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The VinDr-Mammo is a passive notification for prioritization-only, a parallel-workflow software tool used by MQSA qualified interpreting physicians to prioritize patients with suspicious findings in the medical care environment. VinDr-Mammo utilizes an artificial intelligence algorithm to analyze 2D FFDM screening mammograms and flags those that are suggestive of the presence of at least one suspicious finding at the exam-level. VinDr-Mammo produces an exam-level output to a PACS/ Workstation for flagging the suspicious case and allows worklist prioritization. MQSA qualified interpreting physicians are responsible for reviewing each exam on a display approved for use in mammography, according to the current standard of care. VinDr-Mammo device is limited to the categorization of exams, does not provide any diagnostic information beyond triage and prioritization, does not remove images from the interpreting physician's worklist, and should not be used in lieu of full patient evaluation, or relied upon to make or confirm diagnosis. The VinDr-Mammo device is intended for use with complete 2D FFDM mammography exams acquired using validated FFDM systems only.

The VinDr-Mammo is an innovative medical device designed to assist in the analysis and triage of 2D full-field digital mammogram (FFDM) screening mammograms. Operating as non-invasive computer-assisted software, known as SaMD, it employs a machine learning algorithm to identify potential suspicious findings within the images. Once identified, the system promptly notifies a PACS/workstation for further examination. This passive-notification feature enables radiologists to prioritize their workload efficiently and view studies in order of importance using standard PACS or workstation viewing software. It is important to note that the VinDr-Mammo software is intended solely to aid in the prioritization and triage of radiological medical images. It serves as a valuable tool for MQSA interpreting physicians who specialize in mammogram readings, complementing the standard of care. It should be emphasized that the device does not replace the need for a comprehensive evaluation as per established medical practices. During the algorithm's training, independent datasets from various global sites were utilized, ensuring a robust and diverse training experience. The VinDr-Mammo code can be viewed by radiologists on a Picture Archiving and Communication System (PACS), Electronic Patient Record (EPR), and/or Radiology Information System (RIS) worklist and can be used to reorder the worklist: the mammographic studies with code 1 should be prioritized over those with code 0 and, thus, should be moved to the top of the worklist. As a software-only device, VinDr-Mammo can be hosted on a compatible host server connected to the necessary clinical IT systems such that DICOM studies can be received and the resulting outputs returned where they can be incorporated into the radiology worklist. The following modules compose the VinDr-Mammo software: - Data input and validation: Following retrieval of a study, the validation feature assessed the input data (i.e. age, modality, view) to ensure compatibility for processing by the algorithm. - VinDr-Mammo algorithm: Once a study has been validated, the algorithm analyzes the 2D FFDM screening mammogram for detection of suspected findings. - API Cognitive service: The study analysis and the results of a successful study analysis are provided through an API service, whose outputs will then be sent to the appropriate clinical IT system for viewing on a radiology worklist. - Error codes feature: In the case of a study failure during data validation or the analysis by the algorithm, an error is provided to the system.