Search Results

A powder-free nitrile examination gloves is a disposable device intended for medical purposes that is worn on the examiner 's hand or finger to prevent cross-contamination between patient and examiner.

Disposable Nitrile Powder Free Examination Gloves (Non-sterile)

This document is a 510(k) clearance letter from the FDA for "Disposable Nitrile Powder Free Examination Gloves (Non-sterile)." It is not a study describing acceptance criteria or performance data for an AI/ML medical device.

Therefore, I cannot provide the requested information about acceptance criteria and study details as it pertains to AI/ML devices. The document concerns traditional medical devices (examination gloves) and focuses on regulatory clearance based on substantial equivalence to predicate devices, rather than performance data against specific acceptance criteria for an AI algorithm.

Ask a specific question about this device

Disposable Latex Powder Free Patient Examination Gloves (Non-sterile) Are intended for use in the medical field and worn on the examiner's hands to protect patient and user from cross contamination.
Disposable Nitrile Powder Free Patient Examination Gloves (Non-sterile) Are intended for use in the medical field and worn on the examiner's hands to protect patient and user from cross contamination.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding "Disposable Latex Examination Gloves (Non-Sterile)" and "Disposable Nitrile Examination Gloves (Non-Sterile)."

This document does not contain information about a medical device that uses AI or machine learning, nor does it discuss acceptance criteria and study results for such a device. Instead, it is a regulatory document for standard patient examination gloves.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement, as this information is not present in the given text.

Ask a specific question about this device

A powder-free latex examination gloves is a disposable device intended for medical purposes that is worn on the examiner 's hand or finger to prevent cross-contamination between patient and examiner.

Disposable Latex Powder Free Examination Gloves (Non-sterile)

The provided document is a 510(k) clearance letter from the FDA for "Disposable Latex Powder Free Examination Gloves (Non-sterile)". It does not contain information about acceptance criteria or a study proving the device meets those criteria, as it is a regulatory document, not a scientific study report.

Therefore, I cannot fulfill your request for:

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

This document is solely focused on the regulatory clearance process for a medical device (gloves), confirming its substantial equivalence to legally marketed predicates. It does not delve into the detailed performance study data you are seeking.

Ask a specific question about this device