(234 days)
Mepelix 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 polyurethane 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.
This document describes the Mepilex Ag Absorbent Silicone-Coated Dressing, a wound dressing with antimicrobial properties. The key information is extracted and presented below regarding its acceptance criteria and the studies performed.
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state quantitative acceptance criteria in a dedicated section. However, the "Summary of Testing for Anti-microbial Properties" describes the demonstrated performance, which implicitly serves as the criteria for substantial equivalence.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Non-cytotoxic, non-irritating, non-sensitizing for a surface device used on breached or compromised surfaces for up to several days. | Mepilex Ag was tested for cytotoxicity, sensitization and irritation and was found to be non-cytotoxic, non-irritating and non-sensitizing. |
| Microbial Barrier | Provide a barrier against microbial contamination. | The Mepilex Ag has been shown to provide a barrier against microbial contamination. |
| Inactivation of Bacteria & Fungi (24 hr) | Inactivate a wide range of bacteria and fungi during a 24-hour period (in-vitro). | The Mepilex Ag has been shown to inactivate a wide range of bacteria and fungi during a 24 hour period as shown in-vitro in the Corrected Zone of Inhibition (CZOI) test method. |
| Sustained Inactivation of Bacteria (7 days) | Inactivate representative bacteria up to 7 days (in-vitro). | Mepilex Ag has also been shown to inactivate representative bacteria up to 7 days, as shown in vitro in CZOI. |
| Rapid Inactivation of Bacteria | Inactivate bacteria within 30 hours (in-vitro). | Mepilex Ag has also been shown to inactivate bacteria within 30 hours, as shown in vitro in Shake flask method ASTM E2141-01. |
| Sustained Silver Ion Release | Demonstrate a sustained release of silver ions. | The Mepilex Ag has demonstrated a sustained release of silver Ions for up to 7 days. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the exact sample sizes used for the in-vitro antimicrobial tests (CZOI and Shake Flask). It only states that the tests were conducted in-vitro.
- Test set sample size: Not explicitly stated for each test.
- Data provenance: In-vitro laboratory tests. No country of origin is mentioned for the data, but the applicant is Mölnlycke Health Care from Norcross, GA, USA. The nature of the studies is experimental, not retrospective or prospective clinical studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This submission pertains to in-vitro laboratory testing and biocompatibility testing, not clinical studies involving interpretation of medical images or patient outcomes by experts. Therefore, the concept of "experts establishing ground truth for a test set" with qualifications like "radiologist with 10 years of experience" is not applicable here. The ground truth for these types of tests is established by adhering to standardized laboratory protocols and measurement techniques.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where human readers interpret data or images. This is not applicable to the in-vitro performance and biocompatibility tests described in this 510(k) summary. The results of the laboratory tests are objective measurements based on established protocols.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned or conducted, as this device submission relies on in-vitro performance and biocompatibility rather than clinical efficacy involving human readers. The document states that the device is "substantially equivalent in composition, function and 'indications for use' to the Contreet Foam Dressings and the 3M Tegaderm Silver Nonwoven Dressing," and "substantially equivalent in design to the currently marketed Mepilex Absorbent Silicone-Coated Dressing." This is a comparison to predicate devices, not a study involving human readers with and without AI assistance.
6. Standalone Performance Study
Yes, standalone (i.e., algorithm only without human-in-the-loop performance) studies were done. The antimicrobial properties and biocompatibility were evaluated through in-vitro laboratory tests (CZOI, Shake Flask method, and standard biocompatibility assessments) without human intervention in the performance of the device's core function. The device's performance in reducing microbial colonization is inherent to its design and material properties, tested independently.
7. Type of Ground Truth Used
The ground truth for the performance tests is based on:
- Biocompatibility: Standardized in-vitro tests for cytotoxicity, sensitization, and irritation as recommended by FDA guidance (using the "FDA-modified matrix"). The "ground truth" is the objective biological response observed in these controlled experiments.
- Antimicrobial Properties: Established in-vitro laboratory methods, specifically the Corrected Zone of Inhibition (CZOI) test method and the Shake Flask method ASTM E2141-01. The "ground truth" is the quantitative measurement of bacterial/fungal reduction or inhibition zone size according to these validated protocols.
8. Sample Size for the Training Set
This submission does not discuss any "training set" in the context of machine learning or AI. The tests performed are laboratory-based experimental validations of device properties, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a "training set" or AI/machine learning model in this 510(k) summary, the concept of establishing ground truth for a training set is not applicable. The product is a physical wound dressing, and its performance is evaluated through direct in-vitro and biocompatibility testing.
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