Cerebral Autoregulation Index (CAI) Algorithm
Edwards LifesciencesThe Cerebral Autoregulation Index (CAI) Algorithm is a software tool designed to help clinicians monitor whether cerebral autoregulation—the brain's ability to maintain stable blood flow—is intact or impaired. It analyzes signals from cerebral oximetry and blood pressure monitors to provide an index value indicating the level of coherence between these parameters. This helps guide advanced hemodynamic monitoring in critical care patients without making direct therapeutic decisions.
Intended Use
The Cerebral Autoregulation Index (CAI) Algorithm is intended to represent a surrogate measurement of whether cerebral autoregulation is likely intact or impaired by analyzing coherence between Mean Arterial Pressure (MAP) and absolute cerebral blood oxygen saturation (StO2) in patients over 18 years receiving advanced hemodynamic monitoring.
Technology
The CAI Algorithm calculates the level of coherence between cerebral tissue oxygen saturation measured by near-infrared spectroscopy (NIRS) signals and mean arterial pressure (MAP) signals. It outputs an index value between 0 to 100 shown in trend plots at a 20-second update rate. The device combines data from FDA cleared cerebral oximeter cables (ForeSight) and pressure cables (HemoSphere). No alarms are provided, the index informs clinicians of cerebral autoregulation status.
Performance
Performance testing included software verification per IEC 62304 and FDA guidance, using animal and clinical data; clinical validation was performed on 50 adult subjects undergoing surgery at multiple sites. The ROC AUC was 0.92 with sensitivity 82% and specificity 94% at the CAI threshold of 45, demonstrating effective discrimination of impaired versus intact cerebral autoregulation across sites.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/4/2024
7 months - 2
FDA Approval
10/16/2024
Other devices from Edwards Lifesciences
- Global Hypoperfusion Index (GHI) Algorithm2023 • 510K
- Acumen Hypotension Prediction Index (HPI) Feature Software2018 • DE NOVO
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