Analytic for Hemodynamic Instability (AHI)
Fifth Eye Inc.The Analytic for Hemodynamic Instability (AHI) is a software device that analyzes ECG signals to monitor patients' hemodynamic status, detecting signs of instability defined by low blood pressure combined with high heart rate. It provides clinicians with frequent, updated alerts to increase vigilance for patients at risk of hemodynamic deterioration, serving as an adjunctive monitoring tool alongside other patient data to improve early detection and patient management in clinical settings.
Intended Use
The Analytic for Hemodynamic Instability (AHI) software is intended for use by healthcare professionals managing in-hospital patients 18 years or older who are receiving continuous physiological monitoring with electrocardiography (ECG). AHI provides a frequently updated binary output over time based on pattern analysis of a lead-II ECG waveform indicating hemodynamic stability or instability.
Technology
AHI is a software as a medical device (SaMD) that analyzes 5-minute rolling windows of Lead-II ECG data to detect combinations of heart rate ≥ 100 bpm and systolic blood pressure < 90 mmHg or mean arterial pressure < 70 mmHg indicating hemodynamic instability. The system normalizes inputs, assesses signal quality, and outputs classification every 2 minutes.
Performance
Clinical validation showed a sensitivity of 95.6% and specificity of 84.9% for detecting hemodynamic instability using ECG and invasive arterial line blood pressure monitoring on 222 critical care patients. The device demonstrated a high negative predictive value and met pre-specified acceptance criteria. Usability studies confirmed safe interpretation, and software validation included unit, integration, and system testing. The device is intended as adjunctive monitoring and not to independently direct therapy.
Device Timeline
- 1
Submission
4/3/2020
11 months - 2
FDA Approval
3/1/2021
Other devices from Fifth Eye Inc.
- AHI System2021 • 510K
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