(302 days)
The TranS1™ Axial Fixation System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1 or 2), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The TranS1™ Axial Fixation System is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 3 and 4), tumor or trauma. Its usage is limited to anterior supplemental fixation of the lumbar spine at L5-S1 in conjunction with legally marketed pedicle screw systems.
The TranS1 Axial Fixation System is a multi-component system including titanium alloy implantable devices and instrumentation made of titanium alloy and stainless steel. The following components are included: 3D Axial Fixation Threaded Rod/Screw, Axial Fixation Screw Plug, Axial Fixation Screw Driver, Material Inserter, and Axial Fixation Screw Plug Driver.
The provided text is a 510(k) summary for the TranS1 Axial Fixation System, a medical device for spinal fixation. It does not contain information about acceptance criteria, device performance testing, or study details as outlined in your request (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies).
The primary purpose of this document is to demonstrate "substantial equivalence" to a predicate device, which is a regulatory pathway for lower-risk medical devices in the United States. This pathway typically focuses on functional equivalence, material equivalence, and similar intended use, rather than extensive clinical efficacy studies with specific performance metrics and acceptance criteria as you've requested.
Therefore, I cannot populate the table or answer the specific questions about device performance and study details based on the information provided. The document focuses on regulatory classification, device description, and a comparison to a predicate device for market clearance.
§ 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.