(103 days)
Telio CAD Abutment Solutions is intended for single hybrid abutment crowns for temporary restoration (up to 12 months). The system comprises three parts:
- Telio CAD Abutment Solution
- Ti base and
- CAD/CAM software
Telio CAD Abutment Solutions is cemented to the Ti base and used in conjunction with endosseous dental implants.
Telio CAD Abutment Solutions are resin blocks with an interface hole in Small and large sizes to accommodate Sirona Ti bases (K100152 and K111421) in the fabrication of temporary hybrid abutment crowns. The Device is milled using CAD/CAM Technology then cemented to the Sirona Ti base and used for the purpose of temporary hybrid abutment crowns in coniunction with endosseous dental implants. Hybrid abutment crowns are characterized by combining a Ti base and monolithic crown in one piece.
Telio® CAD Abutment Solutions are CAD/CAM-fabricated implant-supported hybrid restorations for individual, temporary single-tooth reconstructions. The material consists of a cross-linked polymer block (PMMA), enabling the fabrication of individual, monolithic hybrid abutment crowns which are directly cemented to a Ti base. Shape, esthetics and emergence profile can be easily designed and adjusted any time.
This document is a 510(k) premarket notification for a medical device called "Telio CAD Abutment Solutions." It focuses on demonstrating the substantial equivalence of the new device to previously marketed predicate devices. The information provided heavily emphasizes physical, mechanical, and biological testing rather than artificial intelligence or diagnostic algorithms. Therefore, many of the typical acceptance criteria questions related to AI performance, such as sensitivity, specificity, or AUC, as well as aspects like reader studies, are not applicable here.
Here's an analysis based on the provided text, addressing the applicable points:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner for each test. Instead, it describes tests performed and states the results were "comparable to the predicate device" or "suitable for use." The focus is on demonstrating equivalence rather than meeting specific numerical thresholds for improved performance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical/Physical Properties: | |
| Flexural strength comparable to predicate TelioCAD | Test conducted per EN ISO 10477:2004; results comparable to predicate TelioCAD. |
| Flexural modulus comparable to predicate TelioCAD | Test conducted per EN ISO 10477:2004; results comparable to predicate TelioCAD. |
| Water absorption comparable to predicate TelioCAD | Test conducted per EN ISO 10477:2004; results comparable to predicate TelioCAD. |
| Solubility comparable to predicate TelioCAD | Test conducted per EN ISO 10477:2004; results comparable to predicate TelioCAD. |
| Ball Hardness comparable to predicate | Internal Ball Hardness test conducted; showed comparable results with the predicate. |
| Dynamic fatigue performance suitable for temporary abutment use (up to 12 months) and comparable to predicate | Test conducted per EN ISO 14801:2007 (worst case); shows performance to be suitable for use as a temporary abutment and comparable to the predicate device. Additional and extensive testing performed to support 12 months temporary use (vs. predicate's 6 months). |
| Biocompatibility: | |
| Meets biocompatibility standards | Biocompatibility testing and evaluation carried out according to ISO 10993-1 and ISO 7504. |
| Design Parameters (Recommendations): | |
| Occlusal minimum thickness 1.5 mm | A recommendation for optimal performance is defined. |
| Circular minimum thickness 0.8 mm (transition to Ti base) | A recommendation for optimal performance is defined. |
| Rim minimum thickness 0.5 mm | A recommendation for optimal performance is defined. |
| Maximum angle 20º | A recommendation for optimal performance is defined. |
| Max width 6.0 mm from axial height of contour to screw channel | A recommendation for optimal performance is defined. |
| Observe implant manufacturer's maximum height recommendations | A recommendation for optimal performance is defined. |
2. Sample Size Used for the Test Set and Data Provenance
The document provides details on types of testing (flexural, fatigue, biocompatibility) and the standards used (EN ISO 10477:2004, EN ISO 14801:2007, ISO 10993-1, ISO 7504). However, it does not specify the sample sizes (e.g., number of test specimens) used for each of these mechanical tests. It also doesn't mention the provenance of any "data" in terms of country of origin or whether it was retrospective/prospective, as this is typically relevant for clinical data, which is not the primary focus of this submission. The testing appears to be laboratory-based physical/mechanical testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This question is not applicable. The device is a dental abutment, and its performance is evaluated through physical, mechanical, and biocompatibility testing, not through a diagnostic algorithm requiring expert-established ground truth.
4. Adjudication Method for the Test Set
This question is not applicable. There is no "test set" in the context of expert review or diagnostic output that would require an adjudication method. The testing described is laboratory-based.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This question is not applicable. MRMC studies are used to evaluate AI performance with human readers. This submission is for a physical medical device (dental abutment) and does not involve AI or human interpretation of diagnostic results.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This question is not applicable. There is no algorithm or AI component mentioned in this submission. The device is a physical product.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established through standardized laboratory testing and material characterization according to international ISO and EN standards. For example, flexural strength is measured directly, dynamic fatigue is assessed against defined cycles and loads, and biocompatibility is evaluated based on established biological safety protocols. There is no expert consensus, pathology, or outcomes data used to establish "ground truth" in the way it would be for a diagnostic tool.
8. Sample Size for the Training Set
This question is not applicable. As there is no AI/machine learning algorithm involved, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable. As there is no AI/machine learning algorithm involved, there is no "training set" or ground truth for such a set to be established.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)