(58 days)
The RESONATE™ Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (as defined by neck pain of discogency origin with deseneration 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 RESONATE™ Anterior Cervical Plate System consists of cervical plates offered in various sizes to accommodate a variety of spinal levels based on surgical need and anatomic requirements. The plate attaches to the anterior portion of the vertebral body of the cervical spine. The plates can be used with fixed angle or variable angle screws. RESONATE™ implants are manufactured from titanium alloy and Nitinol.
The provided text is a 510(k) premarket notification letter and summary for the Globus Medical Inc. RESONATE™ Anterior Cervical Plate System. This document focuses on the mechanical testing and material compatibility of the spinal implant device to demonstrate its substantial equivalence to previously cleared predicate devices.
It does NOT contain information about a study proving that a device meets acceptance criteria for an AI/ML-driven medical device, specifically in terms of diagnostic or clinical performance based on image analysis or similar data.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for an AI/ML device.
The document discusses:
- Device Name: RESONATE™ Anterior Cervical Plate System
- Intended Use: Anterior screw fixation to the cervical spine (C2-T1) for various indications (degenerative disc disease, trauma, tumors, etc.).
- Technological Characteristics: Similar to predicate devices (design, intended use, material composition, function, size range).
- Performance Data: "Mechanical testing (static and dynamic compression bending, and static torsion) was conducted in accordance with ASTM F1717 and, the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004. Performance data demonstrate substantial equivalence to the predicate device. Corrosion testing was also conducted on the RESONATE™ plates in accordance with ASTM F2129."
This is clearly about the physical and mechanical properties of a spinal implant, not a diagnostic or AI-based device. No data related to AI/ML or image processing performance is presented.
§ 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.