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The Vertebral Spacer Ti 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 Vertebral Spacer Ti System is intended to be used with Synthes supplemental internal fixation systems, e.g., ATLP, VentroFix, USS and Small Stature USS. The interior of the spacer component of the Vertebral Spacer Ti can be packed with bone.
The Vertebral Spacer Ti is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

The Vertebral Spacer Ti is a titanium vertebral body replacement device used in conjunction with supplemental internal fixation to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy and consists of: vertebral body replacement devices comprised of a variety of fixed heights and cross-sections. supplemental fixation currently cleared for use in treating patients for tumor, trauma or fractures of the vertebral body and manual surgical instrumentation used to prepare the anatomy and implant the Vertebral Spacer Ti. There are no unique surgical instruments required for implantation of the submitted device system.

This document describes the Synthes Vertebral Spacer Ti, a titanium vertebral body replacement device. The submission is a 510(k) premarket notification, which relies on demonstrating substantial equivalence to a legally marketed predicate device. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context are interpreted as demonstrating this substantial equivalence through comparison and testing against a recognized standard or predicate.

Here's the breakdown of the information based on your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission and not a new AI device or diagnostic, the "acceptance criteria" are based on demonstrating mechanical soundness and substantial equivalence to an already cleared predicate device. The performance is assessed against recognized standards for spinal implants.

2. Sample Size Used for the Test Set and the Data Provenance

This is not applicable to this 510(k) premarket notification for a mechanical spinal implant. There is no "test set" in the context of diagnostic accuracy for AI or clinical images. The "testing" primarily involved mechanical bench testing of the device's physical properties. The data provenance would be laboratory testing rather than patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This is not applicable. "Ground truth" in the context of expert consensus on patient data or pathology is not relevant for the regulatory clearance of a mechanical spinal implant through a 510(k) pathway. The "ground truth" for material and mechanical performance relies on established scientific and engineering standards.

4. Adjudication Method for the Test Set

This is not applicable as there is no "test set" in the diagnostic or clinical sense requiring expert adjudication.

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

This is not applicable. This device is a mechanical implant, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. This device is a mechanical implant, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For this mechanical spinal implant, the "ground truth" for its performance relies on:

• Material specifications: Conformance to industry standards like ASTM F67 and F1295.
• Mechanical engineering principles: Adherence to established biomechanical testing protocols outlined in FDA guidance documents (e.g., "Guidance for Spinal System 510(k)s").
• Predicate device performance: The previously cleared Synthes Vertebral Spacer Ti (K020152) serves as the benchmark for established safety and effectiveness.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is a physical medical device, not an AI model.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reasons as #8.

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