(53 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 may contain tantalum markers for additional visualization under fluoroscopy.
The provided text is related to a 510(k) submission for a medical device called the StaXx® XD System, which is a vertebral body replacement device. The purpose of this specific submission (K111469) is stated as a modification to the labeling and "minor modifications have been made to the surgical gun used to deliver the StaXx® XD Expandable Device."
Crucially, the document explicitly states: "No testing is required for an update to the labeling." This means that the submission does not detail specific acceptance criteria or a study proving the device meets those criteria, as it's primarily a labeling update and minor modification to a delivery tool, not a new device or significant design change requiring extensive performance validation.
Therefore, many of the requested details about acceptance criteria and a study cannot be extracted directly from this document.
However, I can provide what is available or inferable from the document:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (for the modified labeling and minor surgical gun changes) | The device is "substantially equivalent" to the predicate devices (K052670, K090315, K101288, K102682) as determined by the FDA. |
| Safety and Effectiveness (implied from substantial equivalence) | No new issues of safety or effectiveness are presented by the modifications. |
| Same Intended Use and Indications for Use as Predicates | The Intended Use and Indications for Use are identical to the predicate StaXx® XD System. |
| Same Materials as Predicates | The device is manufactured from the same materials (PEEK-OPTIMA with 6% Barium Sulfate, optional tantalum markers) as the predicate. |
| Same Technological Characteristics as Predicates | The device maintains the same technological characteristics as the predicate. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. The document states "Non-clinical testing was performed to demonstrate that the subject StaXx® XD System is substantially equivalent to the listed predicate device. No testing is required for an update to the labeling." This indicates that specific performance testing for this submission, which would include a "test set," was not deemed necessary due to the nature of the changes (labeling and minor surgical gun modifications).
- Data Provenance: Not applicable for this specific submission as detailed test data is not provided. The previous 510(k) submissions for the predicate devices would contain such information.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. As noted above, specific performance testing with a "test set" and corresponding ground truth establishment was not performed for this submission.
4. Adjudication method for the test set:
- Not applicable.
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, 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 device is a surgical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for this submission. The "ground truth" for demonstrating substantial equivalence primarily relied on comparison to legally marketed predicate devices based on their established performance data and the lack of new safety or effectiveness issues with the minor changes.
8. The sample size for the training set:
- Not applicable. This submission does not involve machine learning or AI models that require training sets.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.