MRMCsamplesize: An R Package for Estimating Sample Sizes for Multi-Reader Multi-Case Studies

Multi-Reader Multi-Case (MRMC) studies are typically used to evaluate improvement in diagnostic accuracy of readers (diagnosticians) when they are assisted by a computer-assisted device (CAD) such as, but not limited to, those based on Artificial Intelligence (AI) algorithms. Statistical analysis of MRMC study data is not trivial and these studies can consume a lot of resources. Optimal planning is crucial and estimation of sample size is a significant step during the study planning phase. MRMC sample size estimations require many parameter assumptions and without pilot data this is generally not intuitive. MRMCsamplesize package can help researchers to estimate sample sizes for an MRMC study in the absence of any pilot data. The program outputs the number of cases required for a given number of readers. The package can also estimate sample sizes for scenarios where intra-cluster correlation (ICC) needs to be adjusted. ### Competing Interest Statement DR, SS and PP are full-time salaried employees of Qure.ai. ### Funding Statement This research work did not receive any funding. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes There is no specific data used for this research. The validation results can be reproduced using the R script available online at: https://github.com/technOslerphile/MRMCsamplesize/blob/master/S1.R