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510(k) Data Aggregation

    K Number
    K223754
    Device Name
    BraveCX
    Manufacturer
    Bering Ltd
    Date Cleared
    2023-11-09

    (329 days)

    Product Code
    QFM
    Regulation Number
    892.2080
    Why did this record match?
    Applicant Name (Manufacturer) :

    Bering Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BraveCX is a radiological computer-assisted triage and notification software that analyzes adult (≥18 years old) chest Xray images for the presence of pre-specified suspected critical findings (pleural effusion and/or pneumothorax). BraveCX uses an artificial intelligence algorithm to analyze images for features suggestive of critical findings and provides caselevel output available in the PACS/workstation for worklist prioritization or triage. As a passive notification for prioritization-only software tool within standard of care workflow, BraveCX does not send a proactive alert directly to the appropriately trained medical specialists. BraveCX is not intended to direct attention to specific portions of an image or to anomalies other than pleural effusion and/or pneumothorax. Its results are not intended to be used on a stand-alone basis for clinical decision-making.
    Device Description
    BraveCX is a Deep Learning Artificial Intelligence (AI) software that analyzes adult (≥18 years old) chest X-ray images for the presence of pre-specified suspected critical findings (pleural effusion and/or pneumothorax. It uses deep learning to analyze each image to identify features suggestive of pleural effusion and/or pneumothorax. Upon image acquisition from other radiological imaging equipment (e.g. X-ray systems), Anteroposterior (AP) and Posteroanterior (PA) chest X-Rays are received and processed by BraveCX. Following receipt of an image, BraveCX de-identifies a copy of each DICOM file and analyses it for features suggestive of pleural effusion and/or pneumothorax. Based on the analysis result, the software notifies PACS/workstation for the presence of the critical findings, indicated by "flag" or "(blank)". This allows the appropriately trained medical specialists to group suspicious exams together with potential for prioritization. Chest radiographs without an identified anomaly are placed in the worklist for routine review, which is the current standard of care. The intended user of the BraveCX software is a health care professional such as radiologist or another appropriately trained clinician. The software does not alter the order or remove cases from the reading queue. The software output to the user is a label of "flag" or "(blank)" that relates to the likelihood of presence of pneumothorax and/or pleural effusion. BraveCX platform ingests prediction requests with either attached DICOM images or DICOM UIDs referencing images already uploaded to DICOM storage. The results will be made available via a newly generated DICOM that is stored in DICOM storage or as a JSON file. The DICOM storage component may be a Picture Archiving and Communications (PACS) system or some other local storage platform. BraveCX works in parallel to and in conjunction with the standard of care workflow to enable prioritized review by the appropriately trained medical specialists who are qualified to interpret chest radiographs. As a passive notification for prioritization-only software tool within standard of care workflow, BraveCX does not send a proactive alert directly to the appropriately trained medical specialists who are qualified to interpret chest radiographs. BraveCX is not intended to direct attention to specific portions or anomalies of an image and it should not be used on a standalone basis for clinical decision-making. BraveCX automatically runs after image acquisition. It prioritises and displays the analysis results through the worklist interface of PACS/workstation. An on-device, technologist notification is generated within 15 minutes after interpretation by the user, indicating which cases were prioritized by BraveCX in PACS. The technologist notification is contextual and does not provide any diagnostic information. The on-device, technologist notification is not intended to inform any clinical decision, prioritization, or action.
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