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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

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)

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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