(55 days)
The SEA-LINK Anterior Cervical Plate System is intended for temporary stabilization of the anterior cervical spine (C2-C7) during the development of cervical spinal fusion achieved through ACDF (Anterior Cervical Discectomy & Fusion) or corpectomy in patients with: • Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- ·Trauma (including fractures)
- •Tumors
- ·Deformity defined as kyphosis, lordosis or scoliosis
•Pseudarthrosis - •Failed Previous Fusions
- •Spondylolisthesis
- •Spinal Stenosis
The SEA-LINK Anterior Cervical Plate System is a single use implantable device to assist in the stabilization of the cervical spine during cervical spinal fusion. The device consists of plates and bone screws and is designed to prevent the bone screws from backing out after implantation.
The SEA-LINK Anterior Cervical Plate is designed to fit the lordosis of the cervical spine and to fit the curved medio - lateral anatomy of the spine. The SEA-LINK Anterior Cervical Plate System accommodates from single Level up to five-Level. The plate lengths range from 19mm to 114mm (end to end length) with a width and thickness of 17mm and 2.1mm respectively.
The screws offered are of self-drilling and self-tapping variations. The screws offered are variable angle and fixed angle thus providing four (4) types of screws. The screw diameters are 4mm and 4.5mm. The screw lengths range from 10mm to 20mm. A locking mechanism consisting of a cam fixed atop the plate is used to prevent screw back out.
The device is made from Medical Grade Titanium Alloy (Ti6A14V, ASTM F136).
This document is a 510(k) Premarket Notification from the FDA for the SEA-LINK Anterior Cervical Plate System. It describes a medical device, its intended use, and its equivalence to legally marketed predicate devices, primarily through mechanical testing. It does not contain information about a study involving AI or human reader performance for an imaging-based medical device.
Therefore, I cannot extract the information required to answer your questionnaire about such a study. The provided text discusses:
- Device Type: An implantable medical device for spine stabilization (anterior cervical plate system).
- Assessment Method: Primarily mechanical/performance testing (static compression bending, static torsion, dynamic compression bending) per ASTM standards to demonstrate substantial equivalence to predicate devices.
- No mention of:
- Image analysis or AI.
- Human readers or their performance with or without AI assistance.
- Ground truth establishment based on expert consensus, pathology, or outcomes data in the context of an imaging study.
- Training or test sets for an AI model.
The prompt specifically asks for details related to acceptance criteria and a study proving a device meets these criteria, with explicit mention of AI, human readers, and ground truth for a test set. This document does not provide any of that information.
§ 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.