Bullsai Confirm

Bullsai Confirm is software that assists medical professionals in planning deep brain stimulation (DBS) programming for patients with approved Abbott DBS devices. It visualizes the Volume of Tissue Activated (VTA) relative to patient anatomy by importing MRI and CT images, positioning DBS lead models, and calculating stimulation effects using finite element and neural activation models.

Bullsai Confirm uses finite element-based electric field modeling combined with axon-based neural activation modeling to visualize VTA fields. Key differences from the predicate (SureTune4) include: no O-arm imaging support, no physical media import, web-based interface with PDF output instead of Excel exports, no electrophysiological annotations, no anatomical atlas superimposition, and no manual structure segmentation. Both devices support DICOM image import from PACS and allow 2D/3D image navigation and DBS lead model positioning.

Not stated in this summary.

Bullsai Confirm is substantially equivalent because it shares the same intended use (assisting in DBS programming planning), the same core technological approach (finite element and neural activation modeling to visualize VTA), and identical classification and product code as the predicate. Although Bullsai removes several features (O-arm support, manual segmentation, anatomical atlas) and adds cloud-based workflows, these differences represent simplifications and alternative implementation choices that do not introduce new safety or effectiveness questions, as they do not alter the fundamental software function or change how clinicians use visualization data for DBS programming decisions.