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

SYNTHETIC VINYL PATIENT EXAM GLOVES PRE-POWDERED, YELLOW

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for "Synthetic Vinyl Patient Examination Gloves Pre-Powdered, Yellow," stating that the device is substantially equivalent to legally marketed predicate devices. It does not include details about device performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications.

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

SYNTHETIC VINYL PATIENT EXAM GLOVES POWDER-FREE VELLOW

This document is an FDA 510(k) clearance letter for "Synthetic Vinyl Patient Exam Gloves Powder-Free Yellow." It is a regulatory document and does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML or diagnostic device.

Therefore, I cannot provide the requested information for acceptance criteria and a study that proves the device meets them because the provided text does not contain this information.

The document primarily focuses on:

• The FDA's determination of substantial equivalence for the gloves to legally marketed predicate devices.
• Regulatory requirements for marketing the device.
• The intended use of the patient examination gloves (preventing contamination between patient and examiner).

To answer your request, I would need a document related to an AI/ML or diagnostic device that describes performance studies, acceptance criteria, and ground truth establishment.

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

Not Found

The requested information is not available in the provided text. The document is a 510(k) substantial equivalence letter from the FDA for "Powder-Free Vinyl Exam Gloves." It does not contain details about specific acceptance criteria or a study proving the device meets those criteria. Instead, it confirms that the device is substantially equivalent to a legally marketed predicate device based on its intended use.

The document discusses regulatory information, labeling requirements, and contact information, but not performance study data of the type requested.

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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 finger to prevent contamination between patient and examiner.

Powdered Vinyl Patient Examination Gloves

The provided document is a 510(k) clearance letter from the FDA for "Powdered Vinyl Patient Examination Gloves". This document pertains to the regulatory clearance of a physical medical device (gloves), not an AI/ML powered device. As such, the information requested about acceptance criteria and studies for an AI/ML device is not present in this document.

Therefore, I cannot provide the requested table and study details.

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