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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 tumor, 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.

The PASS Spinal System consists of pedicle screws, rods, 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 component that is the subject of this Special 510(k) submission is the PASS Spinal System Sacral Plate. It has the same polyaxial mechanism as the polyaxial screws cleared in K001024. The difference is that the plate is attached by two additional screws rather than directly to the vertebrae.

The provided text describes a Special 510(k) submission for the PASS Spinal System Sacral Plate, not a study evaluating device performance against acceptance criteria using AI. The document is a regulatory approval letter based on "substantial equivalence" to a predicate device, not on performance data from a clinical or technical study.

Therefore, I cannot extract the requested information (acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set details) from this document as it does not contain such a study.

The relevant sections state:

• "(6) Performance data: The Food and Drug Administration have established no performance standards applicable to pedicle screw spinal systems."
• "(7) Basis for substantial equivalence: The PASS Spinal System Sacral Plate is similar in design, materials and indications to the PASS Spinal System (K001024)."

This indicates that the approval was granted based on the device's similarity to an existing legally marketed device, not on meeting specific performance criteria through a new study.

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