(143 days)
The Orthodontic TAADS Screws are intended to provide a fixed anchorage point for the attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. They are intended for temporary use and should be removed after orthodontic treatment has been completed. The screws are intended for single use only.
The Orthodontic TAADS Screws are single-use, screw-type, root-form endosseous dental implants designed for the anchoring of orthodontic appliances to the jaw. Each Orthodontic TAADS Screw model is designed for optimal holding power and function in a specific region of the mouth or jaw. Each model is also anodized for ease of identification through color. All of the TAADS devices are intended for immediate loading. All of the Orthodontic TAADS Screws are provided in sterile and non-sterile versions.
The Orthodontic TAADS (Temporary Anatomical Anchor Device System) did not undergo clinical testing to establish its performance. The submission states, "Clinical testing was not necessary to determine substantial equivalence between the Orthodontic TAADS Screws and the predicates." Instead, the device's substantial equivalence to predicate devices was determined through a combination of dimensional comparison and engineering analysis.
1. Table of Acceptance Criteria and Reported Device Performance:
Since no clinical or non-clinical performance data (beyond dimensional and engineering analysis related to substantial equivalence) was provided, specific acceptance criteria and detailed performance metrics are not available in the given text. The basis for acceptance was substantial equivalence to predicate devices.
| Metric/Criteria | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Substantial Equivalence (Overall Safety & Effectiveness) | Same intended use, indications for use, materials, and similar design to predicate devices. Passes previously defined performance requirements (external to this submission). | Determined to be substantially equivalent based on dimensional comparison and engineering analysis to specified predicate devices. |
| Material Composition | Same as predicate devices. | Stated as "consist of the same materials as" predicate devices. |
| Design | Similar to predicate devices. | Stated as "similar in design to" and "similar in design and function to" predicate devices. |
| Intended Use | Same as predicate devices. | Stated as "same intended use and indications for use as" predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
No test set for performance evaluation was used, as non-clinical (bench) and clinical testing were explicitly stated as "not performed" or "not necessary." The determination was based on comparison to existing predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable, as no test set requiring ground truth establishment by experts was utilized.
4. Adjudication Method for the Test Set:
Not applicable, as no test set was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. No MRMC study was conducted.
6. Standalone (Algorithm Only) Performance:
Not applicable. This device is a physical medical device (endosseous dental implant), not an algorithm or AI.
7. Type of Ground Truth Used:
Not applicable, as no new performance data was generated that would require independent ground truth. The "ground truth" for substantial equivalence was established by the characteristics and established performance of the legally marketed predicate devices.
8. Sample Size for the Training Set:
Not applicable. There was no training set in the context of an AI/algorithm.
9. How the Ground Truth for the Training Set was Established:
Not applicable.
§ 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.