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When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the CapSure™ PS System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The CapSure™ PS System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S1), and for whom the device is intended to be removed after solid fusion is attained.

The CapSure™ PS System consists of a selection of non-sterile, single use titanium alloy rod and screw components that are assembled to create a rigid spinal construct. The rod and screw components of the CapSure™ PS System are attached to the non-cervical spine in order to stabilize the spine during fusion of the vertebral bodies, and are intended to be removed after spinal fusion is achieved.

The provided document is a 510(k) summary for the CapSure™ PS System, a pedicle screw spinal system. It compares the device to legally marketed predicate devices to demonstrate substantial equivalence, but it does not contain information about acceptance criteria, device performance, or any studies involving human readers, training sets, or ground truth establishment based on clinical data or expert consensus for AI/ML devices.

The study mentioned is a mechanical test according to ASTM F1717, which assesses the mechanical properties of the device. This is a bench-top study, not a clinical study involving patients or human readers.

Therefore, I cannot provide the requested information from the given document as it pertains to AI/ML device studies.

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