Search Results
Found 1 results
510(k) Data Aggregation
(29 days)
BruxZir® Esthetic NOW is used for dental restorations using different CAD/CAM or manual milling machines. All blocks are processed through dental laboratories or by dental professionals.
BruxZir® Esthetic NOW is a chairside zirconia material offering enhanced esthetic performance. These pre-shaded, fully sintered zirconia CAD/CAM blocks are used by dentists in the construction of custom-made dental restorations that require no sintering, staining, glazing or polishing.
The provided text describes the regulatory submission for a dental material (BruxZir® Esthetic NOW) and its comparison to a predicate device. It includes performance data, but NOT information typically associated with AI/ML device studies, such as sample sizes for test sets, data provenance, expert qualifications for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.
Therefore, the response will focus on the available information regarding acceptance criteria and the study that proves the device meets those criteria, highlighting the lack of AI/ML-specific details where applicable.
Here's a summary of the acceptance criteria and study findings based on the provided document:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance (BruxZir® Esthetic NOW) |
|---|---|
| Flexural Strength: >800 MPa (Type II Class 5 per ISO 6872:2024) | Average flexural strength of worst-case shades was above the minimum threshold of 800 MPa (meeting ISO 6872:2024 for Type II Class 5 ceramic). |
| Chemical Solubility: <100 µg/cm² (ISO 6872:2024) | Measured values for worst cases were <100 µg/cm² (meeting ISO 6872:2024 requirement). |
| Coefficient of Thermal Expansion (CTE): 10-11 x 10-6/°C with standard deviation no greater than 0.5 x 10-6/°C (ISO 6872:2024) | Measured values for worst cases were between 10-11 x 10-6/°C and a standard deviation of CTE no greater than 0.5 x 10-6/°C (meeting ISO 6872:2024 requirement). |
| Shade Evaluation: Meets shade match requirements (Implied by comparison to VITA Classical and reference Bleach shade guides) | Evaluations concluded that BruxZir® Esthetic NOW meets shade match requirements and works as intended. |
| Biocompatibility: Biocompatible (per ISO 10993-1:2018; no biocompatibility concern) | Cytotoxicity testing results determined no biocompatibility concern regarding yttria concentration, colorants, or other elements. |
| Radioactivity: Uranium-238 activity concentration no more than 1.0 Bq/g (ISO 6872:2024) | Measured values for worst cases were below the Uranium-238 activity threshold of 1.0 Bq/g (meeting ISO 6872:2024 requirement). |
| Packaging Validation: Suitable to withstand distribution environment (per ASTM D4169-22) | After testing per ASTM D4169-22, it was determined that the respective packaging for BruxZir® Esthetic NOW blocks is suitable for use. |
2. Sample size used for the test set and the data provenance
The document specifies "worst-case shades" for Flexural Strength, Chemical Solubility, CTE, and Radioactivity testing, and "all shades offered" for Shade Evaluation. However, the exact numerical sample sizes for these tests (e.g., number of blocks tested per shade) are not provided.
The data provenance is from non-clinical testing conducted by the manufacturer, Prismatik Dentalcraft, Inc. No information regarding country of origin of data or whether it was retrospective/prospective is specified, as these are material property tests rather than clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
For "Shade evaluation," the document states "qualified evaluators." However, the number of experts and their specific qualifications are not provided. For other non-clinical tests (Flexural Strength, Solubility, CTE, Radioactivity, Biocompatibility, Packaging Validation), ground truth is established by standardized testing methods (e.g., ISO, ASTM) and material science principles, not typically by expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This information is relevant for studies involving human interpretation or subjective assessment with consensus mechanisms, typically in clinical trials or image assessment studies. The described tests are objective material property measurements.
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 device is a dental material (zirconia milling block), not an AI/ML-based diagnostic or assistive device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. As this is not an AI/ML device, this type of study is irrelevant.
7. The type of ground truth used
The ground truth for the performance criteria is established by:
- Standardized measurement thresholds: Specific values defined by international standards (ISO 6872:2024, ISO 10993-1:2018, ASTM D4169-22) for material properties (Flexural Strength, Chemical Solubility, CTE, Radioactivity) and biocompatibility.
- Visual comparison: For shade evaluation, it relied on comparison against VITA Classical shade guides and reference Bleach shade guides by qualified evaluators.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set mentioned or implied.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
Ask a specific question about this device
Page 1 of 1