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The Edwards Lifesciences Acumen Hypotension Prediction Index (HPI) 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 ("the device") consists of software running on the Edwards Lifesciences EV1000 Platform (previously cleared under K100709, K110597, K131892. K140312, and K160552) paired with the FloTrac IQ extravascular blood pressure transducer (K152980) and a radial arterial catheter. The device includes the Hypotension Prediction Index (HPI), the Dynamic Arterial Elastance Parameter (Eagyn), the Left Ventricular Contractility Parameter (dP/dt), and additional graphical user interface features.

HPI is an index related to the likelihood of a patient experiencing a hypotensive event (defined as mean arterial pressure (MAP)

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state numerical acceptance criteria for sensitivity, specificity, and AUC. However, the reported performance metrics from the clinical validation studies demonstrate a level of accuracy deemed acceptable by the FDA for de novo classification. The high specificities and AUC values, along with the detailed performance table for different HPI ranges, suggest that the device's ability to predict hypotension within the 15-minute timeframe was considered sufficient. The acceptance criteria for usability testing (at least 80% of participants agree or strongly agree) are explicitly stated in the Usability Testing section.

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

The "test set" for the HPI algorithm's performance evaluation was derived from two retrospective patient databases:

• First Database (Edwards Lifesciences):
  • Sample Size: 52 subjects (OR patients)
  • Data Provenance: Global clinical sites, collected via prospective, IRB/EC approved clinical protocols with informed consent for each patient. (Retrospective analysis of prospectively collected data).
• Second Database (University Hospital):
  • Sample Size: 204 subjects (OR patients)
  • Data Provenance: From a university hospital, includes OR patients. (Retrospective analysis of an arterial waveform database).

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

The document does not specify the "number of experts" or their "qualifications" used to establish the ground truth for the test set.

Instead, the ground truth for hypotensive events was defined objectively: "mean arterial pressure (MAP)

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The EV1000 Clinical Platform NI and the ClearSightTM Finger Cuffs are indicated for patients over 18 years of age in which the balance between cardiac function, fluid status, and vascular resistance needs continuous assessment. The EV1000 Clinical Platform may be used for the monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol. In addition, the non-invasive system is indicated for use in patients with co- morbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The EV1000 Clinical Platform and the ClearSightTM finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.

The EV1000 Clinical Platform is indicated for use primarily for critical care patients in which the balance between cardiac function, fluid status and vascular resistance needs continuous or intermittent assessment. The EV1000 Clinical Platform may be used for the monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol. Analysis of the thermodilution curve in terms of mean transit time and the shape is used to determine intravascular and extravascular fluid volumes. When connected to an Edwards oximetry catheter, the monitor measures oximetry in adults and pediatrics. The EV1000 Clinical Platform may be used in all settings in which critical care is provided.

The EV1000 Clinical Platform measures patient physiologic parameters in a minimally invasive manner when it is used as a system with various Edwards' components, including the Edwards pressure transducers, the FloTrac sensor, the components of the VolumeView System, oximetry catheters/sensors, and the corresponding accessories applied to the patient.
The EV1000 Clinical Platform consists of the EV1000 Monitor (Monitor), the EV1000 Databox (Databox), and an Ethernet cable to connect the Databox to the Monitor. It may be attached to the patient bedside, an IV pole or roll stand.
The EV1000 Clinical Platform NI with ClearSight Finger Cuffs is a non- invasive monitor that enables the continuous assessment of a patient's hemodynamic function based on the scientific method of Peñàz - Wesseling. The device measures continuous non-invasive blood pressure (Systolic, Diastolic, and Mean Arterial Pressure) and pulse rate. Cardiac Output and other hemodynamic parameters are derived from the blood pressure waveform.
The EV1000 NI consists of the EV1000 monitor (EV1000M), the EV1000 Pump-Unit (Pump-Unit), a Pressure Controller (PC2) that is worn on the wrist, a Heart Reference Sensor (HRS), and the ClearSight™ Finger Cuffs. It may be attached to the patient bedside, an IV pole or roll stand.

This FDA 510(k) summary provides information for the EV1000 Clinical Platform NI with ClearSight™ Finger Cuffs or ClearSight™ System.

Here's an analysis of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document summarizes the clinical study as demonstrating substantial equivalence to the predicate device. However, it does not explicitly list specific numerical acceptance criteria (e.g., accuracy thresholds, precision ranges) for individual hemodynamic parameters, nor does it provide a precise table of the device's reported performance against such criteria. The "Comparative Analysis" and "Functional/Safety Testing" sections state that the device's performance and functionality were compared to the predicate device, and the device was shown to be "safe, effective, and substantially equivalent."

Therefore, I cannot populate a table with specific numerical acceptance criteria and reported device performance from the provided text. The evaluation focused on substantial equivalence rather than meeting pre-defined numerical thresholds for accuracy or precision.

2. Sample Size and Data Provenance for the Test Set

• Sample Size for the Test Set (Clinical Study): The document states that "an evaluation of archived clinical data demonstrated that the device is substantially equivalent to the cited predicate device." It also mentions "a clinical study" in the "Comparative Analysis" section. However, the exact sample size (number of patients or data points) for this clinical study or the evaluation of archived data is not specified in the provided text.
• Data Provenance (e.g., country of origin, retrospective or prospective): The document refers to "archived clinical data," which implies a retrospective evaluation. The country of origin of this data is not specified.

3. Number of Experts and Their Qualifications for Ground Truth

The document does not mention the involvement of experts (e.g., radiologists) to establish ground truth for the test set. Instead, it refers to the device measuring blood pressure and deriving hemodynamic parameters based on the "scientific method of Peñàz - Wesseling" and comparison to a predicate device. This suggests that the "ground truth" or reference standard for comparison would likely be the measurements obtained from the predicate device or a clinical gold standard for blood pressure measurement, not expert consensus on image interpretation.

4. Adjudication Method for the Test Set

Since the establishment of ground truth by multiple experts is not mentioned, an adjudication method is not applicable and therefore not described in the provided text.

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

An MRMC study is relevant for devices that involve human interpretation, such as AI for medical imaging. The EV1000 Clinical Platform NI with ClearSight™ Finger Cuffs is a hemodynamic monitoring device, not an imaging device that requires human interpretation in the same way. Therefore, an MRMC comparative effectiveness study was not performed, nor is it applicable to this type of device based on the information provided. The study focused on device performance and functionality comparison with a predicate, not how human readers improve with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

The device described, the EV1000 Clinical Platform NI, is a continuous monitoring system that directly measures and derives physiological parameters. Its performance, as described, is its standalone performance without explicit human intervention in the real-time measurement or derivation of parameters. The "Functional/Safety Testing" included "software verification and validation, mechanical and electrical testing, and bench studies," which would assess its standalone operational accuracy. The evaluation of archived clinical data also represents a standalone assessment of the device's output against a reference. Therefore, yes, its performance described is essentially its standalone (algorithm only) performance.

7. Type of Ground Truth Used

The type of ground truth used for comparison during the "clinical study" and "evaluation of archived clinical data" was likely:

• Measurements from the predicate device (K140312 – EV1000 Clinical Platform™ NI with ClearSight™ Finger Cuffs or ClearSight™ System).
• A clinically established gold standard for blood pressure and hemodynamic parameter measurement, which the predicate device itself would have been compared against during its clearance. This could involve invasive arterial line measurements for blood pressure or other established methods for cardiac output and fluid volume assessment not explicitly detailed in this summary.

8. Sample Size for the Training Set

The document focuses on the evaluation of the device, which typically refers to testing its performance rather than training an AI model. While the device uses a "scientific method" (Peñàz - Wesseling) and derives parameters, there is no mention of an AI algorithm that was "trained" on a specific dataset as would be the case for machine learning devices. Therefore, a "training set" for an AI algorithm is not explicitly mentioned or applicable in the context presented.

9. How Ground Truth for the Training Set Was Established

As there is no mention of a training set for an AI algorithm, the method for establishing its ground truth is not provided.

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