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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 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

AI/ML Overview

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:

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance
Overall Design	Meets all requirements for overall design (implied: consistent with intended use and predicate device's design principles).	"The Anti-bacterial Bandage meets all the requirements for overall design... confirming that the design output meets the design inputs and specifications for the device."
Sterilization	Compliance with ISO 11135:2014 (Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices).	"EO sterilized... EO sterile, compliance with ISO 11135:2014" and "Sterilization Testing ISO 11135:2014...passed all the testing."
Biocompatibility	Compliance with ISO 10993 standards for various biological effects: Cytotoxicity, Intracutaneous reactivity, Acute system toxicity, Sensitization testing, Material mediated pyrogenicity, Endotoxin testing.	"passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence... Biocompatibility; Cytotoxicity, Intracutaneous reactivity, Acute system toxicity, Sensitization testing, Material mediated pyrogenicity, Endotoxin testing." and "Complies with ISO 10993".
Shelf Life	Compliance with ASTM F1980-16 (Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices). Target shelf life: 3 years.	"Product shelf-life time: Three years" and "Shelf Life Testing ASTM F1980-16...passed all the testing."
Storage & Transport	Compliance with ASTM 4169-16 (Standard Practice for Performance Testing of Shipping Containers and Systems).	"Storage and Transport Testing ASTM 4169-16...passed all the testing."
Antibacterial Activity	Compliance with AATCC 100: 2012 (Antibacterial Finishes on Textile Materials). (Implied: Demonstrated ability of benzalkonium chloride to reduce bacterial colonization as intended.)	"AATCC 100: 2012, Antibacterial Finishes on Textile Materials...passed all the testing." (The document states the mechanism of action is: "Benzalkonium chloride reduce bacterial colonization within dressing.")
Substantial Equivalence	Device characteristics are sufficiently similar to the predicate device such that no new safety or effectiveness issues are raised. Specific comparisons were made for indications for use, mechanism of action, materials, antimicrobial agent, sterile methods, single-use, shelf life, regulation number, use time, packaging, anatomical location, and overall classification.	"most of the characteristics of the subject device are the same as the predicate device, some of the characteristics are similar, one is different, but none of them will cause new safety or effectiveness issues."

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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