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

Powdered Yellow Synthetic Vinyl Patient Examination Gloves

The provided document is a 510(k) clearance letter from the FDA for "Powdered Yellow Synthetic Vinyl Patient Examination Gloves." It does not contain information about acceptance criteria or a study proving the device meets those criteria.

Instead, the document states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as a device already on the market, or has different technological characteristics but those characteristics do not raise new questions of safety and effectiveness and are shown to be at least as safe and effective as the predicate device.

Therefore, I cannot answer the request as the necessary information for acceptance criteria and a study proving the device meets them is not present in the provided text.

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

Powder Free Yellow Synthetic Vinyl Patient Examination Gloves

The provided text is a letter from the FDA regarding the 510(k) premarket notification for "Powder Free Yellow Synthetic Vinyl Patient Examination Gloves." It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This type of information is typically found in the 510(k) submission itself or in detailed study reports, not in the FDA's regulatory clearance letter.

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

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

Powder Free Clear Synthetic Vinyl Examination Gloves

This document is a 510(k) clearance letter for Powder Free Clear Synthetic Vinyl Examination Gloves, not a study report for an AI/ML powered medical device. Therefore, the requested information regarding acceptance criteria and study details for an AI-powered device cannot be extracted from the provided text.

The document discusses the substantial equivalence of the gloves to legally marketed predicate devices and outlines general regulatory requirements for medical devices. It does not contain any information about:

• Acceptance criteria for an AI/ML algorithm.
• Performance metrics of an AI/ML device.
• Sample sizes for test or training sets for AI/ML.
• Data provenance or ground truth establishment for AI/ML.
• Expert involvement in AI/ML performance evaluation.
• MRMC studies for AI/ML.
• Standalone performance or human-in-the-loop performance of AI/ML.

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