Context of Use (COU) Template — MIME

This template helps downstream users define their Context of Use per ASME V&V 40, adapted for microrobotics simulation.

1. Question of Interest

What does the model predict?

Example: “Predict the trajectory and drug release profile of a helical microrobot navigating from the lateral ventricle to the third ventricle via the foramen of Monro.”

2. Quantities of Interest

Which specific output variables?

Example: robot position (x,y,z) vs. time, drug concentration at target site vs. time, step-out frequency for the specific robot geometry.

3. Model Influence

How much does the simulation drive the decision?

Level	Description
Low	Simulation is one of several information sources
Medium	Simulation is the primary information source but clinical judgement dominates
High	Simulation output directly determines the clinical decision

4. Decision Consequence

What is the severity of harm if the simulation is wrong?

Level	Description
Low	No injury; financial or time cost only
Medium	Non-serious injury is possible
High	Death or serious injury is possible

5. Risk Assessment

Model influence x Decision consequence = Required evidence level.

6. Credibility Goals

What verification, validation, and UQ evidence is needed?

• Code verification: which MIME benchmarks (B0–B5) are relevant?

• Calculation verification: mesh convergence, solver settings for the specific COU

• Validation: experimental comparisons for the specific anatomy and robot design

• Uncertainty quantification: which parameters are uncertain, what propagation method?

7. Evidence Plan

How will the required evidence be generated?