(114 days)
GC RELINE II is a resilient material for making soft relining of dentures.
GC RELINE II is a VPS silicone for relining of dentures. The components consist of the base silicone paste and the catalyst silicone paste that are extruded from a cartridge and are automixed with a mixing tip. GC Reline II is available in the following viscosities: Soft, Extra Soft, and Extra Extra Soft.
The cartridge is made of high density polyethylene and the cap is made of polypropylene. The mixing tip is made of polypropylene.
GC Reline Primer for Resin is a resin adhesive that is packaged in a glass bottle.
GC Reline Modifier is available in Liquid A and Liquid B and is similar to the Base and Catalyst of the subject device. Liquid A and Liquid B are dispensed in equal amounts onto the mixing pad and mixed together. It is used to modify (activate) the existing reline surface to accept additional Reline II material.
The provided document describes the FDA 510(k) clearance for the GC Reline II, a denture relining material. This document does not detail a study involving AI or human readers, but rather a non-clinical benchtop study to demonstrate substantial equivalence to a predicate device. Therefore, information regarding human readers, AI assistance, multi-reader multi-case studies, or detailed AI algorithm performance metrics (like sample sizes for training/test sets for AI, data provenance for AI, ground truth for AI, adjudication methods for AI) is not applicable or available in this document.
The acceptance criteria and reported device performance are based on physical properties and biocompatibility in accordance with established ISO standards, comparing the new device (GC Reline II) to a legally marketed predicate device (GC Reline Soft/Extra Soft).
Here's the information extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria (via ISO 10139-2:2009) | Reported Device Performance (GC Reline II) |
|---|---|---|
| Physical Properties | ||
| Shore A hardness, 24h | Meets specifications in ISO 10139-2 | Meets specifications in ISO 10139-2 |
| Shore A hardness, 28d | Meets specifications in ISO 10139-2 | Meets specifications in ISO 10139-2 |
| Bond strength (MPa) | Meets specifications in ISO 10139-2 | Meets specifications in ISO 10139-2 |
| Sorption (µg/mm³) | Meets specifications in ISO 10139-2 | Meets specifications in ISO 10139-2 |
| Solubility (µg/mm³) | Meets specifications in ISO 10139-2 | Meets specifications in ISO 10139-2 |
| Biocompatibility | ||
| Cytotoxicity Test (ISO 10993-1, 10993-5) | Meets test requirements | Pass |
| Irritation and Sensitization (ISO 10993-10) | Meets test requirements | Pass |
Note: The document explicitly states: "Bench top testing indicates that even with different formula, applicant device and predicate devices, meet specifications listed in ISO 10139-2. Therefore, the applicant and predicate device are substantially equivalent. There are no statistically significant differences between GC RELINE II and GC RELINE when comparing performance data."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for the benchtop tests (e.g., number of denture material samples tested for hardness, bond strength, etc.). It refers to testing being done "in accordance with ISO 10139-2," which implies that the material property tests were conducted on batches or samples as prescribed by the standard.
- Data Provenance: The data is from non-clinical benchtop testing. No information is provided regarding the country of origin, but the testing was conducted by GC America, Inc. or contractors on their behalf. The data is prospective in the sense that it was generated specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This was a non-clinical benchtop study evaluating material properties and biocompatibility against ISO standards, not a study involving medical image interpretation or diagnosis requiring human expert consensus. The "ground truth" for material properties is determined by the physical and chemical measurements themselves, compared against the predefined thresholds in the ISO standards.
4. Adjudication Method for the Test Set
- Not Applicable. As this was a non-clinical benchtop study, there was no need for adjudication involving human readers or experts to determine a "ground truth" based on consensus. The results are objective measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study was not done. This submission is for a medical device (denture relining material), not an AI diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not Applicable. This document pertains to a physical dental material, not an algorithm or AI system.
7. Type of Ground Truth Used
- The ground truth used was objective measurements of physical properties and biological responses (biocompatibility) compared against established International Organization for Standardization (ISO) standards:
- ISO 10139-2:2009 (Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term use) for physical properties.
- ISO 10993 series (Biological evaluation of medical devices) for biocompatibility.
8. Sample Size for the Training Set
- Not Applicable. There is no "training set" in the context of this device and study, as it is not an AI/machine learning device. The device's formula and manufacturing processes are developed and optimized by the manufacturer, but this doesn't constitute a "training set" in the AI sense.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no AI training set, this question is not relevant to this submission.
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.