Caption Interpretation Automated Ejection Fraction Software

K210747

Caption Health · cleared 2022-01-19 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“The Caption Interpretation Automated Ejection Fraction Software (“AutoEF”) applies machine learning algorithms to process echocardiography images in order to calculate left ventricular ejection fraction.”
Algorithmmachine learning-based algorithms, with a Simple Pooling network architecture and a Linear Support Vector Machine regressor algorithm
source quote (p.4)
“The Caption Interpretation Automated Ejection Fraction Software (“AutoEF”) applies machine learning algorithms to process echocardiography images in order to calculate left ventricular ejection fraction.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Bench

sample size not stated

endpoints: image video clip selection function performance; AutoEF accuracy; overall functional performance

Retrospective clinical

n=186 patients

endpoints: root mean square deviation (RMSD) of EF% compared to biplane method ejection fraction; outlier rate for EF error >15%; outlier rate for EF error >20%

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

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recalls attributed to this device

  • Recalling firm matches this device's applicant (Caption Health) — same firm and product code, not necessarily this device · initiated 2021-05-19

    The firm is aware of a issue with ultrasound software that results in unintended video frames being included. This could lead to an incorrect automated ejection fraction (AutoEF) and image quality score (IQS) estimates.

    recall event 88101 (openFDA)

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K210747