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CLEARFIL MAJESTY Esthetic PLT is indicated for the following restorative applications:

• 1. Direct restorations for anterior and posterior teeth (Class I V cavities)
• 2. Direct veneers
• 3. Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed tooth, etc.)
• 4. 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.

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.

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1. Direct restorations for anterior and posterior teeth (Class I - V cavities)
2. Direct veneers
3. Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed tooth, etc.)
4. Intraoral repairs of fractured crowns/bridges

CLEARFIL MAJESTY Esthetic is a light-cure, radiopaque restorative composite resin which provides accurate color matching, high polish ability and excellent physical properties, making it suitable for a wide range of restorations. It is formulated with optimal viscosity assuring easy handling and placement. It is classified into tooth shade resin material (21 CFR section 872.3690, Product code: EBF) according to 21 CFR § 872 since it is composed of materials such as 2, 2'-Bis-[p-( 7 -methacryloxy- 3 -hydroxypropoxy) phenyl] propane (Bis-GMA). According to the applicable FDA recognized consensus standard, ISO 4049, 2000 "Dentistry - Polymer-based filling, restorative and luting materials", this device is classified into the following: Type 1: polymer-based filling and restorative materials; Class 2: materials whose setting is effected by light; Class 2. materials whose setting is the energy to be applied intra-orally.

This document describes the 510(k) submission for CLEARFIL MAJESTY Esthetic, a light-cure, radiopaque restorative composite resin. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the format of a clinical trial.

Acceptance Criteria and Device Performance Table:

Given the nature of the provided text, which is a 510(k) summary for a dental restorative material rather than a clinical study report for an AI/medical imaging device, the acceptance criteria are not presented in terms of clinical performance metrics like sensitivity or specificity. Instead, the "acceptance criteria" are compliance with a recognized standard and demonstrated equivalence to predicate devices in specified physical and chemical properties.

Study Details (based on the provided 510(k) summary):

The provided document is a 510(k) summary, which is a premarket notification to the FDA. It does not describe a clinical study in the way one would for an AI or diagnostic imaging device. Instead, it demonstrates compliance with a recognized consensus standard (ISO 4049) and substantial equivalence to existing predicate devices (CLEARFIL AP-X, TETRIC EVOCERAM, GRADIA DIRECT) based on laboratory testing of physical properties and chemical composition.

Therefore, the following points cannot be answered as they pertain to clinical studies, which are not detailed in this 510(k) submission:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no clinical test set for AI performance is described. The "test set" here refers to samples of the material tested in a lab for physical and chemical properties. The document does not specify sample sizes for these lab tests or data provenance beyond the general information about the submitter (Kuraray Medical Inc., Japan).
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical performance is not established in this document. The "ground truth" for material properties would be the specifications outlined in ISO 4049.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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 is not an AI device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the material's properties is based on the specifications within the ISO 4049 standard. For equivalence, it's a comparison to the established properties of predicate devices.
7. The sample size for the training set: Not applicable. There is no "training set" as this is not an AI or machine learning device.
8. How the ground truth for the training set was established: Not applicable.

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