(90 days)
Straumann® Dental implants are indicated for oral endosteal implantation in the upper and lower jaw arches for the functional and aesthetic oral rehabilitation of edentulous and partially dentate patients. Straumann® Dental implants are also indicated 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 through the corresponding components (abutments).
The subject devices of the Straumann® Dental Implant System includes the following: SLActive® and Roxolid®, Standard, Ø3.3 RN, 8, 10, 12, 14 & 16 mm SLActive® and Roxolid®, Standard, Ø4.1 RN, 6, 8, 10, 12, 14 & 16 mm SLActive® and Roxolid®, Standard, Ø4.8 RN, 6, 8, 10, 12 & 14 mm SLActive® and Roxolid®, Standard, Ø4.8 WN, 6, 8, 10 & 12 mm SLActive® and Roxolid®, Standard Plus, Ø3.3 RN, 8, 10, 12 & 14 mm SLActive® and Roxolid® Standard Plus, Ø4.1 RN and Ø4.8 RN, 6. 8. 10. 12 & 14 mm SLActive® and Roxolid®, Standard Plus, Ø4.8 WN, 6, 8, 10, & 12 mm Roxolid®, Standard Plus, Ø4.8 WN, 14 mm SLActive® and Roxolid®, Tapered Effect, Ø3.3 RN and Ø4.1 RN, 8, 10, 12 & 14 mm SLActive® and Roxolid®, Tapered Effect, Ø4.8 WN, 10, 12 & 14 mm SLActive® and Roxolid®, Bone Level, Ø3.3 NC, Ø4.1 RC, and Ø4.8 RC, 8, 10, 12 & 14 mm
Here's a breakdown of the acceptance criteria and study information for the Straumann® Dental Implant System SLActive and Roxolid Product Families, based on the provided 510(k) summary (K130222):
1. Acceptance Criteria and Reported Device Performance
This 510(k) submission is for a change in Indications for Use, not for a new device requiring performance metrics against specific acceptance criteria for a new product. The device itself (Straumann® Dental Implants) is already cleared and its performance is established through prior submissions.
The "acceptance criterion" in this context is primarily focused on demonstrating substantial equivalence to predicate devices and supporting the modification of the indications for use. This modification specifically aims to remove a limitation on the number of implants required for immediate loading in fully edentulous patients.
Therefore, the "reported device performance" relates to the clinical justification for this change, rather than numerical performance metrics.
| Acceptance Criteria (Implicit for Indications for Use Change) | Reported Device Performance (Summary) |
|---|---|
| Bench and Animal Testing Equivalence: The subject devices remain representative of performance as previously cleared. | The bench and animal performance testing previously submitted in support of the referenced Straumann predicate devices were conducted according to the FDA guidance document "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Abutments" and continues to be representative of the performance of the subject devices. (No new performance data needed here as the device itself hasn't changed). |
| Clinical Equivalence for Modified Indication: Justify that two immediately loaded dental implants are equivalent to a greater number of implants for treating fully edentulous patients. | A review and summarization of the clinical literature associated with the use of two immediately loaded dental implants in the treatment of fully edentulous patients was performed. The available data indicate that the use of two dental implants to treat fully edentulous patients is common; the evidence supports that performance of two immediately loaded dental implants is equivalent to the use of a greater number of implants for this indication. |
| Support from Professional Consensus: Align with recognized professional guidelines and consensus statements regarding the proposed change. | Consensus statements from the American Dental Association, the McGill Consensus, and the York Consensus were referenced, indicating that two-implant restoration of fully edentulous mandibles should be the treatment of choice. This literature strongly supports the elimination of the limitation requiring the use of at least four dental implants for the treatment of the fully edentulous patient when the implants are to be immediately loaded. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the traditional sense of a new clinical trial with a "test set" for a device. The study described is a clinical literature review. Therefore, the "sample size" is the cumulative patient data across the various clinical studies analyzed within the literature review. The exact number of patients or studies included in the review is not specified in this 510(k) summary.
- Data Provenance: The data provenance is from clinical literature, which typically includes studies conducted in various countries; specific countries are not mentioned. The studies would be retrospective and prospective in their original design, but the analysis presented here is a retrospective review of existing publications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: This aspect is not directly applicable to this type of submission. The "ground truth" for the modified indication is established through the body of scientific evidence in peer-reviewed clinical literature and professional consensus statements.
- Qualifications of Experts: The "experts" whose opinions form the basis of the mentioned consensus statements (American Dental Association, McGill Consensus, York Consensus) would be recognized leaders and specialists in dentistry and implantology. Their specific qualifications (e.g., years of experience as a radiologist) are not detailed in this summary.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There was no "test set" in the sense of a set of cases requiring independent expert review and adjudication for a device's performance. The clinical literature review relies on the outcomes and conclusions reported in peer-reviewed publications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is typically used to evaluate diagnostic imaging devices or AI algorithms where multiple human readers interpret cases with and without AI assistance. This 510(k) is about an implant system and its indications for use, not an interpretation aid.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
- No, a standalone study was not done. This device is a dental implant, not an AI algorithm. Therefore, "algorithm only" performance is not relevant.
7. The Type of Ground Truth Used
The "ground truth" for justifying the change in indications for use is based on:
- Clinical Literature Evidence: Published clinical studies and data demonstrating the efficacy and safety of two immediately loaded dental implants for fully edentulous patients.
- Expert Consensus Statements: Formal recommendations and conclusions from recognized professional bodies (American Dental Association, McGill Consensus, York Consensus) in the field of dental implantology.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This submission concerns a physical medical device (dental implants) and a change to its indications for use, not an AI algorithm that requires a training set. The "training" for the device's original clearance and subsequent sustained use comes from years of clinical practice and research.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set was Established: Not applicable, as there is no "training set" in the context of this device and submission type. For the original clearance of the implants, ground truth would have been established through pre-clinical testing (bench, animal) and clinical trials (human studies) demonstrating safety and effectiveness, based on recognized clinical outcomes and expert assessment.
§ 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.