(65 days)
KaVo Everest G-Blanks are used in the manufacture of dental prosthetics.
KaVo Everest G-Ceram is used in the manufacture of inlays, crowns, and onlays.
The KaVo Everest G-Blank is a pre-formed material for use by dental laboratories in filling orders/prescriptions for dental prosthetics; KaVo Everest G-Ceram is a porcelain powder for use by dental laboratories in filling orders/prescriptions of dentists for inlays, crowns, and onlays.
The provided text does not contain information regarding acceptance criteria and the study that proves the device meets the acceptance criteria for a medical device that would typically involve performance metrics and clinical studies. Instead, it is a 510(k) premarket notification summary for dental materials (KaVo Everest G-Blank and KaVo Everest G-Ceram).
For these types of materials, the "acceptance criteria" for regulatory clearance are primarily based on substantial equivalence to legally marketed predicate devices and compliance with relevant regulations and material identifications, rather than performance data from a specific study comparing device output to clinical outcomes.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance (from K030607 Summary) |
|---|---|
| Formulation Comparison: Equivalent to predicate device formulations. | "claim of substantial equivalence is based on comparisons of formulations" |
| Intended Use Comparison: Equivalent to predicate device intended uses. | "claim of substantial equivalence is based on comparisons of... intended uses of the KaVo devices to legally marketed predicates" |
| Regulatory Identification: Aligns with the classification regulation (21 CFR 872.6660, Porcelain powder for clinical use). | "IDENTIFICATION of porcelain powders in 21 CFR 872.6660." |
| Safety and Effectiveness: Assumed to be equivalent to predicate devices, thus not requiring specific performance data for clearance beyond formulation and use comparison. | "Performance Data: None required." |
2. Sample size used for the test set and the data provenance:
- Not Applicable. The submission explicitly states "Performance Data: None required." This indicates that no specific test set (clinical or otherwise) with a defined sample size was used to demonstrate performance against acceptance criteria for the purpose of this 510(k) submission. The clearance was based on substantial equivalence to existing devices and their classifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. As no performance data from a test set was required or provided, there were no experts used to establish ground truth in this context.
4. Adjudication method for the test set:
- Not Applicable. No test set or performance study was conducted.
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 Applicable. This device is a dental material, not an AI-powered diagnostic tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a dental material, not an algorithm.
7. The type of ground truth used:
- Not Applicable in the traditional sense. For this 510(k), the "ground truth" for substantial equivalence was established by the pre-existing classification regulation for Porcelain Powder for Clinical Use (21 CFR 872.6660) and the established safety and effectiveness profiles of the cited predicate devices (Empress and ProCAD). The agency determined that the new devices' formulations and intended uses were sufficiently similar to these established entities.
8. The sample size for the training set:
- Not Applicable. As no performance data or machine learning components are involved, there is no training set.
9. How the ground truth for the training set was established:
- Not Applicable. As no performance data or machine learning components are involved, there is no training set and thus no ground truth to establish for it.
Conclusion from the document:
The 510(k) clearance for KaVo Everest G-Blank and KaVo Everest G-Ceram was granted based on a demonstration of substantial equivalence to predicate devices (Empress and ProCAD) in terms of:
- Formulation
- Intended use
- Alignment with the existing regulatory classification (21 CFR 872.6660 for Porcelain Powder for Clinical Use).
The submission explicitly states "Performance Data: None required," indicating that no specific clinical or performance studies with acceptance criteria based on metrics like sensitivity, specificity, or effect size were part of the regulatory review process for this device's clearance.
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.