(89 days)
CEREC Blocs C In are indicated for the fabrication of veneers and of crowns in anterior teeth and in premolars that have not been endodontically treated, using the Sirona CAD/CAM system.
CEREC Blocs C In is an industrially manufactured, silicate glass ceramic block used to produce crowns and veneer. The block consists of an inlying, highly-chromatic dentine core and an overlying translucent enamel layer. It is grinded to custom made dental restorations using Sirona CAD/CAM systems. The block is initially manufactured in a sintered state; then, is individually processed to specification. One end plane of a block is mounted to a metal carrier that is inserted in the spindle's clamping chuck of the grinding machine.
CEREC Blocs C In are available in several colors and additional bleach color. The dental restorations obtain their individual color appearance by stain and glaze firing.
Here's an analysis of the provided text regarding acceptance criteria and the supporting study for the CEREC Blocs C In device:
Based on the provided 510(k) summary, the device is a dental material (porcelain powder) for fabricating restorations, not an AI/ML device. Therefore, many of the typical AI/ML study components (like sample size for test set, experts for ground truth, MRMC studies, standalone performance, training set details) are not applicable.
The acceptance criteria provided are in relation to the physical and chemical properties of the material itself, and the "study" demonstrating compliance is non-clinical testing and comparison to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Properties | Acceptance Criteria (from predicate) / Measurement Standard | Reported Device Performance (CEREC Blocs C In) |
|---|---|---|
| Coefficient of thermal expansion CTE (20 – 500 °C) | Not explicitly stated as acceptance criteria, but for comparison to predicate. | (9.3 ± 0.3) 10^-6 K^-1 |
| Density | Not explicitly stated as acceptance criteria, but for comparison to predicate. | 2.36 g/cm³ |
| Bending strength (ISO 6872) | Meets ISO 6872: 2008 standard (for ceramic materials). | 123 ± 18 MPa |
| Transformation range | Not explicitly stated as acceptance criteria, but for comparison to predicate. | 620 ± 20 °C |
| Biocompatibility | Complies with ISO 10993-1: 2009 | Material is biocompatible |
| Chemical Properties (e.g., SiO2, Al2O3, Na2O, K2O, B2O3) | Similar to predicate device (Wieland Dental + Technik's Press X Zr). | Matches specified percentages. |
| Physical Properties (general) | Similar to predicate devices (Vitablocs®, Vitablocs®). | "Physical properties are similar for all devices." |
| Material compliance | Meets ISO 6872: 2008, "Dentistry -- Ceramic materials". | The device is stated to meet this standard. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. Standard material testing usually involves a sufficient number of samples to achieve statistical significance for each property test, but the exact number isn't detailed in the summary.
- Data Provenance: The tests are non-clinical, likely lab-based measurements performed by the manufacturer, Sirona Dental Systems GmbH, in Germany. The data is prospective in the sense that the tests were performed on newly manufactured blocks to characterize their properties.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a material, not a diagnostic or AI/ML device that requires human expert ground truth. The "ground truth" for material properties is established by recognized international standards (e.g., ISO 6872, ISO 10993-1) and objective physical and chemical testing.
4. Adjudication method for the test set
Not applicable. This is a material properties test, not a subjective assessment requiring adjudication.
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 is not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
The ground truth for the physical and chemical properties of the CEREC Blocs C In is based on:
- International Standards: Specifically, ISO 6872: 2008 ("Dentistry -- Ceramic materials") for bending strength and overall ceramic material compliance, and ISO 10993-1: 2009 for biocompatibility.
- Predicate Device Characteristics: Comparison to the known characteristics and performance of the legally marketed predicate devices (Vita's Vitablocs® and Wieland Dental + Technik's Press X Zr) to demonstrate substantial equivalence.
8. The sample size for the training set
Not applicable. This is not an AI/ML device; there is no "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device. The "ground truth" for the material's development would be established through principles of material science, engineering, and manufacturing processes aimed at achieving desired physical and chemical properties and clinical performance.
§ 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.