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510(k) Data Aggregation
(575 days)
Trinon Q & Q3 Implant System is indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the premolar, cuspid, and incisor regions of partially edentulous jaws. Trinon Q & Q3 Implant System might be loaded in the anterior mandibular arch if four are splinted together with a bar.
This low-cost implant system was developed to cover many indications in implant dentistry. Designed to provide simplicity and clarity, TRINON TITANIUM GmbH has created a system that removes many of the disadvantages of earlier implant systems. This single-phase enossal implant is made of titanium and there are no complex components. Its self-cutting thread allows the immediate placement of a temporary crown. The transgingival healing makes a second operation unnecessary. The application areas are telescopic and conical crowns, crowns and bridges, and ball attachment restorations. Our one-piece implant system line is divided into the Q-implant system and the Q3 implant-system. The top of the Q-implant system was designed with a 7° cone, whereas the Q3-implant sytem is a one-phase implant with a ballpoint-head. The TRINON Q- and Q³ Implants and its components are available in the lengths 8, 10, 12 and 14mm and diameters 3.5 and 4.5mm.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Trinon Q & Q³ implant system.
It's important to note that this document is a 510(k) Summary, which is a premarket notification for devices demonstrating substantial equivalence to a predicate device. This type of submission often focuses on comparing performance and characteristics rather than presenting new, detailed clinical trials with specific acceptance criteria and performance metrics in the same way a PMA (Premarket Approval) submission would for a novel device.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the acceptance criteria and reported performance are primarily established through a comparison to the predicate devices. The "performance" described is largely about equivalence in various aspects rather than specific numerical outcomes from a study against predefined thresholds.
| Acceptance Criteria Category | Specific Criteria (Inferred from comparison) | Reported Device Performance (Reference to Predicate) |
|---|---|---|
| Intended Use & Indications for Use | Must be substantially equivalent to predicate devices. | Trinon Q & Q3 Implant System is indicated for support and retention of fixed single tooth and fixed partial denture restorations in the premolar, cuspid, and incisor regions of partially edentulous jaws. May be loaded in the anterior mandibular arch if four are splinted together with a bar. Result: "s.e." (substantially equivalent) to Zimmer® One-Piece 4.7mm, Straight implants. |
| Material | Must use substantially equivalent and well-researched materials. | TRINON Q-Implants are made of Titanium. Result: "s.e.: Identical" to predicate devices. |
| Target Population | Must be substantially equivalent to predicate devices. | Professional use only - qualified dental implantologists, oral surgeons or maxilla surgeons only. Strictly reserved to specialize and trained users. Result: "Is.e. Identical" to predicate devices. |
| Where Used | Must be substantially equivalent to predicate devices. | Dental practices. Result: "s.e. Dental practises" to predicate devices. |
| Design (Packaging) | Must use substantially equivalent packaging and handling for sterile products. | All implants delivered in double blister packaging for sterile handling, polypropylene sleeve and plug, sealed in double transparent blister with sandwich tag for lot tracking. Result: "s.e.: Identical" to predicate devices. |
| Performance & Biocompatibility | Must meet ISO 10993 Biological Evaluation of Medical Devices and be substantially equivalent to predicate device's material. | Testing according to ISO 10993 for all relevant provisions. Result: "s.e. The same material is used for the predicate devices... which received market clearance and are in commercial distribution." |
| Sterilization | Must be substantially equivalent for sterile and non-sterile components. | Implants, drills, and invasive components sold sterile. Other components and accessories sold non-sterile. Result: "s.e. Identical" to predicate devices. |
| Design, Sizes, Shades (Dimensions) | Must offer sizes and configurations substantially equivalent to predicate devices. | Diameters: 3.5 and 4.5mm. Lengths: 8, 10, 12, and 14mm. Result: "s.e." compared to predicate Zimmer implants which have diameters of Ø3.0, 3.7, and 4.7mm and lengths of 10, 11.5, 13, and 16mm. (Note: While not identical, the overall range and type are considered substantially equivalent for the purpose of a 510(k)). |
| Overall Safety and Efficacy | Must not raise any new issues of safety and efficacy. | Results of risk analysis, case studies, cleanliness testing, biocompatibility, sterilization, cytotoxicity and packaging testing demonstrated equivalence. Bench performance testing met all acceptance criteria and indicated equivalence. Conclusion: "All acceptance criteria were met, and demonstrated the subject implants are equivalent." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly describe a "test set" in the context of human subjects or a clinical study with a defined sample size as one might expect for a novel device. Instead, the testing appears to be primarily non-clinical (bench performance testing, biocompatibility, sterilization, risk analysis, cleanliness, cytotoxicity, and packaging testing).
- Test Set Sample Size: Not applicable in the context of a prospective clinical trial. The "test set" refers to the materials and designs used for bench testing. The specific number of implants or components tested for each non-clinical parameter is not provided.
- Data Provenance: The studies are described as non-clinical testing conducted by TRINON TITANIUM GmbH. The document also mentions that all models have been on the market in Europe for many years with no device failures, implying a retrospective safety record from European clinical use, but specific data or a structured analysis of this European data is not provided as part of the formal predicate comparison.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since the studies described are non-clinical (bench testing and comparison to predicate), there is no mention of experts establishing a "ground truth" for a human-subject test set. The evaluations for biocompatibility, sterility, etc., would have adhered to established international standards (like ISO 10993), which are overseen by qualified personnel in the testing laboratories, but not "experts" in the sense of clinical reviewers for ground truth in diagnostic imaging, for example.
4. Adjudication Method for the Test Set
Not applicable, as this was not a clinical study with human subject data requiring adjudication of clinical outcomes by multiple experts. The non-clinical tests would have internal quality control and verification processes.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No. The document does not describe any MRMC comparative effectiveness study, nor does it suggest the device involves human readers or an AI component that would require such a study to assess human-in-the-loop performance. This device is an endosseous dental implant, which is a physical medical device.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
No. This is not an AI/algorithm-based device.
7. Type of Ground Truth Used
For the non-clinical testing, the "ground truth" would be defined by the specifications within the relevant international standards (e.g., ISO 10993 for biocompatibility) and the performance characteristics of the legally marketed predicate devices. The device's performance was compared against these established standards and predicate performance.
8. Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set mentioned, there is no ground truth established for one.
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