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510(k) Data Aggregation
(27 days)
The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.
BruxZir® Esthetic blanks are zirconia milling blanks used for the production of esthetic zirconia dental restorations. The high esthetics and high strength of BruxZir® Esthetic restorations make them viable for use in all regions of the mouth. The manufactured dental restorations are made utilizing a CAD/CAM system for design and manufacture. The designed and manufactured dental restorations are then sintered at a high temperature. BruxZir® Esthetic blanks are available in white and pre-shaded varieties that can be easily adjusted to match the final shade.
This document describes the premarket notification (510(k)) for the BruxZir® Esthetic device, a dental ceramic material. The focus is on demonstrating its substantial equivalence to a predicate device, which usually involves performance testing against established standards.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Properties: | |
| Flexural Strength: >800 MPa (ISO 6872:2015/Amd 1:2018, Type II, Class 5) | Average flexural strength of each worst-case block batch tested yielded results above 800 MPa minimum. |
| Density: >6.05 g/cm³ | >6.05 g/cm³ (Listed as "Same" with predicate, implying this was met) |
| Coefficient of Thermal Expansion (CTE/25-500°C): 10-11x10⁻⁶/°C and a standard deviation of less than 0.5 x 10⁻⁶/°C (ISO 6872:2015/Amd 1:2018) | Tests performed on high and low colorant extreme shades yielded CTE results within 10-11 x 10⁻⁶/°C and a standard deviation of less than 0.5 x 10⁻⁶/°C. |
| Chemical Solubility: <100 µg/cm² (ISO 6872:2015/Amd 1:2018) | Concluded solubility is below 100 µg/cm² limit, based on similar products with same base powder, yttria content, colorants, and method of introduction. |
| Radioactivity (Uranium-238): No more than 1.0 Bq/g (ISO 6872:2015/Amd 1:2018) | Produced from raw materials certified to meet the radioactivity requirement; processes do not induce radioactivity, therefore meets the requirement. |
| Biocompatibility: Biocompatible and non-toxic (ISO 10993-1:2018 and ISO 14971:2019) | Concluded no biocompatibility concern based on testing results from similar products. |
| Aesthetic Properties: | |
| Color Consistency: ΔE of less than 2.0 within a block, within a batch, and between batches (CEILAB color space) | Maximum ΔE calculations between minimum and maximum L*, a*, and b* coordinate constituents within each dataset falling below 2.0. Conforms to color consistency requirements. |
| Translucency | Device is more translucent than the reference product, demonstrating conformance with acceptance criteria. |
| Shade Match: Meets requirements for VITA Classical and Bleach shade guides | Meets shade match requirements for all batch sizes, restoration types, and press densities tested by qualified reviewers. |
| Packaging: | |
| Packaging Validation (ASTM D4169-14: manual handling, compressive loads, repetitive shocks, vertical vibration, concentrated impacts, secondary manual handling drops) | Shipping containers (GL Single Unit and GL Bridge Block) were visually inspected after tests and determined to be suitable for use. |
Study Information:
-
Sample sizes used for the test set and the data provenance:
- The document does not explicitly state the numerical sample sizes for each test set (e.g., number of blocks tested for flexural strength). It refers to "worst-case group," "high and low colorant extreme shades," "every batch," "each thickness of Zeno block," "each block type pressed from each batch," and "different styles" for packaging.
- Data Provenance: Not explicitly stated, but given it's a FDA submission for a US-based company (Prismatik Dentalcraft, Inc. in Irvine, California), it's highly likely the studies were conducted in the US and were likely prospective in nature, designed specifically for this submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For "Shade Match" evaluation, it states "Evaluations of sintered and glazed restorations by qualified reviewers." The exact number of reviewers and their specific qualifications (e.g., "radiologist with 10 years of experience") are not specified.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- For the aesthetic evaluations (Color Consistency, Translucency, Shade Match), no specific adjudication method (like 2+1 or 3+1) is mentioned. "Qualified reviewers" determined the shade match, implying subjective evaluation against VITA guides. Other tests were objective measurements against quantitative criteria.
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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:
- This is not applicable to this device. The BruxZir® Esthetic is a dental material (zirconia milling block), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI assistance comparison was conducted.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is not applicable as there is no algorithm or AI component to this device. The performance data is based on physical and chemical testing of the material itself.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is established by objective measurements and adherence to international standards (e.g., ISO 6872:2015/Amd 1:2018 for mechanical and physical properties, ASTM D4169-14 for packaging, ISO 10993-1:2018/ISO 14971:2019 for biocompatibility).
- For the aesthetic properties (color consistency, translucency, shade match), the ground truth is based on quantitative color space measurements (ΔE CEILAB) and qualitative assessments by "qualified reviewers" against established dental shade guides (VITA Classical and Bleach shade guides).
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The sample size for the training set:
- This device is a material, not a machine learning model, so there is no training set in the context of AI/ML. All data described are for device performance testing.
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How the ground truth for the training set was established:
- As there is no training set for an AI/ML model, this question is not applicable. The "ground truth" for the material's properties is established through the standardized testing methods outlined above.
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