(21 days)
The Thommen SPI® ONETIME Dental Implant is intended to be surgically placed in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. SPI® ONETIME implants can be loaded immediately if they are splinted with a bar on four implants in the mandibular arch or six implants in the maxillary arch.
The two-stage HA-Ti Dental Implant acquired from HATI Dental AG by Thommen Medical AG has been modified to make it a one-piece one-stage transgingival implant and will be marketed as the SP1® ONETIME Dental Implant. Other components of the HA-Ti Dental Implant System have not been modified and are suitable for use with the modified implant, and will be sold under the SP10 Dental Implant System name.
The Thommen SP1® ONETIME Dental Implant is a one-stage root form endosseous dental implant made of commercially pure grade titanium. The implant surface is smooth machined on the transqingival portion and sandblasted and acid-etched in the area designed to contact bone. The implant is offered in three lengths (8 mm, 11 mm, 14 mm, not including the 2.9 mm transgingiyal portion), with two diameters (4.2 mm, 5.0 mm) for each length. It is constructed of materials that have a long clinical history of proven acceptance and performance,
The provided 510(k) summary for the Thommen SPI® ONETIME Dental Implant does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way that would typically be described for a diagnostic AI device.
This document is a premarket notification for a Class III medical device (an endosseous dental implant), and the regulatory review process for such devices focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through clinical studies designed with AI in mind.
Here's why the requested information cannot be fully provided based on the input:
- Dental Implants vs. AI/Diagnostic Devices: The document concerns a physical implant, not a software algorithm or an AI-powered diagnostic tool. The "acceptance criteria" and "device performance" in this context refer to material properties, sterilization methods, and intended use as defined by the FDA's substantial equivalence pathway, not metrics like sensitivity, specificity, or AUC as seen in AI studies.
- Substantial Equivalence: The primary goal of this 510(k) submission is to demonstrate that the SPI® ONETIME Dental Implant is substantially equivalent to a legally marketed predicate device (Thommen Medical AG HA-Ti Dental Implant). This means showing it has the same intended use, operating principle, basic design, materials, packaging, and sterilization processes. Performance is inferred through the predicate device's established safety and effectiveness, and through material conformity to standards like ASTM F67 and ISO 5832-2.
- Lack of AI-Specific Information: All the points you've requested (sample sizes for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for training/test sets) are specific to the evaluation of AI/ML-based medical devices or diagnostic tools. These concepts are not applicable to the 510(k) submission for a physical dental implant.
Therefore, I cannot populate the table or answer the questions as they pertain to AI device evaluation. The document describes a traditional medical device submission.
§ 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.