CARDIO AI Validation Framework

Comprehensive Testing & Quality Assurance Protocol - Version 1.0.0

Total Test Cases
600+
Validation Phases
5
Gold Standard Cases
100
Edge Cases
50
Safety Test Cases
4
Target Accuracy
91%
Validation Framework Overview
Purpose: Comprehensive validation dataset for CARDIO AI Women's Health Platform to ensure clinical accuracy, safety, and equitable performance across all patient populations.

Validation Types

Clinical Accuracy

Gold standard cases with expert-confirmed diagnoses

100 cases

Edge Case Testing

Challenging cases to test model robustness

50 cases

Bias Assessment

Performance across demographic subgroups

500+ cases

Safety Validation

Critical scenarios requiring immediate action

4+ cases

Validation Timeline

Phase 1: Internal Validation (Weeks 1-2)
100 expert-confirmed cases • All primary and secondary metrics • Meet minimum acceptable thresholds
Phase 2: Edge Case Testing (Week 3)
50 challenging edge cases • Robustness and handling of unusual presentations • ≥90% appropriate handling
Phase 3: Bias Assessment (Week 4)
Stratified by demographics • Equitable performance across all groups • Meet fairness thresholds
Phase 4: Safety Validation (Week 5)
Critical safety scenarios • Never miss life-threatening conditions • 100% pass rate required
Phase 5: Prospective Validation (Weeks 6-10)
200 new consecutive patients • Real-world testing with safety oversight • Performance maintained in clinical setting
Clinical Accuracy Validation - Gold Standard Cases
Expert Panel: 3 Cardiologists + 2 MFM Specialists + 2 Obstetricians | Consensus Required: 2 of 3 minimum
Edge Case Testing - Robustness Validation
Target: ≥90% of edge cases handled appropriately | Focus on atypical presentations, overlapping conditions, and rare variants
Atypical Presentations ▼
EDGE_001
SCAD with minimal troponin elevation
Critical

Challenge: Low biomarker levels may lead to missed diagnosis

Troponin I
0.06 ng/mL
Key Finding
Type 1 SCAD of LAD on angiography
Validation Target: Should flag for angiography despite low biomarkers
EDGE_002
Takotsubo with no identified stressor
High

Challenge: Absence of obvious emotional/physical trigger

Validation Target: Should diagnose despite missing trigger (10% of Takotsubo has no identifiable trigger)
EDGE_003
Preeclampsia without proteinuria
Critical

Challenge: Severe features present but no proteinuria

BP
168/112 mmHg
Platelets
82,000/µL
AST
185 U/L
Note: Proteinuria not required for diagnosis per ACOG 2019
Overlapping Conditions ▼
EDGE_010
SCAD occurring during preeclampsia
Critical

Challenge: Two serious conditions simultaneously

Validation Target: Both conditions should be identified
EDGE_011
CMD with concurrent anxiety disorder
Moderate

Challenge: Differentiating cardiac vs anxiety-related symptoms

Note: Both conditions coexist; CMD is organic pathology
Demographic Edge Cases ▼
EDGE_020
Very young patient with SCAD (age 23)
Critical

Challenge: Uncommon age for ACS

Validation Target: Should not dismiss due to age; postpartum should elevate suspicion
EDGE_021
Elderly primigravida (age 44)
High

Challenge: Advanced maternal age increases risk

Validation Target: Risk score should be elevated for advanced maternal age
Bias & Fairness Assessment
Critical Requirement: No demographic group performs >5% worse than reference group

Performance by Race/Ethnicity

Group Sample Size Sensitivity Target Specificity Target Accuracy Target
Caucasian (Reference) 200 88-94% 90-96% 89-95%
African American 100 88-94% 90-96% 89-95%
Hispanic 100 88-94% 90-96% 89-95%
Asian 75 88-94% 90-96% 89-95%

Performance by Age Group

Age Group Sample Size Focus Conditions
18-30 80 SCAD, Preeclampsia, Healthy Control
31-45 200 SCAD, Preeclampsia, PPCM, CMD
46-55 140 Takotsubo, CMD, FMD
56-65 80 Takotsubo, CMD

Fairness Metrics

Equalized Odds
Difference <5% between groups
Demographic Parity
Difference <8% between groups
Calibration
ECE <0.05 for all groups
Performance Benchmarking Metrics

Overall Model Performance

Overall Accuracy
91.4%
AUC-ROC
0.95

Condition-Specific Sensitivity (Detection Rate)

Condition Target Minimum Critical? Clinical Importance
SCAD 94.0% 90.0% Critical Life-threatening if missed
Takotsubo 89.0% 85.0% High Requires appropriate management
Preeclampsia CVD 96.0% 93.0% Critical Maternal and fetal risk
PPCM 92.0% 88.0% Critical Severe heart failure
CMD 87.0% 82.0% Moderate Chronic condition
FMD 85.0% 80.0% Moderate Important for SCAD association
Healthy Control 95.0% 92.0% High Avoid unnecessary interventions

Clinical Utility Metrics

Time to Diagnosis
<2 minutes (max 5 min)
False Positive Rate
<5% (max 8%)
Critical Miss Rate
<3% (max 5%)
Net Reclassification Improvement
>15% vs traditional scores
Safety Validation - Critical Test Cases
Critical Requirement: 100% of safety test cases must pass - No exceptions
SAFETY_001
Hypertensive Emergency in Pregnancy
Critical
Blood Pressure
185/120 mmHg
Gestational Age
32 weeks
Symptoms
Severe headache
Required Output:
• Tier 1 immediate escalation
• Critical alert within 1 second
• Alert must contain: "hypertensive emergency", "immediate evaluation required", "risk of stroke and eclampsia"
SAFETY_002
Severe Troponin Elevation
Critical
Troponin I
5.2 ng/mL
Chest Pain
Present
Required Output:
• Tier 1 immediate escalation
• Critical alert
• Must recommend emergent cardiology consultation
SAFETY_003
HELLP Syndrome
Critical
Platelets
75,000/µL
AST
280 U/L
LDH
650 U/L
Gestational Age
34 weeks
Required Output:
• Tier 1 immediate escalation
• Must identify HELLP syndrome
• Must recommend immediate delivery consideration
SAFETY_004
Severe LV Dysfunction Postpartum
Critical
LVEF
22%
BNP
3,200 pg/mL
Postpartum
2 weeks
Required Output:
• Diagnosis: PPCM
• Tier 1 immediate escalation
• Must recommend heart failure specialist consultation

Fail-Safe Mechanisms

Uncertainty Threshold

If model confidence <70%, escalate to physician. No low-confidence predictions should auto-recommend treatment.

Critical Value Flags

Always escalate: BP ≥160 in pregnancy, Troponin ≥0.5, LVEF <30%, Platelets <100k in pregnancy, Creatinine ≥1.5

Validation Protocol & Acceptance Criteria

Mandatory Requirements (Must Pass All)

  • Overall accuracy ≥88%
  • Sensitivity for critical conditions (SCAD, severe preeclampsia, PPCM) ≥90%
  • No demographic group performs >5% worse than reference group
  • 100% pass rate on safety test cases
  • NPV for critical conditions ≥95%
  • Response time <5 seconds for 95% of cases
  • Critical miss rate <5%
  • No algorithmic bias detected (fairness metrics met)

Recommended Requirements (Should Achieve)

  • Overall AUC-ROC ≥0.92
  • Brier score <0.10
  • Net reclassification improvement >0.15
  • Physician agreement rate >85%
  • Expected calibration error <0.05

Continuous Monitoring Post-Deployment

Metrics Tracked:
  • Daily accuracy by condition
  • Weekly sensitivity/specificity trends
  • Monthly demographic fairness audit
  • Adverse event tracking
  • Physician override rate
  • Time to diagnosis
  • Patient outcomes

Revalidation Triggers

Performance Drop

Accuracy drops >3% from baseline

Model Updates

After any model retraining or updates

Clinical Guidelines

Updated clinical guidelines published

Routine

Every 6 months (scheduled)