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Updated: Jan 19, 2026
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Sample-Size Determination Methodologies for Machine Learning in Medical Imaging Research: A Systematic Review
Indranil Balki1, Afsaneh Amirabadi2, Jacob Levman3
1Department of Medical Imaging, University of Toronto, Toronto, Ontario, Canada.
Determining the right training sample size for machine learning (ML) in medical imaging is challenging. This review found few studies on sample-size methods, highlighting a need for standardized approaches in ML for medical imaging.
Area of Science:
- Medical Imaging
- Machine Learning
- Data Science
Background:
- The optimal training sample size for machine learning (ML) models in medical imaging is frequently undetermined.
- This uncertainty impacts model reliability and generalizability.
Purpose of the Study:
- To conduct a descriptive review of existing sample-size determination methodologies for ML in medical imaging.
- To propose recommendations for future research and standardization in the field.
Main Methods:
- A systematic literature search was performed using Medline and Embase databases.
- Keywords included "machine learning," "image," and "sample size," with articles published between 1946 and 2018 included.
- Data on ML tasks, sample sizes, and train-test pipelines were extracted for qualitative analysis.
Main Results:
- Out of 167 identified articles, 22 were included for analysis.
- Only 4 studies focused on sample-size determination methodologies; 18 explored sample size effects on model performance.
- Methods varied, including pre hoc model-based and post hoc curve-fitting approaches, with significant variability in testing and reporting.
Conclusions:
- There is a significant lack of research on sample-size determination methodologies for ML in medical imaging.
- Standardization of reporting practices is crucial.
- Future work should focus on developing and streamlining both pre hoc and post hoc sample size determination methods.
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