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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

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.

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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

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).

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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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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.

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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Mepilex is designed for a wide range of shallow wounds, which have low to moderate levels of exudate, e.g., leg ulcers, pressure ulcers and skin lesions.

The Mepilex is a sterile, absorbent silicone-coated dressing designed for a wide range of shallow wounds, which have low to moderate levels of exudate, e.g., leg ulcers, pressure ulcers and skin lesions.

This document is a 510(k) premarket notification for a medical device called Mepilex™, a sterile, absorbent silicone-coated wound dressing. The submission aims to demonstrate substantial equivalence to a predicate device, the Cutinova® Foam Dressing.

The document does not describe a study involving acceptance criteria and device performance in the context of an AI/ML algorithm or software. Instead, it focuses on the substantial equivalence of and biological safety of a wound dressing. Therefore, most of the requested information regarding AI/ML study details (e.g., sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies) is not applicable.

Here's an analysis based on the provided text, focusing on the available information:

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

The document does not contain a table of acceptance criteria in the sense of specific performance metrics for a device, nor does it report specific device performance data for Mepilex™ in a quantitative manner. The acceptance for this submission is based on substantial equivalence to an existing predicate device and biological safety testing.

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

This information is not applicable as the document describes a wound dressing and focuses on substantial equivalence and biocompatibility, not an AI/ML or software device requiring a test set of data. The biological tests performed for ISO 10993 Part I typically involve in vitro and in vivo (animal) studies, not a "test set" of clinical data in the context of AI.

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)

This information is not applicable. Ground truth for a test set is relevant for AI/ML device validation, which is not the subject of this 510(k) submission.

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

This information is not applicable for the same reasons as above.

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

An MRMC study is not applicable as this submission is for a physical wound dressing, not an AI-assisted diagnostic tool.

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

This information is not applicable as the device is not an algorithm.

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

This information is not applicable in the context of AI/ML ground truth. For biological safety testing, the "ground truth" would be the observed biological response to the material as interpreted by toxicologists or biocompatibility experts against established standards (ISO 10993). For substantial equivalence, the "ground truth" is the established characteristics and performance of the predicate device.

8. The sample size for the training set

This information is not applicable as this is not an AI/ML device requiring a training set.

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

This information is not applicable as this is not an AI/ML device.

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