Search Results

The VERTA Corpectomy Cage is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-LS) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The device is intended for use with bone graft and with supplemental fixation systems (such as anterior plating systems, or posterior screw systems) cleared for use in the spine.

The VERTA Corpectomy Cage device is a vertebral body replacement device used to provide structural stability in skeletally mature individuals following Corpectomy or vertebrectomy. The VERTA System is comprised of implants of various heights, to fit the needs of individual patient anatomy. Geometrically, the implants are designed as a load bearing frame with a hollow center which are applied to the spine to provide long-term structural support throughout fusion and to help enhance the fusion rate. Serrations on the superior and inferior surfaces of the device are designed to grip the endplates of the adjacent vertebrae to resist expulsion. The VERTA System implants are made from PEEK radiolucent material with embedded tantalum x-ray markers as specified in ASTM F2026 and ASTM F560, respectively.

This document describes the VERTA Corpectomy Cage, a vertebral body replacement device, and its acceptance criteria as demonstrated by nonclinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the ASTM standards used for testing, indicating the device must meet or exceed the performance requirements specified in these standards for spinal implants. The document states that "The results of these studies showed that the VERTA Cage met the acceptance criteria."

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

The document does not explicitly state the sample sizes used for each nonclinical test (Static Compression, Dynamic Compression, Static Torsion, Dynamic Torsion, Subsidence, Expulsion). The data provenance is from nonclinical, laboratory testing performed specifically for the device's clearance. There is no mention of country of origin of data as it pertains to clinical studies; these are physical tests. All testing appears to be prospective in the sense that it was conducted specifically to support this 510(k) submission.

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

This section is not applicable as there was no clinical study involving human patients or expert interpretation of clinical data for the primary performance evaluation. The "ground truth" for the nonclinical tests is established by the ASTM and ISO standards themselves, against which the device's physical performance is measured.

4. Adjudication Method for the Test Set

This section is not applicable as there were no clinical or image interpretation studies requiring expert adjudication. The tests conducted were physical mechanical and material property tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical tests were performed."

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

This question is not applicable as the device is a physical medical implant (corpectomy cage), not an algorithm or AI software. Therefore, there is no "standalone" algorithm performance to evaluate.

7. The Type of Ground Truth Used

For the nonclinical tests, the "ground truth" is established by adherence to recognized national and international standards for spinal implant testing (ASTM F2077, ASTM F2267, ISO 17665). The device's performance against these standards constitutes the "ground truth" for its mechanical and sterilization efficacy.

8. The Sample Size for the Training Set

This section is not applicable as the device is a physical medical implant. There is no "training set" in the context of an algorithm or AI.

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

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

Ask a specific question about this device