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The Choice Spine Vertebral Body Replacement (VBR) System is 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 VBR device is intended for use with supplemental fixation & is to be used with autograft and/or allograft bone graft material.

The Choice Spine Vertebral Body Replacement (VBR) System devices have a basic oval shape with a hollow center for placement of bone graft. The superior & inferior surfaces have ridges, or 'teeth' for resisting migration. The devices are available in an assortment of heights & multiple angles of lordosis to accommodate different anatomic requirements.

This 510(k) summary describes a medical device called the "Choice Spine Vertebral Body Replacement (VBR) System," not an AI/ML powered medical device. Therefore, many of the requested categories for AI/ML performance studies are not applicable.

However, I can extract information related to the device's mechanical acceptance criteria and the study types performed to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: This is a mechanical device, not an algorithm. The "sample size" refers to the number of devices or test specimens subjected to mechanical testing. The exact number of test specimens is not specified in the 510(k) summary but would be reported in the full test reports referenced by the ASTM standards.
• Data Provenance: The mechanical testing was performed in the context of demonstrating substantial equivalence for a medical device (spinal implant). The data provenance is from laboratory mechanical testing, not clinical data or human subjects.

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

• Not applicable. This is a mechanical device, and "ground truth" in the context of expert consensus or clinical outcomes is not relevant here. The "ground truth" for mechanical testing is established by engineering standards (e.g., ASTM F2267-04, ASTM F2077-03) and the quantitative measurements against those standards.

4. Adjudication method for the test set

• Not applicable. This is a mechanical device.

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 is a mechanical device, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used

• The "ground truth" for this device's performance relies on validated engineering standards and quantitative measurements of mechanical properties (e.g., load-bearing capacity, resistance to subsidence, resistance to expulsion, fatigue life). The acceptance criteria are typically defined as meeting or exceeding the performance of legally marketed predicate devices, as assessed by these standardized tests.

8. The sample size for the training set

• Not applicable. This is a mechanical device, not an AI algorithm requiring a training set.

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

• Not applicable. This is a mechanical device, not an AI algorithm.

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