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

Pre-Powdered Vinyl Non-sterile Examination Glove

I am sorry, but the provided text is an FDA 510(k) clearance letter and related documentation for "Pre-Powdered Vinyl Non-Sterile Examination Gloves." This document does not contain information about acceptance criteria or a study proving that a device (in the context of an AI/software device) meets such criteria. Instead, it is about the regulatory clearance of a physical medical glove.

Therefore, I cannot extract the requested information regarding AI device performance, sample sizes, ground truth, expert qualifications, or MRMC studies from this text.

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A 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.

Jiatai Synthetic Vinyl Exam Gloves, Powdered, USP

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to Shanghai Jiatai Plastic Products Company, Limited regarding their Pre-Powdered Non-Sterile Vinyl Examination Gloves.

This document confirms that the device has been found substantially equivalent to a predicate device and allows it to be marketed. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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