(51 days)
The Insignia™ Anterior Cervical Plate System is intended for anterior screw fixation to the C2-T1) for the following indications: degenerative disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), turnors, deformity (kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.
The Insignia Anterior Cervical Plate System is intended for anterior fixation to the cervical spine. The Insignia Anterior Cervical Plate System consists of a variety of sizes of plates and screws that are manufactured from titanium alloy conforming to ASTM F136 and are offered non-sterile. The instruments in this system are intended for use in surgical procedures. This submission seeks clearance for redesigned Insignia plates and screws.
This is a 510(k) premarket notification for a medical device (Insignia™ Anterior Cervical Plate System), not an AI/ML medical device. Therefore, the information typically requested regarding acceptance criteria and performance studies for an AI/ML device (e.g., sample sizes for test and training sets, expert ground truth establishment, MRMC studies, standalone performance) is not applicable or present in this document.
The provided document describes a spinal implant and its mechanical testing to demonstrate substantial equivalence to a predicate device. It explicitly states under "Clinical Information": "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."
Therefore, I cannot provide the requested information for an AI/ML device based on this document. The document focuses on:
- Device Description: Spinal plates and screws made from titanium alloy.
- Intended Use: Anterior screw fixation to the cervical spine (C2-T1) for various spinal conditions.
- Technological Comparison: Demonstrating substantial equivalence to predicate devices in intended use, indications, design, function, and technology.
- Performance Data (Nonclinical): Mechanical testing (static compression, static torsion, dynamic compression, screw push-out) according to ASTM F1717 and FDA guidance for spinal plating systems.
No information about AI/ML algorithms, image analysis, diagnostic performance, or human-in-the-loop studies is 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.