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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.

powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4

The provided text describes a 510(k) premarket notification for "Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)." The submission focuses on demonstrating substantial equivalence to a predicate device, rather than a novel AI/ML medical device. Therefore, many of the requested categories (such as AI-specific study details, sample sizes for training/test sets, expert adjudication, MRMC studies, or standalone algorithm performance) are not applicable or cannot be extracted from this document.

The document outlines the acceptance criteria and the "device performance" in terms of meeting established standards 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

The document does not specify a "test set" in the context of an AI/ML algorithm. The performance evaluation is based on meeting industry standards and regulations for medical gloves. The tests for these characteristics are typically performed on representative samples from manufacturing batches. The document does not provide details on the sample sizes for these tests or their provenance (country of origin, retrospective/prospective).

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

Not applicable. Ground truth, in the context of AI/ML, refers to clinically validated diagnoses or measurements. For a medical glove, "ground truth" is established by adherence to physical, chemical, and biological performance standards defined by regulatory bodies and consensus organizations (e.g., ASTM, FDA). There is no mention of experts establishing a "ground truth" for a test set in the way it would be done for an AI/ML diagnostic device.

4. Adjudication method for the test set

Not applicable. There is no "test set" requiring adjudication in the context of an AI/ML algorithm. The evaluations are direct measurements against predefined 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

Not applicable. This is not an AI/ML device, and no MRMC study was performed.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

The "ground truth" for the device's performance is based on established industry standards and regulatory requirements. Specifically, these include:

• ASTM standard D 5250-00e4 (for dimension, physical properties, powder amount)
• 21 CFR 800.20 (for freedom from pinholes)
• ISO 10993-10 (for biocompatibility, specifically primary skin irritation and dermal sensitization)

8. The sample size for the training set

Not applicable. This is not an AI/ML device. There is no concept of a "training set."

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

Not applicable. This is not an AI/ML device.

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