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510(k) Data Aggregation
(19 days)
The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.
Contraindication: This device is contraindicated for dental restorations greater than 3-units in length.
BruxZir® Radiant are zirconia milling blanks used to produce highly esthetic zirconia dental restorations. The high esthetics and high strength of BruxZir® Radiant 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® Radiant Blanks are available in 6 shades, Brite, White, 100, 200, 300, 400, that can be easily adjusted to match the final shade.
The provided document is a 510(k) summary for the medical device BruxZir® Radiant. It outlines the acceptance criteria and the studies conducted to demonstrate that the device meets these criteria.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Flexural Strength: >500 MPa per ISO 6872:2015/Amd 1:2018 (Type II Class 4) | The results of the verification activities confirmed that the design of the subject device met all the predetermined criteria, including Flexural Strength >500 MPa. |
| Translucency at 700nm: | The results of the verification activities confirmed that the design of the subject device met all the predetermined criteria, indicating that the translucency of each formulation was higher than the specified values: |
| * White: >59% | * White: >59% |
| * Brite: >65% | * Brite: >65% |
| * 100: >57% | * 100: >57% |
| * 200: >57% | * 200: >57% |
| * 300: >57% | * 300: >57% |
| * 400: >57% | * 400: >57% |
| Visual Shade Match: Grade of "Pass" for all shades | The results of the verification activities confirmed that the design of the subject device met all the predetermined criteria, implying a "Pass" grade for Visual Shade Match for all shades. |
| Color Consistency: ΔE < 2.00 between samples measured | The results of the verification activities confirmed that the design of the subject device met all the predetermined criteria, meaning Color consistency ΔE was less than 2.00 between samples measured. |
| Coefficient of Thermal Expansion (CTE): 10-11 x 10^-6/^℃ and standard deviation of CTE no greater than 0.5 x 10^-6/^℃ per ISO 6872:2015/Amd 1:2018 | The results of the verification activities confirmed that the design of the subject device met all the predetermined criteria, indicating CTE was between 10-11 x 10^-6/^℃ and its standard deviation was no greater than 0.5 x 10^-6/^℃. |
| Chemical Solubility: <100 µg/cm² per ISO 6872:2015/Amd 1:2018 | The results of the verification activities confirmed that the design of the subject device met all the predetermined criteria, showing solubility was lower than 100 µg/cm². |
| Radioactivity: Activity concentration of Uranium-238 no more than 1.0 Bq/g per ISO 6872:2015/Amd 1:2018 | The results of the verification activities confirmed that the design of the subject device met all the predetermined criteria, indicating the activity concentration of Uranium-238 did not exceed 1.0 Bq/g. |
| Biocompatibility: Biocompatible, safe, and non-toxic | The results of the verification activities confirmed that the design of the subject device met all the predetermined criteria, meaning BruxZir® Radiant is biocompatible, safe, and non-toxic. This was evaluated according to ISO 10993-1:2018 and ISO 10993-5:2009. |
2. Sample size used for the test set and the data provenance
The document states that "The test samples were made using the standard manufacturing process and QC process for BruxZir® Radiant." It does not specify the exact sample size for each test. The data provenance is internal, originating from Prismatik Dentalcraft, Inc., and appears to be from prospective testing of manufactured samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts or the establishment of ground truth by experts for the test set. The tests performed are primarily laboratory-based physical, chemical, and biological evaluations according to ISO standards. For "Visual Shade Evaluation," it simply states a "Grade of 'Pass'," without detailing the evaluators or their qualifications.
4. Adjudication method for the test set
The document does not describe any adjudication method as the tests are primarily objective measurements against established international standards.
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
No MRMC comparative effectiveness study was done, and this device is a dental material (zirconia milling blank), not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done as this is not an AI/algorithm-based device.
7. The type of ground truth used
The ground truth for the performance criteria is established by international standards (ISO 6872:2015/Amd 1:2018, ISO 10993-1:2018, and ISO 10993-5:2009). These standards define the acceptable ranges and methodologies for evaluating dental ceramics.
8. The sample size for the training set
No training set is applicable as this is not an AI/machine learning device. The device's performance is based on its material properties, not on an algorithm trained on data.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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