Methinks CTA Stroke

Methinks CTA Stroke is an AI-powered software tool that analyzes CT angiography images of the brain to detect suspected large vessel occlusions (LVO) in acute stroke patients. It sends notifications to neurovascular specialists in parallel with standard clinical workflow to flag cases requiring urgent review, without providing diagnostic interpretation.

Both the subject device and predicate (ContaCT) use artificial intelligence algorithms to analyze CT angiogram images and notify trained clinicians of suspected LVO. The subject device expands vessel analysis to include terminal ICA, MCA-M1, and MCA-M2, whereas the predicate analyzes only ICA and MCA-M1. Both devices do not highlight or annotate findings, provide compressed preview images for informational purposes only, and operate as parallel workflow tools independent of standard-of-care interpretation.

Not stated in this summary.

Both devices share identical intended use as notification-only, parallel workflow tools for LVO triage using CT angiography with identical product codes and regulatory classification. The expansion to analyze MCA-M2 vessels does not raise new safety or effectiveness questions because it represents an incremental addition to the same clinical indication using the same algorithmic approach and risk mitigation strategies (non-diagnostic preview images, requirement for clinician review on diagnostic viewers). Performance validation demonstrated sensitivity of 98.2% and specificity of 91.6% across multiple patient subgroups and imaging vendors, with mean notification time of 3.3 minutes, establishing equivalence in safety and performance.