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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.

Device Description

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.

AI/ML Overview

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.

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