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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. Monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol enables consistent in the intended patient populations. 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 Edwards Lifesciences Acumen Hypotension 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 nonsurgical 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 EV1000 Clinical Platform NI and the ClearSight finger cuffs are indicated for patients over 18 years of age in which the balance between cardiac fluid status and vascular resistance needs continuous assessment. The EV 1000 Clinical Platform may be used for the monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol. In addition, the noninvasive system is in patients with comorbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The EV1000 Clinical Platform NI and the ClearSight finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.

EV1000A:
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 includes an Acumen Hypotension Index (HPI) feature, which is an index related to the likelihood of a patient experiencing a hypotensive event (defined as mean arterial pressure (MAP) < 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.

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.

No changes were made directly to the EV1000A system (i.e. Databox). However, since the monitor (EV1000M) is shared by the both platforms (EV1000N), the new software updates, Fluid Responsiveness Test feature, enhanced cybersecurity, and data download option to the EV1000NI impacted the EV1000A platform. Additionally, dP/dt, Eadyn, and PPV as key parameters, as well as minor updates to the graphic user interface to the key parameters and secondary screens were reflected in the operator's manual. All of these software changes reside in the EV1000 monitor.

EV1000NI:
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), a Pressure Controller (PC2K or PC2) that is worn on the wrist, a Heart Reference Sensor (HRS), and Edwards ClearSight finger cuffs (It may be attached to the patient bedside, an IV pole or roll stand.

Software modifications were made to support new features such as Fluid Response Interpretation. Blood Pressure Calibration, ClearSight Workflow Options, Focused Screens, enhanced error messaging/help screens, finger cuff brand recognition, enhanced cybersecurity updates, data download options, and Heart Reference Sensor (HRS) EEPROM update were included as part of this submission.

The provided text does not contain specific acceptance criteria with numerical thresholds or detailed study results for device performance related to specific clinical metrics. Instead, it describes general verification and validation activities conducted for software modifications and system functionality.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria with specific performance metrics and their corresponding reported values. It generally states that "All tests passed" and that the device "meet their predetermined design and performance specifications."

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

The document mentions "retrospective data analysis for algorithm and performance verification" but does not specify the sample size for this analysis nor the country of origin. It also does not explicitly state whether the test set was retrospective or prospective, though the mention of "retrospective data analysis" suggests a retrospective component.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

The document mentions "an assessment by clinicians of its usability and human factors considerations" for usability testing. However, it does not specify the number of experts used to establish ground truth for any of the performance verification, nor their qualifications.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) 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 comparing human readers with and without AI assistance. This type of study seems irrelevant given the device's function as a monitoring platform rather than an AI-assisted diagnostic tool for image interpretation.

6. Standalone (Algorithm Only) Performance Study:

The document mentions that "Measured and derived parameters were tested using a bench simulation" and "individual components were tested at a sub-system level" and "integrated as a system and verified for their safety and effectiveness." This implicitly describes standalone (algorithm-only) performance testing against simulations and individual component verification. However, it does not provide detailed numerical results or specific performance metrics from these standalone tests.

7. Type of Ground Truth Used:

The ground truth for the verification activities appears to be based on:

• Predetermined design and performance specifications: The document states that the device "meet their predetermined design and performance specifications."
• Bench simulation: Used for testing "measured and derived parameters."
• Comparison to predicate devices: The submission aims to demonstrate substantial equivalence to predicate devices.

8. Sample Size for the Training Set:

The document does not mention a training set or its sample size. The submission focuses on software modifications and verification, and if any machine learning algorithms were involved (e.g., for the Acumen HPI feature which was previously cleared), the details of their training are not part of this specific submission summary. The Acumen HPI feature itself was cleared in a separate submission (K183646), and this submission for K203131 only notes minor updates to its display.

9. How Ground Truth for the Training Set Was Established:

Since a training set is not mentioned in this document, the method for establishing its ground truth is not provided.

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