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The Convertors®Trilaminate Drapes are devices intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.

These drapes will be comprised of an outer and inner layer of polyolefin-based nonwovens with an inner layer of polyolefin-based film. Several drapes will also have clear polyethylene side panels on either end of the drapes.

The provided text describes a 510(k) premarket notification for "Convertors® Trilaminate Drapes." This document focuses on the substantial equivalence to a predicate device and safety testing for the materials used. It does not describe a study that involves acceptance criteria for device performance based on a test set, expert ground truth, or human reader performance.

Therefore, many of the requested sections regarding acceptance criteria, study details, and AI performance cannot be extracted from this document, as they are not present.

Here's a breakdown of what the document does provide in relation to your request format:

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

• Not applicable. The document does not describe acceptance criteria in terms of device performance metrics for a specific function or a study comparing performance against such criteria. It describes safety testing of the materials.

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

• Not applicable. There is no "test set" described for device performance. The testing mentioned is for the materials used in the drapes.

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)

• Not applicable. No ground truth establishment for a performance study is mentioned.

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

• Not applicable. No adjudication method for a performance study is mentioned.

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 document is for a physical medical device (surgical drapes), not an AI/software device that would involve human readers or AI assistance.

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

• Not applicable. This document is for a physical medical device, not an algorithm.

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

• Not applicable. No ground truth for a performance study is mentioned. The "ground truth" here would relate to the established standards for biocompatibility and material properties, not diagnostic or clinical accuracy.

8. The sample size for the training set

• Not applicable. There is no mention of a training set as this is not an AI/software device.

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

• Not applicable.

Information that is available regarding testing (for materials, not device performance):

• Summary of testing: "All materials used in the fabrication of the Convertors® Trilaminate drapes were evaluated through biological qualification safety tests as outlined in in ISO 10993 Part-1 "Biological Evaluation of Medical Devices". The biocompatibility tests performed were cytotoxicity, sensitization, and intracutaneous reactivity. These materials also were tested in accordance with industry recognized test methods. These materials have met the requirements of the identified tests and were found to be acceptable for the intended use."

This indicates that the device met safety requirements by adhering to ISO 10993 Part-1, which specifies standards for biocompatibility. The specific numerical acceptance criteria or detailed results of these tests (e.g., specific cytotoxicity values, sensitization indices) are not provided in this summary. The "reported device performance" in this context refers to the materials meeting the requirements of these biological safety tests.

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