(250 days)
TribusConnect is a medical image management and processing device which facilitates remote viewing on different locations of CT images stored in DICOM format, allowing healthcare professionals to access, review, manipulate, measure and visualize simulated patient data from different sources.
TribusConnect is suitable for, but not limited to, pre-procedural planning of cardiac interventions and post procedural analysis of cardiac interventions.
To facilitate the above, TribusConnect uses CT DICOM data to output volume renderings, ML-based heart segmentation, a simulated fluoroscopy view, endo views, MIP and MPR views. Measurements can only be performed on MPR views.
TribusConnect is not intended for diagnostic use on mobile displays.
TribusConnect is not intended to serve as the primary archive for medical imaging data.
TribusConnect is an adjunct tool and is not intended to replace a physician's own review on the images.
The intended patient population is comprised of adult patients (22 years of age and older)
TribusConnect is a cloud-based software application that facilitates remote viewing on different locations of CT images stored in DICOM format, allowing healthcare professionals to access, review, manipulate, measure and visualize simulated patient data from different sources through a secure internet connection. TribusConnect offers a secure and efficient solution for accessing, reviewing, and visualizing CT images in DICOM format. Measurements can be performed on MPR views. TribusConnect is provided to its users as a Saas solution, TribusMed will be in control of installation, configuration, updates etc.
TribusConnect can be used in healthcare facilities, hospitals, and remote locations, including home environments, when accessed by authorized users through a secure internet connection.
CT scans can be uploaded to the server and will be de-identified before the upload. On the server the heart structures will be segmented using a ML based algorithm. Also a ML based semi-automated localization of the Left Atrial Appendage (LAA) will be performed.
All rendering of image data is done on the server te results can be viewed on standard computing devices (e.g., desktop, laptop, tablet, smartphone) with an internet connection.
Images can be rendered as Volume rendering, segmentations, simulated fluoroscopy, endo view, MIP or MPR. The user can interact with the data like zooming, rotating, changing the window. On the MPR views measurements can be performed.
The device's cloud infrastructure and encryption protocols ensure data protection and compliance with security standards.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria | Reported Performance |
|---|---|---|
| Heart Segmentation: | ||
| Bone Removal | In at least 80% of cases, bone removal should be performed correctly. | 100% of cases bone removal correct. |
| Segmented Structure Visibility | In at least 80% of cases, each segmented structure should be clearly visible. | 99% of cases each segmented structure is clearly visible. |
| Clinical Usability of Rendered View | In at least 80% of cases, the rendered view of the heart should be clinically usable. | 100% of cases the rendered view of the heart is clinically usable. |
| LAA Localization: | ||
| Accuracy | LAA localized within 10mm of the landing zone contour center as computed by the predicate device, in 95% of all cases, with a confidence of 95% and a statistical power of 80%. | 97% of the cases are within 10mm of the landing zone contour center as computed by the predicate device. Average distance was 4.40 mm, and its standard deviation was 2.74 mm. 95 out of 98 cases (97%) had a distance |
§ 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).