(113 days)
The EBI® SpineLink™ - II Spinal Fixation System is a spinal fixation device for pedicle screw fixation, and a non-pedicle hook and sacral/iliac screw fixation system of the non-cervical spine, and an anterior fixation system.
When used as a pedicle screw fixation system, in the non-cervical spine of skeletally mature patients, the System is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocations; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system in skeletally mature patients, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5 - S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.
When used as a posterior hook and sacral/iliac screw fixation system, the levels of attachment are the lumbar and thoracic spine, and screw fixation is limited to the sacrum and ilium. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); pseudarthrosis; stenosis; scoliosis; spondylolisthesis; fracture; previous failed fusion; or tumor resection.
When used as an anterior fixation system, the levels of attachment are the anterolateral vertebral bodies of the lumbar and thoracic spine. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); pseudarthrosis; stenosis; scoliosis; spondylolisthesis; fracture; previous failed fusion; or tumor resection. The transverse connector is not intended for anterior fixation.
The EBI® SpineLink™ II Spinal Fixation System is a spinal fixation device that utilizes interconnecting links, screws (fixed and polydirectional designs), transverse connectors, hooks, endcaps, locknuts, and link ties.
This document is a 510(k) summary for a medical device called the EBI® SpineLink™ - II Spinal Fixation System. It is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices. The document does not describe an AI/ML powered device, and therefore the request for acceptance criteria and study details related to an AI/ML device is not applicable.
The document focuses on demonstrating that the EBI® SpineLink™ - II Spinal Fixation System is substantially equivalent to predicate devices in regards to intended use, materials, and function. The only mention of "study" is for mechanical testing, which is a standard engineering evaluation, not an AI/ML performance study.
Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/ML device from this document.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.