(123 days)
- Splinting mobile teeth
G-Fix is a light-cured resin cement for splinting mobile teeth. G-Fix is used in combination with phosphoric acid as a pre-treatment agent of tooth surfaces.
This document describes the premarket notification for the device G-Fix, a light-cured resin cement for splinting mobile teeth. The study compares G-Fix to a legally marketed predicate device, GRADIA DIRECT Flo (UNIFIL FLOW), to demonstrate substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance:
The acceptance criteria for G-Fix are based on ISO 4049:2009 (Dentistry - Polymer-based restorative materials) and ISO/TS 11405:2003 (Dentistry - Interaction of dental materials with hard tooth tissue - Principles for the assessment of biocompatibility). The table below summarizes the performance benchmarks, required specifications, and the test results for G-Fix and the predicate device.
| Property | Standards | Requirements | G-Fix Test Results (Applicant Device) | Predicate Device Test Results (GRADIA DIRECT Flo (UNIFIL FLOW)) | Compare to Standard | Compare to Predicate Device |
|---|---|---|---|---|---|---|
| Sensitivity to ambient light | ISO 4049: 2009 5.2.7 Sensitivity to ambient light | Remain physically homogeneous. | Conformed | Conformed | Equal | Equal |
| Depth of cure | ISO 4049: 2009 5.2.8 Depth of cure | Not less than 1.5 mm | 5.7 (0.1) mm | 3.0 (0.0) mm | Exceeds | Exceeds |
| Flexural strength | ISO 4049: 2009 5.2.9 Flexural strength | Greater than 80 MPa | 94 (5) MPa | 96 (3.2) MPa | Exceeds | Equal |
| Water sorption | ISO 4049: 2009 5.2.10 Water sorption and solubility | Less than 40 µg/mm³ | 35 (0.9) µg/mm³ | 35 (1.3) µg/mm³ | Exceeds | Equal |
| Solubility | ISO 4049: 2009 5.2.10 Water sorption and solubility | Less than 7.5 µg/mm³ | 0.6 (0.1) µg/mm³ | 0.5 (0.1) µg/mm³ | Exceeds | Equal |
| Color stability after irradiation and water sorption | ISO 4049: 2009 5.4 Color stability after irradiation and water sorption | No more than slight change in color | Conformed | Conformed | Equal | Equal |
| Adhesion to tooth structure (Enamel) | ISO/TS 11405: 2003 5.2.5 Shear bond strength | Greater than 5 MPa | 29 (1) MPa | 31 (2) MPa* | Equal | Equal |
*This result was obtained by the combination with phosphoric acid.
2. Sample Sizes Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes used for each performance test (e.g., number of specimens for depth of cure, flexural strength, etc.). The results for properties like Depth of Cure, Flexural Strength, Water Sorption, Solubility, and Adhesion to Tooth Structure provide multiple individual measurements, suggesting that a sufficient number of samples were tested to achieve the reported mean and standard deviation.
The data provenance is from internal performance bench tests conducted by GC America Inc. The country of origin of the data is not specified directly, but GC America Inc. is based in Alsip, Illinois, USA. The tests are retrospective, as they were conducted to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This document does not involve a clinical study with human interpretation or diagnostic evaluation. Therefore, there are no "experts" in the sense of medical professionals establishing a ground truth for a test set. The ground truth for the performance tests is based on the specified international standards (ISO 4049:2009 and ISO/TS 11405:2003) and objective measurements performed in a laboratory setting.
4. Adjudication Method for the Test Set:
Not applicable, as this is a performance bench test study and not a clinical study involving human interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This device is a dental material, and the study focuses on its physical and chemical properties and biocompatibility, not on a diagnostic algorithm requiring human reader interpretation. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This is not an AI/algorithm-based device. The study evaluates the standalone performance of the material itself through objective laboratory tests.
7. Type of Ground Truth Used:
The ground truth used for this study is based on established international standards and objective laboratory measurements (e.g., ISO 4049:2009 for physical properties, ISO/TS 11405:2003 for adhesion, and ISO 10993 series for biocompatibility). The results are quantitative and directly compared against the numerical requirements set forth by these standards.
8. Sample Size for the Training Set:
Not applicable. This is not a machine learning or AI-based device, so there is no training set in the conventional sense. The "training" for the device's development would involve material science research and formulation, but not in the context of data used for an algorithm.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for an algorithm. The development of the material (G-Fix) would have been guided by material science principles and existing knowledge of dental materials, with experimental validation for optimization, but this doesn't constitute a "training set" with established ground truth in the context of this request.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.