Acumen Hypotension Prediction Index (HPI) Feature Software

DEN160044

Edwards Lifesciences LLC · granted 2018-03-16 · product code QAQ · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.1)
“The adjunctive predictive cardiovascular indicator is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events.”
Algorithmdata-driven model developed from retrospective analysis of an arterial waveform database
source quote (p.3)
“HPI is not defined by a single equation. HPI uses features extracted from FloTrac IQ measurements, some compared to an initial base value determined over the first 10 minutes of the patient monitoring session, to a data-driven model developed from retrospective analysis of an arterial waveform database collected from ICU and OR patients containing annotated hypotensive (defined as MAP <65 mmHG for at least 1 minute) and non-hypotensive events.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.5)
“Cybersecurity information was provided in accordance with the FDA Guidance Document, “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices – Guidance for Industry and Food and Drug Administration Staff" (issued October 02, 2014).”

Validation studies (4)

Bench

sample size not stated

Bench

n=5 other

Retrospective clinical

n=52 patients

endpoints: sensitivity; specificity; area under the receiver operating characteristic

Retrospective clinical

n=204 patients · 1 site(s)

endpoints: sensitivity; specificity; area under the receiver operating characteristic

Reported performance (10 observations)

sensitivity83.7CI [81.5, 86.0]
source quote (p.3)
“The sensitivity, specificity, and area under the receiver operating characteristic for the first database of 52 subjects were 83.7%, 99.8%, and 0.95 respectively.”
specificity99.8CI [99.4, 100.0]
source quote (p.3)
“The sensitivity, specificity, and area under the receiver operating characteristic for the first database of 52 subjects were 83.7%, 99.8%, and 0.95 respectively.”
aurocas written: “auc”0.95
source quote (p.3)
“The sensitivity, specificity, and area under the receiver operating characteristic for the first database of 52 subjects were 83.7%, 99.8%, and 0.95 respectively.”
sensitivityas written: “Sensitivity (Study 2)”65.8CI [63.7, 67.9]
source quote (p.3)
“The sensitivity, specificity, and area under the receiver operating characteristic for the second database of 204 subjects were 65.8%, 99.4%, and 0.88 respectively.”
specificityas written: “Specificity (Study 2)”99.4CI [99.2, 99.7]
source quote (p.3)
“The sensitivity, specificity, and area under the receiver operating characteristic for the second database of 204 subjects were 65.8%, 99.4%, and 0.88 respectively.”
aurocas written: “AUC (Study 2)”0.88
source quote (p.3)
“The sensitivity, specificity, and area under the receiver operating characteristic for the second database of 204 subjects were 65.8%, 99.4%, and 0.88 respectively.”
ppvas written: “PPV (Study 1)”99.9CI [99.7, 100.0]
source quote (p.11)
“99.9 (=886/887) [99.7, 100.0]”
npvas written: “NPV (Study 1)”75.1CI [71.9, 78.4]
source quote (p.11)
“75.1 (=520/692) [71.9, 78.4]”
ppvas written: “PPV (Study 2)”98.3CI [97.6, 99.0]
source quote (p.11)
“98.3 (=1265/1287) [97.6, 99.0]”
npvas written: “NPV (Study 2)”84.9CI [83.9, 86.0]
source quote (p.11)
“84.9 (=3709/4367) [83.9, 86.0]”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: De Novo decision summary PDF.

Predicate network

Postmarket — what happened after clearance

Not yet tracked — the weekly postmarket refresh hasn't snapshotted this device.

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 De Novo 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/DEN160044