(84 days)
For use in prosthetic dentistry to create an all-ceramic prosthesis.
- Ceramic for coverage of a zirconia substructure
- Ceramic for coverage of a lithium disilicate substructure
[CTE: 9.5~11.0×10-6/K (50-500°C)]
CERABIEN MiLai is a specific type of porcelain for dental restorations. The system consists of Powder, Paste and Liquids for powder/paste, to be applied utilizing layering technique and baked onto a ceramic frame of zirconia (ZrO2) or different lithium disilicate glasses.
The provided FDA 510(k) clearance letter pertains to CERABIEN MiLai, a porcelain powder for clinical use in prosthetic dentistry. The documentation focuses on demonstrating substantial equivalence to predicate devices through compliance with established international standards for dental ceramics.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are derived from the requirements of the recognized consensus standards ISO 6872:2015 and ISO 9693:2019. The reported device performance indicates compliance with these standards. Specific quantitative acceptance criteria or detailed device performance values (e.g., specific flexural strength values, CTE measurements) are not explicitly itemized in the document but are stated to have been met.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| ISO 6872:2015 (Dental ceramic - Strength): This standard specifies requirements for dental ceramic materials for fixed dental prostheses, including flexural strength. The specific numerical acceptance criteria within this standard are not detailed in the provided document, but compliance implies meeting these thresholds. | The subject device met the requirements of ISO 6872:2015, indicating its mechanical strength properties are suitable for its intended use and comparable to predicate devices. |
| ISO 9693:2019 (Dental ceramic - Compatibility): This standard specifies requirements for the compatibility of ceramic materials intended for veneering metallic and ceramic substructures for dental restorations. It includes tests for thermal compatibility (e.g., thermal shock) and bond strength. For the thermal shocking testing, the acceptance criterion implies no cracking, checking, or delamination after the specified thermal cycles. | The subject device met the requirements of ISO 9693:2019 for compatibility testing for ceramic-ceramic systems. Specifically, it met the requirement of thermal shocking testing according to ISO 9693:2019, confirming its suitability with zirconia and lithium disilicate substructures within the specified CTE range (9.5~11.0×10-6/K). |
| Thermal Shock Testing (Specifically for CTE range 9.5~11.0×10-6/K): The specific acceptance criterion for the thermal shocking testing with different lithium disilicate substrates is that the device "meets the requirement of thermal shocking testing according to ISO 9693:2019." This implies no failures such as cracking or delamination. | The subject device met the requirement of thermal shocking testing according to ISO 9693:2019 when tested with different lithium disilicate substrates with CTEs ranging from 9.5×10-6/K to 11.0×10-6/K. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for the non-clinical tests (physical and mechanical tests, thermal shocking tests). It only indicates that "Physical and mechanical tests were conducted according to ISO 6872: 2015 and ISO 9693: 2019" and "the thermal shocking testing was conducted according to ISO 9693: 2019."
The provenance of the data (country of origin, retrospective/prospective) is not mentioned. However, since the applicant is Kuraray Noritake Dental Inc. located in Tokyo, Japan, it is reasonable to infer the testing was conducted either in Japan or under their direction.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the device is a material (porcelain powder) for dental prosthetics, not a diagnostic or screening device that requires expert interpretation for ground truth establishment. The performance is assessed through objective physical and mechanical tests based on recognized international standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for a physical material testing study. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or diagnostic agreement, which is not the case here.
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
This is not applicable. MRMC studies are typically performed for AI or diagnostic imaging devices where human readers interpret medical images. The CERABIEN MiLai is a dental material, and its performance is evaluated through non-clinical physical and mechanical testing.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a material, not an algorithm. Its performance is inherent to its physical and chemical properties and is tested in a standalone manner against established standards without human-in-the-loop interaction in the performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device, the "ground truth" is established by the well-defined physical and mechanical requirements and test methods outlined in the recognized international standards ISO 6872:2015 and ISO 9693:2019. This includes objective measurements of properties like flexural strength and thermal compatibility, rather than subjective expert consensus or pathology.
8. The sample size for the training set
This is not applicable. The device is a physical product, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI.
9. How the ground truth for the training set was established
This is not applicable for the reasons mentioned in 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.