(29 days)
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 Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure
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)
This document is a 510(k) premarket notification for the Edwards Lifesciences EV1000 Clinical Platform. It describes a corrective action related to a hardware change in the AC inlet to prevent liquid ingress. The primary focus of the provided text is on demonstrating the safety and substantial equivalence of this modified device to a previously cleared predicate device, specifically regarding the hardware change.
Therefore, the study information requested (acceptance criteria related to device performance, sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance, and training set details) is not detailed in this document. The document describes a design verification test for a hardware modification, not a clinical performance study of a device feature like the Acumen Hypotension Index (HPI).
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: The document states that "a reduction in occurrences of liquid ingress at the AC inlet was achieved." This implies an acceptance criterion related to reducing liquid ingress, but specific quantitative targets (e.g., maximum ingress rate, number of failures allowed) are not provided.
- Reported Device Performance: The document states that the device "successfully passed functional and bench studies to demonstrate that the device is substantially equivalent to the cited predicate device and the Power Adapter Cover reduces the possibility of fluid ingress." Again, specific quantitative performance metrics (e.g., exact reduction percentage, ingress test results) are not provided.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document mentions "functional and bench studies" but does not detail the number of units tested.
- Data Provenance: Not specified, but given it's bench testing for a hardware modification, it would be laboratory data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable for this type of hardware verification study. "Ground truth" in the context of device performance, specifically for preventing liquid ingress, would be determined by physical measurements and observations during bench testing, not expert consensus.
4. Adjudication Method for the Test Set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for interpreting clinical data or images, not for bench testing hardware modifications.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC study was not done. This document pertains to a hardware modification for liquid ingress prevention, not the clinical performance or AI features of the device. The "Acumen Hypotension Index (HPI) feature" is mentioned as part of the overall device, but this submission is not a study of its effectiveness. It's a special 510(k) for a corrective action related to a physical design change.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not explicitly stated, but not applicable. This document describes a hardware change, not an evaluation of an algorithm's standalone performance. While the HPI is an algorithm, its performance evaluation is not the subject of this specific submission.
7. The type of ground truth used:
- For the liquid ingress test, the ground truth would be physical observation and measurement of liquid ingress during bench testing, as per relevant standards (e.g., IPX ratings).
8. The sample size for the training set:
- Not applicable. This document describes verification testing for a hardware change, not an AI model's training.
9. How the ground truth for the training set was established:
- Not applicable.
In summary, this 510(k) submission addresses a specific hardware modification for liquid ingress and demonstrates its safety and substantial equivalence through functional and bench studies. It does not contain the detailed clinical study information that would typically be provided for evaluating the performance of a diagnostic or predictive algorithm like the Acumen Hypotension Index. For such details, one would need to refer to separate 510(k)s or clinical trial reports specifically for those features.
§ 870.1435 Single-function, preprogrammed diagnostic computer.
(a)
Identification. A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.(b)
Classification. Class II (performance standards).