Accuracy assessment methods for physiological model selection toward evaluation of closed-loop controlled medical devices.

ABSTRACT: Physiological closed-loop controlled (PCLC) medical devices are complex systems integrating one or more medical devices with a patient's physiology through closed-loop control algorithms; introducing many failure modes and parameters that impact performance. These control algorithms should be tested through safety and efficacy trials to compare their performance to the standard of care and determine whether there is sufficient evidence of safety for their use in real care setting. With this aim, credible mathematical models have been constructed and used throughout the development and evaluation phases of a PCLC medical device to support the engineering design and improve safety aspects. Uncertainties about the fidelity of these models and ambiguities about the choice of measures for model

SUBMITTER: Bighamian R 

PROVIDER: S-EPMC8087034 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature