TribusConnect
K242166TribusMed Beheer BV · cleared 2025-03-31 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“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.”
source quote (p.6)
“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.”
source quote (p.17)
“A penetration test was conducted by an external company, and the cybersecurity assessment was successfully completed, validating the system's security measures and resilience. No issues classified as medium or higher were identified. Cybersecurity testing was performed in accordance with the FDA guidance document: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”
Validation studies (2)
Bench
sample size not stated
endpoints: accuracy of all measurements is within 5% of the true value
standards: IEC 62304:2015, ISO 14971:2019, NEMA 3.1-3.20 (2016) DICOM standard
Retrospective clinical
n=100 cases · 14 site(s)
endpoints: In at least 80% of cases bone removal should performed correctly; In at least 80% of cases each segmented structure should be clearly visible; In at least 80% of cases the rendered view of the heart should be clinically usable; 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%
Reported performance (1 observation)
source quote (p.7)
“The accuracy of all measurements is within 5% of the true value.”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).