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A Nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

WHITE NITRILE POWDER-FREE PATIENT EXAMINATION GLOVE, NON STERILE

This document is an FDA 510(k) clearance letter for a medical device: "White Nitrile Powder-Free Patient Examination Glove, Non Sterile." It does not contain information about a study that proves the device meets acceptance criteria in the context of an AI/ML medical device.

The document is a clearance for a physical medical device (gloves), not an AI/ML algorithm. Therefore, the requested information (acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, etc.) for a study on an AI/ML device is not present in this text.

The information provided in the document pertains to:

• Device Name: White Nitrile Powder-Free Patient Examination Glove, Non Sterile
• Regulation Number: 21 CFR 880.6250 (Non-powdered patient examination glove)
• Regulatory Class: Class I, reserved
• Product Code: LZA
• Indications for Use: A disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
• Type of Use: Over-The-Counter Use

For physical medical devices like gloves, "acceptance criteria" and "device performance" are typically defined by international standards (e.g., ASTM, ISO) regarding physical properties (tensile strength, puncture resistance, barrier integrity) and biocompatibility, as well as sterility if applicable. The "study" that proves these are typically laboratory tests on batches of the product, not clinical studies involving "test sets," "ground truth experts," or "AI assistance" as would be relevant for software as a medical device.

Therefore, I cannot fulfill your request using the provided text because it describes the clearance of a physical medical device and lacks the specific details you've asked for regarding AI/ML device performance studies.

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