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The XPAND Corpectomy Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The XPAND Corpectomy Spacer is intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material.

The XPAND Corpectomy Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

The XPAND CORPECTOMY SPACER is a vertebral body replacement device used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The system is comprised of spacers of various fixed heights and footprints to fit the anatomical needs of a wide variety of patients. Each spacer has an axial hole to allow grafting material to be packed inside of the spacer. Protrusions on the superior and inferior surfaces of each device will grip the endplates of the adjacent vertebrae to resist expulsion.

The XPAND Corpectomy Spacer devices are made from titanium alloy as specified in ASTM F1295 and F136.

This document describes the marketing authorization for a medical device called the "XPAND Corpectomy Spacer". It is not a study that proves a device meets acceptance criteria, but rather a submission for substantial equivalence to a predicate device. Therefore, many of the requested categories (e.g., sample size for test/training set, number of experts, adjudication methods) are not applicable or cannot be extracted from this type of regulatory document.

However, I can provide the relevant information that is present in the document.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable. This document is a 510(k) summary for regulatory clearance, not a clinical study report. Mechanical testing was performed, but specific sample sizes for these tests are not provided.
• Data Provenance: The document does not specify the country of origin for the mechanical testing data. The submission is for a US FDA clearance, so the testing would have been conducted to meet US regulatory guidance. The data is retrospective in the sense that it was generated prior to the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. This is not a study requiring expert-established ground truth for a test set.

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

• Not applicable. This device is a physical medical implant, not an AI or imaging 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.)

• For mechanical testing, the "ground truth" would be established by the physical and mechanical properties and performance standards defined in the "Guidance for Spinal System 510(k)s".
• For substantial equivalence, the "ground truth" is the established safety and effectiveness profile of the predicate device (Globus Sustain Spacer K031302).

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning study.

9. How the ground truth for the training set was established

• Not applicable.

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