(69 days)
BRILLIANT Crios is indicated for:
- Crowns, inlays, onlays and veneers
- Implant-supported crowns.
BRILLIANT Crios is a radiopaque composite material composed of crosslinked methacrylate based polymerized monomers and dental glass fillers. The subject device is made available in block forms of different sizes, shades and translucencies for the fabrication of permanent tooth restorations such as inlays, onlays, crowns and veneers using CAD/CAM milling equipment.
This document is a 510(k) summary for a dental restorative material called BRILLIANT Crios. It focuses on demonstrating substantial equivalence to a predicate device, CERASMART™, rather than providing detailed acceptance criteria and study results for a diagnostic AI device.
Therefore, the provided text does not contain the information requested in points 1-9 regarding acceptance criteria and a study proving device performance for an AI/diagnostic device.
The document describes the physical and mechanical properties of the BRILLIANT Crios material and compares them to a predicate device, CERASMART™, and a reference device, SYNERGY®. It also mentions that the company conducted performance and biocompatibility testing.
Here's what can be extracted, though it doesn't directly answer your specific questions in the context of an AI/diagnostic device:
1. A table of acceptance criteria and the reported device performance:
The document provides a comparison table (Table 5-1) for physical and mechanical properties. While not explicitly "acceptance criteria" in the AI sense, these are performance metrics for a dental material.
| Attributes | Predicate Device (CERASMART™) | Subject Device (BRILLIANT Crios) |
|---|---|---|
| Flexural Strength | 160 (MPa) | 198 (MPa) |
| Flexural Modulus of Elasticity | 8.3 (GPa) | 10.3 (GPa) |
| Compressive Strength | 429 (MPa) | 426 (MPa) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. This is a material science study, not a clinical study on a test set for an AI device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. This is a material science study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is a material science study.
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 is a material science study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a material science study.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" here would be laboratory measurements of physical and mechanical properties.
8. The sample size for the training set:
Not applicable. This is a material science study, not an AI training process.
9. How the ground truth for the training set was established:
Not applicable. This is a material science study.
Summary of what the document does indicate about the study:
- Study Type: Non-clinical (benchtop) performance and biocompatibility testing of a dental restorative material.
- Standards Used: ISO 4049 (Polymer-based Restorative Materials), ISO 7405 (Biocompatibility of medical devices in dentistry), ISO 10993-1 (Biological Evaluation of Medical Devices).
- Performance Metrics: Flexural strength, flexural modulus, compressive strength, and biocompatibility.
- Conclusion: The subject device (BRILLIANT Crios) "passed all required testing" and was determined to be "as safe and effective as the predicate device" based on these tests.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.