Search Results

• [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.

Ask a specific question about this device