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The Edwards Acumen Hypotension Prediction Index software feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events and the associated hemodynamics. The Acumen 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 is not intended to make therapeutic decisions solely on the Acumen Hypotension Prediction Index (HPI) parameter.

The Acumen Hypotension Prediction Index parameter (HPI) provides the clinician with the likelihood that the patient may be trending toward a hypotensive event. The Acumen HPI feature is intended for use in surgical or non-surgical patients. By default, the software defines a hypotensive event as mean arterial pressure (MAP)

The Edwards Acumen Hypotension Prediction Index (HPI) software feature was evaluated through algorithm verification and a usability study. The key aspects of the evaluation are as follows:

1. Acceptance Criteria and Reported Device Performance:

The document primarily focuses on verifying that the changes to the HPI algorithm (adjustable MAP targets) and the expansion to non-surgical patients did not negatively impact its safety and effectiveness. Specific numerical acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) are not explicitly stated in the provided text. Instead, the document states:

• "The results establish that the usage of the HPI algorithm with the adjustable Mean Arterial Pressure (MAP) targets for hypotension (55, 60, 70, 75, 80, 85 mmHg) did not adversely affect the safety and effectiveness of the subject device."
• "The usability study demonstrated that the intended users can perform primary operating functions and critical tasks of the system without any usability issues that may lead to patient or user harm."

Without specific performance metrics and their corresponding acceptance thresholds, a table of acceptance criteria versus reported performance cannot be fully constructed from the provided text. The overall reported performance is that the device meets the implicit acceptance criterion of not adversely affecting safety and effectiveness with the modifications.

2. Sample Size and Data Provenance for Test Set:

• Algorithm Verification: The algorithm verification was performed using "clinical data." For the expanded non-surgical indication, "non-surgical clinical data collected retrospectively" was used.
• Sample Size: The document does not specify the sample size for the clinical data used in the algorithm verification test set.
• Data Provenance: The data used for the non-surgical indication was "retrospectively" collected. The country of origin is not specified.

3. Number of Experts and Qualifications for Ground Truth:

The document does not provide information on the number of experts used or their qualifications for establishing the ground truth for the test set.

4. Adjudication Method:

The document does not specify any adjudication method used for the test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide any effect size of human readers improving with AI vs. without AI assistance. The HPI is an "Adjunctive Predictive Cardiovascular Indicator" providing "additional quantitative information" and is "not intended to make therapeutic decisions solely on the Acumen Hypotension Prediction Index (HPI) parameter," suggesting it is an aid rather than a replacement for human decision-making. However, the exact nature of human-in-the-loop studies, if any, is not detailed.

6. Standalone Performance:

Yes, a standalone (algorithm only) performance evaluation was done through the "Algorithm Verification" section. The verification confirmed that the modified algorithm, with adjustable MAP targets, did not adversely affect safety and effectiveness. This indicates an evaluation of the algorithm's performance independent of real-time human interaction.

7. Type of Ground Truth:

The ground truth used for algorithm verification appears to be based on observed "hypotensive events" defined by Mean Arterial Pressure (MAP) falling below user-defined thresholds (e.g.,

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