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The Edwards Lifesciences Acumen Hypotension Prediction Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure

The Acumen Hypotension Prediction Index feature consists of software running on the Edwards Lifesciences HemoSphere Advanced Monitoring Platform paired with the Acumen IQ extravascular blood pressure transducer (K152980) and a peripheral arterial catheter. The monitoring system includes the Acumen Hypotension Prediction Index (HPI), and graphical user interface features displaying hemodynamic parameters relevant to assessing the root cause of a potential hypotensive event. The Acumen Hypotension Prediction Index is an index related to the likelihood of a patient experiencing hemodynamic instability defined as a hypotensive event* within 15 minutes, where zero (0) indicates low likelihood and one hundred (100) indicates a hypotensive event is occurring. The Acumen Hypotension Prediction Index parameter (HPI), should not be used exclusively to treat patients. A review of the patient's hemodynamics is recommended prior to initiating treatment. * A hypotensive event is defined as mean arterial pressure (MAP)

Here is the extracted information regarding the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

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The Edwards Lifesciences Acumen Hypotension Prediction Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure

The Acumen Hypotension Prediction Index Feature (DEN160044) consists of software running on the Edwards Lifesciences EV1000 Clinical Platform (DEN160044) and HemoSphere Advanced Monitoring Platform (K180881) paired with the FloTrac IQ or Acumen IQ extravascular blood pressure transducer (K152980) and a radial arterial catheter. The software includes the Acumen Hypotension Prediction Index (HPI), the Dynamic Arterial Elastance Parameter (Eadyn), the Systolic Slope Parameter (dP/dt), and additional graphical user interface features. The Acumen Hypotension Prediction Index is an index related to the likelihood of a patient experiencing a hypotensive event (defined as mean arterial pressure

Here's a breakdown of the acceptance criteria and study information for the Acumen Hypotension Prediction Index based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific numerical targets. However, the overall goal of the device, as described in the Indications for Use and Device Description, is to predict hypotensive events (MAP

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