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510(k) Data Aggregation
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Color and Multilayer-SHT are intended for the manufacturing of partial and single crowns, full arch occlusally screwed bridges, inlays, onlays, and veneers, full contour restorations as well as reduced structures in combination with veneering ceramics. The products are categorized into class 5 according to ISO 6872.
Multilayer-3D is intended for the manufacturing of partial and single crowns, max. 3-unit bridges, inlays, onlays and veneers, full contour restorations as well as for reduced structures in combination with veneering ceramics and implant superstructures for 3-unit restorations in the anterior and posterior tooth region. The products are categorized into class 4 according to ISO 6872.
The products are suitable for all milling machines which are able to process presintered zirconia and which have the proper clamping device for the corresponding block.
Dental Zirconia Pre-shaded Block is composed of yttria-stabilized zirconia. It contains ZrO2+HfO2+Y2O3+Al2O3 and very small amount of additional inorganic pigments (Fe2O3+Er2O3+Mn2O3). The inorganic pigments generate the color on the restorations, after sintering at dental labs, that matches natural color of patient's teeth.
Dental Zirconia Pre-shaded Block has two color representations (i.e. monolayer and multilayer), corresponding to the categories of Color and Multilayer. The Multilayer also divided into two subcategories (Multilayer-SHT and Multilayer-3D) according to the consistency of the translucency across the zirconium block. And it offers various shapes and dimensions suitable for different milling systems.
The proposed device is processed into the dental restorations such as crowns, bridges, veneers, inlays and onlays based on the anatomical rendering of the patient's teeth using CAD/CAM (computer aided design / computer aided manufacturing) method or manual milling method.
The performance of the proposed device conforms to ISO 6872:2015 Dentistry: Ceramic Materials. It is a single-use device, and provided non-sterile.
This document is a 510(k) summary for a medical device called "Dental Zirconia Pre-shaded Block". The 510(k) process is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This process does not involve the type of acceptance criteria and study design typically associated with AI/ML-driven diagnostic devices that assess patient conditions or make clinical recommendations.
Because this document is about a material used in dentistry (zirconia blocks for crowns and bridges), the "acceptance criteria" and "study" are related to material properties and biocompatibility as per relevant international standards (ISO), rather than diagnostic performance metrics like sensitivity, specificity, or AUC, which are common for AI/ML devices.
Therefore, many of the requested elements for describing AI/ML device acceptance criteria and studies (e.g., sample size for test set, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this type of medical device submission.
However, I can extract information related to the performance testing of the material, which serves as its "acceptance criteria" in the context of material science.
Acceptance Criteria and Device Performance for "Dental Zirconia Pre-shaded Block"
The acceptance criteria for this dental material are based on the international standard ISO 6872:2015 Dentistry - Ceramic materials. The study proving the device meets these criteria involved non-clinical performance testing and biocompatibility testing.
1. Table of Acceptance Criteria and Reported Device Performance
The requirements are defined by ISO 6872:2015. The device's performance is reported for two categories: "Multilayer-3D" and "Color, Multilayer-SHT".
| Test Item | Acceptance Criteria (from ISO 6872:2015) | Reported Device Performance (Multilayer-3D) | Reported Device Performance (Color, Multilayer-SHT) | Judgment |
|---|---|---|---|---|
| Physical Properties | ||||
| Uniformity | Uniform (as per standard) | Uniform | Uniform | Pass |
| Freedom from extraneous materials | Free from extraneous materials | Free from extraneous materials | Free from extraneous materials | Pass |
| Radioactivity | ≤ 1.0 Bq·g⁻¹ | 0.019 Bq·g⁻¹ | 0.019 Bq·g⁻¹ | Pass |
| Flexural strength | Multilayer-3D: ≥ 500 MPa | 1172.2 MPa | 1110.9 MPa | Pass |
| Color, Multilayer-SHT: ≥ 800 MPa | (N/A for Multilayer-3D) | (N/A for Color, Multilayer-SHT) | ||
| Linear thermal expansion coefficient | (10.5 ± 0.5) × 10⁻⁶ K⁻¹ (as per standard) | 10.8 × 10⁻⁶ K⁻¹ | 10.9 × 10⁻⁶ K⁻¹ | Pass |
| Chemical solubility | < 100 µg/cm² | 53.4 µg/cm² | 52.6 µg/cm² | Pass |
| Shrinkage factor | Not explicitly defined numerically in comparison, but inherent to material processing | 1.255 | 1.259 | Pass |
| Fracture Toughness | Multilayer-3D: ≥ 3.5 MPa·m¹/² | 18.24 MPa·m¹/² | 17.88 MPa·m¹/² | Pass |
| Color, Multilayer-SHT: ≥ 5.0 MPa·m¹/² | (N/A For Multilayer-3D) | (N/A for Color, Multilayer-SHT) | ||
| Biocompatibility | ||||
| Cytotoxicity | No cytotoxicity | No cytotoxicity | No cytotoxicity | Pass |
| Skin Sensitization | No skin sensitization | No skin sensitization | No skin sensitization | Pass |
| Oral Mucosa Irritation | No oral mucosa irritation | No oral mucosa irritation | No oral mucosa irritation | Pass |
| Acute Systemic Toxicity | No acute systemic toxicity | No acute systemic toxicity | No acute systemic toxicity | Pass |
| Subchronic Systemic Toxicity | No subchronic systemic toxicity | No subchronic systemic toxicity | No subchronic systemic toxicity | Pass |
| Genotoxicity | No genotoxicity | No genotoxicity | No genotoxicity | Pass |
| Implantation | No local effects | No local effects | No local effects | Pass |
(Note: "N/A" indicates that the specific performance metric threshold applies to a different product category/class within the device, or the value is directly given without a specific numeric range from the predicate comparison, but judged against the ISO standard.)
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes (number of material samples, or human subjects for biocompatibility) used for each individual test. The tests were performed "according to ISO 6872:2015" and "ISO 7405:2018", which would imply the use of sample sizes consistent with these material science standards.
- Data Provenance: The tests are non-clinical (laboratory-based material testing) and performed by the manufacturer, Shenzhen Yurucheng Dental Materials Co., Ltd. The country of origin of the data is implicitly China, where the manufacturer is located. The nature of the data is prospective in the sense that these tests were conducted specifically for this 510(k) submission to demonstrate compliance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. For material testing, "ground truth" is established by the physical and chemical properties measured according to standardized methods (e.g., universal testing machines for flexural strength, chemical analysis for composition, standardized biological assays for biocompatibility). It does not involve human expert consensus or clinical interpretation typical of imaging or diagnostic AI. The "experts" are likely the qualified laboratory personnel conducting the tests.
4. Adjudication Method for the Test Set
- Not Applicable. Material property measurements do not typically involve adjudication in the clinical sense. Results are quantitative values obtained via standardized test methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness study was done
- No. This type of study (MRMC) is relevant for AI/ML diagnostic interpretation where human readers' performance with and without AI assistance is evaluated. This is a material science device, so MRMC studies are not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical dental material; there is no "algorithm" to evaluate in a standalone manner. The performance refers to the intrinsic properties of the material itself.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is based on standardized laboratory measurements of physical, chemical, and biological properties as defined by the ISO 6872:2015 (Dental Ceramic Materials) and ISO 7405:2018 (Biological Evaluation of Medical Devices Used in Dentistry) series of standards. This includes mechanical properties (flexural strength, fracture toughness), chemical properties (solubility, composition), physical properties (radioactivity, uniformity, thermal expansion, shrinkage factor), and biocompatibility endpoints (cytotoxicity, sensitization, systemic toxicity).
8. The Sample Size for the Training Set
- Not Applicable. This is a manufactured material, not an AI/ML model that undergoes "training" on a dataset. The consistent manufacturing process and material formulation are what ensure its properties.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no "training set," there is no ground truth established in this context. The manufacturing process of the zirconia block is controlled to meet the desired material specifications.
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