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Antibacterial bandages are to be applied to the skin for the management of minor cuts.minor scrapes. This device is only applicable to adults.

The device, Antibacterial bandage, is to be applied topically to the skin for management of minor cuts, minor scrapes. Antibacterial bandage is made of polyethylene tape, absorbent pad and release paper. The absorbent pad contains 95±10 ug/cm2 (0.8% by weight) benzalkonium chloride. Antibacterial bandage is available in different sizes. The antibacterial bandage is EO sterilized and is for single use only.

The provided text describes an antibacterial bandage, not an AI device. Therefore, it does not contain information about acceptance criteria or studies related to AI device performance. The document focuses on regulatory approval (510(k)) for the antibacterial bandage based on substantial equivalence to a predicate device.

The document discusses the following for the Antibacterial bandage:

• Acceptance Criteria (as demonstrated by testing):

  • Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous reactivity, Systemic Toxicity, Material-mediated Pyrogenicity, Endotoxin testing)
  • Sterilization (EO sterilization, complying with ISO 11135:2014)
  • Shelf Life (Accelerated Aging per ASTM F1980-16, Real-time ageing study)
  • Storage and Transport (ASTM 4169-16)
  • Antibacterial Finishes (AATCC 100: 2019)
  • Wound Healing Performance (comparable to predicate device in porcine study)

• Study Proving Acceptance Criteria:

  • Non-clinical tests: Conducted to verify the proposed device met design specifications and was safe and effective.
    • Biocompatibility tests
    • Sterilization testing
    • Shelf life testing (accelerated aging and real-time ageing)
    • Storage and transport testing
    • AATCC 100: 2019 for antibacterial finishes.
  • Animal studies: A porcine wound healing study was carried out to evaluate the cytotoxicity and wound healing performance, demonstrating no significant difference from the predicate device.

The document explicitly states: "No clinical study is included in this submission."

Therefore, I cannot provide the requested information regarding AI device acceptance criteria, performance tables, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI device, as this information is not present in the provided text.

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

The subject device. Antibacterial bandage, is to be applied topically to the skin for the management of minor cuts, minor scrapes and minor burns. The subject devices are available sterile in three models. All of devices contain three layers: (1) adhesive backing layer (fabric or plastic); (2) exactly same antibacterial non-stick absorbent pad layer (composed of Polyester fiber, viscose fiber, PE mesh, Benzalkonium chloride); (3) release liner. Each model is available in different sizes with identical materials, chemicals and physical properties, therefore, size of the device will not affect the function and performance of products. All models of subject device, Antibacterial bandage, are for single use only and sterilized by Ethylene Oxide using conditions validated following ISO 11135:2014.

The provided text describes a 510(k) premarket notification for an "Antibacterial Bandage" (K221311) and compares it to a predicate device (K113583) and a reference device (K200821). The submission aims to demonstrate substantial equivalence, not to prove that the device meets specific acceptance criteria through a clinical study. Therefore, a direct answer to the request regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of device performance metrics often expected for AI or diagnostic devices (e.g., accuracy, sensitivity, specificity, MRMC studies) cannot be fully provided from the given document.

However, I can extract the non-clinical test conclusions which serve as the basis for demonstrating substantial equivalence based on performance and biocompatibility. These tests implicitly define "acceptance criteria" through their methodologies and the successful comparison to the predicate device.

Here's a breakdown of the information that can be extracted, framed as closely as possible to the request:

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

The document does not explicitly list numerical "acceptance criteria" with corresponding "reported device performance" in a typical clinical study outcome format like sensitivity or specificity. Instead, the "acceptance criteria" are implied by the successful completion of specified performance and biocompatibility tests, demonstrating equivalence to the predicate device or compliance with standards.

For Antibacterial Effectiveness, a specific quantitative measure is mentioned for both the subject and predicate devices:

For other performance tests and biocompatibility, the reported "performance" is that the device "met the requirement" or "complied with the corresponding standards," or "was not different" from the control.

Here's how the other "acceptance criteria" and "reported performance" can be inferred from the non-clinical tests:

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

• Non-Clinical Performance Tests & Biocompatibility Tests: The document does not specify sample sizes (e.g., number of bandages tested for peel strength) or the data provenance for these lab-based tests. These are typically performed in a controlled laboratory setting.
• Animal Study: A "porcine wound healing study" was carried out, indicating an animal model. The sample size for this study is not specified, nor is the country of origin of the animal data. It would be considered prospective for the animal subjects involved.

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 the provided document. The device is an antibacterial bandage, not an AI or diagnostic device that requires expert review for ground truth establishment for a diagnostic test set. The ground truth for the non-clinical and animal studies is based on objective laboratory measurements and biological observations, not expert consensus on interpretations of images or signals.

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

This question is not applicable. Adjudication methods like 2+1 are typically used for establishing ground truth in clinical studies involving human interpretation (e.g., radiologists reviewing images). The studies described here are non-clinical and animal studies.

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

No MRMC study was done. This type of study is relevant for AI-powered diagnostic devices, which is not the case for an antibacterial bandage.

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

This question is not applicable. The device is not an algorithm.

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

• Non-Clinical Performance Tests: Ground truth is established by the specified test methods and standards (e.g., EN 13726-1:2002, ASTM D3330/D3330M). The "truth" is the measured physical or chemical property of the bandage.
• Biocompatibility Tests: Ground truth is defined by the biological response observed according to the specific ISO standards (e.g., presence/absence of cytotoxicity, sensitization).
• Animal Study: Ground truth is based on observed wound healing performance characteristics and local tolerance in the porcine model.

8. The sample size for the training set

This question is not applicable. The device (antibacterial bandage) does not involve machine learning or AI, and therefore does not have a "training set" in that context.

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

This question is not applicable, as there is no training set for this device.

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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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