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A patient examination glove 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.

Shanghai Giantmax Plastic Products Powdered Clear Vinyl Examination Glove

The provided text is a 510(k) premarket notification letter for a medical device, specifically a "Shanghai Giantmax Powdered Clear Vinyl Examination Glove." This document is a regulatory approval letter from the FDA and does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or technical performance reports.

The letter states that the FDA reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices for the indicated use. This determination is based on the device meeting the general controls provisions of the Federal Food, Drug, and Cosmetic Act.

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

1. A table of acceptance criteria and reported device performance.
2. Sample size or data provenance for a test set.
3. Number or qualifications of experts used for ground truth.
4. Adjudication method for a test set.
5. Details of a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Results of a standalone (algorithm-only) performance study.
7. Type of ground truth used.
8. Sample size for a training set.
9. How ground truth for a training set was established.

This document focuses on regulatory compliance and substantial equivalence rather than detailed performance study results.

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A patient examination glove 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.

Shanghai Giantmax Plastic Products Powder-Free Clear Vinyl Examination Glove

The provided document is a 510(k) premarket notification letter from the FDA regarding a sterile patient examination glove. This document does not contain information about a medical device that uses artificial intelligence (AI) and thus does not include acceptance criteria, study details, or performance metrics in the way your request describes for AI-enhanced devices.

The document essentially states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It refers to general controls and regulations but does not delve into specific performance studies with acceptance criteria as would be expected for a novel AI device.

Therefore, I cannot fulfill your request for the specific details about acceptance criteria and study information for an AI device. The information provided in the document is for a traditional medical device (gloves) and does not align with the nature of your questions.

Ask a specific question about this device