(293 days)
The Zeramex® T Dental Implant System is intended to be surgically placed in the bone of the upper and lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore aesthetics and chewing function.
The Zeramex® T Dental Implant System can be used for single or multiple unit restorations.
Zeramex® T implants are intended for delayed loading.
The Zeramex® T dental implants are specially indicated for patients with metal allergies and chronic illnesses due to metal allergies.
The Zeramex® T (Ø 3.5 mm) implant may only be used in the anterior teeth in the lower jaw and lateral teeth in the upper jaw.
The Zeramex® T System is an endosseous dental implant/abutment system. The Zeramex® T implants are placed using the Zeramex® T surgical tools. The implants are provided in three diameters (Ø 3.5 mm, 4.2 mm, and 5.5 mm) and three lengths (8 mm, 10 mm, and 12 mm). The Ø 4.2 mm implant is also offered in a 14 mm length. Dentalpoint AG offers several compatible abutments and other accessories including straight and angular (15°) abutments in small, regular/wide, and wide sizes, healing caps, and gingiva formers. The abutments are bonded to the implants using dental cements which have been tested and validated for use with the Zeramex system: Panavia (K032455) and 3M ESPE RelyX (K111185).
Class I, 510(k) exempt accessories are provided in the Zeramex® T tray and include drill bits, screwdrivers, countertorque devices, placement and removal tools, laboratory pieces used for fabrication or dental prosthetics, and trial abutments. The surgical tools are intended to be reprocessed (cleaned, disinfected, and sterilized) after each procedure.
Here's an analysis of the acceptance criteria and study information for the Zeramex® T Dental Implant System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria for the clinical study endpoints. However, it does report the device performance for key safety and effectiveness measures. The "acceptance criteria" listed below are inferred as the performance observed in the study.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Minimum 2-year cumulative survival rate for implants | 87% |
| Maximum soft-tissue complication rate | 0% |
| Maximum technical complication rate | 4% |
| Maximum complication rate for bone loss greater than 2 mm | 0% |
| Maximum aesthetic complication rate | 0% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Study): 49 implants
- Data Provenance:
- Country of Origin: Not explicitly stated, but the manufacturer is Dentalpoint AG, located in Zurich, Switzerland. The clinical study was a "single-center" study.
- Retrospective or Prospective: Prospective
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide details on the number of experts or their qualifications for establishing ground truth in the clinical study. The "ground truth" for the clinical study would likely be the direct clinical observation and measurements by the treating clinicians and study staff.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used for the test set (clinical study). Outcomes were presumably assessed by the clinical site directly.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The clinical study described is a single-arm study evaluating the device's performance, not comparing it against human readers or other devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The Zeramex® T Dental Implant System is a physical medical device (dental implant), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
For the clinical study, the ground truth was based on:
- Outcomes data: Specifically, implant survival rates, and reported complication rates (soft-tissue, technical, bone loss, aesthetic). These are direct measures from the patients and their clinical follow-ups.
8. The Sample Size for the Training Set
This question is not applicable. The Zeramex® T Dental Implant System is a physical medical device, not an AI/ML algorithm that requires a training set. The "training" for such a device involves engineering design, material science, and manufacturing processes, supported by pre-clinical testing, rather than data-driven machine learning.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no "training set" in the context of an AI/ML algorithm. The development of the device involves pre-clinical testing:
- Fatigue testing in accordance with ISO 14801
- Surface chemical analysis
- Validation of cleaning, disinfection, and sterilization processes
- Packaging and transport validation
The "ground truth" for these pre-clinical tests would be the established scientific standards, protocols, and measurable outcomes (e.g., meeting specific force thresholds in fatigue testing, chemical composition analysis results, sterility assurance levels).
§ 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.