(292 days)
Zibone one-piece ceramic dental implants are indicated for implantation into the upper or lower jaw to replace missing teeth. They are indicated for (delayed or immediate) loading once primary stability has been achieved.
Zibone ® Ceramic (Zirconia) Dental Implants are threaded; root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices. The implants are manufactured from yttrium stabilized zirconium oxide bioceramics material conforming to ISO 13356-2008: Implants for surgery-ceramic materials based on yttria-stablized tetragonal ziconia (Y-TZP). The implant has a one-piece design (both implant and abutment), which simplifies the surgical procedures.
The implants are single use devices and are delivered in sterile condition have been sterilized with moisture heat. Zibone ceramic dental implants are also subjected to a sandblasting process that is used to impart the surface of the devices to enhance the osseointegration process.
Zibone dental implants are offered in three diameters (3.6mm, 4mm and 5mm) and 5 insertion lengths (8mm, 10mm, 11.5mm, 13mm and 14.5mm) for different teeth. The general rule is to select largest and longest implant size that the indication permits.
The provided text is a 510(k) summary for the Zibone Ceramic Dental Implant System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed device performance metrics in the way one might find for an AI/CADe device.
Therefore, many of the requested sections about acceptance criteria, study design, and performance metrics (especially those pertaining to AI/CADe systems like sensitivity, specificity, reader studies, etc.) are not applicable to this type of submission.
Here's a breakdown based on the information provided:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Bench Testing) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Fatigue Test to ISO 14801 | Reviewed and supports performance |
| Material Performance: | |
| Surface Analysis | Reviewed and supports performance |
| Biocompatibility Testing | Reviewed and supports performance |
| Sterilization & Shelf Life: | |
| Sterilization Validation | Reviewed and supports performance |
| Shelf Life Testing | Reviewed and supports performance |
| Absence of new questions of safety or effectiveness associated with identified differences compared to predicate device. | Bench testing demonstrates any differences do not raise any new questions of safety or effectiveness. |
Note: The document states "The following were reviewed to support the performance of Zibone Summary of 8. Ceramic Dental Implant System: Fatigue test to ISO 14801, Nonclinical Testing: Sterilization validation, Shelf life testing, Surface analysis & Biocompatibility testing." It does not provide specific numerical acceptance criteria or performance values for each of these tests, but concludes they support performance and substantial equivalence.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as no clinical studies with test sets are reported for this 510(k) submission. The testing conducted was bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as no clinical studies requiring ground truth by experts are reported.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as no clinical studies requiring adjudication are reported.
5. 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
This information is not applicable as no MRMC study or AI components are described. This device is a physical dental implant, not an AI/CADe system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable as no clinical studies requiring ground truth are reported. Performance was evaluated through non-clinical (bench) testing against established standards (e.g., ISO 14801) and material properties.
8. The sample size for the training set
This information is not applicable as no training set (for an algorithm) is mentioned or relevant to this physical device submission.
9. How the ground truth for the training set was established
This information is not applicable as no training set or ground truth in that context is mentioned or relevant.
§ 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.