(60 days)
CLEARFIL MAJESTY Flow is indicated for the following restorative applications:
- Direct restorations for anterior and posterior teeth (Class I III, V cavities, cervical caries, root erosion)
- Cavity base / liner
- Intraoral repairs of fractured crowns / bridges / composite resin
CLEARFIL MAJESTY Flow is a flowable, radiopaque restorative composite resin which provides true to life color matching, high polish ability and excellent physical properties, making ideal for both anterior and posterior restorations. CLEARFIL MAJESTY Flow can be used alone or together with CLEARFIL AP-X and CLEARFIL MAJESTY Esthetic. It is classified into tooth shade resin materia" (21 CFR section 872.3690, Product code: EBF ) according to 21 CFR § 872 since it is composed of materials such as methacrylate monomers.
This 510(k) summary describes a dental restorative material, not a software or AI-enabled device, and therefore the requested information regarding AI-specific evaluations (such as sample sizes for test and training sets, expert adjudication methods, MRMC studies, or standalone performance) is not applicable or extractable from the provided text.
The acceptance criteria and study information provided in the document pertain to the physical and chemical properties of a dental resin material.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Criterion (from ISO 4049: 2000) | Acceptance Criteria | Reported Device Performance (CLEARFIL MAJESTY Flow) |
|---|---|---|
| Safety | Not explicitly stated as numerical criteria in this document, but implied by use of known ingredients. | All chemical ingredients have been used in predicate devices, indicating substantial equivalence in safety. |
| Effectiveness / Performance (General) | Compliance with ISO 4049: 2000 "Dentistry - Polymer-based filling, restorative and luting materials" | The applicant device (CLEARFIL MAJESTY Flow) complies with the requirements of ISO 4049: 2000. |
Study that Proves the Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is an evaluation against the ISO 4049: 2000 "Dentistry - Polymer-based filling, restorative and luting materials" consensus standard.
2. Sample size used for the test set and the data provenance:
Not applicable as this is a material science study adhering to an ISO standard, not a data-driven AI study.
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):
Not applicable. The ground truth is established by the ISO standard's defined tests and methodologies for material properties, not by expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Testing is based on standardized physical and chemical measurements according to ISO 4049:2000.
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, an MRMC study was not done as this is a material science study, not an AI-assisted diagnostic or interpretive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is compliance with the specified physical and chemical property requirements outlined in the ISO 4049: 2000 standard for dental polymer-based restorative materials.
8. The sample size for the training set:
Not applicable as this is a material science study, not a machine learning study.
9. How the ground truth for the training set was established:
Not applicable as this is a material science study. The "ground truth" for material properties is inherent in the internationally recognized ISO standard and its associated test methods.
§ 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.