(171 days)
Brainomix 360 e-CTA is an image processing software package to be used by trained professionals, including, but not limited to physicians and medical technicians. The software runs on standard "off the-shelf" hardware (physical or virtualized) and can be used to perform image viewing, processing, and analysis of images. Data and images are acquired through DICOM compliant imaging devices.
Brainomix 360 e-CTA provides viewing and analysis capabilities for imaging datasets acquired with CTA (CT Angiography).
Brainomix 360 e-CTA is not intended for mobile diagnostic use.
Brainomix 360 e-CTA vessel density asymmetry ratio applies only to the MCA region.
Brainomix 360 e-CTA is a medical image visualization and processing software package compliant with the DICOM standard and running on an off-the-shelf physical or virtual server.
Brainomix 360 e-CTA allows for the visualization, analysis and post-processing of DICOM compliant CTA images which, when interpreted by a trained physician or medical technician, may yield information useful in clinical decision making.
Brainomix 360 e-CTA provides a wide range of basic image viewing, processing and manipulation functions, through multiple output formats. Functionality includes image registration and visualization of large cerebral vessels to provide an analysis of hemispheric difference via contralateral comparison (displayed as a relative percentage).
Brainomix 360 e-CTA processes the images using Al/ML algorithms where the input channels will help the software distinguish bone from vessels and reduce image grain.
Brainomix 360 e-CTA automatically provides a colored overlay to provide a visual reference of the MCA hemisphere of the brain with lower vessel density, and corresponding contrast intensity measurements and estimated phase.
Brainomix 360 e-CTA can connect with other DICOM-compliant devices, for example to transfer CTA scans from a Picture Archiving and Communication System (PACS) to Brainomix 360 e-CTA software for processing. Results and images can be sent to a PACS via DICOM transfer and can be viewed on a PACS workstation or via a web user interface on any machine and accessed within a hospital network and firewall and with a connection to the Brainomix 360 e-CTA software (e.g. a LAN connection).
Brainomix 360 e-CTA notification capabilities enable clinicians to preview images via e-mail notification with result image attachments. Images that are previewed via e-mail are compressed, are for informational purposes only, and not intended for diagnostic use beyond notification.
Brainomix 360 e-CTA is not intended for mobile diagnostic use. Notified clinicians are responsible for viewing non-compressed images on a diagnostic viewer and engaging in appropriate patient evaluation and relevant discussion with a treating physician before making care-related decisions or requests.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) submission document for Brainomix 360 e-CTA.
1. A table of acceptance criteria and the reported device performance
The document provides performance metrics, primarily focusing on Dice Similarity Coefficient (DSC) for vessel and parenchyma delineation, and Mean Absolute Error (MAE) for vessel density ratio. The "acceptance criteria" are implied by the "Summary performance metrics from full sample" and comparison to a previous version of the device.
| Metric Name | Acceptance Criteria (Implied/Compared To) | Reported Device Performance (Brainomix 360 e-CTA) | Pass/Fail |
|---|---|---|---|
| Digital Phantom Validation (Vessel Density Ratio) | |||
| Left-MAE |
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).