(56 days)
- Direct restorations for all cavity classes in anterior and posterior teeth
- Direct veneers
- Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed tooth, etc.)
- Intraoral repairs of fractured restorations
The subject device, CLEARFIL MAJESTY ES-2, is a light-cure, radiopague restorative material which provides accurate color matching, high polishability and excellent physical properties, making it ideal for both anterior and posterior restorations. It is formulated with optimal viscosity assuring easy handling and placement. It is packaged in traditional svringes or Pre-loaded tips (PLTs). The lightness/ value based unique shade taking system of its Shade guide provides shade taking options for single (Classic) and dual (Premium) shade lavering for highly esthetic restorations.
The provided document is a 510(k) summary for a dental restorative material (CLEARFIL MAJESTY ES-2) and does not describe a study involving an AI/CADeX device or its performance against acceptance criteria in the way typically expected for such devices (e.g., sensitivity, specificity, AUC).
Instead, this document focuses on proving substantial equivalence to predicate devices based on intended use, chemical ingredients/safety, and physical/mechanical properties as measured against an industry standard (ISO 4049:2009).
Therefore, a table of acceptance criteria and device performance, as well as details regarding sample sizes, ground truth establishment, expert involvement, and MRMC studies, are not applicable in the context of this device's submission and the information provided.
However, I can extract the relevant information regarding how the device's "effectiveness/performance" was established for its substantial equivalence claim:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with ISO 4049: 2009 for Polymer-based Restorative Materials | The subject device, CLEARFIL MAJESTY ES-2, "complies with all requirements of ISO 4049: 2009." |
| Substantial equivalence to predicate devices (CLEARFIL MAJESTY Esthetic and CLEARFIL MAJESTY Flow) based on ISO 4049: 2009. | The subject device and the predicate device comply with ISO 4049: 2009, indicating substantial equivalence in safety and effectiveness. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. The document describes a comparison against an international standard (ISO 4049:2009) for physical and mechanical properties, not a clinical test set with patient data. The standard itself would specify testing methodologies and sample sizes for various properties, but these details are not provided in this 510(k) summary.
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 a medical device involving clinical assessment or image interpretation, is not relevant here. The "ground truth" for this device's performance is adherence to the physical and mechanical property specifications outlined in ISO 4049:2009. This standard is established by technical committees.
4. Adjudication method for the test set:
- Not Applicable. There was no "test set" in the sense of a set of cases requiring adjudication by experts.
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, not an AI/CADeX system for diagnostic assistance. No MRMC study was performed or is relevant.
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 or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" or reference standard for evaluating the device's technical performance was adherence to the physical and mechanical property specifications defined by the international standard ISO 4049:2009 for polymer-based restorative materials.
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not Applicable. There is no "training set" for this type of 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.