thickness grafts, lacerations, diabetic ulcers, and arterial ulcers. Silver Sulphate is added to the dressing as a preservative to inhibit or reduce microbial growth on the dressing.
Mepitel Ag is a soft silicone wound contact layer that allows exudate to pass vertically into a secondary dressing. Mepitel Ag makes it possible to change only the secondary absorbent dressing. It maintains its structural integrity and can be left in place for up to eight (8) days depending on the wound condition and surrounding skin (or as indicated by accepted clinical practice). In vitro testing demonstrates that Mepitel Ag gives a ≥4 log reduction, on the dressing, of the following Gram positive bacteria, Gram negative bacteria and yeast; Enterococcus feacalis (VRE), Staphylococcus aureus (MRSA), Staphylococcus epidermidis, Acinetobacter baumanii, Enterobacter cloacae, Pseudomonas aeruginosa, Candida albicans, Candida guillermondi, Candida lusitiane. The dressing sustains antimicrobial activity for up to eight (8) days in in vitro studies. By reducing the number of micro-organisms, Mepitel Ag may also reduce odour. Mepitel Ag has shown to have a 4 log microbial reduction up to eight (8) days when tested in vitro with a secondary dressing. Mepitel Ag maintains a moist wound environment in combination with a secondary dressing. Mepitel Ag can be used under compression bandaging. Mepitel Ag consists of: - a Safetac adhesive layer containing silver sulphate and cellulose compound. Safetac is a unique and a 1. patented adhesive technology. - 2. a polyamide net Contents of the dressing: Polydimethylsiloxane, Polyamide, Sodium carboxymethylcellulose. The product and its packaging are not made with natural rubber latex.
The provided text describes the regulatory submission for a wound dressing, Mepitel® Ag, and its performance testing. However, it does not include information about AI/ML device performance, multi-reader multi-case (MRMC) studies, or complex ground truth establishment as often seen in diagnostic imaging or AI applications. The "device" in this context is a wound dressing, not a software algorithm.
Therefore, the following information is extracted and presented as per the request, but many sections will be marked as "Not Applicable" because the provided document is for a medical device (a wound dressing) that does not employ AI or require those types of studies.
K130040: Mepitel® Ag Wound Dressing Acceptance Criteria and Performance
This summary is based on the provided 510(k) submission for the Mepitel® Ag wound dressing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Antimicrobial Effect (In vitro) | ≥4 log reduction of specified bacteria and yeast on the dressing | Mepitel Ag gives a ≥4 log reduction, on the dressing, of the following Gram positive bacteria, Gram negative bacteria and yeast; Enterococcus faecalis (VRE), Staphylococcus aureus (MRSA), Staphylococcus epidermidis, Acinetobacter baumanii, Enterobacter cloacae, Pseudomonas aeruginosa, Candida albicans, Candida guillermondi, Candida lusitiane. |
| Antimicrobial Duration (In vitro) | Sustained antimicrobial activity for up to eight (8) days | The dressing sustains antimicrobial activity for up to eight (8) days in in vitro studies. |
| Antimicrobial Effect with Secondary Dressing (In vitro) | 4 log microbial reduction up to eight (8) days when tested in vitro with a secondary dressing | Mepitel Ag has shown to have a 4 log microbial reduction up to eight (8) days when tested in vitro with a secondary dressing. |
| Moist Wound Environment | Maintains a moist wound environment in combination with a secondary dressing | Mepitel Ag maintains a moist wound environment in combination with a secondary dressing. |
| Compatibility with Compression | Usable under compression bandaging | Mepitel Ag can be used under compression bandaging. |
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a "test set" in the context of an algorithm. The testing described is in vitro (laboratory) against microbial strains, not human data.
- Data Provenance: In vitro laboratory testing. Not applicable for country of origin or retrospective/prospective human data.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- Not applicable. The "ground truth" for this device's performance is determined by microbiological and physical in vitro testing, not by expert consensus on clinical data.
4. Adjudication Method (Test Set)
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review of clinical cases. This device underwent in vitro performance testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No. This is a wound dressing, not an AI performance study with human readers.
- Effect size of human readers improve with AI vs without AI assistance: Not applicable.
6. Standalone (Algorithm Only) Performance Study
- Was it done? No. This is a physical wound dressing, not a software algorithm.
7. Type of Ground Truth Used
- Ground Truth: In vitro microbiological data (specific bacterial and yeast strains and their reduction rates) and physical performance characteristics of the dressing (e.g., maintaining moist environment, structural integrity, compatibility with compression).
8. Sample Size for Training Set
- Not applicable. This is a conventional medical device (wound dressing), not an AI/ML algorithm that requires a training set.
9. How Ground Truth for Training Set Was Established
- Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
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