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A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is for over-the counter use.

Powder-Free Nitrile Examination Gloves, Black

The provided text is related to an FDA 510(k) clearance for "Powder-Free Nitrile Examination Gloves, Black." This document is a regulatory approval and does not contain the acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for an AI/ML medical device.

The document states that the FDA reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. For a Class I device like examination gloves, substantial equivalence is often demonstrated through adherence to recognized standards and manufacturing processes, rather than a clinical study with detailed performance metrics like sensitivity, specificity, or reader studies.

Therefore, I cannot extract the requested information as it is not present in the provided text. The questions about test set sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment are all relevant to AI/ML device studies, which is not what this document describes.

In summary, the provided content is a regulatory clearance for a medical glove, not a technical study report for an AI/ML device. Therefore, the requested information elements related to AI/ML device performance and study design are not applicable or available in this document.

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