Validation of a Computational Respiratory System Model for Mechanical Ventilation
Computational modeling and simulation have emerged as powerful tools for assessing medical device performance and safety, particularly in silico clinical trials (ISCTs) for automated medical systems. In ventilation, where gas exchange, respiratory mechanics, and patient-ventilator interaction must be managed under evolving pathophysiology, clinical translation of automated control strategies remains slow and resource-intensive. These challenges are particularly relevant for AI-based therapy-control systems, whose data-driven decision-making must be evaluated across heterogeneous and safety-critical patient states that may be sparsely represented in clinical datasets. Mechanistic, physiology-based models provide a complementary and interpretable environment for testing such scenarios. This paper applies a standards-aligned framework for 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 validation workflow. The model integrates respiratory mechanics, gas exchange, respiratory control, and a ventilator representation, with validation under a 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, and gaps are transparently reported. The resulting credibility argument supports applicability of the model for medium-low-risk preclinical ISCTs of automated weaning strategies. Residual limitations relate to the extent of in vivo evidence, population representativeness, and external validation. The validation procedure provides a blueprint for validation of this and similar models in mechanical ventilation and related use cases.