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The Nitrile Patient Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device is Powder Free Nitrile Patient Examination Gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124,ASTM D5151, and ASTM D6319. The proposed device is non-sterile.

The provided text is a 510(k) summary for Nitrile Patient Examination Gloves (K211914). This document pertains to the regulatory clearance of a medical device, specifically patient examination gloves, and does not describe an AI/ML-based device that would require the detailed acceptance criteria and study information requested.

Therefore, I cannot provide the information requested for the following reasons:

1. Nature of the Device: The device described (Nitrile Patient Examination Gloves) is a physical medical device. The requested information (acceptance criteria for an AI/ML device, ground truth establishment, expert adjudication, MRMC studies, training/test set sample sizes, etc.) is specific to the development and validation of artificial intelligence and machine learning algorithms, particularly in medical imaging or diagnostic applications.
2. Absence of AI/ML Study Data: The document outlines non-clinical performance testing for physical properties (e.g., tensile strength, freedom from holes, biocompatibility) of the gloves to demonstrate substantial equivalence to a predicate device. It explicitly states, "Clinical testing is not needed for this device." There is no mention of any AI or software components, nor studies related to their performance.

Without information on an AI/ML component or a study designed to evaluate such a component, I cannot fulfill the request to describe acceptance criteria and the study that proves an AI/ML device meets those criteria.

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