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Z-Look3 Dental Implants are suitable for all indications of endosseous implants in the upper and lower jaw, for the functional and aesthetic oral rehabilitation of edentulous and partially edentulous patients. The Z-Look3 Dental Implants with modifiable abutments are restored with fixed / cemented crowns and bridges. A special indication of the Z-Look3 Dental Implant System is for patients with metal allergies and chronic illnesses due to metal allergies.

Contraindications for the Z-Look3 Dental Implant Ø 3.25 mm:

• Restoration of posterior teeth in the upper or lower jaw
• Single-tooth restoration of canines and central incisors in the upper jaw

The Z-Look3 Dental Implant is a one-piece, self tapping, threaded, root form endosseous dental implant. Z-Look3 Dental Implants are offered in three diameters (3.25 mm, 4.0 mm, 5.0 mm) and four lengths (10 mm, 11.5 mm, 13.0 mm, 14.0 mm).

The provided text is a 510(k) summary for the Z-Look3 Dental Implant System. It describes the device, its intended use, and its equivalence to marketed devices. However, it does not contain information about acceptance criteria, specific studies proving the device meets those criteria, or details regarding performance evaluation studies such as sample sizes, ground truth establishment, or expert involvement.

The document states that the Z-Look3 Dental Implant System is "substantially equivalent in indications and design principles to predicate devices," implying that its performance is implicitly accepted based on the established safety and effectiveness of its predicates.

Therefore, I cannot provide the requested information. The text does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for a test set, data provenance, or details about training sets.
3. Number or qualifications of experts used to establish ground truth.
4. Adjudication methods.
5. Information about multi-reader multi-case (MRMC) comparative effectiveness studies or the effect size of AI assistance.
6. Results from standalone (algorithm only) performance studies.
7. The type of ground truth used.
8. Sample size for the training set.
9. How the ground truth for the training set was established.

The document primarily focuses on administrative information, device description, materials, and a declaration of substantial equivalence to predicate devices for regulatory clearance.

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