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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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FILM DRESSING
ARGLAES-AB Antimicrobial Film Dressings are sterile, transparent, and self-adherent dressings intended for the local management of pressure sores, incisions, donor sites, minor burns, abrasions and lacerations, superficial leg ulcers and other dermal ulcers.
ARGLAES-AB Antimicrobial Film Dressings are also intended to help secure and protect intravenous catheters.

ISLAND DRESSING
ARGLAES-AB Antimicrobial Barrier Island Dressings are sterile wound dressingscomposed of a calcium alginate pad presented on a visually clear, selfadherent, antimicrobial barrier film backing.
ARGLAES-AB Antimicrobial Barrier Island Dressings are intended for the local management of exuding wounds, including infected and non-infected:

• Pressure Ulcers
• Venous Ulcers
• Diabetic Ulcers
• Arterial Ulcers
• Donor Sites and other bleeding surface wounds
• Dermal lesions, trauma injuries or incisions.
  ARGLAES-AB Antimicrobial Barrier Island Dressings are contraindicated for third degree burns or for use on individuals with a known sensitivity to silver.

ARGLAES-AB™ Antimicrobial Barrier Film Dressings are sterile, visually clear, oxygen and moisture vapor permeable, and self-adherent dressings for use in wound care and venipuncture site management. ARGLAES-AB™ dressings are an effective protection against microbial contamination.
ARGLAES-AB™ Antimicrobial Barrier Island Dressings are sterile wound dressings composed of a calcium alginate pad presented on a visually clear, self-adherent, antimicrobial barrier film backing. The ARGLAES-AB™ island dressing combines the advantages of a calcium alginate wound dressing together with ARGLAES-AB™ antimicrobial barrier film protection against wound site contamination.

The provided document is a 510(k) Summary for a medical device submitted to the FDA in 1999. It focuses on establishing substantial equivalence to previously cleared devices for wound care dressings with antimicrobial barrier properties.

Based on the content, here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of "Acceptance Criteria": In a 510(k) submission, formal "acceptance criteria" for performance are often outlined by the FDA and/or derived from recognized standards. This summary focuses on demonstrating equivalence, so the "acceptance criteria" here are implicitly linked to the performance characteristics of the predicate devices and the specific claims being made (sustained antimicrobial barrier). The success criterion for the in vitro tests was that the film "demonstrate sustained antimicrobial barrier activity."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the exact sample size (number of dressings tested) for the in vitro 7-day antimicrobial barrier (strike-through) tests. It lists the microbial strains challenged but not the number of replicates or individual dressings used for each challenge.
• Data Provenance: The studies were "in vitro," meaning they were conducted in a laboratory setting, not on human or animal subjects. The country of origin of the data is not explicitly stated, but the submitter is "MAERSK MEDICAL, LTD." from England. The studies are described as "preclinical performance studies," and there is no indication of retrospective or prospective human clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

• Not Applicable: This was an in vitro laboratory study. There was no "ground truth" to be established by human experts in the context of diagnostic interpretation or clinical outcomes. The "ground truth" was the objective measurement of microbial growth through the barrier film in a controlled laboratory environment.

4. Adjudication Method for the Test Set

• Not Applicable: As an in vitro study with objective measurements of microbial growth, there would be no need for an adjudication method by human observers.

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: This is not a study involving AI, human readers, or diagnostic image interpretation. It's an in vitro performance study of a wound dressing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• Not Applicable: See point 5. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

• Objective Laboratory Measurement / Experimental Result: The ground truth for the antimicrobial barrier studies was the measurable outcome of the in vitro experiments – specifically, whether the microbial strains successfully "struck through" the ARGLAES-AB™ film within the 7-day test period. A "sustained antimicrobial barrier activity" was the desired objective result.

8. The Sample Size for the Training Set

• Not Applicable: There is no "training set" in this context. This is a traditional medical device (wound dressing) being evaluated for physical and biological properties, not a machine learning model.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable: See point 8.

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ARGLAES-AB Antimicrobial Barrier Island Dressings are intended for the local management of exuding wounds, including infected and non-infected:

• Pressure Ulcers
• · Venous Ulcers
• · Diabetic Ulcers
• Arterial Ulcers
• Donor Sites and other bleeding surface wounds
• Dermal lesions, trauma injuries or incisions.

ARGLAES-AB Antimicrobial Barrier Island Dressings are contraindicated for third degree burns, for use on individuals with a known sensitivity to silver, and are not intended to be surgically implanted.

ARGLAES-AB Antimicrobial Barrier Island Dressings are sterile wound dressings composed of a calcium alginate pad presented on a visually clear, self-adherent, antimicrobial barrier film backing.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a device called "Arglaes-AB Antimicrobial Barrier Island Dressing."

This letter confirms that the FDA has reviewed the manufacturer's submission (K973657) and determined the device is "substantially equivalent" to predicate devices marketed before May 28, 1976. It outlines the regulatory class, product code, and specific limitations on labeling claims for the device. The "Indications For Use Statement" provides details on what the dressing is intended for and its contraindications.

However, the document does not contain:

• A table of acceptance criteria or reported device performance.
• Details on sample sizes, data provenance, or types of studies conducted (e.g., test sets, training sets) for performance evaluation.
• Information about expert involvement for ground truth, adjudication methods, or MRMC studies.
• Any discussion of standalone algorithm performance or specific ground truth types used for device validation.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive new clinical trials or performance studies that would typically include the kind of detailed information you're asking for.

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ARGLAES Film Dressings are sterile, transparent, and self-adherent dressings intended for the local management of pressure sores, incisions, donor sites, minor burns, abrasions and lacerations, superficial leg ulcers and other dermal ulcers. ARGLAES Film Dressings are also intended to help secure and protect intravenous catheters.

ARGLAES-AB Antimicrobial Barrier Film Dressing

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a medical device (ARGLAES-AB Antimicrobial Barrier Film Dressing) from 1997. It outlines the regulatory classification, limitations on labeling, and general controls, as well as the device's intended use.

However, it does not include any details about an acceptance criteria table, device performance, sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established. This type of detailed study information is typically found in a separate clinical study report or a more comprehensive summary of safety and effectiveness, which is not part of this 510(k) clearance letter.

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