Search Results

This glove is disposable and is intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Smart-Fit; Nitrile Examination Gloves Powderfree.

The provided text is a 510(k) premarket notification letter from the FDA regarding "Smart-Fit, Powderfree Nitrile Examination Gloves." This document does not describe the acceptance criteria or a study proving that a device meets those criteria in the context of an AI/ML medical device.

The letter pertains to a simple medical device (examination gloves) and confirms its substantial equivalence to previously marketed devices. The listed information is for regulatory approval of the manufacturing and marketing of these gloves, not for evaluating performance of an AI/ML system.

Therefore, I cannot extract the information required in your request from the provided text. The questions you posed, such as sample size for test sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details, are all specifically related to the evaluation and validation of AI/ML models, which is not discussed in this document.

Ask a specific question about this device