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Erran Dental Zirconia are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facing, and veneers.
Normally, Erran Dental Zirconia are offered in blocks and powder and the size as shown below in Table 5-1, and are similar to the sizes and shapes of the predicate device.
There are two types of our device, one is block, another is powder. The main difference is that the blocks are made by powder, zirconia blocks is prepared and have a fixed shape, while zirconia powder is used to directly product the shape of the tooth.
Erran Dental Zirconia are derived from Zirconia powder that has been processed into their final net shapes. Erran Dental Zirconia have are then being further fabricated in to all-ceramic restoration such as crowns, bridge, veneers, inlay/onlay. The zirconia powder is composed of ZrO2+Y2O3+HfO2+Al2O3 with its composition conforms to ISO13356-2015, Implants for Surgery-Ceramic Materials Based in Yttria-Stabilized Tetragonal Zirconia(Y-TZP). The performance of the dental zirconia conforms to ISO 6872-2015, Dentistry: Ceramic Materials.
The provided text describes the acceptance criteria and a study conducted for the Erran Dental Zirconia device. Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Item | Acceptance Criteria | Reported Device Performance | Conclusion |
|---|---|---|---|
| Chemical Composition (%) | Meet the ISO 13356-2015 | ZrO2+HfO2 ≥99 +Y2O3; Y2O3 4.5~6.6; HfO2 ≤5; Al2O3 ≤0.5; SiO2 ≤0.3; Fe2O3 ≤0.2 | Meet the ISO 13356-2015 |
| Appearance | There is no spot cracks and foreign matter on the surface of Erran Dental Zirconia. | There is no spot cracks and foreign matter on the surface of Erran Dental Zirconia. | Conform |
| Size (mm) | The size deviation of zirconia blocks is within 1.0mm. The weight deviation of zirconia powder is within 10g. | Meet the requirement. | Conform |
| Density (g/cm³) | Not less than 2.6, the deviation is less than 0.05 compared with marked value (3.16). | Meet the requirement. | Conform |
| Sintering Density (g/cm³) | Not less than 6.02 | 6.025 | Conform |
| Fracture Toughness (post sintering) (MPa) | At least 8 samples of the 10 samples have a fracture toughness greater than 800 | The samples met the criteria. | Conform |
| Chemical Solubility (µg/cm²) | <100 | 12.42 | Conform |
| Shrinkage | At least 8 samples of the 10 samples have a Shrinkage which should between 19~27 | Average is 19.61, all samples are between 19-27 range. | Conform |
| Mixing and Condensation Properties (only for zirconia powder) | After the zirconia powder is compacted, it should not be cracked or broken, and after forming compaction, it may not be agglomerated. | The samples meet the requirements. | Conform |
| The coefficient of thermal expansion (only for zirconia powder) | $6.5 × 10^{-6} K^{-1}~11.5 × 10^{-6} K^{-1}$, the deviation is less than $0.5 × 10^{-6} K^{-1}$ | $10.5 × 10^{-6} K^{-1}$ | Conform |
| Radioactivity | The activity concentration of U-238 is not more than 1.0 | <0.005 | Conform |
| Biocompatibility (Cytotoxicity, Irritation Oral Mucosa, Irritation, Sensitization, Subacute, Subchronic Toxicity, Genotoxicity) | Biocompatibility testing including cytotoxicity, mucosal irritation, sensitization conducted in accordance with ISO 7405-2008 and ISO 10993-10. | We conducted comparative performance testing for biocompatibility testing including cytotoxicity, mucosal irritation, sensitization and etc. conducted in accordance with ISO 7405-2008 and ISO 10993-10, and meet the requirements. | Conform |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Test Set Sample Size: For "Fracture Toughness" and "Shrinkage," the criteria specify "At least 8 samples of the 10 samples," implying a sample size of 10 for these specific tests. Other tests do not explicitly state a sample size, but the results indicate that they were performed.
- Data Provenance: The document states "Bench testing was performed per ISO 6872-2015 and internal procedures." It also mentions "Biocompatibility testing was performed to verify the equivalent safety of the materials that are used." There is no information provided regarding the country of origin of the data or whether the study was retrospective or prospective.
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)
The study involves bench testing and biocompatibility testing based on recognized international standards (ISO 6872-2015, ISO 7405-2008, ISO 10993-1-2009). For these types of tests, "ground truth" is typically established by fulfilling the requirements and methodologies outlined in the respective standards, rather than expert consensus on clinical cases. Therefore, information about the number or qualifications of experts establishing ground truth in the context of clinical interpretation is not applicable here. The "experts" would be the scientists and technicians conducting the standardized tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a study based on physical and chemical bench testing and biocompatibility assessment against established standards, not a clinical study requiring adjudication of expert interpretations.
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-assisted diagnostic device, but rather a dental material (zirconia) whose performance is evaluated through material science and biocompatibility tests.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a dental material, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this study is defined by the acceptance criteria specified in internationally recognized standards for dental materials, specifically ISO 6872-2015 (Dentistry: Ceramic Materials) and ISO 13356-2015 (Implants for Surgery-Ceramic Materials Based in Yttria-Stabilized Tetragonal Zirconia). For biocompatibility, ISO 7405-2008 and ISO 10993-10 were used. The device performance is measured against these quantitative and qualitative requirements.
8. The sample size for the training set
Not applicable. This is a material testing study, not a machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device and study.
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