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This powdered, 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 (21CFR 880.6250).

powdered vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-004.

The provided text is a 510(k) Premarket Notification Summary for Powdered Vinyl Patient Examination Gloves, White (Non-colored). This type of document is about demonstrating substantial equivalence to a predicate device, not necessarily proving novel clinical effectiveness or advanced AI performance. As such, the requested information regarding AI device acceptance criteria, expert adjudication, MRMC studies, and standalone algorithm performance, as well as specific details about training and test sets common for AI/ML device submissions, are not applicable to this traditional medical device submission.

The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical tests conducted to ensure the gloves meet established standards for similar devices.

Here's the relevant information based on the provided document:

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

2. Sample size used for the test set and the data provenance

The document specifies that the device meets requirements per ASTM D5250-00e4, ASTM D6124-01, 21 CFR 800.20, and ISO10993-10. These are established standards for patient examination gloves and biocompatibility. The sample size for these tests is generally defined within the respective ASTM and ISO standards for statistical validity. However, the exact sample sizes used for the testing of this specific device are not explicitly stated in the provided summary.

The provenance of this data would be from laboratory testing conducted by the manufacturer or accredited testing facilities to comply with these standards. The information does not specify country of origin for the data (beyond the manufacturer being in China) or whether it was retrospective or prospective, as these terms are not typically applicable to this type of device testing.

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. The "ground truth" for this device is established by objective physical and chemical testing against recognized industry standards (ASTM, ISO, and CFR regulations), not by expert human interpretation or consensus.

4. Adjudication method for the test set

This question is not applicable. As the evaluation is based on objective physical and chemical tests against predefined standards, there is no need for expert adjudication.

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 question is not applicable. This submission is for traditional patient examination gloves, not an AI-powered device.

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

This question is not applicable. This submission is for traditional patient examination gloves, not an AI-powered device.

7. The type of ground truth used

The ground truth used is based on pre-established objective standards and specifications from ASTM International (e.g., D5250-00e4 for physical properties and dimensions), the Code of Federal Regulations (e.g., 21 CFR 800.20 for freedom from pinholes), and ISO (e.g., ISO10993-10 for biocompatibility).

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of this traditional medical device submission, as it does not involve machine learning or AI.

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

This question is not applicable. There is no "training set" in the context of this traditional medical device submission.

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