(190 days)
A composite material which has resin organic and inorganic fillers as ingredients, which are being used for aesthetic restoration by getting polymerized directly in the oral cavity. - Direct anterior and posterior restorations
The product belongs to Group 1, Class 2 of Type 1 according to the standard classification of ISO 4049. It is a nano hybrid typed light-curved complex resin for aesthetic restoration for both anterior and posterior parts, which is used for restoration that requires aesthetics through decay and damage in a form of paste with unpolymerized dimethacrylate monomer, inorganic filler, and photoinitiators mixed. That is, after recovering with the unpolymerized product, to make a hard restoration by polymerizing through dental visible-ray polymerizer.
Here's a breakdown of the acceptance criteria and study information based on the provided text, where applicable:
1. Table of acceptance criteria and the reported device performance:
| Item | Acceptance Criteria (Requirement) | Reported Device Performance (Result) | Pass/Fail |
|---|---|---|---|
| Depth of cure | Opaque: not less than 1 mm | ||
| Non-opaque: not less than 1.5 mm | Opaque: 2.8 mm (min value) | ||
| Non-opaque: 2.4 mm (min value) | Pass | ||
| Sensitivity of ambient light | No change in consistency | No change in consistency | Pass |
| Flexural strength | More than 80 Mpa | 92.6 Mpa (min value) | Pass |
| Water sorption | Less than 40 µg/mm³ | 5.7 µg/mm³ (max value) | Pass |
| Solubility | Less than 7.5 µg/mm³ | 0.7 µg/mm³ (max value) | Pass |
| Color | Color of samples shall be matched closely with the manufacturer's shade guide | Color of samples was matched closely with the manufacturer's shade guide | Pass |
| Color stability | No color change | No color change | Pass |
| Radio-opacity | Equivalent to not less than 3 mm of aluminum | Not less than 3 mm of aluminum | Pass |
| Biocompatibility | Biocompatible, conforming to ISO 10993 (implied acceptance for each specific test) | Confirmed through various ISO 10993 tests (Cytotoxicity, Oral mucosa irritation, Skin sensitization, Acute Systemic Toxicity, Genetoxicity: Bacterial Reverse Mutation, Genetoxicity: Micronucleus test) | Pass |
| Performance Standard (General) | Meet ISO 4049 standard | Meet ISO 4049 standard (stated directly) | Pass |
2. Sample size used for the test set and the data provenance:
The document describes non-clinical performance data and biocompatibility tests. It does not specify the exact sample sizes for each of these tests, nor the country of origin of the data. It is implicitly retrospective as it's a submission for regulatory clearance based on completed tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The tests described are non-clinical, laboratory-based performance and biocompatibility studies, not studies involving expert interpretation or "ground truth" derived from human assessment in the way that would apply to, for example, medical imaging or diagnostic devices.
4. Adjudication method for the test set:
Not applicable. This is not a study requiring adjudication of expert interpretations.
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 device is a dental restorative material (tooth shade resin), not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a dental restorative material, not an algorithm.
7. The type of ground truth used:
For the non-clinical performance tests, the "ground truth" is established by the specifications and acceptance criteria defined in the harmonized standards (e.g., ISO 4049). For biocompatibility, the "ground truth" is determined by meeting the specified endpoints and requirements of the relevant ISO 10993 standards (e.g., no cytotoxicity, no irritation, etc.).
8. The sample size for the training set:
Not applicable. This is a material device, not a machine learning model.
9. How the ground truth for the training set was established:
Not applicable. This is a material device, not a machine learning model.
§ 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.