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The TIGER™ Spine System 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 of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

When used as a pedicle screw system, the TIGER™ 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 TIGER™ Spine System is composed of rods, connectors, and pedicle screws. It can be used for single or multiple level fixations.

This document does NOT describe a study that uses AI/ML to detect or diagnose a condition and does not contain the requested information. The document describes a Special 510(k) submission for the Tiger™ Spine System, which is a medical device (pedicle screw system) used for spinal fixation.

Here's why the requested information cannot be provided from this document:

• Acceptance Criteria and Reported Device Performance (Table): The document reports non-clinical test results (static and dynamic compression, static torsion) and states that the results "indicate that the TIGER™ is equivalent to predicate device(s)." It does not provide specific numerical acceptance criteria or detailed performance metrics in the way one would for an AI/ML diagnostic device (e.g., sensitivity, specificity, AUC). The "performance" here relates to mechanical strength and equivalence.
• Sample Size for Test Set and Data Provenance: Not applicable as no clinical study or AI/ML model evaluation involving human data was performed.
• Number of Experts and Qualifications: Not applicable.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: The document explicitly states, "No clinical studies were performed." Therefore, no MRMC study was conducted.
• Standalone (Algorithm Only) Performance: Not applicable, as this is a physical medical device, not an algorithm.
• Type of Ground Truth Used: Not applicable. The "ground truth" for this device's evaluation was based on mechanical test standards (ASTM F1717) and demonstrating equivalence to predicate devices, not clinical outcomes or expert consensus on a diagnosis.
• Sample Size for Training Set & How Ground Truth for Training Set was Established: Not applicable, as no AI/ML model was developed or trained.

In summary, this document is a regulatory submission for a physical medical device, not a diagnostic algorithm. The "study" referenced is non-clinical mechanical testing to demonstrate substantial equivalence to existing devices.

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