{
  "id": "https://uofa.net/nagaraja/cou/cou1-noncannulated",
  "type": "ContextOfUse",
  "name": "COU1: Non-cannulated construct compression-bending prediction",
  "description": "FEA predicts construct stiffness, yield force, and force at 40 mm displacement for the non-cannulated 7.5 mm pedicle screw design under ASTM F1717 static compression-bending. Validated by direct comparison to bench testing (N=11 constructs across two laboratories). Model influence MEDIUM (testing confirms results); decision consequence MEDIUM (pedicle screw fracture leads to revision surgery, not death).",
  "intendedUse": "Demonstrate that the FEA modeling framework reproduces experimental compression-bending behavior of a non-cannulated pedicle screw construct within pre-established acceptance bounds (<10% QoI difference, E/uval < 1.96).",
  "deviceClass": "Class II",
  "modelInfluence": "Medium",
  "decisionConsequence": "Medium"
}