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A topical wound dressing for the treatment of difficult to dress wounds, surface wounds, exudating wounds, including:

• pressure ulcers,
• venous ulcers
• diabetic ulcers
• arterial ulcers
• donor sites
• dermal lesions
• trauma injuries
• incisions

Laboratory studies for Arglaes AB wound powder have shown the product to resist bacterial penetration through the dressing which may help minimize the risk of infection¹. This effect may be limited based upon evenness of application and contact with the wound surface.

Arglaes-AB Powder is a dressing in powder form that is comprised of silver oxide stabilized within a polymer composed of phosphorus oxide, sodium oxide, calcium oxide and silver oxide. The balance of the powder is comprised of phosphorus oxide, sodium oxide and calcium oxide (no silver) and of sodium alginate powder.
Sodium alginate is substantially equivalent to the alginate component of the Arglaes-AB Antimicrobial Barrier Island Dressing. Its primary function is to absorb wound exudate and to help control minor bleeding.
The silver oxide is substantially equivalent to the silver oxide component of the Arglaes-AB Antimicrobial Barrier Film and Island dressings. This helps resist bacterial penetration through the dressing.³

This document describes the FDA 510(k) clearance for the Arglaes-AB Antimicrobial Barrier Powder Dressing. It is important to note that this is a 510(k) clearance for a medical device (a wound dressing), not an AI/ML powered device. Therefore, many of the requested specific details related to AI/ML device studies (e.g., sample sizes for AI test/training sets, number of experts for ground truth, MRMC studies, standalone performance) are not applicable or available in this type of FDA submission.

However, I will extract and present the information that is relevant to the device's performance and testing as described in these documents.

The device in question is a wound dressing with antimicrobial barrier properties, not an AI/ML powered medical device. Therefore, the types of studies and acceptance criteria are focused on the physical and biological characteristics of the dressing, rather than algorithmic performance.

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

Important Note: The document explicitly states: "Laboratory studies for Arglaes AB wound powder have shown the product to resist bacterial penetration through the dressing which may help minimize the risk of infection. This effect has not been demonstrated clinically at this time." This indicates that while in vitro performance criteria were met, clinical efficacy was not part of this 510(k) submission.

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

• Sample Size: The document does not specify the sample sizes used for the USP XXIII Preservative Test, 7-Day Antimicrobial Barrier Test, or biocompatibility tests. These are typically standard laboratory tests with defined numbers of samples per group (e.g., replicates for microbial assays, number of animals for biocompatibility).
• Data Provenance: The studies are described as "Laboratory studies" and "in vitro." The sponsor, Maersk Medical, Ltd., is located in Redditch, Worcestershire, England. The studies were likely conducted either by Maersk Medical or contracted by them, but the specific country of origin for the data generation is not explicitly stated. These are in vitro and in vivo (animal for biocompatibility) studies, not human clinical trials.

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 question is not applicable to this 510(k) submission for a wound dressing. "Ground truth" in the context of AI/ML usually refers to human-labeled data used to evaluate algorithm performance. For laboratory tests of a wound dressing, the "ground truth" is established by the well-defined procedures and objective measurements of the standardized tests themselves (e.g., microbial counts, visual inspection for irritation scores). No human experts are used in this capacity to "establish ground truth" for these types of tests.

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

Not applicable. Adjudication methods like "2+1" or "3+1" are typical for resolving discrepancies among human readers/annotators in AI/ML studies. For standardized laboratory tests, results are typically determined by adherence to a protocol and objective measurement, not by expert adjudication.

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. MRMC studies are specifically designed for evaluating diagnostic devices, often involving human interpretation of medical images, and are highly relevant for AI-assisted diagnostic tools. This submission is for a physical wound dressing, not a diagnostic or AI-powered device.

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

Not applicable. This is not an AI algorithm; it is a physical wound dressing with antimicrobial properties.

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

For the antimicrobial tests, the "ground truth" is the demonstrable presence or absence of microbial growth or penetration based on objective laboratory assays (e.g., colony forming units, visual evidence of strikethrough). For biocompatibility, the "ground truth" is the observed biological response (e.g., cell viability in cytotoxicity, skin reaction scores in irritation/sensitization) as measured against control groups and defined thresholds within standardized test protocols.

8. The sample size for the training set

Not applicable. This is not an AI/ML device; therefore, there is no "training set."

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

Not applicable. As there is no AI/ML component, there is no training set and no ground truth established for it.

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