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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 vinyl examination gloves. The subject device's color is clear. 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 conducted for a Disposable Vinyl Examination Glove (K220469).

Here's a breakdown of the requested information:

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 full sample size for all tests. However, for the Watertightness Test (ASTM D5151), a sample size of 125 was used (0/125/Pass).

The data provenance is not explicitly mentioned as "country of origin" or "retrospective/prospective" studies. However, the tests are non-clinical, meaning they are laboratory-based and not derived from patient data. The submitter is CHIFENG HUAWEI MEDICAL SCIENCE & TECHNOLOGY CO.,LTD. (China), suggesting the non-clinical testing likely took place in China or a contracted lab.

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

This information is not applicable as the described tests are non-clinical (material and performance testing of a physical product) and do not involve expert interpretation or ground truth establishment in a clinical sense. The "ground truth" for these tests are the established standards (e.g., ASTM, ISO) and their defined acceptance criteria.

4. Adjudication method for the test set

This information is not applicable for these non-clinical, objective tests. Adjudication methods are typically used in studies involving subjective interpretation, often in clinical imaging or diagnostic contexts, where multiple experts might disagree on an assessment.

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

An MRMC comparative effectiveness study was not performed. This type of study is relevant for AI-powered diagnostic tools or imaging analysis where human readers are involved. The device in question is a disposable vinyl examination glove, which does not involve human reader interpretation or AI assistance in its core function.

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

A standalone performance study in the context of an algorithm or AI was not done. The tests performed are for the physical and biological properties of the glove itself, not for an algorithm.

7. The type of ground truth used

The "ground truth" for these tests is based on established standard specifications and analytical measurements. For example:

• Physical dimensions are measured against defined ranges.
• Tensile strength and ultimate elongation are measured against minimum values.
• Powder content is measured against a maximum value.
• Biocompatibility (cytotoxicity, irritation, sensitization) is assessed by laboratory tests based on ISO standards to determine if the device elicits a specific biological response.

8. The sample size for the training set

This information is not applicable. The tests described are for a physical product, a disposable glove. There is no AI algorithm being "trained" in this context, so there is no training set in the conventional machine learning sense.

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

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

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