(46 days)
The EMERGE™ Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (DDD) (defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors (primary and metastatic), deformity (kyphosis, lordosis), failed previous fusions (pseudarthrosis), spondylolisthesis, and spinal stenosis. The EMERGE™ Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
The EMERGE™ Anterior Cervical Plate System consists of cervical plates offered in various sizes to accommodate surgical needs 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 screws. The system is comprised of a Titanium Alloy (Ti-6Al-4V ELI) plates and bone screws. The subject 510(k) adds additional 3-screw plates to the system.
This document describes the FDA's 510(k) clearance for the EMERGE™ Anterior Cervical Plate System. It details the device's indications for use, its substantial equivalence to predicate devices, and the performance testing conducted.
However, the provided text does not contain information related to an AI/ML-driven medical device. It describes a traditional implanted medical device (a spinal plate system). Therefore, it is not possible to answer the specific questions about acceptance criteria, study design, ground truth, expert adjudication, or MRMC studies for an AI/ML device, as these concepts are not applicable to the information given in the document.
The document focuses on:
- Device Type: Anterior Cervical Plate System (a mechanical implant).
- Purpose: Spinal fixation.
- Regulatory Pathway: 510(k) clearance, establishing substantial equivalence to existing predicate devices.
- Performance Data: Mechanical testing (static compression, static torsion, dynamic compression) according to ASTM F1717, demonstrating compliance with performance criteria for Spinal Plating Systems.
In summary, this document does not provide the information needed to answer your questions about the acceptance criteria and study proving an AI/ML device meets those criteria.
§ 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.