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Powder free vinyl patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-000

The provided document describes the acceptance criteria and performance of "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)" and not an AI/ML device. Therefore, many of the requested categories for AI/ML device evaluation are not applicable.

Here's the information that can be extracted from the provided text regarding the glove's acceptance criteria and how its compliance was demonstrated:

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 size used for the testing of these gloves. The testing is based on compliance with ASTM standards, 21 CFR regulations, and ISO standards, which typically involve standardized methods for sampling and testing. No specific data provenance (country of origin, retrospective/prospective) is mentioned beyond the standards themselves.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable as the device is a medical glove, not an AI/ML diagnostic or assistive device. Ground truth is established by standardized physical and chemical testing methods, not expert interpretation.

4. Adjudication method for the test set

This is not applicable for a medical glove. The compliance is determined by laboratory testing against established physical, chemical, and biological standards.

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

This is not applicable as the device is a medical glove.

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

This is not applicable as the device is a medical glove.

7. The type of ground truth used

The "ground truth" for the medical glove is established by adherence to:

• Performance Standards: ASTM standard D 5250-00cd for Dimensions, Physical Properties, and Powder Residual.
• Regulatory Standards: 21 CFR 800.20 for Freedom from pinholes.
• Biocompatibility Standards: ASTM D6124-01 (for powder residual), ISO10993-10 for biocompatibility evaluation (Primary Skin Irritation and Dermal sensitization).

These standards define the objective criteria that the glove must meet.

8. The sample size for the training set

This is not applicable as the device is a medical glove. There is no "training set" in the context of an AI/ML device. The manufacturing process is designed to consistently produce gloves that meet the specified standards.

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

This is not applicable as the device is a medical glove.

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