The MedTech Sample Size Planner

Exploratory estimates for feasibility or first-in-human studies. Not for confirmatory/pivotal trials. Consult a biostatistician for final sizing.

Quick Start with Preset Scenarios

You can edit all values after selecting a scenario

Adverse Event Reduction

Testing if your device reduces complication rates

p₀ 20%

p₁ 10%

α 0.05

power 0.8

Success Rate Increase

Testing if your device improves success rates

p₀ 60%

p₁ 75%

δ 5%

α 0.05

power 0.8

Continuous Improvement

Testing improvement in a measured outcome (e.g., pain score)

μ₀ 16

μ₁ 20

σ 5

δ 1

α 0.05

power 0.8

Important Disclaimer:

This tool is for educational and learning purposes only. The sample size outputs are not valid for planning or conducting clinical studies. They must not be used "as is" for feasibility, pivotal, or confirmatory trials. Always consult with a qualified biostatistician for proper study design, sample size determination, and compliance with regulatory and study-specific requirements.

Or use a preset scenario above for quick start

Legal disclaimer: always consult a biostatistician before study initiation. Never use these results as-is for a clinical study.