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510(k) Data Aggregation
(536 days)
Acumen Hypotension Prediction Index (HPI) Feature Software
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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