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510(k) Data Aggregation
(144 days)
Dental Glass Ceramics are indicated for fabrications such as veneers, inlay/ onlay/ onlay/ partial crowns, anterior crowns, posterior crowns, using the hot press technique or CAD/CAM system.
This product is composed of SiO2 , Al2O3 , Li2O , K2O , Na2O , CeO2 , Pr6O11 , ZrO2 , P2O5 , СаО , МпО2 , Ег2Оз .
The provided document is a 510(k) Premarket Notification for a medical device called "Dental Glass Ceramics". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or developing an AI algorithm. Therefore, many of the requested categories for AI-based device studies are not applicable to this document.
Here's an analysis based on the information available:
1. Table of acceptance criteria and the reported device performance
| ID# | Test | Method | Acceptance Criteria | Test Result | Conclusion |
|---|---|---|---|---|---|
| 1.1 Material Composition Content | |||||
| Silicon dioxide (SiO2) | Ingredient Content (%) | 60~75 | 68.32% | Pass | |
| Alumina (Al2O3) | Ingredient Content (%) | 2~7 | 4.02% | Pass | |
| Lithium oxide (Li2O) | Ingredient Content (%) | 5~17 | 13.09% | Pass | |
| Potassium oxide + sodium oxide (K2O+Na2O) | Ingredient Content (%) | 1~5 | 3.02% | Pass | |
| Phosphorus pentoxide (P2O5) | Ingredient Content (%) | 3~4 | 3.53% | Pass | |
| Zirconium (hafnium) dioxide (Zr (Hf) O2) | Ingredient Content (%) | 0.5 ~ 6 | 1.86% | Pass | |
| Praseodymium oxide (Pr6O11) | Ingredient Content (%) | ≤5 | 1.66% | Pass | |
| Cerium dioxide (CeO2) | Ingredient Content (%) | ≤2.5 | 1.61% | Pass | |
| Erbium oxide (Er2O3) | Ingredient Content (%) | ≤4.5 | 1.59% | Pass | |
| Manganese dioxide (MnO2) | Ingredient Content (%) | ≤1 | < 0.01% | Pass | |
| Calcium oxide (CaO) | Ingredient Content (%) | ≤1.5 | 0.78% | Pass | |
| Other oxides | Ingredient Content (%) | ≤2 | 0.51% | Pass | |
| 1.2 Size Requirement | The deviation of specifications and dimensions shall be ± 0.5 mm. | Length: 18.47mm, 18.43mm, 18.41mm, 18.42mm, 18.48mm. Width: 14.84mm, 14.87mm, 14.82mm, 14.85mm, 14.82mm. Height: 12.36mm, 12.47mm, 12.41mm, 12.39mm, 12.38mm | Pass | ||
| 1.3 Appearance | No spot cracks and foreign bodies were visible on the surface | No spotted cracks and foreign bodies were found on the surface of the sample | Pass | ||
| 1.4 Porcelain block density | Should be ≥2.2g/cm3 | 2.45g/cm3 | Pass | ||
| 1.5 Flexural strength | The average flexural strength of 10 samples after sintering should be ≥300MPa | 393.8MPa | Pass | ||
| 1.6 Chemical solubility | Should the final sintering be <100ug/cm2 | 29.7µg/cm2 | Pass | ||
| 1.7 Radioactivity | The active concentration of uranium-238 should be ≤1.0Bq/g | <0.022Bq/g | Pass | ||
| 1.8 Linear expansion coefficient | It should be $(9.7\pm0.5) \times 10^{-6}K^{-1}$ | $9.4\times10^{-6}K^{-1}$ | Pass | ||
| 1.9 Glass transition temperature | It should be $(530\pm20)$ °C | 541.3°C | Pass | ||
| 2 Biocompatibility Testing | |||||
| 2.1 Cytotoxicity | ISO 10993-5:2009 | Non-cytotoxic | Pass | Pass | |
| 2.2 Delayed hypersensitivity | ISO 10993-10:2010 | Non-Delayed hypersensitivity | Pass | Pass | |
| 2.3 Intradermal reaction | ISO 10993-10:2010 | Non-Intradermal reaction | Pass | Pass | |
| 2.4 Acute systemic toxicity | ISO 10993-11:2017 | Non-Acute systemic toxicity | Pass | Pass | |
| 2.5 Subchronic systemic toxicity | ISO 10993-11:2017 | Non-Acute systemic toxicity | Pass | Pass | |
| 2.6 Genotoxicity | ISO 10993-3:2014 | Non-genotoxicity | Pass | Pass |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set:
- For material composition, appearance, porcelain block density, radioactivity, linear expansion coefficient, and glass transition temperature, individual measurements are reported.
- For Flexural strength, the testing involved 10 samples.
- For Size requirement, 5 measurements each for length, width, and height are reported.
- For Biocompatibility testing (Cytotoxicity, Delayed hypersensitivity, Intradermal reaction, Acute systemic toxicity, Subchronic systemic toxicity, Genotoxicity), the document states "Pass" for each, implying sufficient samples were used to meet the ISO standards' requirements, but specific numbers are not provided.
- Data Provenance: The document does not explicitly state the country of origin for the test data. However, the submitter is Chengdu Besmile Medical Technology Co., Ltd. from Chengdu, Sichuan, China. The testing is described as "Non-clinical Testing (Bench)," indicating laboratory testing rather than data from human subjects. The data is retrospective in the sense that it's generated from manufactured samples for submission.
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 a non-clinical, material properties testing submission, not an AI or diagnostic device that requires expert-established ground truth. The acceptance criteria are based on recognized consensus standards (e.g., ISO 10993 series) and product technical requirements for dental materials. Therefore, no human experts were involved in establishing "ground truth" in the diagnostic sense.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring adjudication of diagnostic outcomes.
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 a material science device, not an AI-based diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
Not applicable. This is a material science device, not an AI-based diagnostic tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" here is defined by the acceptance criteria established by recognized consensus standards (e.g., ISO 10993 for biocompatibility) and internal product technical requirements for dental glass ceramics. These are objective, measurable physical, chemical, and biological properties, not human-interpreted diagnostic outcomes.
8. The sample size for the training set
Not applicable. This device is a material, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is a material, not an AI model that requires a training set.
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