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A powder-free patient examination glove is a disposable device intended for medical purpose that is worn upon the examiner's hand or finger to prevent contamination between patient and examiner.

Powder-Free Vinyl Non-Sterile Examination Glove

The provided text is a 510(k) clearance letter from the FDA for a Powder-Free Vinyl Non-Sterile Examination Glove. This document pertains to the regulatory clearance of a medical device, specifically a physical product (gloves), and not a digital health device or AI/ML-based software.

Therefore, the requested information about acceptance criteria for a device's performance, human reader studies, AI/ML training, and ground truth establishment is not applicable to this document. The FDA letter confirms the device's substantial equivalence to a legally marketed predicate device based on its intended use as a patient examination glove to prevent contamination, and its adherence to general controls and good manufacturing practices. There is no mention of a study involving performance metrics like sensitivity, specificity, or AUC, as these are typically associated with diagnostic or AI-driven devices.

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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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