(141 days)
CharmFil is indicated for following restorative applications.
- Class I, II, V restorations of posterior teeth
- Class III, IV, V restorations of anterior teeth
- Cervical cavities or defects involving root surfaces
This device is light curing dental for dental surgery treatment and type 1, class 2, group 1 according to ISO 4049 classification. It is made in the form of paste and filled in syringe. When you use the product, press out the content in the syringe by screw. It is used to restore a cavity as taking out from it as much as you need with an instrument. It is dental filling material for restoring the cavities.
The acceptance criteria and the study proving the device meets them are outlined below based on the provided text for the CharmFil device.
1. Table of Acceptance Criteria and Reported Device Performance
| No. | Test Item | Acceptance Criteria (Requirements) | Reported Device Performance (Result) |
|---|---|---|---|
| Physical and chemical property (Polymerization time) / ISO 4049 | |||
| 1 | Color | The exposed and unexposed halves of each of the specimens and the unirradiated specimen for any color difference | Suitable |
| 2 | Appearance test | Shall be homogeneous and co substances are observed | Suitable |
| 3 | Quantity test | No less than ±5% that claimed value | Suitable |
| 4 | Sensitivity to ambient light | After exposure for 60sec, it should be not any charge of consistency | Suitable |
| 5 | Polymerization depth | After exposure for 1 minute, Opaque shade is more than 1mm, and other shades is over 1.5mm | Suitable |
| 6 | Flexural strength | +80 MPa | Suitable |
| 7 | Water solubility | - 40 µg/mm² | Suitable |
| 8 | Water sorption | -7.5 µg/mm² | Suitable |
| 9 | Radio-opacity | Shall be equal to or greater than that of the same thickness of aluminum and no less than 0.5mm | Suitable |
| 10 | Color stability | The exposed and unexposed halves of each of the specimens and the unirradiated specimen for any color difference | Suitable |
| Elution substance test | |||
| 11 | Character test | It should be homogeneous and appropriate. Without any foreign substance, impurity, floating substance. | Suitable |
| 12 | pH | pH difference ≤ 1.5 | Suitable |
| 13 | Heavy metal (Lead content) | It should be less ticker than comparison liquid. (-100ppm) | Suitable |
| 14 | Permanganic acid calcium reduction nature substance | Difference of consumption of permanganic acid calcium≤ 2.0 ml | Suitable |
| 15 | Evaporation residue | Difference of residues ≤ 1.0 mg | Suitable |
| 16 | Ultraviolet rays absorption spectrum | Max. absorbance numerical value ≤ 0.1 | Suitable |
| Biological safety test (Biocompatibility, irritation) | |||
| 17 | Cell toxicity test | 0 | Suitable |
| 18 | Short period whole body toxicity test (Oral route) | During the period of examination, there should not be odd or dead on it. | Suitable |
| 19 | Oral route impetus test | Compare it with contrast product, stimulus response should not appear on mouth mucous | Suitable |
| 20 | Endo-toxin test | According to the method of examination, it should be appropriate. | Suitable |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each performance test. The nature of the tests (physical and chemical properties, elution substance, biological safety) suggests that material samples of the CharmFil device were tested in a laboratory setting. The data provenance is not specified beyond indicating that Dentkist, Inc. is located in Gunpo-si, Gyeonggi-do, Korea, implying that the testing likely occurred in South Korea. The study appears to be retrospective, as it's a submission for premarket notification based on completed tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a dental restorative material, and the acceptance criteria are based on objective physical, chemical, and biological safety standards (ISO 4049). There is no mention of expert readers establishing ground truth in the context of diagnostic interpretation.
4. Adjudication Method for the Test Set
Not applicable, as the acceptance criteria are objective and assessed against established international standards (ISO 4049) and biological safety guidelines. There is no qualitative assessment that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This type of study is typically used for diagnostic devices that involve human interpretation of images or other data. The CharmFil device is a dental restorative material, and its performance is evaluated based on material properties and biological safety.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in essence. The performance testing described is "standalone" in that it assesses the intrinsic properties and safety of the material itself, without direct human interaction as part of the performance evaluation (beyond conducting the tests).
7. The Type of Ground Truth Used
The "ground truth" for the performance tests consists of established industry standards (e.g., ISO 4049 for physical and chemical properties) and biological safety criteria. These are objective, quantitative or qualitative thresholds that the device's characteristics must meet.
8. The Sample Size for the Training Set
Not applicable. As this device is a dental restorative material and its performance is assessed against standardized material properties and biological safety, there is no "training set" in the context of machine learning or diagnostic algorithm development.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
§ 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.