(85 days)
Straumann® dental implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients (unless specific indications and limitations are present, as stated below). Straumann® dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). When placing implants in the posterior region, we recommend using only large diameter implants. In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.
The proposed Straumann Tissue Level Ø4.1 mm and Ø4.8 mm Roxolid (TiZr) Dental Implants utilize the Straumann Titanium Zirconium material, Roxolid, to the currently cleared Straumann Tissue Level Ø4.1 mm and Ø4.8 mm Titanium dental implants.
The proposed devices are Tissue Level Roxolid dental implants with apical diameters of 4.1 mm and 4.8 mm, and coronal diameters of 4.8 mm and 6.5 mm. The implants will be available in varying lengths of 6.0.to 16mm.
The body of the proposed implants has a threaded implant body design made of Straumann's Titanium Zirconium (TiZr) Alloy material with Straumann's SLActive surface treatment. The proposed changes are a material change only. There are no changes to the surface treatment, indications for use, fundamental operating principles, or sterilization processes or procedures as a result of the proposed change. No new surgical instruments are being introduced as placement of the proposed implants will follow the established surgical protocols of the currently cleared Straumann Dental Implant Systems.
The provided document describes the acceptance criteria and the study that proves the device meets them for the "Straumann Tissue Level Ø4.1 mm and Ø4.8 mm Roxolid Dental Implants".
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Fatigue Testing in accordance with ISO 14801.2007(E), "Dentistry-Implants-Dynamic fatigue test for endosseous dental implants". | The results from the testing conducted demonstrated that the Straumann Tissue Level Ø4.1 mm and Ø4.8 mm Roxolid Dental Implants function as intended and met the pre-determined acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size used for the fatigue testing.
The data provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective). This type of bench testing typically does not involve human subjects or retrospective/prospective data collection in the clinical sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This was a physical bench test (fatigue testing) and did not involve expert review or ground truth establishment in the context of clinical images or diagnostic performance.
4. Adjudication Method for the Test Set
Not applicable. No expert adjudication was involved for a bench test.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study was not done. This submission is for a material change to an existing dental implant and relies on bench testing to demonstrate substantial equivalence, not a clinical effectiveness study involving human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is a physical medical device (dental implant), not an algorithm or AI system.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is defined by the ISO 14801.2007(E) standard for dynamic fatigue testing of endosseous dental implants. The device's ability to withstand the forces defined by this standard serves as the "ground truth" for its mechanical performance.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device. There is no concept of a "training set" as would be used for an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device and testing.
§ 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.