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The Invictus Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (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 and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Invictus Spinal Fixation System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Invictus Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis / spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatric pedicle screw fixation is limited to a posterior approach.

The Invictus Spinal Fixation System is intended to be used with autograft and/or allograft.

The Invictus Spinal Fixation System is a thoracolumbosacral pedicle screw system designed to be implanted through a posterior surgical approach. The implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136, commercially pure titanium (CP Ti Grade 2) per ASTM F67 and cobalt chromium (Co-28Cr-6Mo) alloy per ASTM F1537. The Invictus System consists of a variety of shapes and sizes of screws, hooks, rods, connectors, and cross-connectors to create a rigid construct as an adjunct to fusion for temporary internal fixation and stabilization of the thoracic, lumbar and sacral spine.

The purpose of this submission is to add new components to the Invictus Spinal Fixation System.

The provided text describes the 510(k) premarket notification for the Invictus™ Spinal Fixation System. This document is a regulatory submission for a medical device that does not involve Artificial Intelligence (AI). It focuses on demonstrating substantial equivalence to existing predicate devices based on mechanical and material properties, rather than an AI algorithm's performance.

Therefore, the information required to answer your request (acceptance criteria, study details for AI performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, etc.) is not present in this document. The document explicitly states:

"Clinical Information: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."

This clarifies that no clinical performance study (which would be the context for AI model evaluation) was conducted for this submission. The "acceptance criteria" discussed are related to the mechanical performance of the spinal fixation system (e.g., ASTM F1717 Dynamic Compression Bending, ASTM F1798 Static Flexion-Extension Moment), not the output of an AI algorithm.

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