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The BCT Antimicrobial Dressing & BCT Silver Bandage Dressings are intended for the management of wounds and to provide an antimicrobial barrier. These dressings are applied topically and are in direct contact with the wound. Both are intended to be used for indications such as:

• Partial and full thickness wounds;
• Pressure ulcers;
• Diabetic ulcers;
• Surgical wounds;
• Acute wounds ( 1st and 2nd degree burns )

BCT Antimicrobial Dressing consists of polyethylene terphthalate (PET) non-woven, silver-coated activated carbon fiber cloth and polyethylene (PE) film. BCT Silver Bandage contains the same ingredients, but includes an adhesive layer. The dressings and bandages contain 100 µg/cm² of silver and are available in several sizes to accommodate different wound sizes.

BCT Antimicrobial Dressing and BCT Silver Bandage absorbs wound fluid and exudates containing infectious organisms into the dressing fabric, where the silver exerts its antimicrobial action. The silver ions act locally within the dressing, eliminating the absorbed bacteria and pathogens.

The activated carbon fiber cloth in BCT Dressings absorbs bacterial toxins and offensive odors.

The dressings are individually packaged in a pouch. All dressings are sterile and are for single use only.

Here's a breakdown of the acceptance criteria and study information for the BCT Antimicrobial Dressing & BCT Silver Bandage, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated as a separate "test set" for performance evaluation in the typical sense of clinical trials. The antimicrobial testing referenced AATCC Test Method 100-2004, which is a standardized lab test. The biocompatibility tests were "appropriate in vivo and in vitro tests" according to ISO 10993. These are lab-based tests, not human subject trials.
• Data Provenance: The studies were non-clinical (lab-based). The sponsor is Bio-medical Carbon Technology Co., Ltd. from Taiwan. The AATCC and ISO standards are international standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This information is not applicable as the studies were non-clinical (biocompatibility and antimicrobial effectiveness) and did not involve expert-established ground truth in the context of diagnostic or interpretive performance. The "ground truth" for these tests are the established parameters and endpoints of the specified ISO and AATCC standards.

4. Adjudication Method for the Test Set

• Not applicable. There was no human interpretation or adjudication involved in the non-clinical biocompatibility or antimicrobial effectiveness tests.

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, an MRMC comparative effectiveness study was not done. This device is a wound dressing, not an AI-powered diagnostic or interpretive tool. Therefore, the concept of "human readers improve with AI" is not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This device is a physical wound dressing and does not involve any algorithm or AI component.

7. The Type of Ground Truth Used

• For Biocompatibility: The "ground truth" is adherence to the requirements and established safety profiles outlined in ISO 10993 standards.
• For Antimicrobial Activity: The "ground truth" is the quantitative reduction in microbial population as measured by AATCC Test Method 100-2004, with a specific criterion of "> 4 log reduction".

8. The Sample Size for the Training Set

• Not applicable. This device does not use machine learning or AI, so there is no training set in this context.

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

• Not applicable. As there is no training set, there is no ground truth established for it.

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