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Ceraloy alloy is intended to be used by dentists and dental laboratories for the fabrication of custom made dental devices such as onlays, ¼ crowns, veneers, inlays long and short span bridgework and PFM restorations.

Ceraloy

It appears the provided text is a 510(k) clearance letter from the FDA for a dental alloy named "Ceraloy." This type of document primarily confirms that a new device is "substantially equivalent" to a legally marketed predicate device.

This document does NOT contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth adjudication, or any details typically associated with AI/ML device evaluations.

The FDA 510(k) clearance process for a material like a dental alloy focuses on comparing its characteristics (e.g., composition, mechanical properties, biocompatibility) to an already approved predicate device, rather than conducting new clinical performance studies as would be required for a novel diagnostic or AI-driven device.

Therefore, I cannot extract the requested information based on the provided text. To answer your questions, I would need a document detailing the results of a performance study for an AI/ML medical device.

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Ceraloy Solder is intended to be used by dentists and dental laboratories as a solder for Ceraloy alloy. It is used in the repair and fabrication of crowns, veneers, onlays, 34 crowns, short and long span bridgework and PFM restorations.

Not Found

This letter from the FDA is a determination of substantial equivalence for a medical device called "Ceraloy Solder," not a study that proves the device meets specific acceptance criteria based on performance data. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics cannot be extracted from the provided text.

The document indicates that the device is a "Base Metal Alloy" (Regulation Number: 872.3710) and is considered substantially equivalent to pre-amendments devices. This means its safety and effectiveness are deemed comparable to predicate devices already on the market, rather than being demonstrated through a contemporary performance study against specific acceptance criteria.

Here's what can be stated based on the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. The letter does not detail specific acceptance criteria for performance nor does it report any device performance metrics. It's a regulatory clearance based on substantial equivalence, not a performance study report.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided. The letter does not describe any specific test set, its sample size, or the provenance of any performance data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Cannot be provided. No information about a test set or ground truth establishment is present.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Cannot be provided. No information about a test set or adjudication method is 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

• No such study was done or reported. This type of study relates to AI-assisted diagnostics, which is not applicable to a "Base Metal Alloy" solder.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a physical dental material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Cannot be provided. No information about ground truth is present.

8. The sample size for the training set

• Not applicable. This device is a physical dental material, not a machine learning algorithm.

9. How the ground truth for the training set was established

• Not applicable. This device is a physical dental material, not a machine learning algorithm.

In summary, the provided document is a regulatory clearance letter (510(k)) based on substantial equivalence. It does not contain the kind of performance data or study details that would allow for an answer to the requested questions about acceptance criteria and study design.

Ask a specific question about this device