Search Results

The PASS Spinal System consists of pedicle screws, rods, nuts and crosslink members utilized 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal turnor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system, the PASS Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

When used as a posterior, non-cervical, non-pedicle screw fixation syste, the PASS Spinal System is intended for hook fixation from T1 to the illium/sacrum. The non-pedicle screw indications are spondification disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), deformities (scoliosis, kyphosis and lordosis), tumor, pseudoarthrosis, trauma (fracture or dislocation) and/or previous failed fusion surgery.

The PASS Spinal System consists of pedicle screws, rod-plates, nuts and crosslink members. It can be used for single or multiple level fixation. All components are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.

The additional components that are the subject of this Special 510(k) submission are 04.5mm polyaxial pedicle screws and crosslinks (Exhibit I). The pedicle screws are the same design as the polyaxial screws cleared in K001024. The crosslinks are nut, rod and clamp assemblies that hook onto the rods of the assembled PASS Spinal System (K001024) to provide torsional stability to the construct.

The provided text is a 510(k) summary for a spinal system, not a study report that details performance against acceptance criteria for a device. Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given input.

The document indicates that:

• No performance standards are applicable. "The Food and Drug Administration have established no performance standards applicable to pedicle screw spinal systems."
• Substantial equivalence is based on design, materials, and indications. "The PASS Spinal System 4.5 mm Screws and Crosslinks is similar in design, materials and indications to the PASS Spinal System (K001024)."

Based on this, the other requested information regarding sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, ground truth type, and training set details are not applicable as this 510(k) relies on substantial equivalence to a predicate device rather than a performance study demonstrating new acceptance criteria for the subject device.

Ask a specific question about this device