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510(k) Data Aggregation
(120 days)
Glass Ceramic are indicated for fabricating all-ceramic restorations such as veneers, inlays, onlays, crowns, 2-unit anterior bridges, using the CAD/CAM system.
Glass Ceramic is indicated for fabricating all ceramic restorations such as veneers, inlay/ onlay, partial crowns, anterior crowns, posterior crowns, using the CAD/CAM system.
The Glass Ceramic is composed of SiO2, Li2O, K2O, P2O5, Al2O3 and other oxides, the performance of the Glass Ceramic conforms to ISO 6872: 2015 Dentistry: Ceramic Materials.
The Glass Ceramic is disposable device, and provided as non-sterile.
The provided text describes a 510(k) premarket notification for a dental Glass Ceramic device and outlines non-clinical tests conducted to demonstrate substantial equivalence to a predicate device. It does not contain information about a study involving human readers, AI assistance, or expert ground truth for image analysis.
Here's a breakdown of the available information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily based on the ISO 6872:2015 standard for Dentistry: Ceramic Materials and relevant ISO 10993 standards for biological evaluation.
| ITEM | Acceptance Criteria (from ISO Standard) | Reported Device Performance (K223194) | Remark |
|---|---|---|---|
| Performance (ISO 6872:2015) | |||
| Uniformity | No segregation of pigment(s) when the powder is mixed, check by visual inspection. | Conformance to requirements | SAME |
| Freedom from extraneous materials | Free from extraneous materials when assessed by visual inspection. | Conformance to requirements | SAME |
| Radioactivity | < 1.0Bq·g⁻¹ of ²³⁸U | < 1.0Bq·g⁻¹ of ²³⁸U | SAME |
| Biaxial flexure | Type II Class 2 > 100MPa | 308.4MPa | Different 1 (Meets & Exceeds) |
| Linear thermal expansion coefficient | Shall not deviate by more than 0.5×10⁻⁶K⁻¹ from manufacturer's stated value. | 10.8×10⁻⁶K⁻¹ | SIMILAR |
| Glass transition temperature | Shall not deviate by more than 20°C from manufacturer's stated value. | 553.5°C | Different 2 (Meets) |
| Chemical solubility | Type II Class 2 < 100µg·cm⁻² | 9.5µg·cm⁻² | SIMILAR |
| Fracture toughness | Type II Class 2 > 1MPa√m | 3.83MPa√m | Different 3 (Meets & Exceeds) |
| Biocompatibility (ISO 10993 series) | |||
| Cytotoxicity (Agar diffusion) | Conformance to requirements in ISO 10993-5 | Conformance to requirements | SAME |
| Sensitization | Conformance to requirements in ISO 10993-10 | Conformance to requirements | SAME |
| Acute systemic toxicity (Oral) | Conformance to requirements in ISO 10993-11 / ISO 10993-23 | Conformance to requirements | SAME |
| Oral mucosa irritation | Conformance to requirements in ISO 10993-10 | Conformance to requirements | SAME |
| Bacterial reverse mutation (Ames test) | Conformance to requirements in ISO 10993-3 | Conformance to requirements | SAME |
Study Proving Device Meets Acceptance Criteria:
The study conducted was a series of non-clinical tests to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The results are summarized in Section 7 and further detailed in the comparison tables (Table 5-2 for Performance and Table 5-3 for Biocompatibility).
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document does not specify the exact sample sizes (e.g., number of test specimens) used for each non-clinical test. It only states that "Non clinical tests were conducted".
- Data Provenance: The tests were conducted by the manufacturer, Shenzhen Xiangtong Co.,Ltd., in China, as implied by their address and the submission origin. The tests are non-clinical, so "retrospective or prospective" doesn't directly apply in the human data sense. It refers to laboratory testing of material properties.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This section is not applicable as the document describes non-clinical material testing, not a study involving human interpretation or ground truth establishment by medical experts for diagnostic purposes. The "ground truth" for these tests is defined by the objective measurement standards outlined in the ISO standards.
4. Adjudication Method for the Test Set
This section is not applicable as the document describes non-clinical material testing, not a study involving human interpretation or adjudication processes.
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
There was no MRMC comparative effectiveness study done. The device is a dental material (Glass Ceramic) used for restorations, not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable as the device is a physical material, not an algorithm.
7. The type of ground truth used
The "ground truth" for the non-clinical tests was established by objective measurement against the specified criteria and methodologies detailed in the referenced ISO standards (e.g., ISO 6872 for ceramic materials, ISO 10993 for biological evaluation). These standards define acceptable ranges and test methods for properties like biaxial flexure strength, chemical solubility, and biocompatibility.
8. The sample size for the training set
This section is not applicable. The document describes the testing of a manufactured material, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as above.
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