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The StaXx® XD System is a vertebral body replacement device in the thoracolumbar spine (T1-L5) to replace and restore height of a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (i.e., fracture). The system is to be placed bilaterally and used with autograft and supplemental spinal fixation. The supplemental fixation system that is intended to be used with the StaXx® XD System is the CapSure® PS Spine System.

The StaXx® XD System is composed of wafers that are stacked into an expandable implant to adjust the height of the implants are to be used with autograft or allograft and supplemental spinal fixation. The implants are manufactured from PEEK-OPTIMA with 6% Barium Sulfate, tantalum markers (ASTM F560), and a plasma-sprayed commercially pure titanium coating (ASTM F1580). The implants are available in a variety of shapes and sizes, to accommodate variations in anatomy. The system also includes a delivery device to both implant and expand the implant.

The provided text describes a medical device, the StaXx® XD System, and its 510(k) submission to the FDA. The submission's purpose is to gain clearance for adding a commercially pure titanium coating to the device. However, the document does not contain information about acceptance criteria, study methodologies (like sample size for test sets or training sets, data provenance, expert qualifications, or adjudication methods), or any comparative effectiveness studies involving human readers or standalone algorithm performance. The document focuses on regulatory approval based on substantial equivalence to predicate devices, supported by non-clinical performance testing of the device's materials and mechanical properties.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test set, data provenance, number of experts for ground truth, adjudication method.
3. Multi-reader multi-case (MRMC) comparative effectiveness study details.
4. Standalone (algorithm only) performance details.
5. Type of ground truth used.
6. Sample size for the training set.
7. How ground truth for the training set was established.

This information is typically found in clinical study reports or detailed engineering reports, which are not part of this FDA 510(k) summary document. The non-clinical performance testing mentioned relates to the physical and mechanical properties of the device and its titanium coating, not its diagnostic or clinical efficacy in the context of AI or imaging.

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