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Z5-TL implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. Z5-TL implants are suitable for patients with metal allergies and the chronic diseases resulting from them. Z5-TL implants are intended for delayed loading.

Z5-TL is a dental implant system that includes root-form, endosseous threaded dental implants indicated for tissue level placement. The dental implants are provided in two endosseous body diameters (4 mm and 5 mm) and each diameter is provided in three endosseous lengths (8 mm, 10 mm, and 12 mm). The corresponding platform diameters are: 4.8 mm platform diameter for 4 mm body diameter, and 6 mm platform diameter for 5 mm body diameter. The dental implants are manufactured from Y-TZP zirconia conforming to ISO 13356. The system also includes gingiva formers and a temporary abutment manufactured from polyetheretherketone (PEEK). Zirconia abutments for single-unit and multi-unit cemented restorations are provided in straight and 15° angled designs. For retention of overdentures, zirconia Locator-type abutments are provided in straight and 15° angled designs.

The subject device is compatible with the following components cleared in K190243: a healing cap manufactured from PEEK; Locator-type abutments manufactured from zirconia; and occlusal (abutment) screws manufactured from zirconia and from Ti-6Al-4V alloy conforming to ASTM F136.

The subject device implants are provided sterilized by plasma gas. All other subject device components are to be sterilized by the end user by moist heat (steam).

The provided text describes a 510(k) premarket notification for a dental implant system (Z5-TL) and does not contain information about the acceptance criteria and study design you've requested for typical AI/ML device evaluations. This document focuses on demonstrating substantial equivalence to already-marketed predicate devices, primarily through non-clinical data.

Therefore, I cannot populate the table or provide answers to most of your questions as the information is not present in the provided text.

Here is what can be extracted based on the document:

1. A table of acceptance criteria and the reported device performance
No specific acceptance criteria or tabulated performance data for an AI/ML device are provided in this document. The performance data discussed relates to the mechanical properties and sterilization of the dental implant itself.

2. Sample size used for the test set and the data provenance
Not applicable. This is not an AI/ML device relying on a test set of data. The "performance data" section refers to non-clinical testing of the dental implant's physical properties.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.

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
No MRMC study was mentioned or performed, as this is not an AI/ML diagnostic or assistive device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For the non-clinical tests, the "ground truth" would be established by validated test methods and physical measurements according to specified ISO and ASTM standards.

8. The sample size for the training set
Not applicable.

9. How the ground truth for the training set was established
Not applicable.

Summary of relevant performance data (non-clinical, from the document):

The performance data submitted was non-clinical and aimed to demonstrate substantial equivalence of the Z5-TL dental implant device.

• Sterilization Validation: According to ISO 14937 and ISO 17665-1 (referenced from predicate K132881).
• Sterile Product Shelf Life Testing: According to ISO 11607-1, ISO 11607-2, ASTM F1886/F1886M, and ASTM D3078 (referenced from predicate K132881).
• Biocompatibility of PEEK material: According to ISO 10993-3, ISO 10993-12, ISO 10993-10, ISO 19003-11, ISO 10993-18, and USP Class VI testing according to USP 37-NF32 (referenced from predicate K190243).
• Static compression and compression fatigue testing: Of the zirconia implants and abutments according to ISO 14801.
• Assessment of abutment screw loosening and removal torque testing: According to ISO 18130, after insertion and dynamic testing (ISO 14801), including microscopic examination, and comparison to reference devices K063286 and K072642.
• Assessment of wear particles: Associated with the Ti-6A1-V alloy abutment screw used with zirconia implant bodies and abutments after dynamic testing (ISO 14801), including light microscopy and SEM/EDX, and comparison to all-titanium constructs of reference devices K063286 and K072642 (leveraged from K190243).

Conclusion on Performance: The document states that the non-clinical data demonstrated that the device has "sufficient strength for their intended use" and supports substantial equivalence to the predicate devices. No clinical data was included in the submission.

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