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Powdered 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.

Powdered 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.

The provided document describes the acceptance criteria and performance of "Powdered Free Vinyl Patient Examination Gloves, Clear (non-colored)" manufactured by Hongxin Plastic Products Co.,Ltd. It's important to note that this is a medical device (gloves), not an AI algorithm, so many of the questions related to AI studies (like MRMC studies, training sets, expert ground truth for imaging, etc.) are not applicable.

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Acceptance Criteria and Device Performance

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 a "test set" in the context of an algorithmic evaluation. The performance criteria are based on standardized tests for medical gloves. Sample sizes for these tests are typically defined within the respective ASTM and ISO standards (e.g., number of gloves tested for pinholes, number of rabbits for irritation tests). The document does not provide these specific sample sizes.

Data Provenance: The tests were conducted by the manufacturer to demonstrate compliance with the specified standards. The country of origin of the data is not explicitly stated beyond the manufacturer being in China. The data would be considered prospective as it's generated through testing the manufactured product according to established protocols.

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

This question is not applicable as the device is a physical medical product (gloves) and not an AI algorithm requiring expert adjudication for ground truth. The "ground truth" here is determined by objective measurements and tests against established physical and biological standards. For biocompatibility tests (like skin irritation), qualified laboratory personnel would conduct and interpret the results to determine "passes" or "fails" against defined criteria, but these are not "experts establishing ground truth" in the sense of medical image interpretation.

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

Not applicable for a physical medical device. Performance is determined by test results against predefined criteria in the standards.

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-powered diagnostic or assistive device.

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

Not applicable. This is not an algorithm.

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

The "ground truth" for this device is based on objective measurements and laboratory tests defined by:

• ASTM standards: For dimensions, physical properties, and powder residue.
• 21 CFR 800.20: For freedom from pinholes.
• ISO 10993-10: For biocompatibility (primary skin irritation and dermal sensitization).

8. The sample size for the training set

Not applicable. This is not an AI algorithm requiring a training set.

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

Not applicable. This is not an AI algorithm.

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