Validation of a Computational Respiratory System Model for Mechanical Ventilation

Computational modeling and simulation are powerful tools for the assessment of medical device performance and safety, particularly for in silico clinical trials for automated medical systems.

In ventilation, where managing gas exchange, respiratory mechanics, and patient-ventilator interaction is required under evolving pathophysiology, the clinical translation of automated control strategies remains slow and resource-intensive.

This paper applies a standards-aligned framework for the credibility assessment of a computational respiratory model, demonstrated using an automated weaning case study.

The framework operationalizes ASME V&V 40 and FDA principles within a structured, guidance-based validation workflow.

The computational physiological model integrates respiratory mechanics, gas exchange, respiratory control, and a ventilator representation, validated under a clearly defined context of use and explicit questions of interest.

Model credibility is assessed through calibration, physiological plausibility, population-based evaluation, and reproduction of emergent behavior.

All model requirements derived from the intended context of use are addressed within the proposed credibility assessment plan, and documented gaps are transparently reported.

The resulting credibility argument supports the applicability of the model for its context of use.

Strengths are demonstrated in population-based comparison and mechanistic plausibility, while residual limitations relate to the extent of in vivo evidence, population representativeness, and external validation.

Overall, the model is considered fit for purpose for medium-low risk preclinical in silico clinical trials of automated weaning strategies.

Furthermore, the validation procedure outlined in this article provides a blueprint for the validation of this and similar models in other mechanical ventilation algorithms and related use cases.