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510(k) Data Aggregation
(89 days)
BruxZir™ Opaque Coloring Liquid is used for coloring pre-sintered zirconia structures.
BruxZir™ Opaque Coloring Liquid comprises a set of solutions that enhance the esthetic properties of zirconia restorations. The solution is applied to the zirconia restorations before sintering, by dipping the framework into the liquid or by using a metal-free brush. Afterwards, the structure is dried and subsequently sintered at temperatures above 1400°C.
BruxZir™ Opaque Coloring Liquid is available in different colors, Opaq-Lite, Opaq-A, Opaq-C, Opaq, Opaq Plus. The devices are intended to be used solely by dental technicians for fabrication of zirconia restorations for individual dental patients.
This document describes the premarket notification (510(k)) for the BruxZir™ Opaque Coloring Liquid, a dental device. The information provided outlines the device's technical characteristics and the performance data submitted to demonstrate substantial equivalence to a predicate device.
Key takeaway: This submission focuses on the chemical and mechanical properties of the coloring liquid and its effect on zirconia, not on the performance of an AI-powered medical device. Therefore, many of the requested criteria regarding AI device studies (like sample size for data provenance, expert ground truth establishment, MRMC studies, etc.) are not applicable to this document.
However, I can extract the relevant acceptance criteria and performance data for this specific type of dental product:
Acceptance Criteria and Reported Device Performance
None of the provided sections deal with general medical device acceptance criteria. However, specific performance tests and their conclusions are mentioned in the "PERFORMANCE DATA" section (VII). These can be interpreted as the "acceptance criteria" met by the device.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Test Performed) | Performance Measurement / Standard | Reported Device Performance |
|---|---|---|
| Flexural Strength | Does not significantly affect the mechanical property of zirconia substrate. (Per ISO 6872:2015/Amd 1:2018) | The results demonstrated that the subject device does not significantly affect the mechanical property of zirconia substrate. The testing addressed substantial equivalence based on differences in device design. |
| Solubility | Solubility below 100 µg/cm² limit. (Per ISO 6872:2015/Amd 1:2018) | The solubility was concluded to be below 100 µg/cm² limit, meeting the ISO 6872:2015/Amd 1:2018 requirement (tested on the worst case with all 5 shades). The testing addressed substantial equivalence based on differences in device design. |
| Visual Shade Evaluation | Meets shade match requirements and works as intended (visual assessment against reference shade guides). | It was concluded that BruxZir™ Opaque Coloring Liquid meets shade match requirements and works as intended. The testing addressed substantial equivalence based on differences in device design. |
| Shelf Life | Establishes a shelf life. (Per ASTM F1980-16 for accelerated aging) | It was concluded that the shelf life of BruxZir™ Opaque Coloring Liquid is 2 years. The results addressed substantial equivalence based on differences in shelf life. |
| Packaging Validation | No damage to packaged contents or leaks of coloring liquids after distribution simulation. (Per ASTM D4169-16) | Visual examination of the parts did not reveal any damage of the packaged contents and any leaks of the coloring liquids, and revealed that the seal of the bottles was intact. The testing addressed substantial equivalence based on differences in packaging configuration. |
| Biocompatibility | Meets biocompatibility requirements (Cytotoxicity, Sensitization, Oral Mucosal Irritation) (Per ISO 10993-1, 10993-5:2009, 10993-10:2010). | Based on the biocompatibility testing results (Cytotoxicity, Sensitization, Oral Mucosal Irritation), it was determined that there is no biocompatibility concern for the subject device. The testing addressed substantial equivalence based on differences in chemical composition. |
Further Requested Information (and why it's not applicable in this context):
Given that this is a 510(k) submission for a dental coloring liquid, not an AI-powered diagnostic or therapeutic device, most of the remaining questions are not directly addressed in the provided document, as they pertain to clinical studies, AI algorithms, and human-in-the-loop performance evaluation.
- Sample size used for the test set and the data provenance: Not applicable. Tests involve material properties and physical assessments, not clinical data sets in the typical sense.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: For "Visual Shade Evaluation," "qualified reviewers" are mentioned, but the number and specific qualifications are not detailed. For material property tests, ground truth is established by standardized testing methods (e.g., ISO, ASTM).
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for material and physical property testing. Visual shade evaluation would likely have involved a consensus or multiple assessments, but details are not provided.
- 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 coloring liquid, not an AI system.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth was established by adherence to recognized international standards (ISO, ASTM) for physical and chemical properties, and subjective "shade match requirements" for visual evaluation.
- The sample size for the training set: Not applicable. This is not an AI/machine learning device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
In conclusion, the document provides evidence of the device's compliance with established material and performance standards relevant to dental coloring liquids, ensuring its substantial equivalence to a predicate device. It does not involve AI or the associated clinical study methodologies.
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