A Generative Approach to Testing the Performance of Physiological Control Algorithms

Author:

Tivay Ali123,Bighamian Ramin45,Hahn Jin-Oh6,Scully Christopher G.45

Affiliation:

1. University of Maryland, College Park Mechanical Engineering, , 2181 Glenn L. Martin Hall, College Park, MD 20742 ;

2. University of Maryland Mechanical Engineering, , 2181 Glenn L. Martin Hall, College Park, MD 20742 ;

3. U.S. Food and Drug Administration Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, , Silver Spring, MD 20903

4. United States Food and Drug Administration Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, , 10903 New Hampshire Ave, Silver Spring, MD 20993

5. U.S. Food and Drug Administration Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, , 10903 New Hampshire Ave, Silver Spring, MD 20993

6. University of Maryland Mechanical Engineering, , 2181 Glenn L. Martin Hall, College Park, MD 20742

Abstract

Abstract Physiological closed-loop control algorithms play an important role in the development of autonomous medical care systems, a promising area of research that has the potential to deliver healthcare therapies meeting each patient's specific needs. Computational approaches can support the evaluation of physiological closed-loop control algorithms considering various sources of patient variability that they may be presented with. In this article, we present a generative approach to testing the performance of physiological closed-loop control algorithms. This approach exploits a generative physiological model (which consists of stochastic and dynamic components that represent diverse physiological behaviors across a patient population) to generate a select group of virtual subjects. By testing a physiological closed-loop control algorithm against this select group, the approach estimates the distribution of relevant performance metrics in the represented population. We illustrate the promise of this approach by applying it to a practical case study on testing a closed-loop fluid resuscitation control algorithm designed for hemodynamic management. In this context, we show that the proposed approach can test the algorithm against virtual subjects equipped with a wide range of plausible physiological characteristics and behavior and that the test results can be used to estimate the distribution of relevant performance metrics in the represented population. In sum, the generative testing approach may offer a practical, efficient solution for conducting preclinical tests on physiological closed-loop control algorithms.

Funder

Directorate for Computer and Information Science and Engineering

Directorate for Engineering

Publisher

ASME International

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