(212 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 bone graft and supplemental spinal fixation. The supplemental fixation system that is intended to be used with the StaXxTM XD System is the Stryker Xia® Spinal System.
The StaXxTM XD System is a vertebral body replacement device composed of wafers that are stacked into an expandable implant to adjust its height. The implant components are manufactured from PEEK-OPTIMA with 6% Barium Sulfate. The system also includes a delivery device to implant and expand the system. The device is offered in sizes ranging from 7mm to 30mm.
This document is a 510(k) summary for the StaXx™ XD System, a vertebral body replacement device. It primarily focuses on demonstrating substantial equivalence to predicate devices through mechanical testing and a comparison of intended use, rather than a clinical study with detailed acceptance criteria and performance metrics typically associated with AI/software devices. Therefore, much of the requested information regarding acceptance criteria, study details, and expert involvement is not applicable or cannot be extracted from this document.
However, I can provide the available information:
1. A table of acceptance criteria and the reported device performance
Based on the document, the primary "acceptance criterion" presented implicitly is the device's ability to meet "performance requirements for its intended use" through mechanical testing, demonstrating its substantial equivalence to predicate devices. Specific quantitative acceptance criteria or performance metrics (e.g., sensitivity, specificity, accuracy) are not detailed in this 510(k) summary, as it's for a hardware medical device rather than an AI/software device.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Meets performance requirements for intended use. | "Mechanical testing demonstrated that the StaXx™ XD System meets the performance requirements for its intended use" and that "the StaXx™ XD System and the predicate devices do not affect the safety or effectiveness of this device." (Page 2) |
| Substantial equivalence to predicate devices based on design and intended use. | The StaXx™ XD System was demonstrated to be substantially equivalent to the VERTE-STACKTM Spinal System, the Blackstone™ PEEK VBR System, the PEEK Tetris™ System, the Sustain Radiolucent Spacer, and The Wafer System. (Page 1) |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical "test set" in the context of diagnostic performance or AI model evaluation. The "testing" mentioned is mechanical testing. Therefore, sample size and data provenance in this context are not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically defined for AI/software devices (e.g., expert consensus on clinical diagnoses) is not relevant to this 510(k) summary for a hardware implant.
4. Adjudication method for the test set
Not applicable. There is no clinical test set described that would require an adjudication method.
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 document describes a medical device (spinal implant), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document is not about an algorithm or software. It describes a physical spinal implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical testing mentioned, the "ground truth" would implicitly be relevant engineering standards and biomechanical properties required for spinal implants. This is not explicitly detailed in the document beyond stating that the device "meets the performance requirements."
8. The sample size for the training set
Not applicable. There is no AI model or "training set" described in this document.
9. How the ground truth for the training set was established
Not applicable. There is no AI model or "training set" described in this document.
§ 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.