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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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A powdered 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 Nitrile Examination Gloves, Blue

The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for "Powdered Nitrile Examination Gloves, Blue". This document does not contain information about acceptance criteria and a study proving the device meets those criteria, as it pertains to a medical glove. The type of information requested (e.g., sample sizes for training/test sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, ground truth types) is typically found in submissions for AI/ML-based medical devices or diagnostic tools, not for a physical device like examination gloves.

Therefore, I cannot fulfill your request based on the provided text.

Ask a specific question about this device