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The barrier functions of Urgocell Ag, antimicrobial wound dressing with silver, may help reduce infection in moderately to high exuding partial and full thickness wounds, including decubitus ulcers, venous static ulcers, diabetic ulcer, first and second degree burns, donor and graft sites.

Urgocell® Ag, antimicrobial wound dressing with silver, is a non-adhesive, non-occlusive, antimicrobial absorbent dressing, composed of 3 layers:

• in contact with the wound, a polyester mesh impregnated with a matrix comprising of hydrocolloid particles (carboxymethylcellulose), cohesion polymers, petroleum jelly and silver sulphate (3.22 mg/sq.in)
• a non-sensitising, super-absorbent polyurethane foam pad,
• a protective, semi-permeable polyurethane backing.

The provided text describes a 510(k) premarket notification for a medical device called Urgocell® Ag Antimicrobial Wound Dressing with Silver. The focus of the submission is to demonstrate substantial equivalence to a legally marketed predicate device (Urgocell Ag K062559).

The document does not describe a study that uses acceptance criteria in the traditional sense of a clinical trial proving specific performance metrics with statistical significance. Instead, it relies on demonstrating equivalence through various comparisons, primarily related to antimicrobial activity and safety.

Here's a breakdown of the requested information based on the provided text:

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

The concept of "acceptance criteria" for a new, modified device in a 510(k) submission is typically focused on demonstrating that the modified device is as safe and effective as the predicate device. For this submission, the key acceptance criteria revolve around antimicrobial activity and safety.

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

• Antimicrobial Activity Studies: The text only states "Studies of antimicrobial activity were previously conducted" and "data was submitted concerning the antimicrobial activity of Urgocell® Ag on three new strains." It does not specify the sample size (e.g., number of replicates or experiments) for these in-vitro tests, nor does it explicitly state the data provenance (country or retrospective/prospective). These are typically laboratory-based, prospective studies.
• Safety Studies (Cytotoxicity, Irritation, Sensitization): These are standard biocompatibility tests, likely conducted in a preclinical (animal or in-vitro) setting. The sample sizes (e.g., number of rabbits, guinea pigs, or cell cultures) are not specified in this summary. The text implies these were "previously conducted," suggesting prospective studies.

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 type of information is not applicable to this submission. The "ground truth" (e.g., presence or absence of infection) for efficacy is not established by expert review of patient data, but rather through in vitro microbiological testing (for antimicrobial activity) and preclinical safety studies. There's no human diagnostic component that would require expert consensus for ground truth.

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

This is not applicable as there is no human interpretation or diagnostic task involved that would require 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

This is not applicable. This submission is for a wound dressing, not an AI-powered diagnostic device or a system that involves human readers interpreting images.

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

This is not applicable. The device is a wound dressing, not an algorithm.

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

• Antimicrobial Activity: The "ground truth" for antimicrobial activity is established through direct laboratory microbiological assays (e.g., measuring zones of inhibition, reduction in bacterial count).
• Safety Studies: The "ground truth" for safety (cytotoxicity, irritation, sensitization) is established through standardized preclinical testing protocols (e.g., observing cellular viability, skin reactions, immune responses) as defined by ISO standards and regulatory guidelines.

8. The sample size for the training set

This is not applicable. The device is a physical wound dressing; it does not involve machine learning or a "training set."

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

This is not applicable for the same reason as point 8.

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The barrier functions of Urgocell® Ag, antimicrobial wound dressing, may help reduce infection in moderately to high exuding partial and full thickness wounds including decubitus ulcers, venous stasis ulcers , diabetic ulcers , first and second degree burns, donor and graft sites.

Urgocell® Ag wound dressing is a sterile, antimicrobial absorbent wound contact dressing with silver.

Urgocell® Ag wound dressing is non-occlusive and non-adhesive for painless removal.

Urgocell® Ag is composed of three layers :

• in contact with the wound, a polyester mesh impregnated with a matrix of carboxymethylcellulose hydrocolloid particles, cohesion polymers and Vaseline containing silver,
• a non-sensitising, super-absorbent polyurethane foam pad, -
• a protective, semi-permeable polyurethane backing. -

The provided text describes the 510(k) premarket notification for Urgocell® Ag, an antimicrobial wound dressing. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving device performance through a clinical or standalone study as one might expect for a novel AI/software device.

Therefore, many of the requested points regarding AI/algorithm performance and study design are not applicable to this 510(k) submission for a wound dressing.

Here's an analysis based on the provided text, addressing the applicable points and noting where information is not available or relevant:

Description of Acceptance Criteria and Study for Urgocell® Ag Antimicrobial Wound Dressing

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Not Applicable. The submission describes in vitro (biocompatibility and antimicrobial) and comparative design studies, not a clinical "test set" in the context of an AI/software device. The biological studies would have used laboratory samples (e.g., cell cultures, animal models for irritation/sensitization, bacterial cultures). Specific sample sizes for these in vitro and animal studies are not provided in this summary.
• Data Provenance: Not specified in terms of country of origin or retrospective/prospective for these general safety and antimicrobial tests. These are typically standard laboratory tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. This is not an AI/software device requiring expert ground truth for image or diagnostic interpretation. The "ground truth" for the safety and antimicrobial studies would be laboratory measurements and established biological responses.

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

• Not Applicable. This type of adjudication is relevant for human expert review in diagnostic studies, not for the in vitro and animal safety/efficacy tests described for this wound dressing.

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 a wound dressing, not an AI or imaging device with human reader interaction.

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

• Not Applicable. This is a medical device (wound dressing), not an algorithm.

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

• For Safety Studies (Cytotoxicity, Irritation, Sensitization): Ground truth would be established by standard biological assays and the observed cellular or animal responses according to scientific protocols (e.g., cell viability, erythema scores, immune responses).
• For Antimicrobial Activity Studies: Ground truth would be established by microbiological methods measuring bacterial growth inhibition or reduction, typically compared against control groups and predicate devices.
• For Substantial Equivalence: The ground truth for substantial equivalence is the demonstration of comparable characteristics (material, function, indications for use, safety, and effectiveness) to already legally marketed predicate devices, assessed by FDA.

8. The sample size for the training set:

• Not Applicable. This is not an AI/machine learning device. The studies described are for physical and biological properties of a wound dressing.

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

• Not Applicable. See point 8.

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