(319 days)
maxFiT II Dental Implant System is for single-stage or two-stage surgical procedures and cemented or screw retained restorations. maxFiT II Dental 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. Multiple tooth applications may be splinted with a bar.
The maxFiT II Dental Implant System includes implant, screw and abutment. The maxFiT II Dental Implant System is designed for single-stage or two-stage surgical procedures and cemented or screw retained restorations. The maxFiT II Dental Implant System consists of solid threaded, self-tapping dental implants in Ø3.5."604."70."5.6mm diameters with 8."32."34."14mm lengths. The implant of maxFiT II Dental Implant System is made from CP titanium Grade 4 which complies with ISO 5832-2 and ASTM F67. The implant surface treatment is SLA (Sand-blasted, Large grit, Acid -etched) technology which involves sandblasting with large grit and acid etching techniques, creates micron and macrosubmicron pores morphology. The abutments are made of Ti6A14V Eli, which complies with ISO 5832-3 and ASTM F136.
The maxFiT II Dental Implant System does not involve an AI algorithm, therefore, the following information is not available:
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- Multi-reader multi-case (MRMC) comparative effectiveness study information
- Standalone algorithm only without human-in-the-loop performance
- Sample size for the training set
- How the ground truth for the training set was established
1. Table of Acceptance Criteria and Reported Device Performance for the maxFiT II Dental Implant System
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Corrosion Test (SLA-surface treated CP4 dental implant and Ti-6Al-4V abutment) | Compliant with ASTM F746, ASTM F2129, and "Guidance for Industry and Staff - Class II Special Controls Guidance Document: Endosseous Dental Implants and Root-form Endosseous Dental Implant Abutments" | The results prove the maxFiT II Dental Implant System is corrosion resistant. |
| Fatigue Test | Compliant with ISO 14801 and "Guidance for Industry and Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments" | All test results demonstrate that maxFiT II Dental Implant System meets the requirements of its pre-defined acceptance criteria. |
| Sterilization Test | Not explicitly stated but implied to meet relevant standards for sterile medical devices. | Performed; results implicitly met requirements for substantial equivalence. |
| Shelf Life Test | Not explicitly stated but implied to meet relevant standards for medical devices. | Performed; results implicitly met requirements for substantial equivalence. |
| Biocompatibility Tests (In vitro Cytotoxicity, Intracutaneous Reactivity, Skin Sensitization, Acute Systemic Toxicity, Pyrogenicity, In vitro Bacterial Reverse Mutation (AMES), In vitro Chromosome Aberration, In vitro Mammalian Cell Gene Mutation, 14-Day Repeated Exposure Systemic Toxicity, 90-Day Bone Implantation Study) | Not explicitly stated but implied to meet relevant standards for biocompatibility. | Performed; results implicitly met requirements for substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This device is a physical dental implant system and the testing involves bench testing (physical and chemical properties), not a retrospective or prospective study with a test set of data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth for the performance of a physical dental implant (e.g., corrosion resistance, fatigue strength) is established through standardized engineering and material science tests, not expert consensus on medical images or clinical data.
4. Adjudication Method for the Test Set
Not applicable. Physical performance tests do not involve an adjudication method in the human evaluation context. The results are quantitative and determined by the test protocols.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done as this is a physical medical device, not an AI algorithm for diagnostic or screening purposes involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the regulatory submission describes "Non-clinical Testing" which constitutes standalone performance evaluations of the device itself (e.g., sterilization, biocompatibility, corrosion, fatigue). These are "algorithm only" in the sense that they assess the device's inherent physical and material properties without human intervention in the performance measurement.
7. The Type of Ground Truth Used
The ground truth for the device's performance is established through internationally recognized standards and test protocols, such as ASTM F746, ASTM F2129, ISO 14801, ISO 5832-2, ASTM F67, ISO 5832-3, and ASTM F136, as well as FDA guidance documents for specific device types. These standards define the expected physical, chemical, and biological properties and behaviors (e.g., corrosion resistance, fatigue life, material composition via spectroscopy, biocompatibility assays).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device requiring a training set or associated ground truth.
§ 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.