(57 days)
The XPand Radiolucent Corpectomy Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to turnor or trauma (i.e., fracture). The XPand Radiolucent Corpectomy Spacer is intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material.
The XPand Radiolucent Corpectomy Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
The XPand Radiolucent Corpectorny Spacer device is a vertebral body replacement device used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The system is comprised of spacers of various heights and footprints to fit the anatomical needs of a wide variety of patients. Each spacer has an axial hole to allow grafting material to be packed inside of the spacer. Protrusions on the superior and inferior surfaces of each device will grip the endplates of the adjacent vertebrae to resist expulsion.
The XPand devices are made from radiolucent polymer, titanium alloy, and tantalum as specified in F2026. F136, F136, F1295, and F560.
The XPand Radiolucent Corpectomy Spacer (K060665) underwent mechanical testing to demonstrate substantial equivalence to its predicate device, the XPand Corpectomy Spacer (K050850). The evaluation focused on mechanical performance in accordance with FDA guidance for spinal systems.
Here's an analysis of the provided information:
Acceptance Criteria and Device Performance
The document does not explicitly state numerical acceptance criteria in a table format, nor does it provide specific quantitative results of the device performance. Instead, it broadly states that:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical testing in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004. | Testing was performed in accordance with the specified guidance. |
| Substantial equivalence to predicate device (K050850) with respect to functional design, indications for use, principles of operation, and performance. | The device was found to be substantially equivalent. |
Missing Information: Specific numerical acceptance criteria (e.g., strength, fatigue life) and the actual numerical results from the mechanical testing are not provided in the supplied text. The document only confirms that testing was done in accordance with the guidance and that substantial equivalence was found.
Study Details
Based on the provided text, the characteristics of the study are as follows:
- Sample Size used for the test set and the data provenance: The document does not specify a "test set" in the context of clinical data for human or animal subjects. The evaluation focused on mechanical testing of the device itself. Therefore, the "sample size" likely refers to the number of devices or components tested, which is not detailed in the provided text. The data provenance is mechanical test data, not patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for this device's evaluation was established through mechanical engineering principles and testing standards outlined in the FDA guidance, not through expert clinical consensus on patient data.
- Adjudication method for the test set: Not applicable. There was no clinical test set requiring adjudication. The assessment was based on objective mechanical measurements and comparison to predicate device performance.
- 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 a medical device (spinal implant), not an AI/imaging diagnostic device. Therefore, no MRMC study, human readers, or AI assistance is relevant to its approval process as described.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.
- The type of ground truth used: Mechanical testing standards and performance benchmarks derived from the predicate device. The "truth" is whether the device met the established mechanical requirements for its intended use and was comparable to the predicate.
- The sample size for the training set: Not applicable, as this refers to a medical device's mechanical properties, not a machine learning model.
- How the ground truth for the training set was established: Not applicable for the same reason as above.
In summary, the provided text details a regulatory submission for a medical device focusing on its mechanical performance and substantial equivalence to a legally marketed predicate device, rather than a clinical study evaluating an AI algorithm or diagnostic tool.
§ 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.