EFAI ChestSuite XR Pleural Effusion Assessment System
K222076Ever Fortune.AI Co., Ltd. · cleared 2022-09-08 · product code QFM · Radiology
Premarket evidence — what FDA accepted
source quote (p.7)
“EFAI Chestsuite XR Pleural Effusion Assessment System is a software-only device which operates in four stages - data transfer, data preprocessing, AI inference and data post processing.”
source quote (p.7)
“The software uses deep learning techniques to automatically analyze PA chest x-rays and sends notification messages to the picture archiving and communication system (PACS)/workstation to allow suspicious findings of pleural effusion to be identified. EFAI Chestsuite XR Pleural Effusion Assessment System analyzes cases using an artificial intelligence algorithm to identify suspected findings on chest x-ray images taken in PA position.”
source quote (p.10)
“Additionally, the software validation activities were performed in accordance with IEC 62304:2006/A1:2016 Medical device software Software life cycle processes, in addition to the FDA Guidance documents, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices”(2005) and the recently published "Content of Premarket Submissions for Devices Software Functions (11-04-2021), and "Content of Premarket Submission for Management of Cybersecurity in Medical Devices."”
Validation studies (2)
Standalone
n=1,454 images
endpoints: assessing pleural effusion
standards: IEC 62304:2006/A1:2016 Medical device software Software life cycle processes, FDA Guidance documents, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices”(2005), Content of Premarket Submissions for Devices Software Functions (11-04-2021), Content of Premarket Submission for Management of Cybersecurity in Medical Devices
Retrospective clinical
n=600 cases
endpoints: pleural effusion classification performance; processing time
standards: IEC 62304:2006/A1:2016 Medical device software Software life cycle processes, FDA Guidance documents, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices”(2005), Content of Premarket Submissions for Devices Software Functions (11-04-2021), Content of Premarket Submission for Management of Cybersecurity in Medical Devices
Reported performance (3 observations)
source quote (p.11)
“Overall, the EFAI Chestsuite XR Pleural Effusion Assessment System was able to demonstrate sensitivity and specificity of 0.9510 (95% CI=0.9195-0.9706) and 0.9745 (95% CI=0.9505-0.9870) respectively”
source quote (p.11)
“Overall, the EFAI Chestsuite XR Pleural Effusion Assessment System was able to demonstrate sensitivity and specificity of 0.9510 (95% CI=0.9195-0.9706) and 0.9745 (95% CI=0.9505-0.9870) respectively”
source quote (p.11)
“as well as an AUC of 0.9712 (95% CI=0.9538-0.9885).”
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).