(78 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 for 11.5 mm implant and 14.5 mm for 13.0 implant 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 Trefoil Implants are made of CP4 titanium. The implants are parallel walled and have an internal conical abutment connection. The implants have a 13.0 mm threaded portion and are available with both a 4.5 and 6.0 mm collar height. The apex of the implants have cutting chambers allowing for self-tapping. The implant bone interface has the TiUnite implant surface treatment.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets those criteria, specifically concerning an AI/algorithm-based diagnostic device. The document is a 510(k) premarket notification for a dental implant system (TREFOIL System) and discusses its substantial equivalence to previously marketed predicate devices.
The text does not include details about:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, or training sets for an AI/algorithm.
- Number or qualifications of experts, or ground truth adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used (e.g., pathology, outcomes data).
- How ground truth for any training set was established.
The document primarily focuses on:
- Device Description: The TREFOIL System is a dental implant system consisting of implants, surgical components, and prosthetic components for restoring chewing function in fully edentulous mandibles.
- Predicate Devices: It compares the subject device to two predicate TREFOIL Systems (K152836 and K170135).
- Technological Characteristics Comparison: The key difference noted is a change in implant length from 11.5 mm to 13.0 mm, which is already present in a reference predicate. All other technological characteristics (design, material, surface modification) are stated to be the same as the predicate devices.
- Non-Clinical Testing Summary: The document explicitly states that "No clinical data was used to support the decision of safety and effectiveness." Instead, the manufacturer leveraged data from the predicate devices because the subject device "does not represent a new worst case" for aspects like sterilization, packaging, shelf life, biocompatibility, and fatigue testing.
Therefore, I cannot fulfill your request for information about acceptance criteria and an AI/algorithm study based on the provided text.
§ 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.