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Topic-Contributed Paper Session

A "menu" of statistical challenges to illustrate how statistical science applied to medical devices and diagnostics (MDD) advances health and quality of life in our society

Wed, Aug 5, 8:30 AM - 10:20 AM Room CC-212 Thomas M. Menino Convention & Exhibition Center

Cristiana MayerOrganizerWright ShampOrganizerCristiana MayerChair

Section on Medical Devices and Diagnostics co: Biopharmaceutical Sectionco: No Additional Sponsor Applied

4 Presentations

Compare Modeling Approaches for Estimating Incidence Rate in Sparse Data with Zero-Event Studies

8:35 AM - 8:55 AM

Co-authors: Cristiana Mayer

Incidence rate Sparse data Rare-event Highly skewed Poisson models Meta-analysis

Learning Trial Eligibility Criteria from Real-World Critical Care Data: An End-to-End, AI-Enabled Emulation Framework

8:55 AM - 9:15 AM

Xiaofeng Wang (The Cleveland Clinic Foundation)

Co-authors: Shuaiqi Huang (Cleveland Clinic Research), Yan Zou (Case Western Reserve University), Yifan Xu (IBM Watson Health)

Target trial emulation Immortal-time bias Eligibility criteria Artificial intelligence Critical care

Real-World Evidence for Medical Device Performance Evaluation: Statistical Innovations and Regulatory Implications

9:15 AM - 9:35 AM

Martin Ho (Pfizer Inc)

Real-World Evidence Medical Device Performance Statistical Innovations Regulatory Implications novel device claims

Recommendations for Variance Estimation in a Gauge Repeatability & Reproducibility Study for Medical Devices in Ophthalmology

9:35 AM - 9:55 AM

Daniel Muenz (Johnson & Johnson)

Gauge R&R Gage R&R Analysis of variance ANOVA Measurement system analysis

Discussant

Telba Irony (Johnson & Johnson)

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