(64 days)
The FloSpine KeyLift™ Expandable Interlaminar Stabilization System is a posterior non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (TI-S1). It is intended for plate fixation/attachment to the spinous processes/lamina for the purpose of achieving supplemental fusion in the following conditions: Lumbar spinal stenosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The KeyLif("M Expandable Interlaminar Stabilization System is intended for use with allograft bone and is not intended for stand-alone use.
The KeyLift™ implant is an expandable, interlaminar stabilization device that is implanted posteriorly between the lamina and spinous processes of the thoracic and lumbar region. The implant features an expanding distal end which increases the height between the vertebral bodies. The superior and inferior wings are crimped to the spinous process, and a clamp is attached to the implant for final fixation. The components of the KeyLift™ system of implants and reusable instruments are manufactured from titanium alloy per ASTM F136 and stainless steel per ASTM F138 and A564. KeyLift™ implants are available in a range of sizes to accommodate surgeon and patient needs. Both the KeyLift implant and KeyLift Clamp are provided pre-assembled.
This 510(k) summary does not contain information about a study proving device performance against acceptance criteria. The submission is for a medical device (KeyLift™ Expandable Interlaminar Stabilization System), not a diagnostic algorithm or AI system that would typically undergo such a study.
The "PERFORMANCE DATA" section mentions:
- "Axial dynamic and static compression, static and dynamic offset torsion, static axial torsion, static and dynamic compression-bending, ring pushout, and axial pulloff testing demonstrated substantially equivalence mechanical performance."
- "Worst-case implants were identified using FEA and/or engineering analyses."
- "Surgeon-user cadaver evaluation demonstrated the KeyLift™ system of implants and instruments performs as described in the surgical technique and instructions for use."
These describe common mechanical and usability testing for orthopedic implants, aiming to show substantial equivalence to existing predicate devices, rather than meeting specific performance criteria related to diagnostic accuracy or AI model performance.
Therefore, I cannot provide the requested information regarding acceptance criteria, sample sizes, ground truth, or MRMC studies, as these types of studies are not relevant to the content of this 510(k) summary for a physical medical implant.
§ 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.