(137 days)
Vertex™ ThermoSens is a thermoplastic material that is intended to be used in the fabrication of removable full and partial dental prostheses. The product is based on a compounded mixture of Polyamide and pigments.
Vertex™ ThermoSens Rigid is a thermoplastic material that is intended to be used in the fabrication of removable full and partial dental prostheses. The product is based on a compounded mixture of Polyamide and pigments. The Vertex™ ThermoSens material is incorporated in an aluminium tube, which is heated up to 280 degrees Celsius. After a heating period of 18 minutes, the material is injected into the flask by pressure. The technique can be done in an automatic injection machine or manually. The preparations of the model and flask are according to standard procedures of the dental technique. An instruction for use is in writing, film and pictures available. Also a course can be taken to learn the technique and work with the product.
The provided document is a 510(k) summary for the Vertex™ ThermoSens Rigid denture base material. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device's efficacy through a clinical study that establishes specific acceptance criteria and then proves the device meets those criteria through performance data.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment (which are typically relevant for AI/ML device evaluations or detailed clinical trials) is not applicable to this 510(k) submission.
This submission demonstrates substantial equivalence by comparing the new device's Indications for Use, Intended Use, Composition of Polymer, and Physical Properties to those of predicate devices (TCS® Unbreakable - K053060 and Lucitone® FRS™ Flexible Dental Resin - K992956). The "acceptance criteria" here are essentially the properties and characteristics of the predicate devices, and the "study" is a comparative analysis and laboratory testing against established ISO standards.
Here's how the provided information can be structured based on the request, acknowledging the limitations inherent in a 510(k) substantial equivalence submission:
1. Acceptance Criteria and Reported Device Performance
For a 510(k) submission of a material like a denture base, the "acceptance criteria" are typically defined by recognized standards (like ISO 20795-1:2008 for dental materials) and the performance of predicate devices. The device "meets" these criteria by demonstrating similar properties to the predicates and conforming to the standard.
| Acceptance Criterion (from ISO 20795-1:2008 / Predicate Device) | Vertex™ ThermoSens Rigid Performance | Predicate Device (TCS Unbreakable) Performance |
|---|---|---|
| Impact Strength (≥ 7.0 kJ/m²) | 8.0 ± 7.0 kJ/m² | 8.5 ± 1.2 kJ/m² |
| Flexural modulus (≥ 1000 MPa) | 1339 ± 54 MPa | 353 ± 4.24 MPa |
| Water absorption (≤ 32.0 µg/mm³): | 31.2 ± 0.8 µg/mm³ | 14.6 ± 0.4 µg/mm³ |
| Water solubility (≤ 1.6 µg/mm³): | -0.20 ± 0.25 µg/mm³ | 2.5 ± 0.7 µg/mm³ |
| Maximum stress intensity factor (≥ 2.5 MPa m1/2) | 3.5 ± 0.3 MPa m1/2 | Not explicitly provided for predicate |
| Total fracture work (≥ 125000 J/m²) | 160250 ± 16120 J/m² | Not explicitly provided for predicate |
Note: For "Maximum stress intensity factor" and "Total fracture work", specific predicate values were not provided in the table, but the device's performance is presented against the ISO requirement. For other properties, comparisons are made to TCS Unbreakable. The Lucitone® FRS™ predicate was noted as "Not Tested by Sponsor" for physical properties.
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the 510(k) summary. The physical properties testing would have involved material samples, but the number of samples for each test is not detailed.
- Data Provenance: The testing was performed by the "Sponsor" (Vertex Dental B.V.). The country of origin for the data is implicitly The Netherlands, where Vertex Dental B.V. is located. This is laboratory-based testing on material samples, not patient data, so "retrospective or prospective" is not applicable in the usual clinical sense.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable. This is a material substantial equivalence submission based on laboratory physical property testing and comparison to existing devices and standards, not an AI/ML device requiring expert ground truth for image interpretation or diagnosis.
4. Adjudication Method for Test Set
- Not Applicable. See point 3. Testing involves material property measurements, not expert consensus on findings.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable. This is a material safety and performance submission, not an AI-assisted diagnostic or triaging device.
6. Standalone (Algorithm Only) Performance
- Not Applicable. This is a physical product (denture base material), not a software algorithm.
7. Type of Ground Truth Used
- Laboratory Measurements against ISO Standard and Predicate Performance: The "ground truth" for the physical properties is defined by the requirements of the ISO 20795-1:2008 standard for dental materials and the measured performance of predicate devices. For composition and indications, the ground truth is established by the specifications of the predicate devices.
8. Sample Size for Training Set
- Not Applicable. This is a physical product, not a machine learning model requiring a training set. The material itself is the "product," and its properties are measured directly.
9. How Ground Truth for Training Set was Established
- Not Applicable. See point 8.
§ 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.