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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, Colored (White)

The provided information describes a K100075 premarket notification for "Powder-free Vinyl Patient Examination Gloves, Colored (White)". This is a medical device subject to general controls and a substantial equivalence determination, not an AI/ML powered device. As such, many of the requested fields (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set sample size) are not applicable because these types of studies are not typically conducted for this class of device.

However, I can extract the relevant information regarding acceptance criteria and device performance based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not provided in the document. For general purpose examination gloves, extensive human-reader test sets are not typically required. The tests focus on material properties and regulatory compliance.

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)

This information is not applicable and not provided in the document. Ground truth for glove testing pertains to meeting specific physical, chemical, and biological standards, not expert consensus on medical images or clinical outcomes.

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

This is not applicable and not provided. Performance is determined by meeting objective standards, not by expert adjudication of human readers.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic or assistive devices, not for examination gloves.

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

This is not applicable. The device is a physical product (gloves), not an algorithm.

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

The ground truth used for the device performance evaluation is based on established industry standards and regulatory requirements:

• ASTM standard D 5250-06 (for Dimensions and Physical Properties)
• 21 CFR 800.20 (for Freedom from pinholes - Waterleak test AQL)
• ASTM standard D 6124-06 (for Powder Residual)
• ISO 10993-10 (for Biocompatibility, specifically Primary Skin Irritation and Dermal Sensitization)

8. The sample size for the training set

This is not applicable. The device is a physical product, not an AI/ML model that requires a training set.

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

This is not applicable as there is no training set for this device.

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