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Clearfil tri-S bond Single dose is indicated for the following applications:

1. Direct restorations using light cured composite resin
2. Cavity sealing as a pretreatment for indirect restorations
3. Treatment of exposed root surfaces
4. Core build-ups using light- or dual-cured composite resin

This device is classified into the resin tooth bonding agent, CFR 21 Section 872.3200, because it is a device composed of materials such as dimethacrylate monomers intended to be painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials. The ingredients and composition of this device are the same as that of Clearfil tri-S bond (K042913) and it only differs in that it is filled in single dose tips (disposable tips).

The provided document is a 510(k) premarket notification for a dental adhesive system, "Clearfil tri-S bond Single dose." It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study with acceptance criteria and device performance in the way typically seen for AI/ML-based medical devices or diagnostic tools.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable as this document describes a traditional medical device (a resin tooth bonding agent) where performance is evaluated through material properties and mechanical tests rather than diagnostic accuracy or human-AI interaction.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

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

• Sample Size: Not specified quantitatively in this summary. The tests were performed "between bovine tooth and a composite resin" and "between bovine dentin and core build up composite resin."
• Data Provenance: Not specified, but given the manufacturer is in Japan, it's likely the testing was conducted in Japan. The study is akin to in vitro or ex vivo testing, not a clinical study on human subjects.

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. This is a material testing study, not a diagnostic study requiring expert ground truth for interpretation. Performance is assessed through physical and mechanical properties.

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

• Not Applicable. Adjudication methods are relevant for clinical or diagnostic studies involving human interpretation. This summary describes material property testing.

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/ML device, nor is it a diagnostic tool that involves human readers or AI assistance.

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)

• Direct measurement of material properties: "Bond strengths" and "marginal sealing" are direct measurements or observations of the material's physical performance, not a "ground truth" established by human experts in a diagnostic context. The "truth" is based on the quantifiable physical properties of the materials and their interaction.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device that requires a training set.

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

• Not Applicable. This is not an AI/ML device that requires a training set or its associated ground truth establishment.

Summary of Study:

The study described is a comparison of the "Clearfil tri-S bond Single dose" device to its predicate device, "Clearfil tri-S bond (K042913)," focusing on material properties and performance. The primary findings are:

• Safety: The device is considered safe because its ingredients and composition are identical to the predicate device, with the only difference being the single-dose packaging.
• Effectiveness: The device demonstrates substantial equivalence to the predicate in effectiveness, as evidenced by comparable "bond strengths" (between bovine tooth/composite and bovine dentin/core build-up) and "marginal sealing."

The 510(k) summary asserts substantial equivalence based on these comparisons, indicating that the new device performs at least as well as the legally marketed predicate device for its intended uses. No quantitative results for bond strength or sealing are provided in this summary, only the statement of substantial equivalence.

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ESTENIA C&B is indicated for the following applications for the restoring crowns and defects.

1. Facing cast crowns and facing cast bridges
2. Jacket crowns
3. Inlays and onlays
4. Bridges with frameworks

This device is a polymer based material, used for fabricating prosthetic appliance such as facing cast crowns, facing cast bridges, jacket crowns, inlays, onlays or bridges with frameworks, and for repair of those prosthetic appliances made of resin based crown and bridge materials or porcelain.

The provided text does not contain detailed information about acceptance criteria or a specific study proving the device meets them in the way typically found for an AI/ML medical device. This document is a 510(k) summary for a dental material (ESTENIA C&B), which relies on substantial equivalence to predicate devices rather than a performance study against specific acceptance criteria for AI algorithms.

Here's an analysis based on the provided text, addressing the points where information is available and noting where it is not:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of an AI/ML device. This document describes a dental material and its physical/mechanical properties, not an AI algorithm's performance against clinical endpoints.

The document states:

• "The physical and mechanical properties of ESTENIA C&B are verified by evaluation test based on ISO 10477."

This suggests that compliance with ISO 10477 serves as the "acceptance criteria" for the physical and mechanical properties of the material. However, no specific numerical values or ranges are provided for these properties, nor are the reported results from the evaluation test detailed.

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

Not applicable for an AI/ML device. This document refers to the evaluation of a dental material. The "test set" would likely refer to samples of the material tested in a lab for physical and mechanical properties. No details on the sample size or data provenance (e.g., country of origin, retrospective/prospective) for these material tests are provided.

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

Not applicable. The ground truth for a dental material's physical and mechanical properties is typically established by standardized laboratory testing methods, not by expert consensus in a clinical setting.

4. Adjudication Method

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are for resolving discrepancies in expert interpretations of clinical data, which is not the context here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

Not applicable. MRMC studies are specific to evaluating AI's impact on human reader performance, which doesn't apply to a dental material.

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

Not applicable. This is not an AI algorithm. The performance described relates to the intrinsic physical and mechanical properties of the dental material.

7. The Type of Ground Truth Used

The ground truth for the device's properties is based on standardized laboratory testing methods, specifically those outlined in ISO 10477. In this context, "ground truth" refers to the objectively measured physical and mechanical properties of the material according to established international standards.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no concept of a "training set" in the machine learning sense. The material itself is "trained" through its manufacturing process to achieve certain properties.

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

Not applicable. As noted above, this isn't an AI/ML device. The "ground truth" for the material's properties is established through the ISO 10477 evaluation tests during development and quality control of the manufacturing process.

In summary, the provided 510(k) summary for ESTENIA C&B pertains to a dental material and relies on demonstrating substantial equivalence to predicate devices, primarily through chemical composition and physical/mechanical properties verified against an international standard (ISO 10477). It does not contain the type of AI/ML device performance study details requested.

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