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The Pantheon Pedicle Screw System is intended to provide immobilization of the spine in skeletally mature patients as an adjunct to fusion for procedures of the thoracic, lumbar, and sacral spine (T1-S1). This system is intended for anterior/anteral non-pedicle fixation, posterior non-pedicle fixation, and posterior pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis), tumor, pseudoarthrosis, and failed previous fusion.

The Pantheon Iliac Bolt Fixation System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The Pantheon Pedicle Screw Fixation System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, hooks, and cross links that are used for attachment to the non-cervical spine (the thoracic spine through the sacrum and in the ilium). Implant components are available in a variety of sizes so that constructs may be assembled to suit the individual pathology and anatomy of the patient. Rods span the distance between screws and achieve fixation by the mechanical joining of the rods with screws.

The Pantheon Iliac Bolt Fixation System has threaded screw implants with dual helix threads designed to be able to screw into pre-drilled bone in the sacrum. Implant components are available in a variety of sizes so that constructs may be assembled to suit the individual pathology and anatomy of the patient. Optional lag rings are also available.

Screws, rods, cross links, and other implant components are made from titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or ISO 5832-3. Additionally, some rods may be manufactured from cobalt-chrome alloy (Co-Cr) conforming to ASTM F1537 or ISO 5832-12.

The provided text is a 510(k) summary for the Pantheon Pedicle Screw and Iliac Bolt Fixation System, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices based on mechanical performance testing, rather than an AI/ML device that requires performance metrics against specific acceptance criteria.

Therefore, the information requested in your prompt regarding acceptance criteria, study details (sample size, data provenance, expert adjudication, MRMC studies, standalone performance), ground truth, and training set information is not applicable to this document.

The document explicitly states: "No clinical testing is being submitted with the 510(k)." and "Mechanical performance testing of the Pantheon Pedicle Screw and Iliac Bolt System was evaluated based on the Guidance for Industry and FDA Staff, Spinal System 510(k)s. The Pedicle Screw System was evaluated per ASTM F1717 and ASTM F1798. The Iliac Bolt Fixation System was evaluated per ASTM F2193 and ASTM F543."

This indicates that the acceptance criteria are based on meeting the requirements of specific ASTM standards for mechanical performance, and the "study" is the mechanical testing itself, not a clinical or AI-centric performance study.

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