(62 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. 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 the Surgical Gun, a delivery device to place and expand the system.
The provided document is a 510(k) summary for the StaXx® XD System, which is a vertebral body replacement device. This summary describes the device and its intended use, but it does not contain information related to software or AI performance, nor does it present "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the context of device performance metrics often associated with AI/software-based medical devices (e.g., sensitivity, specificity, accuracy).
Instead, the "Performance Data" section (Section 8) indicates that the device's substantial equivalence to a predicate device was demonstrated through:
- Dynamic axial compression testing according to ASTM F2077.
This type of testing is a standard mechanical engineering test for spinal implants to assess their structural integrity and performance under simulated physiological loads. Therefore, the "acceptance criteria" and "device performance" would relate to the results of these physical tests, compared against the predicate device or established standards.
Given the nature of the document, the following requested information cannot be fully provided, as it pertains to AI/software performance studies which are not relevant to this submission:
- A table of acceptance criteria and the reported device performance: This would be specific to the mechanical testing (e.g., yield strength, stiffness, fatigue life). The document states "Dynamic axial compression testing according to ASTM F2077 was performed to demonstrate that the modified StaXx® XD System is substantially equivalent to the predicate StaXx® XD System." The specific numerical acceptance criteria and reported device performance values from this testing are not included in the provided summary.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a physical device subject to mechanical testing, not a dataset for software evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for a mechanical device is its physical properties and measured performance against engineering standards.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided submission is for a physical medical device (vertebral body replacement) and focuses on demonstrating substantial equivalence to a predicate device through mechanical testing, not through AI/software performance evaluation.
§ 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.