(390 days)
Microdent Genius Implant System is indicated for surgical placement in the upper or lower jaw arches, for single-stage or two-stage surgical procedures and cemented, screw retained restorations or overdentures. Microdent Genius Implant System is intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.
Small diameter implants are indicated only for replacement of central and lateral incisors in the maxillar and mandible.
Microdent Genius Implant System is comprised of dental implants and prosthetic components. Microdent Genius dental implants are internal connection endosseous implants machined titanium that can be used with deferred load or immediate load techniques. If sufficient bone depth is available the implant can be inserted sub-crestal. Microdent Genius Implant is recommended to place 2mm sub-crestal position.
The implant has a connection formed by six grooves extending radially around the axis of the implant to provide a precise position of the abutment.
Microdent Genius Implants are provided with blasted surface.
The implants are supplied sterile and the abutments are provided non-sterile.
Implants are also offered in various diameters and length.
Contained various Microdent Genius abutments made of Ti-6AL 4-V-ELI alloy.
The abutments Conical, Angled and Mini Capitel are used for cemented and screw-retained restorations.
A Cover screw protects the inner configuration of the implant and supplied sterile with the implant.
Healing abutment to shape the soft tissue during the healing phase.
The Retention Screws are used for securing the abutments to the implant.
Overdenture retention consists of a titanium alloy socket that attached to a threaded post for use with titanium endosseous implants having an internal threaded socket. Both devices have a plastic component that has a shape on one and that mate into the titanium socket, while the other end with metal cap is attached to the denture.
All abutments include appropriate features and dimensions to mate with Microdent Genius implants.
The provided document is a 510(k) Premarket Notification for the Microdent Genius Implant System, dating back to 2015. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness de novo. Therefore, the information provided is primarily a comparison to predicate devices and describes non-clinical testing for compliance with standards, rather than a study designed to meet specific acceptance criteria for performance as would be seen for complex diagnostic or AI devices.
Based on the provided text, here's a breakdown of the requested information:
Acceptance Criteria and Device Performance
Since this is a 510(k) submission for a dental implant system (a medical device, not an AI/diagnostic device), the "acceptance criteria" are compliance with established ISO standards and demonstration of substantial equivalence to a predicate device. The "device performance" is therefore shown through successful completion of these non-clinical tests and the comparison of characteristics.
| Acceptance Criteria (Compliance with Standards/Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Material: Commercially pure titanium (ISO 5832-2) | Comercially pure titanium (grade 4 as ISO 5832-2) |
| Biocompatibility: ISO 10993-1, -5, USP , | Passed biocompatibility testing, ESEM/EDS analyses, Bacterial Endotoxins Test, Pyrogen Test |
| Sterilization: ISO 11137-1, -2, -3; ANSI/AAMI ST79 | Sterile (Gamma irradiation) and validation completed |
| Packaging: ISO 11607-1, -2; ASTM F1980-07 | Package integrity testing and validation completed |
| Dynamic Fatigue Test: ISO 14801 | Passed dynamic fatigue testing |
| Risk Management: ISO 14971 | Designed and manufactured in accordance with ISO 14971 |
| Intended Use Equivalence | Substantially equivalent to predicate devices' intended use (with specific minor differences noted, e.g., small diameter implant use, immediate loading restrictions) |
| Design/Dimensions Equivalence | Similar in fundamental scientific technology; slight differences in design and dimensions compared to predicate. |
Additional Requested Information:
-
Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test. The document refers to "bench testing" and "analyses" without providing specific numbers of implants or abutments tested for each non-clinical performance test.
- Data Provenance: The testing was "bench testing," meaning it was conducted in a laboratory setting on manufactured devices, not using patient data. The manufacturer (Implant Microdent Systems) is located in Spain.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to this type of submission. "Ground truth" in the context of expert consensus is typically relevant for diagnostic devices (especially AI/imaging devices) where human experts determine the true condition of a patient based on clinical data. For this dental implant system, the "truth" is determined by compliance with engineering and material standards and performance under simulated conditions.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically employed in studies where human readers are interpreting data, and disagreements need to be resolved. This document details non-clinical laboratory testing.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a dental implant system, not a diagnostic or AI device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant to this submission.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a dental implant system, not an algorithm or AI device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is established by engineering standards and material specifications (e.g., ISO standards). Tests were performed according to these standards (e.g., ISO 14801 for fatigue testing, ISO 10993 for biocompatibility), and the device's adherence to these predefined criteria serves as the "truth." There is no clinical "truth" from patients or expert consensus in this non-clinical submission.
-
The sample size for the training set:
- This information is not applicable. There is no "training set" in the context of a dental implant system's 510(k) submission. This concept is relevant for AI/machine learning models.
-
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.