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The Invictus™ CT Spinal Fixation System is intended to provide immobilization of spinal segments as an adjunct into fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7), and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g.,pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Invictus CT Spinal Fixation System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advance stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Invictus CT Spinal Fixation System may be connected to the components in the Arsenal® Spinal Fixation System or the Invictus™ System offered by Alphatec Spine using various rod-to-rod connectors and/or transitional rods.

The Invictus™ CT Spinal Fixation System is a posterior approach system designed to stabilize the cervico-thoracic spine. The Invictus CT system is intended to be compatible with Arsenal® Spinal Fixation System or the Invictus™ Spinal Fixation System offered by Alphatec Spine using various rod-to-rod connectors and/or transitional rods.

The Invictus CT implants are manufactured from titanium allov (Ti-6Al-4V ELI) per ASTM F136, and cobalt chromium (Co-28Cr-6Mo) alloy per ASTM F1537. The Invictus CT System consists of a variety of shapes and sizes of screws. rods, cross connectors, rodto-rod connectors and general surgical instruments that provide internal fixation and stabilization during bone graft healing and/or fusion mass development.

The Invictus CT implants are provided non-sterile to be steam sterilized by the end user. The instruments are made of stainless steel and other materials, and are provided nonsterile to be cleaned and sterilized by the end user.

The provided text is a 510(k) premarket notification summary from the FDA for the Invictus™ CT Spinal Fixation System. This document does not contain information about a study proving that the device meets specific acceptance criteria based on its performance as an AI/ML algorithm.

The "Performance Data" section explicitly states:

• "Nonclinical testing performed on the Invictus CT system supports substantial equivalence to the predicate devices. The following testing was performed:

  • Static and dynamic compression per ASTM F1717
  • Static torsion per ASTM F1717
  • Static axial pull-off testing per ASTM F1798

  The results demonstrate that the proposed Invictus CT system is substantially equivalent to the predicate devices for nonclinical testing."

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

This indicates that the submission focuses on mechanical and material performance testing to establish substantial equivalence to existing spinal fixation systems, rather than demonstrating performance as a diagnostic or analytical AI/ML-based device.

Therefore, I cannot extract the requested information about acceptance criteria for an AI/ML device, the study proving it meets these criteria, sample sizes, ground truth establishment, or expert involvement, as this information is not present in the provided text. The device described is a physical spinal fixation system, not an AI/ML algorithm.

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