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Powder Free Vinyl Patient Examination Gloves, Yellow Color is a non-sterile 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, Yellow Color are disposable devices which made of PVC material ,intended for medical purpose that worn on examiner's hand or finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 e1.

The provided text describes the acceptance criteria and performance of "Powder Free Vinyl Patient Examination Gloves, Yellow Color" but does not describe a study involving a device that uses AI or requires a human-in-the-loop for its operation.

Therefore, most of the requested information (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types for AI/ML models) is not applicable to this medical glove.

Here's the relevant information that can be extracted:

Acceptance Criteria and Device Performance

Additional Information based on the provided text:

1. Sample sizes used for the test set and the data provenance: Not applicable. Performance is based on compliance with ASTM and FDA standards for medical gloves.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Performance is assessed against established technical standards, not expert consensus on medical imaging or diagnoses.
3. Adjudication method for the test set: Not applicable.
4. 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 is a medical glove, not an AI-powered diagnostic device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" here is compliance with defined ASTM standards (D 5250-06 e1, D6124-06) and FDA regulations (21 CFR 800.20, ISO 10993-10) for medical gloves.
7. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

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