(93 days)
The NuVasive® Mesh is a vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The NuVasive® Mesh is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.
The NuVasive Mesh is an implantable titanium vertebral body replacement device indicated for use in the thoracic and lumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
A plurality of rhombic pattern holes are built in the wall, transverse to the longitudinal axis. The hollow core allows for packing of bone grafting materials to help promote a solid fusion. A ring of small spikes or teeth on each end of the device serves to grip the endplates of the adjacent vertebrae to resist expulsion.
The device is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.
The provided text is a 510(k) summary for the NuVasive Mesh, a vertebral body replacement device. It details the device's description, intended use, and comparison to predicate devices, focusing on demonstrating substantial equivalence based on design, materials, and mechanical testing. The document explicitly states that clinical tests were not applicable and focuses solely on non-clinical mechanical tests to establish equivalence, meaning there is no data presented regarding diagnostic performance metrics (e.g., sensitivity, specificity, AUC) or human reader studies.
Therefore, many of the requested categories related to diagnostic performance and human studies cannot be answered from the provided text.
Here's a breakdown of the information that can be extracted:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly list specific acceptance criteria as numerical thresholds for diagnostic performance metrics (e.g., sensitivity, specificity, precision). Instead, the acceptance criteria are implicitly stated through the demonstration of substantial equivalence to a predicate device based on mechanical testing and design control activities.
| Acceptance Criteria Category | Specific Criteria (Implicitly based on substantial equivalence) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Device meets performance standards comparable to predicate device for vertebral body replacement. | Mechanical testing was presented, demonstrating that acceptance criteria were met and design output satisfied design input. (Specific results not detailed in summary). |
| Material Composition | Identical or substantially equivalent material to predicate device. | "Engineering drawings, labeling, and mechanical testing have demonstrated that the subject device is substantially equivalent, if not identical, to its predicate devices in terms of design, materials of composition..." |
| Design Characteristics | Identical or substantially equivalent design to predicate device. | "Engineering drawings, labeling, and mechanical testing have demonstrated that the subject device is substantially equivalent, if not identical, to its predicate devices in terms of design..." |
| Indications for Use | Aligned with predicate device. | "Indications for Use: The NuVasive® Mesh is a vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture..." (Matches predicate device's indications). |
| Safety and Effectiveness | No new safety or effectiveness issues raised compared to predicate device. | "Due to this equivalency, the device raises no new safety or effectiveness issues." |
2. Sample size used for the test set and the data provenance
Not applicable. This device is a mechanical implant, and the assessment was based on non-clinical mechanical testing and a comparison to its predicate device, not on a test set of patient data for diagnostic performance.
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 diagnostic performance is not relevant for a mechanical device's substantial equivalence determination.
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 is not an AI-based diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-based diagnostic device. The "standalone" performance here would refer to the mechanical performance of the implant itself during testing.
7. The type of ground truth used
For the non-clinical mechanical testing, the "ground truth" would be established by engineering standards and specifications for material properties, structural integrity, and functional performance (e.g., load-bearing capacity, resistance to expulsion). These are determined against pre-defined engineering requirements and industry standards for vertebral body replacement devices.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" in the context of mechanical device testing for substantial equivalence, as there is no machine learning or AI algorithm being developed.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI algorithm.
§ 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.