(126 days)
The StaXx® XD System is a vertebral body replacement device intended for use 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 or allograft 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 implant components are manufactured from PEEK-OPTIMA with 6% Barium Sulfate. The system also includes a delivery device to both implant and expand the system.
The purpose of this submission is to gain clearance for the addition of tantalum markers to the implants for added visualization under fluoroscopy.
The provided text describes a 510(k) submission for the Spine Wave StaXx® XD System, a vertebral body replacement device. The assessment of acceptance criteria and device performance is based on mechanical testing rather than a clinical study involving human patients or imaging analysis.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Testing: | |
| Dynamic axial compression per ASTM F 2077 | Results indicated that all acceptance criteria were met. |
| Dynamic torsion per ASTM F 2077 | Results indicated that all acceptance criteria were met. |
| Substantial Equivalence to Predicate Device | Demonstrated; minor differences do not raise new questions of safety or effectiveness. |
2. Sample size used for the test set and the data provenance
The study described is mechanical testing, not a test set involving human data. Therefore:
- Sample size: Not applicable in the context of human or imaging data. It would refer to the number of physical devices tested. The specific number of devices tested mechanically is not provided in the text; it only states "mechanical testing" was performed.
- Data provenance: Not applicable in the context of human or imaging data. It's mechanical test data from product testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for mechanical testing is established by engineering standards (ASTM F 2077) and the physical properties of the device, not by expert consensus on clinical data.
4. Adjudication method for the test set
Not applicable. This concept applies to the interpretation of clinical or imaging data, not mechanical testing against engineering standards.
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 surgical implant, and the submission is for the addition of tantalum markers for visualization under fluoroscopy, not an AI-powered diagnostic tool. The assessment is purely mechanical.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used
For the mechanical testing, the "ground truth" is defined by the acceptance criteria specified in ASTM F 2077 for dynamic axial compression and dynamic torsion, which are established engineering standards for spinal implant testing.
8. The sample size for the training set
Not applicable. There is no training set mentioned or implied as this is not a machine learning or AI-driven device.
9. How the ground truth for the training set was established
Not applicable. There is no training set involved. The evaluation of this device is based on compliance with established mechanical testing standards.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.