(46 days)
NANO COMPOSITE is designed for Class I-V dental restorations, direct veneering of anterior teeth, splinting, and repair of composite or ceramic restorations.
Cosmedent NANO COMPOSITE is a light-cure composite resin fabricated from difunctional acrylic monomers and silicaceous fillers. These materials possess physical and mechanical properties that allow them to function in the oral cavity with esthetic qualities that mimic natural tooth appearance.
The provided text is a 510(k) summary for a dental composite material, not an AI/ML device. Therefore, the questions related to AI/ML device performance, such as sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies, are not applicable.
Here's the relevant information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate device, Tetric EvoCeram. This involves comparing key physical and mechanical properties.
| Property | Acceptance Criteria (Predicate: Tetric EvoCeram) | Reported Device Performance (Cosmedent NANO COMPOSITE) |
|---|---|---|
| Compressive strength | 313 MPa | 400 MPa |
| Flexural strength | 120 MPa | 125 MPa |
| Modulus of elasticity | 9500 MPa | 12000 MPa |
| Radiopaque | Yes | Yes |
2. Sample size used for the test set and the data provenance
Not applicable. This is a material comparison study, not an AI/ML diagnostic study with a "test set" in that context. The data would have been generated from laboratory testing of the material. The document does not specify the sample sizes (e.g., number of specimens tested for each property) or data provenance in terms of country of origin, or if it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth in the context of AI/ML diagnostics for medical images is not relevant here. The "ground truth" for material properties is established through standardized laboratory testing methods.
4. Adjudication method for the test set
Not applicable. No expert adjudication is described for material property testing.
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 not an AI/ML diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML diagnostic device.
7. The type of ground truth used
The "ground truth" for the device's performance is based on the results of physical and mechanical properties testing performed according to implied standard laboratory methods.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML 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.