ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)

K252360

Anumana, Inc. · cleared 2026-03-28 · product code SAT · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“The ECG-AI PH 12-Lead algorithm is software intended to aid in earlier detection of elevated mean pulmonary arterial pressure (mPAP), an indicator of pulmonary hypertension, in adults presenting with dyspnea. ECG-AI PH 12-Lead algorithm interprets 12-lead ECG voltage time series data using an artificial intelligence-based algorithm. ECG-AI PH 12-Lead algorithm is provided as a software module packaged in a Docker container to facilitate installation.”
Algorithmartificial intelligence-based algorithm, machine learning-based algorithm
source quote (p.5)
“ECG-AI PH 12-Lead algorithm interprets 12-lead ECG voltage time series data using an artificial intelligence-based algorithm. Machine learning-based algorithm”
Adaptive (vs locked)Yes
source quote (p.7)
“As part of this authorization, the device software may be updated periodically to enhance performance, including for higher sensitivity and/or specificity.”
PCCPYes
source quote (p.1)
“FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). This device has been cleared by the U.S. Food and Drug Administration (FDA) with a Predetermined Change Control Plan (PCCP).”
Cybersecurity addressedYes
source quote (p.7)
“The performance characteristics for the ECG-AI PH 12-Lead Algorithm have been evaluated with the following non-clinical testing: software verification and validation (per IEC 62304), cybersecurity, labeling verification and validation, and human factors. Identical. Subject and predicate device algorithms are compliant with FDA Guidance and Standards for Cybersecurity.”

Validation studies (1)

Retrospective clinical

n=21,066 patients · 5 site(s)

endpoints: diagnostic performance

standards: IEC 62304

Reported performance (6 observations)

sensitivity73CI 95% CI of 72.1% to 73.9%
source quote (p.9)
“Within this enriched study sample, a total of 10,036 PH Positive cases were identified from 21,066 records. The Anumana ECG-AI PH 12-Lead device achieved a sensitivity of 73.0% (95% CI of 72.1% to 73.9%), and a specificity of 74.4% (95% CI of 73.5% to 75.2%).”
specificity74.4CI 95% CI of 73.5% to 75.2%
source quote (p.9)
“Within this enriched study sample, a total of 10,036 PH Positive cases were identified from 21,066 records. The Anumana ECG-AI PH 12-Lead device achieved a sensitivity of 73.0% (95% CI of 72.1% to 73.9%), and a specificity of 74.4% (95% CI of 73.5% to 75.2%).”
ppvas written: “Positive Predictive Value (Validation Study)”28.7
source quote (p.7)
“Positive Predictive Value (Validation Study) 28.7%”
npvas written: “Negative Predictive Value (Validation Study)”95.1
source quote (p.7)
“Negative Predictive Value (Validation Study) 95.1%”
ppvas written: “Positive Predictive Value (Estimated Prevalence of US adults with dyspnea: 4.36%)”11.5CI 95% CI of 11.2% to 11.8%
source quote (p.9)
“This resulted in a PPV of 11.5% (95% CI of 11.2% to 11.8%) and NPV of 98.4% (95% CI of 98.3% to 98.4%).”
npvas written: “Negative Predictive Value (Estimated Prevalence of US adults with dyspnea: 4.36%)”98.4CI 95% CI of 98.3% to 98.4%
source quote (p.9)
“This resulted in a PPV of 11.5% (95% CI of 11.2% to 11.8%) and NPV of 98.4% (95% CI of 98.3% to 98.4%).”

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
0
drift signals on this device

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/K252360