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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 < 65 mmHg for at least one minute in duration) and the associated hemodynamics. The Acumen HPI feature is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring. The Acumen HPI feature is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter.

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 < 65 mmHg for one minute in duration) within 15 minutes, where zero (0) indicates low likelihood and one hundred (100) indicates high likelihood. The Acumen Hypotension Prediction Index, HPI, should not be used exclusively to treat patients. A review of the patient's hemodynamics is recommended prior to initiating treatment.

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 < 65 mmHg for at least one minute in duration) within 15 minutes. The Performance Data section states that "Clinical performance data were provided to demonstrate substantial equivalence of use of the Acumen™ Hypotension Prediction Index software."

The core performance attribute is the ability of the HPI to indicate the likelihood of a hypotensive event. The HPI values range from 0 (low likelihood) to 100 (high likelihood). While specific performance metrics like sensitivity, specificity, or AUC are not provided in this excerpt, the study aims to show that the performance in non-surgical patients is substantially equivalent to its established performance in surgical patients (as the predicate device, DEN160044, already had a grant decision).

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not specify the exact sample size for the test set. It only mentions that "Clinical performance data were provided."

Regarding data provenance:

• Country of origin of data: Not explicitly stated.
• Retrospective or prospective: Not explicitly stated.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not specify the number of experts used or their qualifications for establishing ground truth.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The focus of this 510(k) submission is on expanding the indications for use to non-surgical patients, demonstrating substantial equivalence to the predicate, rather than comparing AI-assisted performance against human readers.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone study was done. The Acumen HPI is described as software that "provides the clinician with physiological insight" and "is considered to be additional quantitative information...for reference only and no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter." This implies that the algorithm generates an output (the HPI score) independently, and its clinical performance data (as mentioned under "Performance Data") refers to this standalone algorithm's ability to predict hypotension.

7. Type of Ground Truth Used

The ground truth used for identifying a hypotensive event is clearly defined: mean arterial pressure (MAP) < 65 mmHg for at least one minute in duration. This is a physiological measurement, not expert consensus or pathology.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set. The submission is focused on demonstrating equivalence for an expanded indication, so information about the original training of the algorithm (which likely happened for the predicate device DEN160044) is not detailed here.

9. How Ground Truth for the Training Set Was Established

The document does not explicitly state how the ground truth for the training set was established, but it can be inferred that it would have used the same physiological definition of hypotension (MAP < 65 mmHg for at least one minute) that is used for the device's indications for use and performance evaluation. This would involve continuous monitoring of MAP in a patient population.

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