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[1] Direct restorations for all cavity classes in anterior and posterior teeth
[2] Direct veneers
[3] Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed tooth, etc.)
[4] Intraoral repairs of fractured restorations

CLEARFIL MAJESTY IC is an intra-oral, light-cured restorative composite that is available direct injection method into preparations with its syringe and replaceable tips. It is the radiopaque equivalent of 1mm aluminium and classified as a Type 1 and Class 2 (Group 1) material by ISO 4049. It is indicated for both anterior and posterior restorations and provides accurate color matching, high polishability and excellent physical properties.

The medical device in question is CLEARFIL MAJESTY IC, a dental light-cured restorative composite. The provided document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study for novel performance claims. As such, the information you've requested about acceptance criteria and study particulars for device performance in a clinical setting is not fully available in this type of submission.

This submission primarily relies on non-clinical testing to demonstrate that the physical and mechanical properties of the subject device are substantially equivalent to those of the predicate device(s).

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for each test item but rather states that the "Result demonstrated substantial equivalence" to the predicate device. The underlying acceptance criterion for each test would be that the subject device's performance falls within a range considered comparable to the predicate device, as defined by relevant ISO standards (specifically ISO 4049:2009 for polymer-based restorative materials) and FDA guidance for dental composite resin devices.

2. Sample Size Used for the Test Set and Data Provenance

The document describes non-clinical testing (e.g., material property tests) rather than a clinical test set involving human subjects. Therefore, information regarding "sample size for the test set" in a clinical context and "data provenance (e.g. country of origin of the data, retrospective or prospective)" is not applicable or provided. The tests described are laboratory-based evaluations of material properties.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable. The evaluations were non-clinical material property tests, not assessments requiring expert consensus on a test set (e.g., image interpretation). The "ground truth" for these tests would be the established scientific methods and resulting measurements according to ISO standards.

4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set

This information is not applicable as the study involved non-clinical material property testing, not an adjudication process for expert opinions.

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

This information is not applicable. The device is a dental restorative material, not an AI-assisted diagnostic or therapeutic device. No MRMC study or AI assistance is mentioned or relevant to this 510(k) submission.

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

This information is not applicable as the device is a dental restorative material, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is based on established scientific and engineering standards and methodologies, specifically:

• ISO 4049: 2009 (Dentistry - Polymer-based restorative and materials) for physical and mechanical properties.
• "Dental Composite Resin Devices – Premarket Notification [510(k)] Submissions – Guidance for Industry and FDA Staff" for additional physical properties.
• ISO 10993-1:2009 for biological evaluation (biocompatibility).

Performance is compared against the predicate device's performance under these established methods.

8. The Sample Size for the Training Set

This information is not applicable. This is not a machine learning device, so there is no concept of a "training set."

9. How the Ground Truth for the Training Set was Established

This information is not applicable. There is no training set for this device.

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[1] Cementation of crowns, bridges, inlays and onlays

[2] Cementation of prosthetic restorations on implant abutments and frames

[3] Cementation of adhesion bridges and splints

[4] Cementation of posts and cores

[5] Amalgam bonding

PANAVIA SA Cement Universal is a dual-cure (light- and/or self-cure), fluoride releasing, radiopaque self-adhesive resin cement for ceramic (porcelain, lithium disilicate, zirconia, etc.), composite resin, and metal restorations. It has a choice of Automix delivery (equal amounts of two components are combined through a mixing tip) or Handmix (equal amount of two components are combined on a mixing pad).

This document describes the premarket notification for the PANAVIA SA Cement Universal dental cement.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The acceptance criteria are generally based on compliance with ISO 4049:2009 (Dentistry - Polymer-based restorative and materials) and a comparative study against a predicate device.

2. Sample Size for Test Set and Data Provenance:

The document does not explicitly state the sample sizes used for each specific test in the comparative study (e.g., number of samples for film thickness, strength, bond strength measurements).

The data provenance is from non-clinical testing performed by the manufacturer, Kuraray Noritake Dental Inc., in Japan. The studies are retrospective in the sense that they are laboratory tests conducted to compare the new device against an already marketed predicate device, rather than a clinical trial with human subjects.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This is a non-clinical, laboratory-based study comparing a new dental cement to a predicate device. Therefore, the concept of "experts establishing ground truth for a test set" in the context of clinical diagnostics or image interpretation does not directly apply. The "ground truth" for these tests is established by adherence to the specifications and methodologies outlined in ISO 4049:2009 for physical and mechanical properties, and internal standards for bond strength. The expertise lies in the laboratory technicians and scientists performing and evaluating these standardized tests. No specific number or qualifications of "experts" are listed for establishing ground truth in this context.

4. Adjudication Method for the Test Set:

No adjudication method (e.g., 2+1, 3+1) is mentioned or applicable as this is a non-clinical laboratory study, not a study evaluating human interpretation of data. The results are obtained through standardized measurements and comparisons.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done. This type of study is typically used for medical imaging devices where human readers interpret images. This document describes a dental cement, and its evaluation focuses on physical, mechanical, and chemical properties, not human interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

Not applicable. PANAVIA SA Cement Universal is a dental cement, not an algorithm or a device requiring human-in-the-loop performance in the context of AI. The performance is the inherent material properties of the cement.

7. Type of Ground Truth Used:

The ground truth used for performance validation is:

• International standards: Specifically, compliance with the requirements outlined in ISO 4049:2009 (Dentistry - Polymer-based restorative and materials) for various physical and mechanical properties.
• Comparative equivalence to a legally marketed predicate device: The subject device's performance (bond strength, fluorine ion release) was compared directly to PANAVIA SA Cement Plus Automix, demonstrating non-inferiority or substantial equivalence.
• In-house standards: For bond strength tests, "In-house standard" was used for assessment.

8. Sample Size for the Training Set:

Not applicable. This is a dental material, not a machine learning algorithm that requires a training set. The term "training set" is typically used in the context of artificial intelligence/machine learning model development.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for a dental cement product.

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