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A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Classified by FDA's General Hospital and Personal Use Device panel as Class I, 21 CFR 880.6250, Power Free Vinyl Patient Examination Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.

The provided text describes the submission of a 510(k) premarket notification for Powder Free Vinyl Patient Examination Gloves. This information focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of a device's performance against specific acceptance criteria for diagnostic or algorithmic tasks. Therefore, many of the requested categories (like number of experts, adjudication methods, multi-reader multi-case studies, standalone performance, and training set information) are not applicable to this type of device submission.

Here's the available information presented in the requested format, with "Not Applicable" for categories that don't fit this context:

Acceptance Criteria and Device Performance Study

The submission demonstrates substantial equivalence to a predicate device by meeting established ASTM standards and FDA requirements for patient examination gloves.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: For the Water Fill Test, inspection levels are S-2 (for Physical and Dimensions) and I (for Water Fill Test), and AQL is 4.0 and 2.5 respectively. The exact number of samples tested is not explicitly stated but is implied by these AQL and inspection level standards.
• Data Provenance: The data is based on non-clinical tests performed by the manufacturer, Hong Di Plastic Products Co., Ltd. (China). It is retrospective in the sense that the tests were conducted prior to the 510(k) submission.

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

Not Applicable. The ground truth for this device (e.g., whether a glove has a pinhole, its dimensions, or causes irritation) is determined by objective physical and chemical tests against established standards, not by expert consensus on subjective observations.

4. Adjudication method for the test set

Not Applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of human-interpreted data (e.g., medical images). For physical and chemical tests, the results are typically direct measurements or observations against a standard, not requiring expert adjudication in this manner.

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 a medical device (patient examination glove), not an AI-powered diagnostic or assistive technology.

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

Not Applicable. This is a physical medical device.

7. The type of ground truth used

The ground truth is based on objective measurements and laboratory test results against established national and international standards (ASTM D-5250-06e1, ASTM D-6124-06) and FDA requirements (e.g., 1000 mL Water Fill Test).

8. The sample size for the training set

Not Applicable. This device does not involve a "training set" in the context of machine learning or AI models.

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

Not Applicable. As there is no training set for this device.

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