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The Disposable Vinyl Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free non-colored vinyl examination glove. It can be available in four specifications: S, M, L and XL. The subject device is non-sterile.

The provided text describes the acceptance criteria and the study that proves a "Disposable Vinyl Examination Glove" meets these criteria. It is important to note that this is a Class I medical device (non-AI/ML).

Here's the breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

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

• Sample Size:
  • Watertightness Test (ASTM D5151): The result 0/125 / Pass indicates that out of 125 units tested, 0 failed, suggesting a sample size of 125 for this specific test.
  • For other tests (Physical Dimensions, Powder Content, Physical Properties, Biocompatibility), the document does not explicitly state the number of samples tested for each criterion. It reports ranges for dimensions and physical properties, which usually implies multiple samples were tested, but the exact count is not given.
• Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective. The manufacturer is located in Jiujiang City, Jiangxi, China.

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 as this device is a physical examination glove, not an AI/ML device requiring expert interpretation for ground truth. The "ground truth" is established by direct measurement and standardized test methods (e.g., ASTM and ISO standards) and their inherent acceptance criteria.

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

This information is not applicable as this device is a physical examination glove. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., medical imaging) where there might be disagreement among reviewers, needing a tie-breaker. The tests for this device involve objective measurements against established 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

This information is not applicable as this device is a physical examination glove and not an AI-assisted diagnostic tool.

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

This information is not applicable as this device is a physical examination glove and does not involve any algorithms.

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

The "ground truth" for this device is based on objective measurements against established industry standards, specifically ASTM D5250, ASTM D5151, ASTM D6124, ISO 10993-5, and ISO 10993-10. These standards define acceptable physical properties, freedom from holes, powder content, and biocompatibility, which are directly measured and compared.

8. The sample size for the training set

This information is not applicable as this is a physical medical device, not an AI/ML device that requires a "training set."

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

This information is not applicable as this is a physical medical device, not an AI/ML device that requires a "training set" or ground truth for such a set.

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