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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 5250-06.

This is a summary of the acceptance criteria and study information for the "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)".

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 explicitly state the sample sizes used for each specific test in the "test set". However, the tests are conducted in accordance with the cited ASTM and CFR standards, which would specify appropriate sample sizes.

Data Provenance: The data provenance is not explicitly stated in terms of country of origin but is based on non-clinical laboratory testing (e.g., in vitro, animal studies for biocompatibility) and adherence to international and national standards (ASTM, CFR). The testing is retrospective in the sense that completed tests are submitted, but the source of the materials tested would be the manufacturer's products.

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

This device does not involve a scenario where human experts establish ground truth for a test set in the way a diagnostic imaging device would. The "ground truth" here is defined by the objective pass/fail criteria of the specified ASTM and CFR standards for physical properties and biocompatibility. The "experts" would be the accredited laboratories and personnel conducting these standardized tests. Their qualifications would involve expertise in materials testing, chemistry, and toxicology, following good laboratory practices (GLP) to ensure the validity and reliability of the results against the defined standards.

4. Adjudication method for the test set

Not applicable. The tests are based on objective measurements and predefined pass/fail criteria from recognized standards. There isn't a need for expert adjudication in the context of image interpretation or subjective assessments.

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 device is a physical medical device (examination glove), not an AI-powered diagnostic or assistive tool.

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

Not applicable. This device is a physical medical device.

7. The type of ground truth used

The ground truth used for this device's performance evaluation is based on objective standards and regulatory requirements. Specifically:

• ASTM standards (D 5250-06, D6124-01) for dimensions, physical properties, and powder residual.
• 21 CFR 800.20 for freedom from pinholes (waterleak test).
• ISO 10993-10 (referenced for biocompatibility testing, specifically primary skin irritation and dermal sensitization).

These standards define the acceptable range or threshold for each characteristic.

8. The sample size for the training set

Not applicable. This device is a physical medical device. The concepts of "training set" and "ground truth for training set" are relevant to machine learning or AI models, not to the premarket notification of a patient examination glove. The manufacturer's production process would involve quality control and specification adherence, but not a "training set" in the computational sense.

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

Not applicable (as explained in point 8).

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