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

Disposable Powder Free Vinyl Exam Glove, Clear/ Yellow

The provided text is an FDA 510(k) clearance letter for a medical device: "Disposable Powder Free Vinyl Exam Glove, Clear/Yellow." This document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML algorithm or software validation.

Instead, this document is a regulatory approval for a physical medical glove. The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices. This type of clearance primarily relies on demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness as a device already on the market, or that any differences do not raise new questions of safety or effectiveness.

Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from this document because it pertains to a different type of device and regulatory review process.

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A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

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Based on the provided text, the document is an FDA 510(k) clearance letter for a Disposable Powder Free Vinyl Exam Glove, Clear/Yellow. This document does not contain any information about an AI/ML-enabled device or its performance criteria and study results.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, expert qualifications, or ground truth methods related to an AI device. The document pertains to a physical medical device (gloves) and its substantial equivalence to predicate devices, not the performance of a software or algorithm.

Ask a specific question about this device