Search Results

A Vinyl examination glove, Powder Free, Clear(Non-Colored) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powder-Free, Vinyl Examination Gloves, Clear (Non-Colored)

Please note that the provided text is a 510(k) clearance letter from the FDA for medical examination gloves. This type of document does not contain the detailed study information typically requested for devices involving algorithms, AI, or advanced diagnostic capabilities.

The product in question, "Powder-Free, Vinyl Examination Gloves, Clear (Non-Colored)," is a Class I medical device (patient examination glove). For such devices, the primary regulatory concerns are typically related to biocompatibility, physical properties (like tensile strength and freedom from holes), and manufacturing quality (GMP). Clinical studies demonstrating diagnostic performance or effectiveness in the way an AI algorithm would be evaluated are generally not required or performed for these low-risk devices.

Therefore, I cannot extract the requested information (such as acceptance criteria for algorithmic performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) from this document because it is not relevant to this type of device and is not present in the provided text.

If you have a different document related to a device that involves AI or algorithmic performance, I would be happy to analyze it for the requested information.

Ask a specific question about this device