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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.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted as requested:

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 specific sample sizes used for each individual test (e.g., how many gloves were tested for pinholes, how many rabbits/guinea pigs for biocompatibility).

The data provenance is for the device's characteristics (e.g., dimensions, physical properties, pinholes, powder residual, biocompatibility) as tested against established ASTM and CFR standards. This implies retrospective testing conducted by the manufacturer to demonstrate compliance with these predefined standards. The product is manufactured in China (Tangshan City, Hebei Province, China).

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

This information is not provided in the document. The "ground truth" for these tests are the established parameters and methodologies defined by ASTM standards and FDA regulations (21 CFR 800.20, ISO10993-10). Compliance is determined through laboratory testing against these objective standards, rather than expert consensus on individual cases.

4. Adjudication method for the test set

This information is not provided and is not applicable in the context of these types of objective performance and biocompatibility tests. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments or when discrepancies arise in human interpretation, which is not the nature of these tests.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is not relevant for a patient examination glove, as it is a physical barrier device, not an AI-powered diagnostic or assistive tool for human readers.

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

No, a standalone algorithm performance study was not done. This device is a physical product, not an algorithm.

7. The type of ground truth used

The ground truth used for this device's acceptance criteria are established objective standards and regulations:

• ASTM standard D 5250-06: Specifies requirements for vinyl patient examination gloves.
• 21 CFR 800.20: Pertains to the water-leak test (pinhole AQL) for medical gloves.
• ASTM standard D6124-06: Method for reporting residual powder on medical gloves.
• ISO10993-10: Biological evaluation of medical devices - Tests for irritation and skin sensitization.

8. The sample size for the training set

This information is not applicable as there is no "training set" for physical examination gloves. The device is not an AI algorithm or a classification system that requires machine learning training.

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

This information is not applicable as there is no "training set" for physical examination gloves mentioned in the document.

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