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Fabrication of dental prostheses like full dentures and metal free partials.

Not Found

The provided text is an FDA 510(k) clearance letter for a dental material named "FUSICRYL". It indicates that the device has been found substantially equivalent to a predicate device and can be marketed.

However, the letter does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC).

Therefore, I cannot provide the requested information. The document focuses solely on the regulatory clearance of the device based on substantial equivalence, not on the detailed technical performance data that would typically be found in a study report.

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Fabrication of 24 karat 99.96% pure gold substructure for porcelain fused to metal restorations.

ProGold - Gold Electrocoping System

I am sorry, but the provided text does not contain the detailed study information required to answer your request about acceptance criteria and device performance. The document is a 510(k) clearance letter from the FDA for a dental system called "ProGold - Gold Electrocoping System." It states that the device is substantially equivalent to previously marketed devices but does not include any specifics about clinical studies, performance metrics, acceptance criteria, or sample sizes.

Therefore, I cannot extract the following information:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes 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
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the 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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Fabrication of dental prostheses like: Clasps, provisional bridges, space maintainers, partials orthodontic devices and abutments.

Not Found

This looks like a 510(k) clearance letter for a dental device, "Dental D," not a study report with performance metrics.

Therefore, the provided text does not contain the information requested regarding:

• Acceptance criteria and reported device performance.
• Sample size for test set, data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study results.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for training set.
• Ground truth establishment for the training set.

The document is a regulatory letter from the FDA stating that the device is "substantially equivalent" to previously marketed devices for the fabrication of dental prostheses. It outlines the regulatory classification and general controls applicable to the device. There is no mention of a performance study or specific acceptance criteria within this document.

Ask a specific question about this device