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A Synthetic Vinyl Examination Glove Powder Free coated with Allogel(Green/Blue/White/Magenta/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.

Synthetic Vinyl Examination Glove Powder Free Coated With Allogel (Green/Blue/White/Magenta/Clear (non colored))

I am sorry, but the provided text does not contain the information requested. The document is an FDA 510(k) clearance letter for a medical device (Synthetic Vinyl Examination Glove), and it primarily addresses the substantial equivalence determination. It does not include details about acceptance criteria, study methodologies, sample sizes, ground truth establishment, or multi-reader multi-case studies as would be expected for an AI/CAD diagnostic device.

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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.

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A Stretch Vinyl Examination Glove Colored(Yellow/White) 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, Stretch Vinyl Examination Gloves, (Yellow/White)

This document is a 510(k) premarket notification decision letter from the FDA for Powder-Free, Stretch Vinyl Examination Gloves. It does not contain information about the acceptance criteria or a study proving the device meets those criteria, as it is a regulatory clearance document rather than a study report. The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

Therefore, I cannot provide the requested information from the provided text. The document does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This type of information is typically found in a separate study report or regulatory submission, not in the FDA's clearance letter itself.

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