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When used as a vertebral body replacement, the X-spine Calix System is intended for use in the thoracic and/or thoracolumbar spine (TI-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e. partial or total vertebrectomy procedures) due to tumor or trauma (i.e. fracture). The Calix device, when used as a vertebral body replacement, can be packed with either allograft or autograft.

When.used as an intervertebral body fusion device, the X-spine Calix System is intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone. Patients should receive 6 weeks of non-operative treatment prior to treatment with the Calix intervertebral body fusion device.

For all indications, this device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical, thoracic or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

The Calix system is a generally box-shaped device with various holes located throughout its geometry and teeth on the superior and inferior surfaces. The device is made from polyetheretherketone (Invibio PEEK-Optima).

The provided text describes a medical device, the Calix Spinal Implant System, and its regulatory clearance as a 510(k) by the FDA. However, it does not contain any information regarding specific acceptance criteria, performance studies with sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device evaluation.

The "Performance Data" section merely states: "Mechanical testing indicates that the Calix system is capable of performing in accordance with its intended use." This is a general statement about the device's mechanical integrity as a physical implant, not a study of a device's diagnostic or predictive performance based on data.

Therefore, I cannot fulfill your request for the following information as it is not present in the provided document:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) 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

This document is from 2009 and pertains to a physical medical device (spinal implant), not a software or AI/ML device that would typically have the kind of performance data you are asking about.

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