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Anti-bacterial bandages are to be applied topically to the skin for the management of minor cuts, minor scrapes.

The Anti-bacterial bandage is EO sterilized and is for single use only. The bandage is made of three layers: Elastic Cloth (Fabric) type (Polyethylene terephthalate) or plastic type (Polyethylene), regenerated cellulose absorbent pad, and release liner (Glassine Release Paper). The absorbent pad contains 0.8% Benzalkonium chloride. Center non-woven absorbent pad is to absorb liquid, Benzalkonium chloride present in the pad is to reduce bacterial colonization within the dressing and backing adhesive (Liquid styrene polymer with 2-methyl-1,3-butadiene, White Mineral Oil, Petroleum Resins) layer is to keep the bandage in place.

The provided text describes an FDA 510(k) summary for an "Anti-bacterial bandage" (K232333), which is a medical device and not an AI/Software as a Medical Device (SaMD). Therefore, the requested information regarding acceptance criteria for AI/SaMD performance, such as sample sizes for test sets, data provenance, expert ground truth establishment, MRMC studies, or training set details, is not applicable or available in this document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Curad Antibacterial Bandage K113583) through non-clinical performance tests and biocompatibility, as is typical for traditional medical devices like bandages.

Here's a breakdown of the available information relevant to traditional device performance, acknowledging that it doesn't align with the AI/SaMD specific questions:

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

The document presents a comparison table (Table 1) between the proposed device and the predicate device, highlighting their technological characteristics. While not explicitly "acceptance criteria" in the sense of a numerical threshold to be met, these are the characteristics used to demonstrate substantial equivalence.

Note: The "Use time" is noted as "Different" but the overall conclusion is Substantial Equivalence based on other testing.

Specific studies and their "performance":

• Biocompatibility: The device was evaluated for Cytotoxicity, Sensitization, Irritation toxicity, Acute systemic toxicity, Material-mediated pyrogenicity, and Bacterial Endotoxins (USP-NF <85>). The conclusion states it "Complies with ISO 10993-1".
• Performance Bench Tests:
  • Liquid absorbency: Complies with EN 13726-1-2002.
  • Peel adhesion: Complies with ASTM D 3330/D3330M.
  • Antimicrobial Efficacy: Complies with AATCC 100-2019 (≥4 Log reduction).
  • Minimum Bacteriostatic Concentration Test: Complies with AATCC 100-2019.

Due to the nature of the device (a bandage, not AI/SaMD), the following points are not addressed in the provided text:

2. Sample sizes used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
4. Adjudication method for the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

Summary of what's provided for this mechanical device:

• Study Proving Device Meets Criteria: Performance bench tests and biocompatibility studies were conducted.
• Proof of Meeting Criteria: The non-clinical test results demonstrated that the proposed device met design specifications and was "as safe, as effective, and performs as well as the legally marketed predicate device." The results indicated compliance with relevant standards (EN 13726-1-2002, ASTM D 3330/D3330M, AATCC 100-2019) and ISO 10993-1 for biocompatibility.
• Clinical Studies: No clinical studies were included in this submission.
• Animal Studies: No animal studies were included in this submission.

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Anti-bacterial bandages are to be applied topically to the skin for the management of minor cuts,minor scrapes.

Anti-bacterial bandages are to be applied topically to the skin for the management of minor cuts,minor scrapes. Anti-bacterial bandage is made of Fabric tape/polyethylene tape, and absorbent pad. Absorbent pad contains 0.1%/0.8% benzalkonium chloride. The Anti-bacterial bandage is EO sterilized, and is for single use only. Product shelf- life time: Three years

The provided text is a 510(k) summary for an Anti-bacterial Bandage. This document describes the device, its intended use, and its comparison to a legally marketed predicate device to demonstrate substantial equivalence, a process frequently used for medical devices that are not high-risk.

It's important to understand that a 510(k) submission generally focuses on demonstrating substantial equivalence to an already legally marketed device (predicate device) rather than proving de novo safety and effectiveness through extensive clinical trials as might be required for a PMA (Pre-Market Approval). Therefore, the "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical performance tests conducted to support substantial equivalence, not typically a large-scale clinical efficacy study.

Here's an analysis of the provided information concerning acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" with corresponding "reported device performance" in the way one might expect for a clinical study comparing numerical metrics of efficacy. Instead, it describes compliance with various standards and internal requirements.

Here's how we can infer and construct this information based on the text:

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

• Test Set Sample Size: The document does not specify the exact sample sizes (e.g., number of bandages tested) for each non-clinical test (biocompatibility, sterilization, shelf life, etc.). These numbers would typically be detailed in the full test reports, which are not included in this summary.
• Data Provenance: The device manufacturer, Planet (Suzhou) Medical Products Co., Ltd, is located in Suzhou, Jiangsu, China. The testing was conducted by or on behalf of this company. The data is retrospective in the sense that the tests were performed on finished devices to gather data for the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not applicable in the context of this 510(k) summary for an anti-bacterial bandage. The "ground truth" for non-clinical performance tests is based on the objective results of the validated test methods and established standards (e.g., ISO, ASTM, AATCC), not on expert consensus or interpretation of complex medical images or clinical outcomes. For example, a cytotoxicity test has objective pass/fail criteria based on cell viability, not expert opinion.

4. Adjudication Method for the Test Set

This information is also not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies, especially those involving human readers interpreting complex data (e.g., radiology images) to establish a consensus ground truth. The non-clinical tests described in this document are objective laboratory tests with defined protocols and metrics for success.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study was not done. Such studies are relevant for evaluating diagnostic imaging devices where human readers interpret images with and without AI assistance. This device is an anti-bacterial wound dressing, and its performance is evaluated through laboratory-based non-clinical tests rather than human interpretation of cases.

6. Standalone Performance Study (Algorithm Only)

A standalone performance study was not done in the sense of an algorithm operating independently to perform tasks. This device is a physical product (bandage) whose performance is assessed through its material properties, biological interactions, and antimicrobial effectiveness using established laboratory methods, not through an algorithm.

7. Type of Ground Truth Used

The "ground truth" for the performance claims in this submission is established through:

• Compliance with validated international and national standards (ISO, ASTM, AATCC): These standards define specific test methods and acceptance criteria for various aspects of medical device performance (e.g., sterilization, biocompatibility, antimicrobial efficacy, shelf-life).
• Objective laboratory test results: The outcomes of these tests (e.g., cell viability in cytotoxicity, bacterial reduction in antimicrobial tests, physical integrity after aging) provide the factual basis for meeting the standards.

8. Sample Size for the Training Set

This concept is not applicable. "Training set" refers to data used to train machine learning algorithms. This anti-bacterial bandage is a physical medical device, not an AI/ML software device.

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

This question is not applicable for the same reasons as #8.

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