EchoConfidence (USA)
K250670Mycardium AI Limited · cleared 2025-06-30 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“EchoConfidence is Software as a Medical Device (SaMD) that displays images from a Transthoracic Echocardiogram, and assists the user in reviewing the images, making measurements and writing a report.”
source quote (p.6)
“Both utilise artificial intelligence to segment and analyse the echo scans.”
source quote (p.7)
“Verification and validation testing were conducted to ensure specifications and performance of the device and were performed per the FDA Guidance documents "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submission for Management of Cybersecurity in Medical Devices".”
Validation studies (2)
Bench
sample size not stated
standards: EN ISO 14971, IEC 62304, IEC 62366-1, IEC 62366-2
Retrospective clinical
n=200 patients
endpoints: comparison of “mean absolute error” (MAE) of the AI against the 3 human expert reads against the "mean absolute error" of the 3 human experts against each other; upper 95% confidence interval of the difference between the AI MAE and human expert MAE is less than +25%
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
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).