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510(k) Data Aggregation
(536 days)
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
| Metric | Acceptance Criteria (Implicit from Clinical Validation) | Reported Device Performance (N=52 Study) | Reported Device Performance (N=204 Study) |
|---|---|---|---|
| Sensitivity | High enough to be clinically useful | 83.7% [81.5, 86.0]% | 65.8% [63.7, 67.9]% |
| Specificity | High enough to avoid excessive false positives | 99.8% [99.4, 100.0]% | 99.4% [99.2, 99.7]% |
| AUC | High enough to indicate good discrimination | 0.95 | 0.88 |
| Positive Predictive Value (PPV) | (Not explicitly stated as AC, but evaluated) | 99.9% [99.7, 100.0]% | 98.3% [97.6, 99.0]% |
| Negative Predictive Value (NPV) | (Not explicitly stated as AC, but evaluated) | 75.1% [71.9, 78.4]% | 84.9% [83.9, 86.0]% |
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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(331 days)
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. 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 consists of Databox and Monitor components, which can be mounted to an IV pole. The EV1000 Clinical Platform measures patient physiologic parameters 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 Databox receives incoming signals from the patient through the connections provided by the accessories applied to the patient. The algorithms embedded in the Databox process the signals and provide parameter calculations.
The EV1000 Monitor is connected to the Databox via an ethernet cable. The Monitor is a touchscreen, panel PC with a graphical user interface (GUI). The Monitor displays the measured and calculated parameter values from the Databox.
The EV1000 Clinical Platform, when used with the VolumeView System, measures and/or calculates hemodynamic parameters such as: Manual-calibrated continuous parameters: cardiac output, cardiac index, stroke volume, stroke volume index, systemic vascular resistance, systemic vascular resistance index, and stroke volume. Manual-calibrated intermittent parameters: cardiac output, cardiac index, extravascular lung water, extravascular lung water index, global ejection fraction, global end-diastolic volume, global end-diastolic volume index, intrathoracic blood volume, pulmonary vascular permeability index, stroke volume, stroke volume index, systemic vascular resistance, and systemic vascular resistance index.
When connected to a FloTrac sensor, the EV1000 Clinical Platform continuously measures/calculates auto-calibrated arterial pressure cardiac output, cardiac index, stroke volume, stroke volume index, stroke volume variation, systemic vascular resistance, and systemic vascular resistance index.
When connected to Edwards oximetry sensors, the EV1000 Clinical Platform continuously measures/calculates oximetry parameters (specifically mixed venous oximetry (SvO2) and central venous oximetry (ScvO2).
Here's a breakdown of the acceptance criteria and the study information for the EV1000 Clinical Platform, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text for the EV1000 Clinical Platform is a 510(k) summary and approval letter, not a detailed study report with specific acceptance criteria and quantitative performance metrics. Therefore, a direct table of numerical "acceptance criteria" and "reported device performance" as one might find for accuracy or precision claims is not available in the provided text.
Instead, the acceptance criteria here are broad statements related to safety, effectiveness, and substantial equivalence to a predicate device. The device performance is described in terms of having "successfully passed functional and performance testing."
Here's how we can infer and represent the information:
| Acceptance Criteria Category | General Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Overall Equivalence | Device must be safe, effective, and substantially equivalent to the predicate device (EV1000 Clinical Platform, K110597) for its intended use in critical care environments. | "The EV1000 Clinical Platform has been shown to be safe, effective, and substantially equivalent to the cited predicate device for its intended use in critical care environments." and "The EV1000 Clinical Platform has been shown to be safe, effective, and is substantially equivalent to the cited predicate device for its intended use in critical care environments." (from Conclusion) |
| Functional & Performance | Device must meet functional and performance requirements. | "The EV1000 Clinical Platform has successfully passed functional and performance testing, including software verification and validation, mechanical and electrical testing, bench studies, pre-clinical animal studies, comparison testing of clinical cases, and clinical utility." |
| Comparative Analysis | Performance and functionality of the device should be comparable to the predicate device. | "Verification and validation testing was conducted to compare the performance and functionality of the EV1000 Clinical Platform to the predicate device. This testing regimen included side-by-side bench and pre-clinical studies, and comparative analysis of clinical data." |
| Intended Use | The device should perform as intended for measuring/calculating hemodynamic parameters (e.g., cardiac output, stroke volume, SVR, EVLW, GEF, GEDVI, ITBV, PVPI, SVV, SvO2/ScvO2) accurately and continuously/intermittently, and for analysis of thermodilution curves to determine fluid volumes, in critical care patients. | The description of the device details its capabilities to measure/calculate these parameters, indicating it is designed to meet these functional aspects of its intended use. The conclusion states it is substantially equivalent "for its intended use in critical care environments," implying it fulfills these functions adequately. (No specific numerical performance data for these parameters is present in the summary, just the assertion of successful testing and equivalence). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the provided text. The text mentions "comparison testing of clinical cases" and "comparative analysis of clinical data" but does not give a number of cases or patients.
- Data Provenance: Not explicitly stated regarding country of origin. The study included "bench studies, pre-clinical animal studies, comparison testing of clinical cases, and clinical utility." No indication if these were retrospective or prospective, or geographically where they were conducted.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable/Not stated. For a device like the EV1000 Clinical Platform, "ground truth" for its measurements (e.g., cardiac output, stroke volume) would typically be established by validated reference methods or the predicate device itself, not by a panel of human experts reviewing observational data.
- Qualifications of Experts: Not applicable/Not stated for the reason above.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/Not stated. Since the "ground truth" for this type of device is usually based on empirical measurements and comparison to a predicate, rather than subjective expert interpretation, an adjudication method for conflicting expert opinions is not relevant or described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described. MRMC studies are typically used for diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is measured. This device is a physiological monitoring platform, hence such a study design is not relevant here.
- Effect Size with AI vs. Without AI Assistance: Not applicable for the reasons above.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study
- Standalone Study: Yes, implicitly. The nature of the device (a cardiac output/oximetry computer) means its core function is to autonomously process signals and calculate parameters. The "functional and performance testing" and "bench studies" inherently evaluate the algorithms' performance in a standalone manner, separate from human interpretation of raw signals. The comparison to the predicate device also assesses the algorithm's output. While not explicitly termed a "standalone study," the entire evaluation process focuses on the device's algorithmic and hardware performance.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the EV1000 Clinical Platform would be derived from:
- Validated Reference Methods: For quantitative physiological parameters, this would involve comparing the device's measurements to established, gold-standard methods (though these specific methods are not detailed in the summary).
- Predicate Device Comparison: A significant part of the substantial equivalence claim relies on "side-by-side bench and pre-clinical studies, and comparative analysis of clinical data" against the EV1000 Clinical Platform, K110597 (the predicate). The measurements from the predicate device serve as the reference.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/Not stated. This summary describes a device that likely uses established physiological algorithms and signal processing, rather than a machine learning or AI model that requires a dedicated "training set" in the modern sense of deep learning. The algorithms are "embedded in the Databox." Therefore, there isn't a "training set" as one would discuss for, say, an image recognition AI. If any form of algorithm tuning or development data was used, it's not documented here.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable/Not stated for the same reasons as #8.
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