(368 days)
The StaXx® XDL 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 used with autograft or allograft and supplemental spinal fixation.
The StaXx® XDL System is composed of wafers that are stacked into an expandable implant to adjust the height of the implant. The implant components are manufactured from PEEK-OPTIMA with 6% Barium Sulfate and contain tantalum markers for additional visualization under fluoroscopy. The system also includes a delivery device to place and expand the system.
The StaXx® XDL System is a vertebral body replacement device. The provided text indicates that the device's acceptance was based on non-clinical performance testing demonstrating substantial equivalence to predicate devices, rather than a study with acceptance criteria in the typical sense of measured performance against a pre-defined threshold. The device is 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).
Here's a breakdown of the information based on the provided text, addressing the points where possible:
1. Table of acceptance criteria and the reported device performance:
The document does not explicitly state quantitative "acceptance criteria" for the StaXx® XDL System or report specific numerical performance outcomes against such criteria. Instead, it states that "Non-clinical testing was performed to demonstrate that the subject StaXx® XDL System is substantially equivalent to the listed predicate devices." The performance evaluation was qualitative in nature, aiming to show similarity to existing approved devices.
| Acceptance Criterion (Implicit) | Reported Device Performance (Achieved through testing) |
|---|---|
| Substantial equivalence to predicate devices for mechanical properties | Demonstrated equivalence through non-clinical testing to ASTM F2077 and ASTM F2267. |
| Performance in static axial compression | Testing performed. |
| Performance in dynamic axial compression | Testing performed. |
| Performance in static torsion | Testing performed. |
| Performance in dynamic torsion | Testing performed. |
| Performance in static subsidence | Testing performed. |
| Performance in static expulsion | Testing performed. |
| Performance in static shear testing | Testing performed. |
| Wear debris characteristics | Testing performed. |
2. Sample size used for the test set and the data provenance:
The document refers to "non-clinical testing" and does not specify a "test set" in the context of human or patient data. The testing involved mechanical evaluations of the device itself. Therefore, concepts like sample size, country of origin, or retrospective/prospective data are not applicable in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as there was no human "test set" or diagnostic ground truth established by experts. The evaluation was based on engineering and mechanical performance testing.
4. Adjudication method for the test set:
Not applicable, as there was no human "test set" requiring 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:
Not applicable. The device is a physical vertebral body replacement system, not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithmic or AI-based device. The "performance" refers to the mechanical integrity and function of the implant itself.
7. The type of ground truth used:
The "ground truth" in this context is the established performance characteristics and safety profiles of the predicate devices. The study aimed to demonstrate that the StaXx® XDL System's mechanical performance was comparable to these known and approved devices.
8. The sample size for the training set:
Not applicable. There was no "training set" as this is not an AI/machine learning model. The mechanical tests were performed on the device prototypes.
9. How the ground truth for the training set was established:
Not applicable. There was no "training set." The engineering standards (ASTM F2077 and ASTM F2267) and the performance of the predicate devices served as the benchmarks for evaluating the substantial equivalence.
§ 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.