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A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powdered Vinyl Patient Examination Gloves

The provided documents are FDA correspondence regarding a 510(k) premarket notification for "Disposable Powdered Vinyl Patient Examination Gloves." This type of document is a regulatory approval and does not contain the detailed performance study information requested about acceptance criteria, sample sizes, ground truth establishment, or AI-related metrics. It primarily focuses on demonstrating substantial equivalence to a predicate device based on general safety and effectiveness.

Therefore, I cannot extract the requested information from the provided text. The document states that the device is "substantially equivalent ... to legally marketed predicate devices," implying that its performance is considered acceptable by meeting the standards established for those predicate devices. However, the specific study details are not present.

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A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powdered Vinyl Patient Examination Gloves

The provided document is a 510(k) clearance letter from the FDA for "Powdered Vinyl Patient Examination Gloves". This document pertains to the regulatory clearance of a physical medical device (gloves), not an AI/ML powered device. As such, the information requested about acceptance criteria and studies for an AI/ML device is not present in this document.

Therefore, I cannot provide the requested table and study details.

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