(416 days)
- Impression material in a dual phase impression technique
- Precise duplication of models
- Capturing multiple unit impressions
- Impression of inlay, crown, bridge and partial denture etc.
Vonflex S™, as the additional polymerization silicone type, is composed of a two component (base and catalyst, mixing ratio 1:1) hydrophilic vinyl polysiloxane impression material for all dental impression techniques. Vonflex S™ consists of light-bodied, medium-bodied or heavy-bodied consistencies in delivery systems of cartridges and/or tubes. It has normal set and fast set that would be desired by the operator.
The provided text is a 510(k) Summary for a dental impression material named "Vonflex S™". This document aims to demonstrate substantial equivalence to a predicate device, not necessarily to set and prove acceptance criteria in the same way one might for an AI/ML medical device.
The study presented here is a comparison of the performance characteristics of the new device (Vonflex S™) against a legally marketed predicate device (Aquasil Ultra Smart Wetting Impression Material). The goal is to show that Vonflex S™ is substantially equivalent and therefore safe and effective for its intended use, not to prove that it meets specific, pre-defined acceptance criteria in isolation.
However, we can infer "acceptance criteria" as the performance characteristics of the predicate device, against which the new device is compared. The study involves bench testing of physical and chemical properties.
Here's an attempt to structure the information based on your request, with the understanding of the nature of this 510(k) submission:
1. Table of Acceptance Criteria (Inferred from Predicate Device Performance) and Reported Device Performance
The acceptance criteria are inferred from the performance of the predicate device, as the goal is to demonstrate substantial equivalence. The tables in the document compare varying consistencies (Heavy, Medium, Light, Light XLV) of Vonflex S™ against their respective predicate device counterparts. Below are representative tables for "Vonflex S™ Heavy" and "Vonflex S™ Light XLV". Similar tables are present for Medium and Light consistencies in the original document.
Vonflex S™ Heavy - Acceptance Criteria (Predicate) vs. Device Performance
| Characteristic | Acceptance Criteria (Aquasil Ultra Rigid Smart Wetting Impression Material) | Vonflex S™ Heavy - Normal Setting | Vonflex S™ Heavy - Fast Setting |
|---|---|---|---|
| Flow properties | 1.82 mm | 3.57 mm | 2.42 mm |
| Wettability | 65.70° | 62.06° | 65.67° |
| Working time | 2'15" - 2'45" | 2'15" | 1'30" |
| Setting reaction time | 5'00" | 4'00" | 2'30" |
| Tear strength | 8.51 N/mm | 10.74 N/mm | 8.73 N/mm |
| Dimensional accuracy | 0.12% | 0.11% | 0.07% |
| Consistency | 34.78 mm | 34.76 mm | 34.78 mm |
| Compatibility (0.05 mm) | Reproduced for 0.05 mm | Reproduced for 0.05 mm | Reproduced for 0.05 mm |
| Curve of the shrinkage | 1.84% | 2.56% | 2.38% |
| Viscosity (Base) | 136,000mPas | 123,000mPas | 131,000mPas |
| Viscosity (Catalyst) | 101,000mPas | 113,000mPas | 108,000mPas |
| Vinyl terminated group | Polydimethylsiloxane polymer | Vinyl siloxanes | Vinyl siloxanes |
| Filler | Silicon Dioxide, Sodium Aluminosilicate | Silica, Fumed silica | Silica, Fumed silica |
| Cross linker | Polymethyl hydrogen siloxane | Hydrogen polysiloxane | Hydrogen polysiloxane |
| Catalyst | Organic platinum complex | Organo platinum complex | Organo platinum complex |
| Colorant | Pigments | Pigments | Pigments |
| Surfactant | Surfactant | Surfactant | Surfactant |
| Standard Conformed | ISO4823 | ISO4823 | ISO4823 |
| Biocompatibility | Yes | Yes | Yes |
| Use | Prescription / Hospital | Prescription / Hospital | Prescription / Hospital |
Vonflex S™ Light XLV - Acceptance Criteria (Predicate) vs. Device Performance
| Characteristic | Acceptance Criteria (Aquasil Ultra XLV Smart Wetting Impression Material) | Vonflex S™ Light XLV - Normal Setting | Vonflex S™ Light XLV - Fast Setting |
|---|---|---|---|
| Flow properties | 23.26 mm | 23.25 mm | 17.49 mm |
| Wettability | 54.96° | 56.98° | 57.40° |
| Working time | 2'15" - 2'45" | 2'30" | 1'30" |
| Setting reaction time | 5'00" | 4'00" | 2'30" |
| Tear strength | 15.32 N/mm | 15.98 N/mm | 16.72 N/mm |
| Dimensional accuracy | 0.17% | 0.08% | 0.11% |
| Consistency | 47.18 mm | 45.73 mm | 45.44 mm |
| Compatibility (0.05 mm) | Reproduced for 0.05 mm | Reproduced for 0.05 mm | Reproduced for 0.05 mm |
| Curve of the shrinkage | 10.79% | 9.98% | 4.20% |
| Viscosity (Base) | 39,375mPas | 45,333mPas | 44,000mPas |
| Viscosity (Catalyst) | 23,125mPas | 59,000mPas | 55,050mPas |
| Vinyl terminated group | Polydimethylsiloxane polymer | Vinyl siloxanes | Vinyl siloxanes |
| Filler | Silicon Dioxide, Sodium Aluminosilicate | Silica, Fumed silica | Silica, Fumed silica |
| Cross linker | Polymethyl hydrogen siloxane | Hydrogen polysiloxane | Hydrogen polysiloxane |
| Catalyst | Organic platinum complex | Organo platinum complex | Organo platinum complex |
| Colorant | Pigments | Pigments | Pigments |
| Surfactant | Surfactant | Surfactant | Surfactant |
| Standard Conformed | ISO4823 | ISO4823 | ISO4823 |
| Biocompatibility | Yes | Yes | Yes |
| Use | Prescription / Hospital | Prescription / Hospital | Prescription / Hospital |
2. Sample Size and Data Provenance
- Sample Size for Test Set: The document does not specify exact sample sizes (e.g., number of impressions or tests performed for each physical property). It only presents the measured values.
- Data Provenance: The tests were conducted by Vericom Co., Ltd. in the Republic of Korea. The data is reported for the new device (Vonflex S™) and the predicate device (Aquasil Ultra Smart Wetting Impression Material). The study is retrospective in the sense that it evaluates the manufactured product against existing standards and a predicate device.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable. This study does not involve human readers or interpretations of images/data that would require expert consensus. The "ground truth" for each characteristic (e.g., flow properties, tear strength) is determined by laboratory measurements according to established international standards (ISO 4823).
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This is a scientific and technical bench testing comparison, not a clinical study involving human judgment that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic interpretation devices, not for a dental impression material's physical and chemical properties.
- Effect Size of Human Readers with/without AI: Not applicable.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study: Not applicable. This device is not an algorithm or software. The performance evaluation focuses on the physical and chemical properties of the material itself.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the performance characteristics is derived from measurements of defined physical and chemical properties conducted according to the ISO 4823 standard. For biocompatibility, the ground truth is established through standard biological evaluation tests (Cytotoxicity, Genotoxicity, Oral mucous Irritation, Sensitization) as per ISO 10993. The performance of the predicate device also serves as a comparative ground truth to establish substantial equivalence.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a material, not a machine learning algorithm that requires a training set.
9. How Ground Truth for Training Set was Established
- How Ground Truth was Established: Not applicable.
§ 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).