(207 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 510(k) summary for the StaXx® XD System does not describe a study involving an AI/Machine Learning device or any software that processes diagnostic images. Instead, it describes a medical implant (vertebral body replacement) and its mechanical performance evaluation.
Therefore, many of the requested points related to acceptance criteria, ground truth, expert review, sample sizes for training/test sets, and MRMC studies, which are standard for AI/ML device descriptions, are not applicable to this submission.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance/Conclusion |
|---|---|---|
| Mechanical Performance | Substantial equivalence in mechanical performance to predicate devices for additional sizes. | Finite Element Analysis (FEA) was performed to demonstrate that the subject StaXx® XD System is substantially equivalent to the listed predicate devices. The submission concludes "does not present any new issues of safety or effectiveness." |
| Material Composition | Use of specified materials (PEEK-OPTIMA with Barium Sulfate, tantalum markers). | Device is composed of wafers manufactured from PEEK-OPTIMA with 6% Barium Sulfate and contains tantalum markers for visualization. This is consistent with predicate materials. |
| Intended Use | Consistency with predicate device's intended use. | The intended use for the expanded StaXx® XD System is consistent with the predicate device: vertebral body replacement in the thoracolumbar spine (T1-L5) for tumor or trauma, to be placed bilaterally with autograft/allograft and supplemental fixation. |
| Design Characteristics | Wafers stacked into an expandable implant for height adjustment. | The system design (stacked wafers for expansion) is consistent with the predicate (K101288, K102682). |
2. Sample size used for the test set and the data provenance
Not applicable. This is a mechanical device, not an AI/ML diagnostic tool. Performance was demonstrated through Finite Element Analysis (FEA), a computational simulation method, rather than a clinical test set with data provenance in the context of AI/ML.
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 performance from FEA typically involves engineering standards and simulation validity, not expert medical consensus on a diagnostic outcome.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This concept applies to human expert review in diagnostic studies, not mechanical testing or FEA.
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 is not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the mechanical performance of this device would be based on established engineering principles, material properties, biomechanical standards, and validated simulation models used in Finite Element Analysis. This is not a biological or diagnostic ground truth.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set." Finite Element Analysis involves creating a model and performing simulations, not training on data.
9. How the ground truth for the training set was established
Not applicable. As above, there is no training set for this type of device submission.
§ 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.