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Cercon Base is a partially sintered yttria (yttrium oxide) stabilized zirconia (zirconium oxide) powder that is machined and then sintered to full density. It is designed for use as a substructure (framework) for single tooth or bridge type restorations. Applications include both anterior and posterior locations.

Cercon Base is a partially sintered yttria (yttrium oxide) stabilized zirconia (zirconium oxide) powder that is machined and then sintered to full density.

I am sorry, but based on the provided text, I cannot extract any information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) premarket notification letter from the FDA regarding a dental ceramic device named "Cercon Base." It primarily discusses the regulatory approval process, classification, and general compliance requirements for marketing the device. There is no mention of specific acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.

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Definite® is a light cured composite intended to be used for all classes of restorations from class I to class V.

Definite® is a light cured composite offered as a single paste system in compules. The system consists of the filling material Definite® and the self etching adhesive Etch&Prime® 3.0.

The provided FDA document (K993514) is a 510(k) clearance letter for a dental restorative material called "Definite®". It is a premarket notification, not a clinical study report. Therefore, it does not contain any information about acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

The document only states that the device is "substantially equivalent" to legally marketed predicate devices for use in "all classes of restorations from class I to class V." This substantial equivalence determination is based on the comparison to predicate devices, not on a new clinical study detailed in this specific document.

To answer the requested questions, one would need access to the full 510(k) submission, which is typically not publicly available in this level of detail, or reference a separate clinical study report, if one was conducted and made public.

Therefore, based solely on the provided document, I cannot provide information for the following:

1. A table of acceptance criteria and the reported device performance: Not present.
2. Sample sizes used for the test set and the data provenance: Not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
4. Adjudication method for the test set: Not present.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not present. This device is a dental restorative material, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. This device is a dental restorative material.
7. The type of ground truth used: Not present.
8. The sample size for the training set: Not present.
9. How the ground truth for the training set was established: Not present.

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Ceramic Core This product 1 S used in the manufacture a "all-ceramic dental restorations, The product in the form of pellets and is processed with corrently marketed fornaces

The product in the form of pellets

The provided text is a 510(k) premarket notification letter from the FDA regarding a dental product named "Cergogold." It confirms substantial equivalence but does not contain information about acceptance criteria or a study proving device performance. Therefore, I cannot generate the requested information based on the provided input.

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