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The Vinyl Examination Glove (Clear, Non-Colored) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device is Powder Free Vinyl Patient Examination Gloves. The colors of proposed device is clear, non-colored. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The proposed device is non-sterile.

This document is a 510(k) summary for a Vinyl Examination Glove (Clear, Non-Colored). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against acceptance criteria in the context of an AI/ML device.

Therefore, many of the requested items (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, how ground truth for training/test set was established, effect size for human readers with/without AI, standalone performance) are not applicable to this submission, as it's for a medical glove, not an AI/ML device.

However, I can extract the acceptance criteria and performance data related to the glove's physical and biological properties and summarize what is available from the document:

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

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

• The document implies testing was performed according to standards like ASTM D5151 for "Freedom from Holes" which specifies sampling procedures (AQL=1.5, per ISO 2859-1:1999). However, the specific sample sizes used for each test (Tensile Strength, Elongation, etc.) are not explicitly stated in this summary.
• Data provenance (country of origin, retrospective/prospective) is not specified for the non-clinical tests.

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. This is not an AI/ML device requiring expert ground truth in that context. The "ground truth" for the glove relates to its physical and biological properties as measured by standard methods.

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

• Not applicable. This is not an AI/ML device requiring expert adjudication.

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. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

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

• For the physical properties (tensile strength, elongation, freedom from holes, powder content) and biocompatibility (irritation, sensitization, cytotoxicity), the "ground truth" is established by adherence to recognized international and ASTM standards (e.g., ASTM D5250, ASTM D5151, ASTM D6124, ISO 10993-10, ISO 10993-5). These standards define appropriate test methods and acceptance criteria.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device with a "training set."

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

• Not applicable. This is not an AI/ML device.

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