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The Z-LINK.pc System implants are intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1-C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. These implants are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Z-LINKPC System may be connected to the Zavation System using rod connectors and tapered rods.

The Z-LINKمc System is a temporary, titanium alloy (Ti-6AL-4V ELI per ASTM F136), multiple component system comprised of a variety of non-sterile, single use implantable components. The system consist of polyaxial screws, hooks, rods, cross-connectors, rod connectors, offsets and cap screws. The components are available in a variety of lengths and sizes in order to accommodate patient anatomy.

The provided text is a 510(k) summary for the Z-LINKpc System, a medical device for spinal fixation. It describes the device, its intended use, and states that performance data was collected. However, it does not contain specific acceptance criteria, detailed study results, or information about how ground truth was established, or the involvement of experts, or MRMC studies.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
6. If a standalone (algorithm only) performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document only states the following regarding performance data:

"Static axial compression bending and torsion, and dynamic axial compression bending test were performed according to ASTM F1717 on a worst-case construct. Axial and torsional grip test were performed according to ASTM F1798 on the connectors. The mechanical test results demonstrated the Z-LINKoc system performs as well as or better than the predicate devices."

This indicates that mechanical tests were performed to compare the device to predicate devices, but the specific numerical acceptance criteria, raw performance data, or details about the study design that would address your questions are not present in this document.

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