(57 days)
Dental Blanks made from StarCeram® Z-Med or StarCeram® Z-Al-Med HD are indicated for crowns, multi-unit bridges and inlay bridges. Applications include both anterior and posterior bridges.
Dental blanks made of StarCeram® Z-Med or StarCeram® Z-AI-Med HD are dental materials (semifinished products) made of yttrium stabilized, presintered zirconium dioxide for milled production of crowns and bridge frameworks on commercial CAD/CAM systems or handoperated copy-milling machines, with outstanding biocompatibility and high resistance against tension and pressure.
Here's an analysis of the provided text regarding the acceptance criteria and study for the StarCeram device:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., tensile strength greater than X, flexural strength greater than Y). Instead, it states that non-clinical testing was performed to validate the design against the company's specified design requirements and to assure conformance with two voluntary design standards.
Therefore, the "acceptance criteria" can be inferred as conformance to these standards and the company's internal design requirements.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformance with ANSI/ADA Specifications No. 69:1999 | Non-clinical testing performed to assure conformance. |
| Conformance with ISO 6872:1995 + Amendment 1-1997 | Non-clinical testing performed to assure conformance. |
| Validation against company's specified design requirements | Non-clinical testing performed to validate the design. |
| Demonstrated "outstanding biocompatibility" | Stated in device description as a characteristic. |
| Demonstrated "high resistance against tension and pressure" | Stated in device description as a characteristic. |
2. Sample Size and Data Provenance for Test Set
- Sample Size: The document does not specify the sample size used for the non-clinical testing.
- Data Provenance: The document states that H.C. Starck Ceramics GmbH & Co. KG performed non-clinical testing. This suggests the data was generated internally by the manufacturer. The company is based in Selb, GERMANY, so the data provenance is likely Germany (retrospective, as it was generated before submission).
3. Number of Experts and Qualifications for Ground Truth, Test Set
This information is not applicable as the device is a material (porcelain powder) and the testing referenced is non-clinical (material property testing) rather than clinical or image-based diagnostic testing requiring expert human interpretation or ground truth establishment in a medical context.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done. The submission explicitly states: "H.C. Starck Ceramics GmbH & Co. KG did not conduct, nor rely upon, clinical tests to determine substantial equivalence." This is a non-clinical device, not an AI or diagnostic device that would typically involve human reader studies.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study was not done. This type of study is relevant for AI algorithms or diagnostic devices. The StarCeram is a dental material, and its evaluation focuses on material properties through non-clinical testing.
7. Type of Ground Truth Used
The "ground truth" for this device's evaluation is primarily based on:
- Voluntary Design Standards: ANSI/ADA Specifications No. 69:1999 and ISO 6872:1995 + Amendment 1-1997.
- Company's Specified Design Requirements: Internal specifications for material properties and performance.
8. Sample Size for the Training Set
This information is not applicable. This device is a material, not an AI system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
§ 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.