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510(k) Data Aggregation
(134 days)
BruxZir® 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® NOW is a pre-shaded, fully sintered zirconia CAD/CAM block used for fabricating single-unit or multiple-unit dental restorations. BruxZir® NOW is used for fabricating single-unit dental restorations, while BruxZir® NOW Bridge Block is used for fabricating multiple-unit dental restorations. BruxZir® NOW is available in the following shades: Bleach White, Bleach 1, Bleach 3, and 16 VITA Classical shades (A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4). BruxZir® NOW Bridge Block is available in the following 6 VITA Classical shades: A1, A2, A3, B1, C2, D2. The method of fabricating the restoration is with CAD/CAM milling systems.
The provided text describes the regulatory clearance of a dental material, BruxZir® NOW, and its comparison to a predicate device, Perfit FS Dental Zirconia Fully Sintered Block. The information primarily focuses on demonstrating substantial equivalence rather than a study proving the device meets acceptance criteria in the context of an AI/ML device.
However, I can extract the relevant performance data and acceptance criteria as described for the dental material itself. The document does not describe an AI/ML device, an MRMC study, or a standalone algorithm performance study. It's about a physical dental material.
Here's the information based on the provided text, interpreted for the dental material:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (ISO/ASTM Standards) | BruxZir® NOW Performance |
|---|---|
| Flexural Strength: | >800 MPa |
| Type II Class 5 per ISO 6872:2015/Amd 1:2018 (>800 MPa) | |
| Solubility: | <100 µg/cm² |
| <2000 µg/cm² (ISO 6872:2015/Amd 1:2018 requirement) | |
| Radioactivity (Uranium-238): | Below 1.0 Bq/g |
| No more than 1.0 Bq/g (ISO 6872:2015/Amd 1:2018) | |
| Biocompatibility: | No biocompatibility concern determined |
| In accordance with ISO 10993-1:2018 and ISO 14971:2019 | |
| Shade Evaluation: | Meets shade match requirements and works as intended |
| (Evaluated against VITA Classical and reference Bleach shade guides) | |
| Packaging Validation: | Suitable for use (withstands distribution environment) |
| Per ASTM D4169-16 (resistance against manual handling, vehicle stacking, loose load vibration, vehicle vibration, and concentrated impact) |
2. Sample Size Used for the Test Set and Data Provenance
- Flexural Strength: Tested on "worst-case groups" for two types of BruxZir® NOW and BruxZir® NOW Bridge Block. Specific sample size not provided.
- Solubility: "The worst case was tested." Specific sample size not provided.
- Shade Evaluation: "All shades offered for BruxZir® NOW were evaluated." Specific sample size (number of restorations/blocks) not provided.
- Biocompatibility: Based on cytotoxicity testing results from the subject device, BruxZir® NOW. Specific sample size not provided.
- Radioactivity: "BruxZir® NOW was tested." Specific sample size not provided.
- Packaging Validation: "BruxZir® NOW and BruxZir® NOW Bridge Block were tested." Specific sample size not provided.
The data provenance is from non-clinical testing conducted by Prismatik Dentalcraft, Inc. (USA). The nature of the tests (e.g., lab bench testing, material property measurements) makes the retrospective/prospective distinction less applicable in the same way as for clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Shade Evaluation: "qualified evaluators." Number and specific qualifications of these evaluators are not provided.
- For other tests (Flexural Strength, Solubility, Radioactivity, Biocompatibility, Packaging Validation), the "ground truth" is established by adherence to recognized international standards (ISO, ASTM) and physical/chemical measurements, not typically by human expert consensus on individual cases.
4. Adjudication Method for the Test Set
Not applicable as the testing involves physical/chemical properties measured against defined standards, not human interpretation requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This document describes a physical dental material, not an AI/ML diagnostic or assistive device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
No, a standalone algorithm performance study was not done. This document describes a physical dental material, not an AI/ML device.
7. The Type of Ground Truth Used
The "ground truth" for the material's properties is derived from measurements against established international standards (ISO 6872:2015/Amd 1:2018, ISO 10993-1:2018, ISO 14971:2019, ASTM D4169-16). For shade evaluation, it was comparison against "VITA Classical shade guide and reference Bleach shade guide."
8. The Sample Size for the Training Set
Not applicable. This document describes a physical dental material, not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This document describes a physical dental material, not an AI/ML device.
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