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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.

Synthetic Powder Free Vinyl Patient Exam Gloves

The provided text is a 510(k) clearance letter from the FDA for a device described as "Synthetic Powdered Free Vinyl Examination Glove." This document does not contain information about acceptance criteria, device performance, sample sizes, ground truth establishment, or any study details as typically associated with performance testing for AI/ML devices or complex medical devices.

The letter is a regulatory notification of substantial equivalence to a predicate device, which primarily concerns the classification and marketability of the device, subject to general controls. It confirms that the device is a Class I medical device (Patient Examination Gloves) and is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the input text. The information requested (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is typically found in a 510(k) summary, clinical study reports, or performance testing documentation, none of which are present in this FDA clearance letter.

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