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The Disposable Vinyl Glove is 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 patient examination gloves. The subject device is clear, non-colored. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.

The provided text describes a 510(k) premarket notification for a Disposable Vinyl Glove. This document demonstrates the substantial equivalence of the subject device to a legally marketed predicate device, rather than proving that an AI/ML medical device meets specific acceptance criteria through a study with outlined performance metrics.

Therefore, I cannot extract the acceptance criteria and study details for an AI/ML device from the provided text.

The document discusses:

• The device: Disposable Vinyl Glove.
• Its intended use: for medical purposes, worn on examiner's hands to prevent contamination.
• Its classification: Class I, patient examination glove.
• Comparison to a predicate device (Hebei Hongtai Plastic Products Company Limited Vinyl Patient Examination Gloves).
• Non-clinical tests performed:
  • Biocompatibility (Irritation, Sensitization, Cytotoxicity) to ISO 10993-10:2010 and ISO 10993-5:2009.
  • Physical properties (Tensile Strength, Ultimate Elongation, Freedom from Holes, Powder Content) to ASTM D5250-19, ASTM D5151-06, and ASTM D6124-06.

None of these tests involve AI/ML performance metrics, a test set with ground truth established by experts, MRMC studies, or standalone algorithm performance.

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The Disposable Vinyl Glove is 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 patient examination gloves. The subject device is clear, non-colored. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.

The provided text is a 510(k) summary for Disposable Vinyl Gloves. This document details the substantial equivalence of the device to a predicate device, focusing on material properties, performance standards, and safety. It does not describe an AI/ML-based medical device. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria and studies proving the device meets those criteria for an AI/ML system.

The prompt asks for details about:

1. Acceptance criteria and device performance for an AI/ML device.
2. Sample sizes and data provenance for an AI/ML device.
3. Number of experts and their qualifications for ground truth establishment for an AI/ML device.
4. Adjudication method for an AI/ML device's test set.
5. MRMC comparative effectiveness study, effect size for human readers with/without AI for an AI/ML device.
6. Standalone performance for an AI/ML device.
7. Type of ground truth used for an AI/ML device.
8. Training set sample size for an AI/ML device.
9. Ground truth establishment for the training set of an AI/ML device.

Since the document is about disposable vinyl gloves, it does not involve AI/ML and thus cannot provide any of the requested information. The "Non-Clinical Test Conclusion" and "Clinical Test Conclusion" sections only discuss physical and biocompatibility tests against ASTM and ISO standards for gloves, and explicitly state "Clinical testing is not needed for this device."

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