(60 days)
The NuVasive Anterior Lumbar Plate System is indicated for use via the lateral or anterclateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (TI-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.
The NaVasive Anterior Lumbar Plate System consists of a variety of plates and screws. Implant components can be rigidly locked to suit the individual pathology and anatomical conditions of the patient.
This document is a 510(k) summary for a medical device (NuVasive Anterior Lumbar Plate System), and it does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML algorithm.
The document states:
- "Summary of Non-Clinical Tests: Mechanical testing was presented." This indicates that physical, engineering-based tests were performed on the device itself (the plate system), likely to assess its strength, durability, and other physical properties. This is typical for orthopedic implants.
- "Summary of Clinical Tests: (Not Applicable)." This explicitly states that no clinical trials were conducted for this submission. This is common for 510(k) submissions where substantial equivalence to a predicate device is demonstrated, meaning the new device is sufficiently similar to an already approved device that clinical trials are not deemed necessary.
Therefore, since the provided text relates to a physical medical implant and not an AI/ML device, the requested information about acceptance criteria, study design, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for an AI/ML algorithm is not present.
§ 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.