(30 days)
The Xia Spinal System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the Xia Spine 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, 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.
This submission is intended to address a line extension to the Xia Spinal System which includes modifications to the Monoaxial and Polyaxial Screws and the addition of a Washer, Offset Connector and Staple.
The provided text describes a 510(k) premarket notification for a line extension to the Xia Spinal System. It is a submission to demonstrate substantial equivalence to a predicate device, not a study evaluating device performance against acceptance criteria in the manner of an AI diagnostic device.
Therefore, the requested information elements (acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication, MRMC studies, standalone performance) for an AI device are not applicable to this document.
The document primarily focuses on:
- Device Identification and Description: Detailing the Xia Spinal System and its modifications (line extension with new screws, washer, offset connector, and staple).
- Intended Use: Specifying the conditions and patient populations for which the system is indicated.
- Technological Comparison: Stating that the modified device shares the same intended use and basic design concepts as the predicate device, and that "mechanical testing demonstrated comparable mechanical properties to the predicate components."
There is no detailed reporting of specific acceptance criteria or quantitative performance metrics from a clinical study or a study directly addressing the performance of a diagnostic algorithm. The "study" mentioned is "Mechanical testing," which demonstrated "comparable mechanical properties to the predicate components." This indicates an engineering-focused equivalence comparison rather than a human-in-the-loop or standalone diagnostic performance study.
In summary, the provided document does not contain the information required to populate the table or answer the questions related to acceptance criteria and device performance as typically expected for a diagnostic device or AI algorithm.
§ 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.