(319 days)
The SATURN Dental Implant System is intended for surgical placement in the maxillary and/or the mandibular arch, to support crowns, bridges, or over dentures, in edentulous or partially edentulous patients. It is intended to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.
The System is intended to be used in either single tooth or multiple teeth restoration for immediate loading after extraction when good primary stability is achieved and with appropriate occlusal loading.
The procedure can be accomplished in a one-stage or two-stage surgical operation.
The SATURN Dental Implant employs a new strategy that of extended sub-crestal threads, expanded out in a wing-like effect to engage socket walls mid-crestally. The implants material composition is: TI 6AL 4V - ELI
The system consists of a variety of bone screw implants in three diameters ø 3.8, 4.2, 5.0 mm diameter. Each respective diameter is available in various lengths from 8 mm to 16mm. The bone screw (implant) is connected to the abutment via an internal connecting screw while the alignment of the abutment is determined.
SATURN Dental Implants are tapered internal hex implants, designed to enable easy insertion, while supporting initial stability. The variable thread (coil) design enables self-tapping, thus providing solution for a variety of bone conditions.The internal hexagon helps to minimize rotation. SATURN Dental Implant System offers a solution for immediate placement and immediate loading.
The SATURN Dental Implant System is cleared for marketing in Europe. The device was implanted in thousands of patients in Israel and Europe.
Materials:
The components are manufactured from titanium alloy (Ti 6Al 4V ELI) per ASTM F136.
Function:
The SATURN Dental Implant System is intended for surgical placement in the maxillary and/or the mandibular arch, to support crowns, bridges, or over dentures, in edentulous or partially edentulous patients. It is intended to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.
The System is intended to be used in either single tooth or multiple teeth restoration for immediate loading after extraction when good primary stability is achieved and with appropriate occlusal loading.
The procedure can be accomplished in a one-stage or two-stage surgical operation.
The medical device in question is the SATURN Dental Implant System by Cortex Dental Implants Industries Ltd.
Here's an analysis of the acceptance criteria and the supporting study information provided:
1. Acceptance Criteria and Reported Device Performance
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than defining specific acceptance criteria for novel performance claims. Therefore, the "acceptance criteria" here are implied by the performance of the predicate devices and the outcome of the non-clinical and clinical tests demonstrating this equivalence.
| Aspect | Acceptance Criteria (Implied by Predicate Equivalence & Regulatory Standards) | Reported Device Performance (SATURN Dental Implant System) |
|---|---|---|
| Material Composition | Biocompatible, suitable for dental implant use (e.g., Titanium alloy). | Manufactured from titanium alloy (Ti 6Al 4V ELI) per ASTM F136. This is consistent with predicate devices (Nobel Active: Titanium; Straumann Bone Level Implant: Titanium alloy). |
| Implant Diameters | Comparable range to legally marketed predicate devices. | Available in ø 3.8, 4.2, 5.0 mm. This range is comparable to Nobel Active (3.5-4.3 mm) and Straumann (4.1-4.8 mm). |
| Implant Lengths | Comparable range to legally marketed predicate devices. | Available in 8 mm to 16 mm. This range encompasses and extends beyond Nobel Active (10-15 mm) and Straumann (8-14 mm). |
| Implant Form | Root form. | Root form. Consistent with predicate devices. |
| Insertion Mechanism | Self-tapping capability. | Variable thread (coil) design enables self-tapping, providing solutions for various bone conditions. Consistent with predicate devices. |
| Mechanical Safety/Fatigue | Must meet ISO 14801:2007 Dentistry-Implants- Dynamic fatigue test for Endosseous Dental implants, and FDA guidelines for "worst-case scenario" (e.g., longest implant with highest angled abutment). | Passed Static and dynamic compression performance test per ISO 14801:2007. The worst-case scenario (16mm implant with 30° angled abutment) was tested. The results "indicate that the SATURN Dental Implant System is equivalent to the predicate devices cited in this submission." (Specific numerical results are not provided in this summary). |
| Clinical Performance | Support for crowns, bridges, or overdentures; restoration of chewing function; ability for immediate loading with good primary stability; minimal bone loss. | "Long-term results of several patients implanted with the SATURN Dental Implant System were presented and support the biomechanical theory concerning the loading on the implant. The implant wing reduces the pressure on the implant neck resulting in less absorption in the neck. The cases presented in this report show no bone loss in the neck of the implanted SATURN." |
| Intended Use | Must be substantially equivalent to predicate devices. | Intent to support crowns, bridges, or overdentures in edentulous or partially edentulous patients, restore chewing function, for single or multiple teeth restoration, and immediate loading when primary stability is achieved. This is affirmed to be substantially equivalent to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Non-Clinical Test (Fatigue): Not explicitly stated as a number of devices. The test was conducted on the "longest implant (16mm) in combination with the highest angled abutment (30°)." It implies testing of a sufficient number of samples of this specific configuration to meet ISO 14801 standards, but the exact count isn't given.
- Sample Size for Clinical Test (Case Reports): "Long-term results of several patients implanted with the SATURN Dental Implant System were presented." The exact number of patients is not provided.
- Data Provenance: The document states, "The device was implanted in thousands of patients in Israel and Europe." This implies the clinical experience referenced is retrospective from real-world usage in Israel and Europe.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Non-Clinical Test: Ground truth is established by adherence to the ISO 14801:2007 standard and FDA guidelines for fatigue testing. No human experts are described as establishing ground truth in this context; rather, the standard dictates the methodology and acceptance criteria.
- Clinical Test (Case Reports): The summary refers to "Case Reports" and mentions the "biomechanical theory." While undoubtedly clinical experts (dentists/oral surgeons) were involved in collecting and reporting these cases, the document does not specify the number or qualifications of experts involved in establishing a formalized "ground truth" for the purpose of a study. The presentation of results seems to be based on the observed clinical outcomes in these patients.
4. Adjudication Method for the Test Set
- Non-Clinical Test: No adjudication method described; results are determined by whether the tested implants meet the criteria of ISO 14801.
- Clinical Test (Case Reports): No formal adjudication method is mentioned for the clinical case reports. The cases were "presented," suggesting a review of clinical outcomes, but not a blinded consensus or similar adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The submission relies on non-clinical testing and clinical case reports to demonstrate substantial equivalence, not a direct comparison of human readers with and without AI assistance. This device is an implant, not an AI-powered diagnostic tool.
6. Standalone Performance Study (Algorithm Only)
Not applicable. The SATURN Dental Implant System is a physical dental implant, not an algorithm or AI system. Therefore, no standalone (algorithm only) performance study was conducted.
7. Type of Ground Truth Used
- Non-Clinical Test: The ground truth for mechanical performance is defined by the ISO 14801:2007 standard for dynamic fatigue testing.
- Clinical Test (Case Reports): The ground truth for clinical performance is effectively the observed clinical outcomes in the reported patient cases, specifically "no bone loss in the neck of the implanted SATURN." This is a form of outcomes data and expert observation, but not a formally established "ground truth" in the way it might be for a diagnostic device.
8. Sample Size for the Training Set
Not applicable. This device is a physical dental implant, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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.