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A Synthetic Vinyl Examination Gloves, Powder-free, Yellow 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 Gloves, Powder-free, Yellow

This document is a 510(k) premarket notification decision letter from the FDA for "Synthetic Vinyl Examination Gloves, Powder-Free, Yellow". It confirms that the device is substantially equivalent to legally marketed predicate devices.

The document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria. It is a regulatory approval letter, not a performance study report.

Therefore, I cannot provide the requested information:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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Synthetic Vinyl Examination Glove, Powder Free 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 Gloves, Powder-Free

This document is a 510(k) clearance letter from the FDA for "Synthetic Vinyl Examination Gloves, Powder-Free". It does not contain information about acceptance criteria or a study proving that a device meets such criteria in the context of an AI/ML medical device.

The document is a regulatory approval for a medical device (gloves) based on substantial equivalence to a predicate device, not on performance studies against specific acceptance criteria like those used for AI/ML algorithms.

Therefore, I cannot provide the requested information. This document does not describe:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test or training sets, nor data provenance.
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance studies.
• Type of ground truth used.
• Ground truth establishment for a training set.

Ask a specific question about this device