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The ISOBAR Semi-rigid Spinal System is a pedicle screw system intended 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, spinal tumor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system, the ISOBAR Semi-rigid 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 ISOBAR Semi-rigid 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 allov (Ti-6Al-4V) that conforms to ASTM F136.

This system consists of pedicle screws that require rod attachment directly over the top of the screw (U-Line Screws) and a combination of screws and clamps that allow the rod to be offset from the screw (Hemispherical Headed Screws).

The provided text is a 510(k) summary for the ISOBAR Semi-rigid Spinal System. It details the device's description, intended use, and states its substantial equivalence to a previously cleared device (ISOBAR Spinal System K990118).

However, the summary does not contain the information requested regarding specific acceptance criteria, a detailed study proving device performance against those criteria, sample sizes for test/training sets, data provenance, expert qualifications, or adjudication methods for ground truth establishment.

Instead, it explicitly states:
"The Food and Drug Administration have established no performance standards applicable to pedicle screw spinal systems. However, static and fatigue compression testing of the U-Line Screws was performed according to ASTM F1717-96."

This indicates that while some testing was conducted to a recognized standard (ASTM F1717-96), it was not against FDA-established performance standards or specific acceptance criteria provided within this document. The primary basis for clearance is substantial equivalence to an existing device, not a new comparative effectiveness study or standalone performance evaluation against predefined criteria as would be typical for an AI/CADe device.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the provided document does not contain this information in the level of detail requested for a typical AI/CADe device submission.

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