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• [1] Direct restorations using light cured composite resin
• [2] Cavity sealing as a pretreatment for indirect restorations
• [3] Treatment of exposed root surfaces
• [4] Intraoral repairs of fractured restorations made of porcelain, ceramic or composite resin
• [5] Surface treatment of non-precious metal posts
• [6] Post cementation and core build·ups using dual·cured composite resin CLEARFIL DC CORE PLUS
• [7] Core build-ups using light-cured composite resin

The subject device is a single-component. light-cured bonding agent that allows simultaneous treatment of both dentin and enamel. A single dose of it comes in a container with an applicator tip for fast, direct placement into the cavity.

The provided text describes a 510(k) premarket notification for a dental bonding agent, CLEARFIL TRI-S BOND PLUS Single Dose. The submission aims to demonstrate substantial equivalence to predicate devices, focusing on chemical ingredients, safety, and technological characteristics/performance.

Here's an analysis of the acceptance criteria and study information based on the provided text:

Acceptance Criteria and Study Details for CLEARFIL TRI-S BOND PLUS Single Dose

The provided information focuses on demonstrating substantial equivalence to existing predicate devices rather than establishing novel safety or efficacy criteria that would necessitate a rigorous clinical trial with pre-defined acceptance criteria for a new device. For devices seeking 510(k) clearance, the "acceptance criteria" are generally that the new device performs "as good as or better than" the predicate device in key performance characteristics relevant to its intended use.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for substantial equivalence, formal, quantitative acceptance criteria with specific threshold values (e.g., "tensile strength > X MPa") are not explicitly stated as they would be for a novel device. Instead, the "acceptance criteria" can be inferred as demonstrating similar or superior performance to the predicate devices.

Study Description:
The study was conducted to demonstrate substantial equivalence to predicate devices, specifically "CLEARFIL TRI-S BOND" for performance aspects. It involved:

• Biocompatibility testing: For two new chemical ingredients, evaluation was done referring to ISO 10993 series and ISO 7405.
• Performance testing: Tensile bond strength test and Fluoride releasing property were performed.

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

The document does not explicitly state the sample sizes used for the tensile bond strength test, fluoride releasing property test, or the biocompatibility evaluations.

The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. It is implied to be laboratory testing for performance characteristics and ingredient evaluations rather than patient data.

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

This information is not applicable in the context of this 510(k) summary. The "ground truth" for chemical composition, biocompatibility, and physical properties (like bond strength) is established through standardized laboratory tests and material science principles, not through expert consensus on patient data.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used for clinical image interpretation or diagnostic studies involving human readers, which is not the nature of the tests described for this dental bonding agent.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study involves human readers interpreting cases with and without AI assistance and is relevant for diagnostic imaging devices. The CLEARFIL TRI-S BOND PLUS Single Dose is a material (dental bonding agent), not a diagnostic or AI-powered device.

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

No, a standalone performance study in the context of an algorithm or AI was not done. This device is a material, not a software algorithm. The "standalone" performance refers to the device's inherent material properties as tested in the laboratory.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed was based on objective laboratory measurements and material science standards.

• Biocompatibility: Determined by adherence to ISO 10993 series and ISO 7405 standards for material safety.
• Tensile Bond Strength: Measured quantitatively in a laboratory setting to evaluate the material's adhesive properties.
• Fluoride Releasing Property: Measured quantitatively to assess this specific characteristic of the material.

8. The Sample Size for the Training Set

This information is not applicable. The concept of a "training set" is relevant for machine learning algorithms or AI models. This submission is for a medical device (dental bonding agent) that does not involve AI or machine learning. The studies described are for material characterization and performance comparison.

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

This information is not applicable as there is no "training set" for this device.

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[1] Direct restorations using light cured composite resin

[2] Cavity sealing as a pretreatment for indirect restorations

[3] Treatment of exposed root surfaces

[4] Intraoral repairs of fractured restorations made of porcelain, ceramic or composite resin

[5] Surface treatment of prosthetic restorations made of porcelain, ceramic or composite resin

[6] Surface treatment of dental posts

[7] Post cementation and core build ups using dual cured composite resin CLEARFIL DC CORE PLUS

[8] Core build ups using light cured composite resin

The subject device is a single-component, light-cured bonding agent that allows simultaneous treatment of both dentin and enamel.

The provided text describes the regulatory submission for a dental bonding agent, CLEARFIL TRI-S BOND PLUS, and references studies conducted to demonstrate its substantial equivalence to predicate devices. However, the document does not contain explicit "acceptance criteria" in a quantitative tabular format or detailed "studies that prove the device meets acceptance criteria" with the specific information requested in your prompt (e.g., sample sizes for test/training sets, data provenance, expert ground truth details, MRMC studies, standalone performance details).

Instead, the submission focuses on demonstrating substantial equivalence based on

1. Intended uses
2. Chemical ingredients/safety (biocompatibility)
3. Technological characteristics/effectiveness and performance.

The document indicates that for effectiveness and performance, "certain tests were performed on this device, in comparison with the predicate device and it was confirmed that this device was substantially equivalent to the predicate device in terms of the effectiveness and performance." Specifically, the following tests are mentioned:

• Tensile bond strength test
• Fluoride releasing property

The results of these tests "exhibited almost the same results for the subject device indicating that the subject device was as effective as and performs as good as or better than the predicate device."

Without the full study reports, which are not included in this summary, the detailed information requested cannot be fully extracted. However, based on the provided text, here's what can be inferred:

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 for Test Set: Not specified in the provided summary.
• Data Provenance: Not specified in the provided summary.
  • The submitter is Kuraray Medical Inc., located in Japan, suggesting the studies likely originated from there, but this is an inference, not stated directly about the data itself.
  • The studies were part of a 510(k) submission, typically involving prospective testing for performance evaluations.

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 as the tests described (tensile bond strength, fluoride release) are objective laboratory measurements, not subjective evaluations requiring expert ground truth in the way medical imaging interpretation might.

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

• Not applicable for objective laboratory measurements like tensile bond strength or fluoride release.

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

• No, this type of study is not mentioned. The device is a dental bonding agent, not an AI-powered diagnostic tool for human readers.

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

• Not applicable. The device is a physical product (dental bonding agent), not an algorithm. Its performance is inherent to the material properties.

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

• For Tensile Bond Strength and Fluoride Releasing Property: The "ground truth" would be the direct measurement of these physical/chemical properties using established laboratory testing protocols, likely aligned with ISO or ASTM standards, and validated against the performance of predicate devices.
• For Biocompatibility: The ground truth was established by evaluation against ISO 10993 series and ISO 7405 standards.

8. The sample size for the training set

• Not applicable. The description refers to a medical device (dental bonding agent), not an AI algorithm that requires a training set. Development of such a product involves formulation and testing, but not in the "training set" sense for AI.

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

• Not applicable as there is no "training set" in the context of this device.

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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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CLEARFIL TRI-S BOND 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)Intraoral repairs of fractured crowns/bridges made of porcelain or composite resin 5)Surface treatment of prosthetic appliances made of porcelain or composite resin

6)Core build-ups using light- or dual- cured composite resin

Not Found

This document is a 510(k) premarket notification letter from the FDA for a dental bonding agent named CLEARFIL TRI-S BOND. It is not an AI/ML device, and therefore the types of studies and acceptance criteria typically associated with AI/ML device evaluations do not apply.

The document discusses substantial equivalence to a predicate device, general controls, and good manufacturing practices, which are standard for traditional medical devices. There is no mention of acceptance criteria, device performance metrics (such as sensitivity, specificity, or AUC), sample sizes for test or training sets, expert adjudication, or MRMC studies, as these concepts are specifically relevant to AI/ML device evaluations and not to this type of dental material.

Therefore, I cannot provide the requested information for this specific device based on the provided document.

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