(80 days)
GC Fit Checker Advanced is a silicone impression material intended to check fit by detecting the high spots and pressure points of crowns, bridges, veneers, inlays and dentures.
Checking fit of crowns, bridges, veneers, inlays and dentures.
GC Fit Checker Advanced is a silicone impression material intended to check fit by detecting the high spots and pressure points of crowns, bridges, veneers, inlays and dentures. GC Fit Checker Advanced has two types of packaging/delivery systems in which the base silicone paste and the catalyst silicone are filled. One is in tubes and the other is a cartidge device, similar to silicone impression material. Fit Checker Advanced was developed combining the technology of Fit Checker and vinyl polyether silicone impression material, EXA'lence, to achieve higher hydrophilicity. Due to the improved hydrophilicity, the material easily and uniformly spreads and sets sharply under moist oral environment. The optimal translucency enables the users to examine the thickness with ease.
Here's an analysis of the provided 510(k) summary regarding the GC Fit Checker Advanced device:
Acceptance Criteria and Device Performance Study for GC Fit Checker Advanced
This 510(k) summary focuses on demonstrating that the GC Fit Checker Advanced, a dental impression material, is substantially equivalent to existing predicate devices. The study conducted is a bench study evaluating physical properties directly related to the material's function.
1. Table of Acceptance Criteria and Reported Device Performance
| Specification | Acceptance Criteria (Requirement) | GC Fit Checker Advanced (Test Results) | GC Fit Checker II (Predicate Device) | Meets Acceptance Criteria? |
|---|---|---|---|---|
| Detail Reproduction (μm) | ≤ 20 μm | 20, 20, 20 μm (reported as three measurements) | 20, 20, 20 μm | Yes |
| Elastic Recovery (%) | ≥ 96.5% | 98.9 – 99.3% | 98.5 – 99.6% | Yes |
| Strain in Compression (%) | 2.0 – 20% | 4.2 – 4.5% | 6.1 – 6.5% | Yes |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the numerical sample size (n) for each test. However, for "Detail reproduction," three measurements are reported (20, 20, 20), suggesting at least 3 samples were tested. For "Elastic recovery" and "Strain in compression," ranges are provided, which typically come from multiple measurements but the exact number isn't quantified.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given it's a bench test of a newly developed material by GC America Inc., it's implied to be prospective and likely conducted in-house or by a contracted lab.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this study. The "ground truth" for these physical property tests is based on objective, quantifiable measurements using standardized test methods (ISO 4823), not on expert subjective assessment. Therefore, no human experts were involved in establishing the "ground truth" for the test set.
4. Adjudication Method for the Test Set
This information is not applicable to this study. Since the ground truth is established through objective physical measurements as per ISO standards, there is no need for an adjudication method by human experts.
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 conducted. This is a bench study on the physical properties of a material, not a clinical study involving human readers or cases.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to this device. GC Fit Checker Advanced is a physical dental impression material, not an AI algorithm or software device. The performance evaluation is entirely standalone, as it's the material itself performing under predefined conditions.
7. The Type of Ground Truth Used
The ground truth used for this study is based on objective measurements derived from standardized international testing methods (ISO 4823). These standards define how to quantitatively measure properties like detail reproduction, elastic recovery, and strain in compression, providing a clear, reproducible ground truth.
8. The Sample Size for the Training Set
This concept is not applicable to this device. GC Fit Checker Advanced is a physical material, not a machine learning model. Therefore, there is no "training set." The product's development likely involved iterative formulation and testing, but not in the context of an AI training set.
9. How the Ground Truth for the Training Set was Established
This concept is not applicable as there is no training set for a physical dental material.
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).