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EV1000 Clinical Platform (EV1000A):

The EV 1000 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 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

EV1000 Clinical Platform (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 Prediction Index (HPI) feature, which 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:

The provided document describes a 510(k) submission for modifications to existing devices (EV1000 Clinical Platform and EV1000 Clinical Platform NI) rather than a new device requiring extensive performance acceptance criteria for clinical efficacy. The primary purpose of this submission is a "Special 510(k) Corrective Action Being Effected" to address issues related to fluid exposure and power adapter orientation. Therefore, the acceptance criteria and performance reported are focused on the safety and functional integrity of these modifications.

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

The document does not provide specific sample sizes for a "test set" in the context of clinical performance evaluation (e.g., patient numbers for diagnostic accuracy). Instead, it refers to "Design Verification testing" and "functional and bench studies" which are typically focused on engineering and safety validation, rather than clinical trials with patient cohorts.

• Sample Size for Test Set: Not explicitly stated in terms of patient numbers. The testing appears to be focused on bench and functional validation of the hardware changes.
• Data Provenance: Not specified, but given the nature of the modifications (hardware ingress protection, labeling), the testing would typically be conducted by the manufacturer in a controlled lab environment. There is no indication of clinical data from specific countries or whether it was retrospective or prospective.

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

This information is not applicable to the type of safety and functional testing described. The "ground truth" for the acceptance criteria outlined above would be established through engineering specifications, regulatory standards for ingress protection (e.g., IP ratings), and functional performance benchmarks, rather than expert clinical consensus.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where expert reviewers evaluate performance against a golden standard. For hardware and functional testing, the "adjudication" is based on objective measurements and compliance with engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not performed. The submission focuses on hardware modifications and labeling changes to address safety concerns, not on assessing reader performance or the clinical interpretation of the device's outputs.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. The EV1000 Clinical Platforms are medical monitoring devices that generate physiological parameters for clinicians. The "Acumen Hypotension Prediction Index" (HPI) feature is an algorithm that provides "additional quantitative information regarding the patient's physiological condition for reference only," explicitly stating "no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter." This indicates it's designed to be used with human interpretation, not as a standalone diagnostic or therapeutic tool. The current submission, however, is not about the HPI's performance but modifications to the physical device.

7. The Type of Ground Truth Used:

For the EV1000A, the "ground truth" for the corrected issue (power adapter orientation) is simply the correct physical orientation as defined by engineering and safety standards, communicated via labeling.

For the EV1000NI, the "ground truth" for the corrected issue (liquid ingress) would be objective measurements of liquid ingress (e.g., in milliliters or by visual inspection for presence of liquid) compared against a pre-defined acceptance threshold that demonstrates adequate protection, typically derived from engineering and safety standards (e.g., IEC 60601-1, IP ratings).

8. The Sample Size for the Training Set:

Not applicable. This submission is for modifications to existing cleared devices, not for the development or training of a new algorithm or AI model. The Acumen HPI, which does involve an algorithm, was part of a prior submission (K183646) and would have had its own training and validation data, but that is not the subject of this specific 510(k).

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

Not applicable, as there is no mention of a training set for this specific 510(k) submission.

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