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Authors
van Winkel, Suzanne L. https://orcid.org/0000-0001-7273-4386
Rodríguez-Ruiz, Alejandro
Appelman, Linda
Gubern-Mérida, Albert
Karssemeijer, Nico
Teuwen, Jonas
Wanders, Alexander J. T.
Sechopoulos, Ioannis
Mann, Ritse M.
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Funding
Funding for this research was provided by:
ScreenPoint Medical BV
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Article History
Received: 19 October 2020
Revised: 16 March 2021
Accepted: 9 April 2021
First Online: 4 May 2021
Declarations
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: The scientific guarantor of this publication is Ritse M. Mann, PhD, MD.
: The authors of this manuscript declare relationships with the following companies:The AI support system under investigation (Transpara™) in this study was developed by ScreenPoint Medical (Nijmegen, The Netherlands), a spin-off company of the Department of Medical Imaging, Radboud University Medical Center. Several authors are employees of this company (Alejandro Rodriguez-Ruiz, PhD; Albert Gubern-Merida, PhD; Nico Karssemeijer, PhD). The content of this study was also used for FDA approval. All data was generated by a fully independent clinical research organization (Radboudumc; Radboud University Medical Center, Nijmegen, The Netherlands). Readers were not affiliated with ScreenPoint Medical in any way. Data was handled and controlled at all times by the non-ScreenPoint employee authors.
: One of the authors has significant statistical expertise.The tomosynthesis image files are owned by a third company party (Siemens Medical Solutions, USA) and were made available for research purposes to ScreenPoint Medical (Nijmegen, The Netherlands) only. Without the DBT image data, the observer study data alone is of limited value and challenging to interpret. However, if needed, the observer study data could be made available for auditing purposes.
: Written informed consent was not required for this study because the completely anonymized cases were collected from a library of images collected prospectively for a previously performed, IRB-approved, clinical trial registered with protocol number NCT01373671.
: Institutional Review Board approval was obtained.The conducted observer evaluation study was HIPAA-compliant. Cases were collected from a library of images collected prospectively for a previously performed, IRB-approved, clinical trial registered with protocol number NCT01373671.
: • Prospective• Diagnostic or prognostic study• Multicenter study
