EFAI RTSUITE CT HCAP-Segmentation System
K231928Ever Fortune.AI Co., Ltd. · cleared 2023-09-25 · product code QKB · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“EFAI RTSuite CT HCAP-Segmentation System, herein referred to as EFAI HCAPSeg, is a standalone software that is designed to be used by trained radiation oncology professionals to automatically delineate organs-at-risk (OARs) on CT images.”
source quote (p.3)
“The contours are generated by deep-learning algorithms and then transferred to radiation therapy treatment planning systems.”
source quote (p.5)
“Once data is routed to EFAI HCAPSeg, the data will be processed and no user interaction is required, nor provided.”
source quote (p.11)
“and “Content of Premarket Submission for Management of Cybersecurity in Medical Devices.””
Validation studies (2)
Retrospective clinical
n=1,846 cases · 1 site(s)
endpoints: Dice coefficient (DSC)
standards: IEC 62304:2006/A1:2016, FDA Guidance documents, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices”(2005), FDA Guidance documents, “Content of Premarket submissions for Devices Software Functions (11-04-2021)”, FDA Guidance documents, “Content of Premarket Submission for Management of Cybersecurity in Medical Devices.”
Standalone
n=157 cases
endpoints: mean Dice coefficient (DSC); median 95% Hausdorff Distance (HD)
Reported performance (5 observations)
source quote (p.15)
“The overall performance showed a mean DSC of 0.83 and the non-inferiority tests indicated that EFAI HCAPSeg successfully met the primary endpoint across all body parts.”
source quote (p.16)
“Head & Neck 0.80 0.21”
source quote (p.16)
“Chest 0.90 0.11”
source quote (p.16)
“Abdomen & Pelvis 0.90 0.14”
source quote (p.16)
“Unique OAR 0.82 0.19”
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).