Search Results

This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Polymer Coated Powder Free Nitrile Examination Gloves, Blue, Green and White color.

The provided document is an FDA 510(k) Pre-market Notification letter for Polymer Coated Powder Free Nitrile Examination Gloves. This type of document is a regulatory approval and does not contain the information requested regarding acceptance criteria and a study proving device performance in the context of an AI/ML-based medical device.

The questions you've asked are typical for studies evaluating the performance of algorithms or diagnostic devices (often involving AI/ML), where there's a need to establish sensitivity, specificity, accuracy, and compare to a ground truth established by experts.

This document, however, pertains to a physical medical device (examination gloves) and focuses on substantial equivalence to a predicate device, as per the FDA 510(k) process for Class I devices. The "performance" for such a device is typically assessed through physical properties and safety standards, rather than diagnostic accuracy metrics.

Therefore, I cannot extract the requested information from this document.

Ask a specific question about this device

This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Polymer Coated Powder Free Nitrile Examination Gloves, BLUE

I am sorry, but the provided text is a government document from the Food and Drug Administration (FDA) and does not contain the specific information you are looking for regarding acceptance criteria, study details, or AI performance metrics. It is a 510(k) clearance letter for a medical device (nitrile examination gloves) and an "Indications for Use Statement." These documents typically focus on regulatory compliance and the intended use of the device, rather than detailed performance studies against specific acceptance criteria.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the 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 method.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study details or effect size.
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.

Ask a specific question about this device