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Color staining and glazing of glass ceramic restorations made from 3M ESPE's Glass Ceramics "Jolly".

Bellus Shading Kit contains stain pastes, a glazing paste, and a liquid which can be used to thin the pastes. The pastes serve solely for the color staining and glazing of the surfaces of restorations made from "Jolly" glass ceramic blocks, manufactured for 3M ESPE.

This 510(k) premarket notification for the Bellus Shading Kit does not contain the detailed study information or acceptance criteria typically found for medical devices.

The filing primarily focuses on demonstrating substantial equivalence to predicate devices, particularly regarding safety (biocompatibility) and intended use, rather than presenting a performance study with specific acceptance criteria.

Therefore, most of the requested information cannot be extracted from the provided text. I will explain why each section cannot be answered from the document.

1. Table of acceptance criteria and reported device performance:

• Cannot be provided. The document states "To provide evidence for safety biocompatibility testing was carried out. The results show that Bellus Shading Kit is a safe device." However, it does not specify any quantitative acceptance criteria for biocompatibility nor does it report specific performance metrics for color staining and glazing. The assessment relies on the comparison of chemistry, performance data, and indications for use with predicate devices, implying qualitative rather than quantitative performance comparison.

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

• Cannot be provided. The document does not describe a clinical or performance test set. It mentions "biocompatibility testing," but no details about the sample size, study design (retrospective/prospective), or data provenance are given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Cannot be provided. No test set or ground truth establishment process is described in the document.

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

• Cannot be provided. No test set or adjudication method is described.

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:

• Cannot be provided. This device is a dental material (porcelain powder for clinical use), not an AI-powered diagnostic or therapeutic device. Therefore, a MRMC study or AI assistance is not applicable.

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

• Cannot be provided. This device is a dental material, not an algorithm.

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

• Cannot be provided. No specific ground truth methodology is described as there isn't a performance study in the document. The primary "truth" being established is substantial equivalence to predicate devices based on safety and intended use.

8. The sample size for the training set:

• Cannot be provided. No training set is applicable or described for this type of device.

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

• Cannot be provided. Not applicable.

In summary, the provided 510(k) pertains to a dental material (porcelain powder) and follows a substantial equivalence pathway, not a performance study with explicit acceptance criteria and detailed study results typical of more complex medical devices or software. The emphasis is on demonstrating that the device is safe and performs similarly to already legally marketed predicate devices, primarily through biocompatibility testing and a comparison of intended use and composition.

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