(159 days)
Clinical indications
- Restoration of caries defects
- Reconstruction of lost tooth substance due to attrition, abrasion, erosion
- Restoration of tooth fractures
- Correction of anatomical malformation
Cosmetic indications
- Optimization of old composite restorations
- Extending incisors
- Correction of malpositioned teeth
- Cosmetic corrections for tooth discoloration or incorrect shading
- Closure of diastema
The subject device BRILLIANT COMPONEER is a polymerized, highly filled, submicron hybrid composite enamel shell(s) for direct veneering. It simplifies the direct restoration of front teeth and premolars without having to model the basic shape of the top enamel layer. The thin, anatomical composite shells are available in different shades and shapes allowing a natural, high aesthetic restoration.
The provided text describes a medical device called "BRILLIANT COMPONEER," which is a tooth shade resin material. The FDA 510(k) premarket notification K191385 outlines the substantial equivalence of this device to a predicate device, COMPONEER.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for performance are derived from the predicate device's performance and the general standard for this type of material (ISO 4049). The device is deemed substantially equivalent if its performance is comparable.
| Attribute | Acceptance Criteria (Predicate Device K112168 - COMPONEER) | Reported Device Performance (Subject Device K191385 - BRILLIANT COMPONEER) |
|---|---|---|
| Compressive Strength | 392 MPa | 285 MPa |
| Flexural Strength | 127 MPa | 125.4 MPa |
| Elastic Modulus | 9.0 GPa | 9.8 GPa |
| Radiopacity | 2 mm of Al | 3.24 mm of Al |
| Water sorption | 16 µg / mm³ | 18.2 µg / mm³ |
| Solubility | 0.9 µg / mm³ | 0.3 µg / mm³ |
| Biocompatibility | Conforms with ISO 10993-1 | Conforms with ISO 10993-1 |
| Performance (General Standard) | Conforms with ISO 4049 | Conforms with ISO 4049 |
Note: While some values are different, the submission asserts substantial equivalence based on extensive performance and biocompatibility testing according to applicable standards.
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each non-clinical performance test. It mentions that extensive testing was performed. The data provenance is stated as testing performed by Coltène/Whaledent AG in Switzerland. The studies are retrospective in the sense that they are laboratory bench tests conducted to demonstrate compliance with standards and comparison to a predicate, not prospective clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The ground truth for the performance characteristics is established by objective measurements based on international standards (e.g., ISO 4049). For biocompatibility, it's based on objective assays and assessments according to ISO 10993 and ISO 7405. There is no indication of human expert interpretation being required to establish the "ground truth" for the test set results.
4. Adjudication method for the test set
This information is not applicable as the document describes non-clinical performance testing (bench tests and biocompatibility tests), which do not typically involve human adjudication in the way clinical studies or expert consensus for image interpretation would. The results are based on objective measurements and adherence to specified procedures within the 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a dental material, not an AI-assisted diagnostic tool or an imaging device that would typically involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical dental material, not an algorithm or software. The performance tests are standalone in the sense that they measure the material's inherent properties, without human interpretation in the loop.
7. The type of ground truth used
The ground truth used for the performance tests consists of objective measurements against established international standards. For chemical and physical properties (e.g., compressive strength, water sorption), the ground truth is the measured value itself, compared to the predicate and standard requirements. For biocompatibility, the truth is whether the material elicits a specific biological response based on standardized assays.
8. The sample size for the training set
Not applicable. This device is a physical dental material, not a machine learning model. Therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set for a machine learning model, this question is not relevant to the described device.
§ 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.