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A powder-free 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.

POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE AND BLACK

The provided document is a 510(k) premarket notification letter from the FDA for Powder-Free Nitrile Examination Gloves. This type of document is a regulatory approval for a medical device and therefore primarily focuses on compliance with regulations and substantial equivalence to a predicate device.

It does not contain the detailed information required to describe acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML medical device. The document is for a physical patient examination glove, not a software or AI-driven device.

Therefore, I cannot extract the requested information regarding:

• A table of acceptance criteria and reported device performance
• Sample size and data provenance for a test set
• Number and qualifications of experts for ground truth establishment
• Adjudication method for the test set
• MRMC comparative effectiveness study details
• Standalone performance details
• Type of ground truth used
• Sample size and ground truth establishment for the training set

This document pertains to the regulatory clearance of a physical medical device (gloves) and such information is not applicable or present within this text.

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