(27 days)
The Xia Spinal System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the Xia Spinal System is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at 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; and (d) who are having the device removed after the development of a solid fusion mass.
When used as a pedicle screw fixation system, the Xia Spinal System is also intended to provide immobilization and stabilization of spinal segments in skeletally mature patients 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, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the Xia Spinal System is indicated for patients with degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts.
The 6 mm diameter rods from the DIAPASONTM Spinal System and OPUS™ Spinal System are intended to be used with the other components of Xia " Titanium Spinal System. The Titanium Multi-Axis Cross-Connectors are intended to be used with the other components of Xia® Titanium Spinal System.
The Xia Titanium Spinal System consists of Monoaxial and Polyaxial Screws, Washer, Hooks, Blocker, Rods, Connectors, Multi-Axial Cross Connectors (MACs), and Staple. The components are manufactured from Titanium material (Ti alloy and CP Titanium). The purpose of this submission is to include cannulated polyaxial screws to the Xia Titanium Spinal System.
The provided document is a 510(k) premarket notification for a medical device (Xia® Spinal System with cannulated polyaxial screws), not a study report for an AI/ML powered device. Due to this, the document does not contain the information required to answer the prompt. The request asks for details like "acceptance criteria and the study that proves the device meets the acceptance criteria" for an AI/ML device, which involves specific sections such as performance metrics, sample sizes for test and training sets, ground truth establishment, expert qualifications, and comparative effectiveness studies. None of this information is present in the provided special 510(k) summary, as it pertains to a traditional orthopedic implant modification. Hence, I cannot extract the requested information from the given text.
§ 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.