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Antibacterial bandage is to be applied topically to the skin for management of minor scrapes and minor burns.
Antibacterial bandage is to be applied topically to the skin for management of minor cuts, minor scrapes and minor burns.

The device, Antibacterial bandage, is to be applied topically to the skin for management of minor cuts, minor scrapes and minor burns. The proposed devices are available in fabric backing and plastic backing. All of devices consist of (1) backing (fabric or plastic), (2) absorbent pad (composed of Polyester fiber, viscose fiber, PE mesh, Benzalkonium chloride) and (3) release paper (composed of cellulose pulp, water, kaolin, starch, ethanol and ethylene copolymer). Each device type is available in several models. The difference between each model is the device size. This dressing contains 0.08% benzalkonium chloride which has shown effectiveness against (Staphylococcus Aureus, Pseudomonas Aeruginosa, Escherlchia coli, Enterococcus Faecalis, Klebsiella Pneumoniae, Streptococcus Pyogenes, Candida Albicans and Aspergillus Niger) for up to 24 hours, as demonstrated via in vitro testing.

The provided text describes the 510(k) summary for an "Antibacterial Bandage" (K201324) and compares it to a predicate device (K113583). It outlines non-clinical tests performed to demonstrate substantial equivalence, but it does not include a multi-reader multi-case (MRMC) comparative effectiveness study, standalone algorithm performance, or details on ground truth for AI model training/testing, as it is not an AI/ML device.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes for any of the non-clinical tests (e.g., how many bandages were tested for peel adhesion, antimicrobial efficacy, etc.). All tests are described as in vitro (antimicrobial efficacy) or laboratory tests, and there is no mention of human data or data provenance like country of origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the device is an antibacterial bandage, not an AI/ML diagnostic or prognostic tool. "Ground truth" in the context of expert consensus is not relevant here. The ground truth for the product performance is based on established laboratory standards and test methods.

4. Adjudication method for the test set
Not applicable, as this is related to expert consensus for diagnostic/prognostic ground truth, not the testing of a medical device like an antibacterial bandage.

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 an AI-assisted device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.

7. The type of ground truth used
For the performance tests, the "ground truth" is defined by the requirements of the specified international and national standards (e.g., ASTM, AATCC, ISO, USP). For instance, for antimicrobial efficacy, the ground truth is a "4 log reduction" according to AATCC-100. For peel adhesion, it's >1.0 N/cm as per ASTM D3330/D3330M.

8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set for an algorithm.

9. How the ground truth for the training set was established
Not applicable. There is no training set for an AI/ML algorithm.

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