(195 days)
The TREFOIL System is used to restore chewing function in fully edentulous mandibles.
The three implants of the TREFOIL System are placed between the mental foramina in fully edentulous mandibles in a 1-stage surgical technique combined with an immediate function loading protocol, provided sufficient primary stability for the selected technique is achieved. In cases where sufficient primary stability for two implants or more is not reached, the implants along with the Framework may also be used with an early or delayed loading protocol.
The following prerequisites must be fulfilled:
- Adequate quantity of bone (minimum height of 13 mm and minimum width of 6-7 mm).
- Adequate mouth opening (minimum 40 mm) to accommodate the guided surgery instruments.
- Implant-supported prosthetics seated directly on dedicated implants
The TREFOIL System is a method of placing three dental implants in predetermined positions (between the mental foramina) and using a pre-designed prosthetic bar to act as a screw-retained framework seated on the implants. The TREFOIL System restores chewing function and esthetics in the mandible in completely edentulous patients.
The TREFOIL System consists of dental implants, surgical components necessary to place the implants in predetermined positions, and prosthetic components that are included in the prosthetic bar or are used in the dental lab during the creation of the prosthetic bar.
The dental implants are threaded endosseous implants made of CP4 titanium. The implant is parallel walled and has an internal conical abutment connection. The implant is available in 11.5 mm length with two available collar lengths (4.5, 6.0 mm). The apex of the implants have cutting chamber allowing for self-tapping. The implant bone interface has the TiUnite implant surface treatment. The TREFOIL System bar is made of titanium vanadium alloy. The TREFOIL System surgical tooling is made of stainless steel.
The provided text describes a 510(k) premarket notification for the TREFOIL System, an endosseous dental implant system. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.
Therefore, much of the requested information about acceptance criteria, detailed study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not explicitly available in the provided text.
However, I can extract the information related to the performance data presented and what it aimed to establish.
Here's a summary based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria in a table format, nor does it provide numerical performance results against such criteria. Instead, it describes types of testing performed and their general conclusions.
| Acceptance Criterion (Inferred from testing) | Reported Device Performance |
|---|---|
| Surgical Accuracy (Angular and Translational) | Established the angular and translational accuracy errors generated by the surgical procedure, indicating the system's ability to maintain precision during implant placement. |
| Framework Compensation Mechanism (Passive Fit) | The ability of the Trefoil framework compensation mechanism to adapt to expected angular and translational accuracy errors was established through 3D modeling. The modeling confirmed that the compensation mechanism ensures a passive fit of the framework bar on the implants. |
| Fatigue Strength (Withstand Mastication Forces) | Fatigue testing was performed to establish that the TREFOIL System will withstand foreseeable mastication forces. The results demonstrated a higher fatigue strength than the predicate Branemark Novum (K000018). |
| Sterilization Efficacy | For sterile devices, the sterilization method (Gamma radiation) is the same as the predicate and was validated in accordance with ANSI/AAMI/ISO 11137. For non-sterile devices (for end-user sterilization), pre-vacuum and gravity moist heat sterilization were validated in accordance with ANSI/AAMI/ISO ISO 17665-1. No additional testing was required. |
| Packaging Integrity | The packaging for the subject device is the same as the predicate (titanium cylinder in plastic vial with PVC shrink-wrap and tamper-resistant strip). No additional testing was required. |
| Shelf Life | The packaging for the subject device is the same as the predicate and has a 5-year expiration date, determined by real-time aging. No additional testing was required. |
| Biocompatibility | The device is manufactured from the same material using the same method as the predicate, has the same intended use, and patient contact type/duration. No additional testing was required. |
| Surface Treatment Qualification | The Trefoil implants use the same TiUnite surface treatment as the predicate NobelActive implants. This treatment was qualified through Auger analysis, IR spectrum analysis, and cytotoxicity testing. No additional testing was required. |
2. Sample Size for the test set and data provenance:
- Surgical Accuracy Test: Implants were placed "into bone models." The specific number of models or implants is not stated.
- Data Provenance: The nature of the studies suggests these were retrospective (laboratory-based) tests conducted by the manufacturer, rather than prospective clinical trials with patient data. The country of origin for the data is not specified but is presumably where Nobel Biocare AB conducts its research.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
This information is not provided in the document. The tests described (surgical accuracy in bone models, 3D modeling for passive fit, fatigue testing) are physical or computational tests, not human-interpretation-based tests that would require expert ground truth.
4. Adjudication method for the test set:
This information is not applicable/not provided. The assessment of these non-clinical tests would have been based on measurement and engineering analysis, not expert adjudication of subjective findings.
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 is not applicable. The device is an endosseous dental implant system, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical medical device (dental implant system), not an algorithm or software.
7. The type of ground truth used:
- Surgical Accuracy Test: Ground truth would have been based on physical measurements and engineering specifications of the implant placement within the bone models (e.g., deviation from planned position and angle).
- Framework Compensation Mechanism: Ground truth was established through three-dimensional modeling and simulation, confirming the design's ability to achieve a "passive fit" based on engineering principles.
- Fatigue Testing: Ground truth was based on material science and engineering standards (ISO 14801) and the device's ability to withstand a specified number of cycles at a given load.
- Other tests (Sterilization, Packaging, Shelf Life, Biocompatibility, Surface Treatment): Ground truth was established through adherence to recognized industry standards (e.g., ISO, ANSI/AAMI), analytical chemistry (Auger analysis, IR spectrum), and established biological testing methodologies (cytotoxicity).
8. The sample size for the training set:
This information is not applicable/not provided. The device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable/not provided, as there is no training set for this type of device.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.