Considerations for collecting clinical data and performing Data Management at the launch of a Computer-Assisted Detection Devices (CADe) study, Applied to Radiology Images and Radiology Device Data in – Premarket Notification 510k Submissions
CADe devices are computerized systems that incorporate pattern recognition and data analysis capabilities from patient radiological data, intended to identify, mark, highlight, or in any other manner direct attention to portions of an image, or aspects of radiology device data, that may reveal abnormalities during interpretation of patient radiology images or patient radiology device data by the intended user (i.e., a physician or other health care professional).
The clinical performance assessment of CADe device is typically performed by utilizing a multiple reader, multiple case (MRMC) study design. A set of clinical readers (i.e., clinicians evaluating the radiological images or data in the MRMC study) evaluate image data under multiple reading conditions or modalities (e.g., readers unaided by CADe versus readers aided by CADe). The MRMC design can be “fully-crossed” whereby all readers independently read all of the cases.
Electronic Data Capture (EDC) should support your study with the relevant aspects:
When multiple readers are involved in scoring, training in the use of the CADe device and rating interpretation scale is crucial and may support finer rating score.
A skilled team will know how to combat challenges and avoid impediment in your clinical trial.
*The recommendations in this document are meant to guide you as you develop and lead the data collection steps of the clinical study; they are not meant to specify the full content or type of premarket submission that may be applicable to your device.
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