# Morrison Evidence Folder — COU1 (CPB use)
# Centrifugal Blood Pump Hemolysis CFD Study
# Morrison et al. (2019), DOI: 10.1115/1.4043024
# ──────────────────────────────────────────────────────
#
# This folder contains the evidence artifacts for the V&V 40 credibility
# assessment of Context of Use 1 (CPB — cardiopulmonary bypass).
# Device class II, model risk level 2, assurance level Medium.
# Decision: ACCEPTED with credibility index 1.00.
#
# Sibling folder ../morrison-evidence-cou2/ holds the same shared CFD
# evidence plus the COU2-specific decision rationale and Monte Carlo
# UQ study. The two folders deliberately share data files because the
# underlying model and validation studies are the same — only the risk
# frame and acceptance bar differ between the two clinical contexts.
#
# FILE LISTING:
#
# PDFs (2):
#   risk_assessment_memo.pdf         Model risk assessment for COU1 and COU2
#   decision_rationale_cou1.pdf      Acceptance decision record (COU1: ACCEPTED)
#
# CSVs (3):
#   mesh_convergence_study.csv       Grid convergence data (4 mesh levels, GCI)
#   piv_velocity_validation.csv      PIV vs CFD centerline velocity (17 stations)
#   hemolysis_mih_comparison.csv     MIH values across 7 configurations
#
# Config/Text (2):
#   ansys_cfx_solver_settings.txt    ANSYS CFX solver configuration
#   boundary_conditions_specification.txt  Operating conditions + tolerance study
#
# Word Documents (2):
#   cou_definitions.docx             Context of Use definitions (COU1 + COU2)
#   credibility_assessment_narrative.docx  13-factor V&V 40 assessment narrative
#
# Total: 9 evidence files + this manifest
#
# USAGE:
#   uofa extract tests/fixtures/extract/morrison-evidence-cou1/ --pack vv40
#   uofa import morrison-cou1-extracted.xlsx --pack vv40
