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The Patriot Spinal Fixation System, when used in the non-cervical posterior spine (TI to S1), is 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudoarthrosis, and failed previous fusion.
In addition, when used placed between L5 and S1, the Patriot Spinal Fixation System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) in skeletally mature patients receiving fusion with autologous bone graft.

The Patriot Spinal Fixation System is a posterior, non-cervical, spinal fixation system consisting of a variety of shapes and sizes of rods, screws, and crosslinks, to provide temporary internal fixation and stabilization during bone graft healing as an adjunct to fusion of the thoracic, lumbar and sacral spine.

I am sorry but this document does not contain the information you are looking for. This document is a 510(k) premarket notification for a medical device called the "Patriot Spinal Fixation System." It primarily focuses on demonstrating the device's substantial equivalence to previously marketed predicate devices based on its design, materials, manufacturing, indications for use, and mechanical testing results.

The document does not contain information about:

• Acceptance criteria and reported device performance in the context of an AI/algorithm-based medical device.
• Sample sizes used for test sets or data provenance for such studies.
• Number of experts or their qualifications for establishing ground truth for AI model testing.
• Adjudication methods for test sets.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes of human reader improvement with AI assistance.
• Standalone (algorithm only) performance studies.
• Types of ground truth used in AI model development (e.g., expert consensus, pathology, outcomes data).
• Sample sizes for training sets for AI models.
• How ground truth for training sets was established for AI models.

The "testing performed" mentioned in the document refers to mechanical integrity testing of the spinal fixation system components (static and dynamic compression, static torsion per ASTM F1717), not performance validation of an AI algorithm.

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