(1 days)
VarseoSmile TriniQ is indicated as an indirect restorative for both anterior restorations, including occlusal surfaces. The VarseoSmile TriniQ material is used for fabricating permanent restorations such as inlays, veneers, full crown and bridge restorations. VarseoSmile TriniQ can also be used for the fabrication of artificial teeth and temporary crowns & bridges.
The Subject device is a light-cured methacrylate-based resin used in 3D printers to produce permanent or dental restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations including occlusal surfaces. The Subject device is used by a dental technician for the CAD/CAM manufacturing of temporary or permanent dental restorations. Restorations fabricated using the Subject device are one-time use, prescription-only devices. Commonly used dental CAD software is used by dental professionals to virtually design a fixed indirect restoration and generate an industry standard "STL" 3D dataset which reflects the intended shape and contour. The Subject resin is used within a validated manufacturing workflow to create the intended restoration. The Subject device is available in a variety of optional shades to reproduce the intended tooth shade of the restoration. Methacrylates are known materials, commonly used in the dental industry for fixed and removable prosthetic devices due to their physical-chemical, mechanical, and biocompatible properties. The Subject device is intended to be sold by the bottle and used with compatible hardware in computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and post-cure unit.
The provided text describes the acceptance criteria and study for the VarseoSmile TriniQ device. This device is a light-cured methacrylate-based resin used in 3D printers to produce dental restorations.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document indicates that the device was tested against and met the requirements of specific ISO standards. It mentions a flexural strength criterion.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| ISO 4049:2019 (Dentistry — Polymer-based restorative materials) | Met requirements |
| ISO 10477:2020 (Dentistry – Polymer-based crown and veneering materials) | Met requirements |
| ISO 22112:2017 (Dentistry – Artificial teeth for dental prostheses) | Met requirements (in most cases; comparative testing used where not met) |
| Flexural Strength | ≥ 100 MPa |
| Biological Evaluation | Met requirements based on ISO 10993-1, 10993-5, 10993-10, 10993-17, 10993-18, 10993-23, and ISO/TS 21726 |
| MRI Safety | Met requirements based on FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" |
| Manufacturing Process Consistency | Demonstrated consistency of the process output with that of the process input |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not specify the sample size used for the test set in terms of the number of dental restorations or materials tested for each performance criterion. It generally refers to "Physical property testing" and "Confirmatory testing" without providing specific numbers of samples.
The data provenance is non-clinical performance testing, meaning it's laboratory-based testing of the material's properties rather than human patient data. There is no mention of country of origin for the data; the testing is against international ISO standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not applicable and therefore, not provided. The testing described is for material characteristics against engineering and biocompatibility standards, not for diagnostic accuracy or clinical outcomes that would require expert-established ground truth.
4. Adjudication Method for the Test Set:
This information is not applicable and therefore, not provided. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes, not for laboratory material property testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If so, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
This information is not applicable and therefore, not provided. The device described is a dental restorative material, not an AI-powered diagnostic or treatment assistance tool. No MRMC study was mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This information is not applicable and therefore, not provided. The device is a material, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for the non-clinical performance testing is the established requirements and specifications defined by international ISO standards (e.g., ISO 4049, ISO 10477, ISO 22112, ISO 10993 series) and FDA guidance for MRI safety. For manufacturing process validation, the ground truth is the expected or desired output consistent with the process input.
8. The Sample Size for the Training Set:
This information is not applicable and therefore, not provided. This is a material, not a machine learning model, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and therefore, not provided. As there is no training set mentioned, there is no ground truth to be established for it.
§ 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.