(243 days)
The device is indicated for use for direct anterior and posterior restorations, cavity base or liner, and repair of porcelain/ composite.
The OMNICHROMA FLOW tooth shade resin material is a paste that comes in a plastic syringe (1.8mL). The device is a low viscosity, light-cured, radiopaque composite resin for use in anterior and posterior restorations for all carious classes. OMNICHROMA FLOW is a single shade material. Direct placement of OMNICHROMA FLOW into a prepared cavity allows for easy handling.
OMNICHROMA FLOW is designed to be cured by either a halogen or LED curing-light with a wavelength of 400-500 nm. Be sure to light-cure OMNICHROMA FLOW extra-orally and check the time needed for complete hardening of OMNICHROMA FLOW with your lightcuring unit before performing the bonding procedure.
The device is intended for use by licensed healthcare professionals only. The device does not come sterilized and is not intended to be sterilized prior to use.
The OMNICHROMA FLOW device contains methacrylic monomers and a UV absorber. The device should not be used on patients who are allergic to or hypersensitive to methacrylic and related monomers, UV absorber, or any of the other ingredients.
The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the OMNICHROMA FLOW tooth shade resin material.
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Physical Property) | Reported Device Performance (OMNICHROMA FLOW) | Predicate Device (OMNICHROMA) Performance | Reference Device (ESTELITE UNIVERSAL FLOW) Performance |
|---|---|---|---|
| Sensitivity to ambient light | Conformed to the requirement of ISO 4049 | Conformed to the requirement of ISO 4049 | Conformed to the requirement of ISO 4049 |
| Depth of cure | Conformed to the requirement of ISO 4049 | Conformed to the requirement of ISO 4049 | Conformed to the requirement of ISO 4049 |
| Flexural strength | Conformed to the requirement of ISO 4049 | Conformed to the requirement of ISO 4049 | Conformed to the requirement of ISO 4049 |
| Water sorption | Conformed to the requirement of ISO 4049 | Conformed to the requirement of ISO 4049 | Conformed to the requirement of ISO 4049 |
| Solubility | Conformed to the requirement of ISO 4049 | Conformed to the requirement of ISO 4049 | Conformed to the requirement of ISO 4049 |
| Color stability | Conformed to the requirement of ISO 4049 | Conformed to the requirement of ISO 4049 | Conformed to the requirement of ISO 4049 |
| Radio-opacity | Conformed to the requirement of ISO 4049 | Conformed to the requirement of ISO 4049 | Conformed to the requirement of ISO 4049 |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Shelf life | 3 years at 0-25°C (32-77Fº) | 3 years at 0-25°C (32-77Fº) | 3 years at 0-25°C (32-77Fº) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes for each physical property test. It mentions that "Non-clinical testing of the physical properties of the OMNICHROMA FLOW device was conducted in accordance with ISO 4049:2009, 'Dentistry -- Polymer-based Restorative Materials.'" The ISO standard would define the required sample sizes for each test.
The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. It is implied that the testing was conducted by or for Tokuyama Dental Corporation, a Japanese company.
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)
This information is not applicable. The device is a "tooth shade resin material," and its performance is evaluated against engineering standards (ISO 4049) and biocompatibility, not by expert interpretation of images or clinical outcomes that would require ground truth established by medical experts like radiologists.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the study involves physical property testing against an engineering standard, not clinical adjudication of diagnoses or 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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a dental restorative material, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical material, not an algorithm. The performance testing was of the material itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the physical property testing is based on the requirements and methodologies outlined in ISO 4049:2009, "Dentistry -- Polymer-based Restorative Materials," which are standardized engineering and material science criteria. For biocompatibility, the ground truth is established by standard biological evaluation methods (cytotoxicity, sensitization, oral mucosa irritation, subacute systemic toxicity, acute systemic toxicity, and genotoxicity testing).
8. The sample size for the training set
This information is not applicable. The device is a physical material, not an AI model, and therefore does not have a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
This information is not applicable for the reason stated in point 8.
§ 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.