Analytic for Hemodynamic Instability (AHI)

DEN200022

Fifth Eye Inc. · granted 2021-03-01 · product code QNV · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.2)
“Analytic for Hemodynamic Instability (AHI) is a software as a medical device (SaMD) that analyzes Lead-II ECG signals to identify patients who are showing signs of hemodynamic instability.”
AlgorithmAnalyzes Lead-II ECG signals using pattern analysis over a 5-minute sliding window to classify hemodynamic status as 'Stable' or 'Unstable' based on heart rate and blood pressure thresholds.
source quote (p.2)
“AHI provides a frequently updated binary output over time based on pattern analysis of a lead-II ECG waveform intended to describe a patient's hemodynamic status and indicate if a patient is showing signs of hemodynamic stability or instability. Signs of hemodynamic instability are defined as hypotension (systolic blood pressure <90 mmHg or mean arterial pressure (MAP) <70 mmHg) combined with tachycardia (heart rate " 100 bpm). The device processes 5 minutes of continuously recorded Lead II ECG data to determine the presence of a combination of HR ">= 100 bpm and SBP < 90 mmHg/MAP < 70 mmHg within a 2-minute sliding window as shown in the figure below. The system normalizes input signals and assesses signal quality prior to data analysis.”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedYes
source quote (p.5)
“Fifth Eye's approach to cybersecurity addressed each of the elements identified in the guidance document “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices” (2014).”

Validation studies (1)

Prospective clinical

n=222 patients · 1 site(s)

endpoints: Sensitivity; Specificity; Positive Predictive Value; Negative Predictive Value

Reported performance (5 observations)

sensitivity95.6CI 2.5% LCB: 88.9%
source quote (p.7)
“Sensitivity 95.6% 2.5% LCB: 88.9%”
specificity84.9CI n/a
source quote (p.7)
“Specificity 84.9% n/a”
specificityas written: “1-Specificity”15.1CI 97.5% UCB: 19.7%
source quote (p.7)
“1-Specificity 15.1% 97.5% UCB: 19.7%”
npvas written: “Negative Predictive Value”stated without value
source quote (p.7)
“Negative predictive value is the probability that any window classified as ‘AHI Stable' also is labeled as Normal Range according to the conservative vital signs-based reference standard. The negative predictive value was (b) (4)”
ppvas written: “Positive Predictive Value”stated without value
source quote (p.7)
“Positive predictive value is the probability that any window classified as ‘AHI Unstable' also is labeled as OOR according to the vital signs-based reference standard. In the study, the positive predictive value was (b) (4) reflecting in part the influence of the low prevalence (b) (4) of OOR windows on these statistics.”

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/DEN200022