(97 days)
The indications for use for DC-Cristall is as a substructure for single unit porcelain fused ceramic fixed dental restorations; namely crowns. Substructures of DC-Cristall are machined using the DCS Precident CAD/CAM System.
The DC-Cristall material is a glass ceramic material, furnished in a block form, designed for use as feed stock in the DCS Precident CAD/CAM System.
This describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the DC-Cristall material.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ISO 6872:1999 Dental Ceramics) | Reported Device Performance (DC-Cristall) |
|---|---|
| Mechanical Strength | Complies with ISO 6872:1999 |
| Chemical Solubility | Complies with ISO 6872:1999 |
| Biocompatibility | Complies with ISO 6872:1999 |
| Dimensional Stability | Complies with ISO 6872:1999 |
| Esthetics | Not explicitly detailed but implied by "porcelain fused ceramic" |
Note: The provided document states that "The safety and efficacy of DC-Cristall is assured by compliance with ISO 6872:1999 Dental Ceramics." However, it does not provide specific numerical values or detailed test results for each criterion. It only asserts overall compliance.
2. Sample Size and Data Provenance for the Test Set
The document does not explicitly specify a "test set" in the context of an AI/ML device. Instead, it refers to standard testing of the material itself.
- Sample Size: Not explicitly stated for specific tests, but testing would have been conducted on an appropriate number of DC-Cristall material samples to satisfy the requirements of ISO 6872:1999.
- Data Provenance: Not specified, but standard material testing would typically be performed in a laboratory setting, likely in the country of origin of the manufacturer (USA, based on the address). This would be analogous to a prospective study of material properties.
3. Number of Experts and Qualifications for Ground Truth - Test Set
Not applicable in the context of an AI/ML device. This refers to material scientists and engineers who would conduct the tests and assess compliance with ISO 6872:1999. Their qualifications would be expertise in dental materials testing and adherence to international standards.
4. Adjudication Method for the Test Set
Not applicable in the context of an AI/ML device. Compliance with ISO 6872:1999 would be determined by whether the test results meet the specified thresholds and requirements of the standard, not by expert adjudication of interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. The DC-Cristall is a material for dental restorations, not an AI/ML diagnostic or assistive device that would involve human readers.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a material, not an algorithm. The "performance" is its compliance with material standards.
7. Type of Ground Truth Used
The ground truth used is the standards set forth in ISO 6872:1999 Dental Ceramics. This standard defines the acceptable physical, mechanical, chemical, and biological properties for dental ceramic materials. Compliance with all specified tests and thresholds within this standard constitutes the "ground truth" for the material's safety and efficacy.
8. Sample Size for the Training Set
Not applicable. This is a material, not an AI/ML model that requires a training set. The development of the material would involve R&D and formulation iterations, but not "training data" in the AI sense.
9. How Ground Truth for the Training Set Was Established
Not applicable. As noted above, this is a material, not an AI/ML model. The "ground truth" for material development would be established through established scientific principles, material science research, and iterative testing against desired performance specifications, which would eventually lead to the formulation meeting ISO standards.
§ 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.