3D volume conductor model for electric currents and structural mechanics using Comsol Multiphysics
Ensure that functionality of the RetractiSens is not affected by the bending of the retractor blade and by the application of electrodes and pressure sensors to the retractor surface
Electrocorticography (ECoG) Simulation
Ensure that application of a function generator simulating ECoG signals will result in accurate and precise RetractiSens recordings
Ensure proper biocompatibility of the RetractiSens with brain tissue (ISO 10993-1)
To validate the function of the electrodes and pressure sensors through precision and accuracy verification standard tests
Randomized control trials
Ensure that risk of use and retraction-induced brain damage is statistically significantly reduced when using RetractiSens compared to currently used brain retractors
Ensure that length of surgery when using RetractiSens is not statistically significantly increased compared to currently used brain retractors