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Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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, Clear (non-colored) 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.

Here's a breakdown of the acceptance criteria and the study information for the device, based on the provided text:

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 test set for any of the characteristics. The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. The testing refers to "current standards" (ASTM, ISO, CFR) which implies testing was conducted according to these standards.

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

Not applicable. This device is a Class I medical device (patient examination gloves) where performance is assessed through physical, chemical, and biocompatibility testing against established standards, not through expert interpretation of medical images or other data requiring clinical "ground truth" from experts.

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

Not applicable. See point 3.

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 is not an AI/software device.

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

Not applicable. This is not an AI/software device. The "device performance" described is the standalone performance of the physical glove.

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

The "ground truth" for this device's performance is defined by the objective metrics and acceptance criteria outlined in the referenced standards: ASTM D 5250-06 e1, 21 CFR 800.20, ASTM D6124-06, and ISO 10993-10. These standards set measurable thresholds for properties like dimensions, physical strength, absence of pinholes, powder residue, and biological reactions.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/machine learning algorithm that requires a training set.

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

Not applicable. See point 8.

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