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The BAR Pedicle Screw Spinal Fixation System is intended for posterior non cervical pedicle screw fixation in the lumbo-sacral spine 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 the lumbar or sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

In addition the BAR Pedicle Screw Spinal Fixation System, used as a pedicle screw fixation system is intended for:

a. Patients receiving only autogenous bone graft. b. Patients having the device fixed or attached to the lumbar and sacral spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.

The BAR Pedicle Screw Fixation System consists of pedicle screws, rods, and connectors. It can be used for single level fixation. All components are manufactured from titanium (ASTM F-67), titanium alloy (ASTM F-136), Cobalt Chromium Molybdenum alloy (ASTM F-1547.

The system consists of pedicle screw anchors which are inserted into the pedicle, a connector that has a ball and socket feature that connects to the pedicle screws. The ball and socket feature which allows for adjustment during implantation. The motion allowed by the ball and socket serves to offload the pedicle screws and distribute the stress across the vertebral body. The connector also contains a clamping mechanism which clamps the rigid rod into place.

The provided text describes the "BAR Pedicle Screw Spinal Fixation System" and its 510(k) summary. However, it does not include information about a study proving the device meets acceptance criteria via clinical performance data, nor does it detail acceptance criteria themselves in a quantifiable manner for such a study.

The document primarily focuses on the device description, its intended use, a summary of non-clinical (mechanical) tests, and the basis for substantial equivalence to predicate devices for regulatory clearance. It does not mention any clinical study, reader study, or AI-based performance evaluation.

Therefore, I cannot fulfill your request for the specific details outlined (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study, standalone performance, ground truth types, training set details) because this information is not present in the provided text.

The only "study" mentioned is "Testing was performed per ASTM F1717 and the results are comparable to the predicate devices." This refers to non-clinical mechanical testing, not a study involving human readers or clinical data for performance assessment as implied by your questions.

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