(252 days)
Mepilex Border Ag dressing is indicated for the management of exuding wounds such as leg and foot ulcers, pressure ulcers, traumatic and surgical wounds, superficial and partial thickness burns. Mepilex Border Ag can also be used under compression bandaging. Silver sulfate present in the dressing helps reduce microbial colonization on the dressing.
Mepilex Border Ag consists of a Safetac soft silicone wound contact layer, an absorbent polyurethane foam pad containing a silver compound and activated carbon, a layer with super absorbent polyacrylate fibres, a non woven and a vapour permeable waterproof film. Mepilex Border Ag is a soft silicone foam dressing that absorbs exudate, maintains a moist wound healing environment and has antimicrobial properties. Mepilex Border Ag contains silver sulfate that when in contact with fluid releases silver ions to inactivate a wide range of wound related pathogens (bacteria and fungi), shown in vitro. By reducing the number of wound related putnogens (bacteria and lung), shown in the Mepilex Border Ag has been shown to inactivate wound related pathogens up to 7 days in vitro.
The provided documents describe the Mepilex Border Ag dressing, which is a silver-containing foam dressing. The 510(k) summary focuses primarily on the device's antimicrobial and biocompatibility properties. It details performance tests related to these aspects.
Here's an analysis based on the provided text, addressing your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| Cytotoxicity | Non-cytotoxic |
| Sensitization | Non-sensitizing |
| Irritation | Non-irritating |
| Antimicrobial Properties: | |
| Barrier against microbial contamination | Shown to provide a barrier against microbial contamination |
| Inactivation of broad range of bacteria and fungi | Shown to inactivate a broad range of bacteria and fungi (in vitro, as per ASTM E2149-01) and wound-related pathogens |
| Sustained antimicrobial activity | Shown to inactivate representative bacteria and fungi for up to 8 days (as per ASTM E2149-01) |
| Sustained silver release | Shows a sustained release of silver over this time period (up to 8 days) |
| Rapid antimicrobial activity | Shown to inactivate bacteria within 30 hours (as in demonstrated by ASTM E2149-01 "Determining antimicrobial activity of immobilized antimicrobial agents") |
2. Sample Size Used for the Test Set and Data Provenance
The documents do not provide details on the sample size used for the test set in terms of number of dressings or bacterial/fungal strains specifically. The methods refer to "representative bacteria and fungi" and "broad range of bacteria and fungi" but do not quantify them.
The provenance of the data is in vitro (laboratory testing) as explicitly stated for the antimicrobial properties. There is no information regarding country of origin or whether clinical (prospective/retrospective) data was used.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the given text. The tests described (biocompatibility and antimicrobial) are laboratory-based and generally follow standardized protocols (e.g., ASTM E2149-01) rather than relying on expert consensus for establishing ground truth.
4. Adjudication Method for the Test Set
This information is not applicable/provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human interpretation of data, where discrepancies need to be resolved. The described tests are laboratory analyses with objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done according to the provided text. This type of study is relevant for evaluating diagnostic or interpretive devices where human readers are involved. The Mepilex Border Ag is a therapeutic dressing, and its performance evaluation focuses on its inherent material properties and biological effects.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable to the Mepilex Border Ag dressing. This type of performance evaluation is typically for AI/software-as-a-medical-device (SaMD) products. The device in question is a physical wound dressing; therefore, there is no "algorithm only" performance to evaluate.
7. The Type of Ground Truth Used
The ground truth for the biocompatibility tests (cytotoxicity, sensitization, irritation) would be established by standard biological assays and observation of biological responses (e.g., cell viability, skin reactions) against predefined thresholds for acceptable limits.
The ground truth for the antimicrobial properties was established by in vitro laboratory results using standardized test methods (specifically listed as ASTM E2149-01). This standard dictates how to "Determine antimicrobial activity of immobilized antimicrobial agents," providing objective measurements of bacterial/fungal reduction or inactivation.
8. The Sample Size for the Training Set
This information is not provided and is not applicable in the context of this device. A "training set" refers to data used to train machine learning models. The Mepilex Border Ag is a physical medical device, not an AI/ML-based diagnostic or therapeutic algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable for the reasons stated above (no training set for a physical device).
N/A