Low Ejection Fraction AI-ECG Algorithm

K232699

Anumana, Inc. · cleared 2023-09-28 · product code QYE · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“The subject device, Anumana's Low Ejection Fraction AI-ECG Algorithm, is a Software as a Medical Device (SaMD) provided as a software module packaged in a Docker container.”
Algorithmartificial intelligence-based algorithm
source quote (p.4)
“The Low Ejection Fraction AI-ECG Algorithm interprets 12-lead ECG voltage times series data using an artificial intelligence-based algorithm.”
Adaptive (vs locked)FDA source did not state this
PCCPYes
source quote (p.9)
“Machine learning based algorithm with a predetermined change control plan (PCCP)”
Cybersecurity addressedYes
source quote (p.8)
“The performance characteristics for the Low Ejection Fraction AI-ECG Algorithm have been evaluated with the following non-clinical testing: software verification and validation (per IEC 62304), cybersecurity, labeling validation, and human factors.”

Validation studies (1)

Retrospective clinical

n=16,000 patients · 4 site(s)

endpoints: establish the diagnostic performance of the device for the purpose of detecting the presence of an EF < 40%

Reported performance (4 observations)

sensitivity84.5CI 95% CI of 82.2% to 86.6%
source quote (p.7)
“The Anumana Low EF ECG-AI device achieved a sensitivity of 84.5% (95% CI of 82.2% to 86.6%)”
specificity83.6CI 95% CI of 82.9% to 84.2%
source quote (p.7)
“a specificity of 83.6% (95% CI of 82.9% to 84.2%)”
ppvas written: “Positive Predictive Value (PPV)”30.5CI 95% CI of 28.8% to 32.1%
source quote (p.7)
“a positive predictive value of 30.5% (PPV, 95% CI of 28.8% to 32.1%)”
npvas written: “Negative Predictive Value (NPV)”98.4CI 95% CI of 98.2% to 98.7%
source quote (p.7)
“and a negative predictive value of 98.4% (NPV, 95% CI of 98.2% to 98.7%)”

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
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
1
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K250652 (decision 2025-07-28) from Anumana, Inc. for a matching device line ("ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K250652

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 Cardiovascular 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/K232699