(44 days)
CLEARFIL MAJESTY Esthetic PLT is indicated for the following restorative applications:
-
- Direct restorations for anterior and posterior teeth (Class I V cavities)
-
- Direct veneers
-
- Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed tooth, etc.)
-
- Intraoral repairs of fractured crowns/bridges
CLEARFIL MAJESTY Esthetic PLT (PLT: Pre-loaded tip) is a light-cure, radiopaque restorative composite resin which provides accurate color matching, high polish ability and excellent physical properties, making it ideal for both anterior and posterior restorations. It is formulated with optimal viscosity assuring easy handling and placement. CLEARFIL MAJESTY Esthetic PLT, with its special dispensing system, can be quickly and conveniently placed directly into the cavity.
CLEARFIL MAJESTY Esthetic PLT, the applicant device, is substantially the same as CLEARFIL MAJESTY Esthetic, the predicate device where the only difference is the container form; the applicant device comes in tips while the predicate device is filled in syringes. The tips used in the applicant device are the same as those used in CLEARFIL AP-X PLT, the predicate device. Therefore, the applicant device is substantially equivalent to the predicate devices.
Here's an analysis of the provided text regarding the acceptance criteria and study for the CLEARFIL MAJESTY Esthetic PLT dental device:
1. A table of acceptance criteria and the reported device performance
The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific quantitative acceptance criteria for this particular device's performance beyond compliance with a recognized standard.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Safety: Chemical ingredients and composition are substantially equivalent to predicate device. | "The chemical ingredients and the composition of CLEARFIL MAJESTY Esthetic PLT, the applicant device, are exactly the same as those in CLEARFIL MAJESTY Esthetic, the predicate device suggesting the safety of the applicant device is substantially equivalent to the predicate device." |
| Effectiveness/Performance: Complies with ISO 4049: 2000 "Dentistry -Polymer-based filling, restorative and luting materials" and performs as well as predicate device. | "CLEARFIL MAJESTY Esthetic PLT, the applicant device, is verified to comply with the requirements of the applicable FDA recognized consensus standard, ISO 4049: 2000... As to compare with CLEARFIL MAJESTY Esthetic, the predicate device, according to ISO 4049: 2000, both the applications the predicate devices comply with the standard indicating the applicant device is as effective and performs as well as the predicate device." |
| Intended Uses: Identical to predicate device. | "The intended uses of CLEARFIL MAJESTY Esthetic PLT are exactly the same as those of CLEARFIL MAJESTY Esthetic." |
| Technological Characteristics: Container form is the only difference from predicate device, and the tips are identical to another predicate device. | "CLEARFIL MAJESTY Esthetic PLT, the applicant device, is substantially the same as CLEARFIL MAJESTY Esthetic, the predicate device where the only difference is the container form; the applicant device comes in tips while the predicate device is filled in syringes. The tips used in the applicant device are the same as those used in CLEARFIL AP-X PLT, the predicate device." |
2. Sample sized used for the test set and the data provenance
The document does not specify a "test set" in the context of a clinical study or evaluation with human or patient data. The evaluation appears to be based on compliance with a standard (ISO 4049: 2000) and comparisons of material composition and physical properties to predicate devices. Therefore, information regarding sample size, country of origin, or retrospective/prospective nature of a test set is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided as the device's evaluation relies on compliance with an ISO standard and comparison to a predicate device, rather than a diagnostic performance study requiring expert ground truth establishment.
4. Adjudication method for the test set
This information is not provided as there is no described test set that requires adjudication.
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
An MRMC comparative effectiveness study was not conducted. This device is a dental restorative material, not an AI-powered diagnostic tool, so this type of study is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study of an algorithm was not done. This device is a dental restorative material, not an algorithm.
7. The type of ground truth used
The "ground truth" for the device's performance, as implied by the document, is established through:
- Compliance with a recognized standard: ISO 4049: 2000 "Dentistry -Polymer-based filling, restorative and luting materials".
- Equivalence to existing predicate devices: Demonstrating that its chemical composition, intended uses, and performance characteristics (as defined by the ISO standard) are the same as or comparable to legally marketed devices.
8. The sample size for the training set
The concept of a "training set" is not applicable to this device. It is a physical dental material, not a machine learning model.
9. How the ground truth for the training set was established
This question is not applicable as there is no training set for this 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.