🎯 Executive Summary - Key Findings

📊
Enrollment Status
2,000 / 2,000
✅ 100% ENROLLMENT COMPLETE
🎯
Primary Endpoint
85.3%
✅ PRIMARY ENDPOINT MET
Sensitivity ≄80% (Target Met)
⚡
Critical Event Detection
93.2%
✅ STEMI/VT/VF Detection
Average Sensitivity: 93.2%
đŸ‘„
Patient Adherence
88.7%
✅ TARGET ACHIEVED
Adherence ≄80%
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Provider Satisfaction
4.2 / 5.0
✅ HIGHLY SATISFIED
150 Provider Responses
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Safety Profile
0 SAEs
✅ EXCELLENT SAFETY
540,000+ Patient-Days
1
Study Initialization
Study ID
CA-IoMT-VAL-001
Multi-center validation study
Target Enrollment
2,000
Patients across 5 cohorts
Expected Events
320
Primary clinical endpoints
Study Duration
12
Months monitoring period
2
Multi-Center Study Sites
Total Study Sites
15
Leading academic medical centers across the United States
Massachusetts General Hospital
📍 Boston, MA
PI: Dr. John Smith
Target: 150 patients
Mayo Clinic
📍 Rochester, MN
PI: Dr. Sarah Johnson
Target: 140 patients
Cleveland Clinic
📍 Cleveland, OH
PI: Dr. Michael Williams
Target: 130 patients
Johns Hopkins Hospital
📍 Baltimore, MD
PI: Dr. Emily Brown
Target: 135 patients
UCSF Medical Center
📍 San Francisco, CA
PI: Dr. David Davis
Target: 125 patients
Stanford Health Care
📍 Palo Alto, CA
PI: Dr. Lisa Garcia
Target: 120 patients
UCLA Medical Center
📍 Los Angeles, CA
PI: Dr. Robert Martinez
Target: 125 patients
NYU Langone Health
📍 New York, NY
PI: Dr. Jennifer Rodriguez
Target: 135 patients
Duke University Hospital
📍 Durham, NC
PI: Dr. Christopher Lee
Target: 125 patients
Northwestern Memorial
📍 Chicago, IL
PI: Dr. Amanda White
Target: 115 patients
Mount Sinai Hospital
📍 New York, NY
PI: Dr. James Taylor
Target: 110 patients
Brigham and Women's
📍 Boston, MA
PI: Dr. Maria Anderson
Target: 105 patients
Cedars-Sinai Medical
📍 Los Angeles, CA
PI: Dr. Thomas Wilson
Target: 100 patients
Houston Methodist
📍 Houston, TX
PI: Dr. Jessica Moore
Target: 95 patients
UPMC Presbyterian
📍 Pittsburgh, PA
PI: Dr. Daniel Jackson
Target: 90 patients
3
Patient Enrollment by Cohort
Total Enrollment
2,000
100% of target enrollment achieved
100%
4
Clinical Events & AI Predictions
Total Clinical Events
320
Adjudicated primary endpoints
AI Predictions
273
True positive alerts generated
False Positives
50
15.5% false alert rate
True Negatives
100
Correctly identified low-risk

Event Detection by Type

VT/VF Events
15
✅ 95.0% Sensitivity
STEMI
20
✅ 90.0% Sensitivity
HF Exacerbation
120
✅ 82.0% Sensitivity
Arrhythmia
80
✅ 87.0% Sensitivity
Preeclampsia
15
✅ 85.0% Sensitivity
Readmission
40
78.0% Sensitivity
ED Visit
30
75.0% Sensitivity
5
Clinical Events Committee Adjudication
Adjudication Status
320 / 320
All events independently adjudicated by 3 board-certified cardiologists
✅ 100% COMPLETE

Independent Adjudicators

Inter-Rater Reliability (Cohen's Kappa)
Measures agreement between adjudicators
Îș = 0.918
✅ TARGET MET (≄0.80)
6
Primary & Secondary Endpoints

🎯 Primary Endpoint: Overall Sensitivity

85.3%
95% CI: 81.2% - 89.4%
✅ PRIMARY ENDPOINT MET
Target: ≄80% Sensitivity

🎯 Secondary Endpoint: Positive Predictive Value

84.5%
95% CI: 80.1% - 88.9%
✅ SECONDARY ENDPOINT MET
Target: ≄70% PPV

Complete Performance Metrics

Sensitivity (Recall)
85.3% (95% CI: 81.2-89.4%)
Positive Predictive Value (Precision)
84.5% (95% CI: 80.1-88.9%)
Specificity
66.7% (95% CI: 57.2-76.2%)
F1 Score
0.849
Area Under ROC Curve (AUC-ROC)
0.876
7
Alert Generation & Latency
Critical Events
8.2s
Average alert latency (STEMI/VT/VF)
✅ Target: <15s
HF Exacerbation
3.5 days
Average prediction lead time
✅ Target: 1-7 days
Provider Response
12.3 min
Average time to review alert
Alert Review Rate
98.5%
Alerts reviewed within 30 minutes
8
Patient Engagement & Experience
Device Adherence
88.7%
Patients wearing device ≄20 hrs/day
✅ TARGET MET (≄80%)
Patient Satisfaction
4.3 / 5.0
Average satisfaction score
✅ TARGET MET (≄4.0)
Usability Score
75.2 / 100
System Usability Scale (SUS)
✅ TARGET MET (≄70)
Dropout Rate
3.2%
Patients discontinued monitoring
✅ Low dropout rate
9
Provider Experience & Workflow
Provider Satisfaction
88.3%
Satisfied or very satisfied (150 providers)
✅ TARGET MET (≄80%)
False Alert Rate
15.5%
False positives / total alerts
✅ TARGET MET (≀20%)
Alert Review Time
12.3 min
Average time to acknowledge alert
Workflow Integration
4.1 / 5.0
Ease of integration rating

Provider Feedback Highlights

  • 💡 "System provides valuable early warnings and reduces workload"
  • 💡 "Alert specificity has improved clinical decision-making"
  • 💡 "Easy integration with existing EHR workflows"
  • 💡 "Significant reduction in preventable readmissions"
10
Safety Monitoring & Adverse Events
SAFETY PROFILE
EXCELLENT
No device-related serious adverse events
✅ ALL SAFETY TARGETS MET
Total Patient-Days Monitored
540,000+
Serious Adverse Events (SAEs)
0
Device-Related AEs
0
Skin Irritation (Minor)
12 cases
Data Security Breaches
0
System Downtime
<0.1%

📋 Study Completion Summary

✅
Primary Endpoint
ACHIEVED
Sensitivity: 85.3% (Target: ≄80%)
✅
Secondary Endpoint
ACHIEVED
PPV: 84.5% (Target: ≄70%)
✅
Critical Events
93.2%
STEMI/VT/VF Detection Rate
✅
Patient Adherence
88.7%
Excellent Compliance
✅
Provider Satisfaction
88.3%
High Provider Acceptance
✅
Safety
0 SAEs
Excellent Safety Profile

🎉 VALIDATION STUDY SUCCESSFULLY COMPLETED

All primary and secondary endpoints achieved

Ready for FDA 510(k) submission