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A Patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.

Powder Free Latex Examination Gloves Contains 50 microgram or less of total water Extractable Protein per gram

This document is a 510(k) premarket notification for "Powder Free Latex Examination Gloves" and does not contain information about the acceptance criteria and study proving a device meets those criteria. The document is for a medical device (gloves), which typically undergo different types of testing (e.g., integrity, biocompatibility, dimensions) rather than the type of performance study with "ground truth" and "expert readers" that your questions imply for AI-powered diagnostic devices.

Therefore, I cannot provide the requested information based on the input document.

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A patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.

Powdered Latex Examination Gloves Contains 200 microgram or less of total water Extractable Protein per gram

The provided text is a letter from the FDA regarding a 510(k) premarket notification for "Powdered Latex Examination Gloves." This document does not contain information about software as a medical device (SaMD), AI/ML, or the specific types of studies, metrics, and acceptance criteria normally associated with such devices.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment. This document pertains to a physical medical device (gloves) and its regulatory clearance based on substantial equivalence to predicate devices, not performance metrics derived from a study comparing algorithms or human readers.

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