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

CLEARFIL MAJESTY Posterior 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 Posterior PLT, with its special dispensing system, can be quickly and conveniently placed directly into the cavity.
In this application, we have precisely defined the amount of dl-Camphorquinone and N.N-Diethanol-p-toluidine (DEPT) contained in CLEARFIL MAJESTY Posterior PLT in range of chemical composition shown in the original application in order to improve its sensitivity to ambient light.

The provided text describes a 510(k) premarket notification for a dental restorative material, CLEARFIL MAJESTY Posterior PLT. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with new acceptance criteria and performance evaluations for the subject device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not present in this document.

The document primarily relies on:

• Comparison of Chemical Composition: The subject device has precisely defined amounts of dl-Camphorquinone and N,N-Diethanol-p-toluidine (DEPT) within the range of the predicate device.
• Compliance with Standards: The subject device, like the predicate, complies with ISO 4049:2000 "Dentistry - Polymer-based filling, restorative and luting materials" for physical and mechanical properties.
• Similarity of Intended Use: The intended uses are identical to the predicate device.
• Biocompatibility by Reference: All chemical ingredients are the same as the predicate and its safety has been previously established and confirmed by the predicate device being on the market for 2 years with no reported problems or recalls.

In lieu of a table of acceptance criteria and reported device performance, the document states:

"Furthermore, physical and mechanical properties of the subject device were evaluated according to ISO 4049 in comparison with the predicate device, in which the substantial equivalence between the subject device and the predicate device was shown in terms of effectiveness/performance."

And, "As to comparison with the predicate device, according to ISO 4049: 2000, both the subject device and the predicate device comply with ISO 4049: 2000, indicating that the subject device is as effective as and performs as well as the predicate device."

Summary of available information:

1. A table of acceptance criteria and the reported device performance: Not explicitly stated as acceptance criteria in the context of a new efficacy study. The device's performance is demonstrated by its compliance with ISO 4049:2000, which is also met by the predicate device.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for this type of submission. Performance was shown through compliance with an international standard.
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.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 diagnostic or assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. Compliance with an engineering standard (ISO 4049:2000) was used to demonstrate performance.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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

CLEARFIL MAJESTY Posterior 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 Posterior PLT, with its special dispensing system, can be quickly and conveniently placed directly into the cavity.

CLEARFIL MAJESTY Posterior PLT, the applicant device, is substantially the same as CLEARFIL MAJESTY Posterior, 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, except for the color. The applicant device is substantially equivalent to the predicate devices.

This document is a 510(k) premarket notification for a dental restorative material, not a software or AI-powered device. Therefore, many of the requested elements for an AI/software device study are not applicable or present in this submission.

Based on the provided text, here's a breakdown of the acceptance criteria and the "study" (validation) for the device:

Acceptance Criteria and Reported Device Performance

Study Information (as applicable to this type of device submission):

• Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

  • This document does not describe a clinical study of the device that would involve a "test set" in the context of an AI/software device. The validation is primarily based on bench testing against an international standard (ISO 4049:2000) and a comparison of chemical compositions and intended uses to existing predicate devices.
  • No specific sample sizes for physical property testing (as would be done for ISO 4049) are provided in this summary.
  • No information on data provenance for testing is provided, beyond the standard itself being international.

• 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 this device, is adherence to a recognized international standard for dental materials and chemical composition.

• Adjudication method (e.g. 2+1, 3+1, none) for the test set:

  • Not applicable.

• 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 or imaging device.

• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

  • Not applicable. This is not an algorithm.

• The type of ground truth used (expert consensus, pathology, outcomes data, etc):

  • The "ground truth" for demonstrating substantial equivalence is:
    • Compliance with ISO 4049:2000 for physical properties.
    • Identical chemical composition to a predicate device.
    • Similar intended uses to predicate devices.
    • Prior safe use of the chemical components in other legally marketed devices.

• The sample size for the training set:

  • Not applicable. This is not an AI/ML device.

• How the ground truth for the training set was established:

  • Not applicable. This is not an AI/ML device.

Key Takeaways from the 510(k) Summary:

The manufacturer is seeking Substantial Equivalence for a new form factor (pre-loaded tips) of an existing dental restorative material. The core of their argument is:

1. Chemical Identity: The new device has the exact same chemical composition as a previously cleared predicate device (CLEARFIL MAJESTY Posterior).
2. Performance Standard Compliance: Both the new device and a predicate device meet the requirements of the international standard ISO 4049:2000 for dental polymer-based restorative materials.
3. Use of Previous Components: The pre-loaded tips themselves are adopted from another existing predicate device (CLEARFIL AP-X PLT), with only a color change.
4. Identical Intended Uses: The indications for use are equivalent to the predicate devices.

This type of 510(k) relies heavily on demonstrating that the new device is fundamentally the same as a legally marketed predicate device, rather than requiring extensive new clinical trials or complex AI model validation.

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

CLEARFIL MAJESTY Posterior 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. It is classified into tooth shade resin material (21 CFR section 872.3690, Product code: EBF ) according to 21 CFR section 872 since it is composed of materials such as 2,2'-Bis-[p-( Y -methacryloxy- 3 -hydroxypropoxy) phenyl] propane (Bis-GMA). According to the applicable FDA recognized consensus standard, ISO 4049: 2000 "Dentistry - Polymer-based filling, res orative 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; - Group 1: materials whose use requires the energy to be applied intra-orally.

The provided text describes a 510(k) summary for a dental restorative material, CLEARFIL MAJESTY Posterior. It focuses on establishing substantial equivalence to predicate devices rather than presenting a study of its own with specific acceptance criteria and performance metrics in the way one might expect for a diagnostic AI device.

Therefore, the requested information components related to an AI device's performance study (such as sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable to this document. This document primarily addresses the chemical composition, intended use, and compliance with general dentistry standards (ISO 4049:2000).

Here's an attempt to extract and frame the relevant information based on the provided text, while acknowledging the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are implied by compliance with established industry standards and substantial equivalence to predicate devices, rather than specific performance metrics measured in a clinical study as would be seen for a diagnostic AI.

2. Sample size used for the test set and the data provenance

• Not Applicable: This document does not describe a performance study with a "test set" in the context of an AI device. The equivalence is based on material properties and chemical composition.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable: No ground truth establishment by experts for a test set is mentioned.

4. Adjudication method for the test set

• Not Applicable: No test set or adjudication method is described.

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 is not an AI device, and no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable: This is not an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not Applicable: The "ground truth" for this submission revolves around chemical composition, material properties, and compliance with ISO standards, evaluated against existing predicate devices and recognized standards, rather than clinical outcomes or diagnostic accuracy.

8. The sample size for the training set

• Not Applicable: This is not an AI device and does not involve a training set.

9. How the ground truth for the training set was established

• Not Applicable: This is not an AI device and does not involve a training set.

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