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510(k) Data Aggregation
(265 days)
QAQ
Indications for Use: This device is intended for use in patients who are morbidly obese and have failed to lose weight with diet and exercise.
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Here's a breakdown of the acceptance criteria and study details for the Hypertension Prediction Index (HePI) Algorithm, based on the provided FDA 510(k) letter:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance (Minimally Invasive) | Reported Device Performance (Non-Invasive) |
|---|---|---|---|
| Sensitivity (%) | > 80% | 99.7% [99.6, 99.9] | 99.6% [99.1, 100.0] |
| Specificity (%) | > 80% | 93.7% [92.9, 94.3] | 91.6% [90.7, 92.5] |
Note: The reported performance is for the overall datasets (N=1813 for Minimally Invasive, N=1351 for Non-invasive). All sub-categories (surgical/non-surgical) also met the acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Minimally Invasive Sensor:
- US Patients: 1615 subjects
- OUS Patients: 198 subjects
- Total N: 1813 subjects
- Non-Invasive Finger Cuff:
- US Patients: 464 subjects
- OUS Patients: 887 subjects
- Total N: 1351 subjects
Data Provenance: The study used retrospective clinical data from multiple independent datasets. Data was collected from both US and OUS (Outside United States) patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The provided document does not specify the number of experts used or their qualifications for establishing the ground truth.
4. Adjudication Method for the Test Set
The provided document does not specify an adjudication method. The ground truth definition of a "hypertensive event" is clearly stated (MAP > 115 mmHg for at least 1 minute or MAP increase of > 20% when current MAP > 95 mmHg), suggesting an objective, pre-defined criterion rather than expert consensus on individual cases that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
The provided document does not indicate that an MRMC comparative effectiveness study was done. The focus is on the standalone performance of the algorithm.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone performance study was done. The results presented in Table 2 (AUC, Sensitivity, Specificity, PPV, NPV) are direct measures of the algorithm's performance in predicting hypertensive events based on retrospective clinical data, without human interaction.
7. The Type of Ground Truth Used
The ground truth used is defined by objective physiological measurements and thresholds:
A "hypertensive event" is defined as:
- Mean Arterial Pressure (MAP) greater than 115 mmHg for at least 1 minute OR
- A MAP increase of more than 20% when current MAP is greater than 95 mmHg.
8. The Sample Size for the Training Set
The provided document does not explicitly state the sample size for the training set. It mentions that "Algorithm performance was tested using retrospective clinical data" and "Prospective analyses of retrospective clinical data from multiple independent datasets...were analyzed to verify the safety and performance of the subject device," referring to the test sets.
9. How the Ground Truth for the Training Set Was Established
The provided document does not explicitly state how the ground truth for the training set was established. However, given the nature of the device and the ground truth definition for the test set, it is highly likely that the same objective physiological measurements and thresholds (MAP > 115 mmHg for at least 1 minute or MAP increase of > 20% when current MAP > 95 mmHg) were used to establish ground truth labels for the training data.
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(150 days)
QAQ
The Edwards Acumen Hypotension Prediction Index software feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events and the associated hemodynamics. The Acumen is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring. The Acumen HPI feature is considered to be additional quantitative information regarding the patient's physiological condition for reference only and is not intended to make therapeutic decisions solely on the Acumen Hypotension Prediction Index (HPI) parameter.
The Acumen Hypotension Prediction Index parameter (HPI) provides the clinician with the likelihood that the patient may be trending toward a hypotensive event. The Acumen HPI feature is intended for use in surgical or non-surgical patients. By default, the software defines a hypotensive event as mean arterial pressure (MAP)
The Edwards Acumen Hypotension Prediction Index (HPI) software feature was evaluated through algorithm verification and a usability study. The key aspects of the evaluation are as follows:
1. Acceptance Criteria and Reported Device Performance:
The document primarily focuses on verifying that the changes to the HPI algorithm (adjustable MAP targets) and the expansion to non-surgical patients did not negatively impact its safety and effectiveness. Specific numerical acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) are not explicitly stated in the provided text. Instead, the document states:
- "The results establish that the usage of the HPI algorithm with the adjustable Mean Arterial Pressure (MAP) targets for hypotension (55, 60, 70, 75, 80, 85 mmHg) did not adversely affect the safety and effectiveness of the subject device."
- "The usability study demonstrated that the intended users can perform primary operating functions and critical tasks of the system without any usability issues that may lead to patient or user harm."
Without specific performance metrics and their corresponding acceptance thresholds, a table of acceptance criteria versus reported performance cannot be fully constructed from the provided text. The overall reported performance is that the device meets the implicit acceptance criterion of not adversely affecting safety and effectiveness with the modifications.
2. Sample Size and Data Provenance for Test Set:
- Algorithm Verification: The algorithm verification was performed using "clinical data." For the expanded non-surgical indication, "non-surgical clinical data collected retrospectively" was used.
- Sample Size: The document does not specify the sample size for the clinical data used in the algorithm verification test set.
- Data Provenance: The data used for the non-surgical indication was "retrospectively" collected. The country of origin is not specified.
3. Number of Experts and Qualifications for Ground Truth:
The document does not provide information on the number of experts used or their qualifications for establishing the ground truth for the test set.
4. Adjudication Method:
The document does not specify any adjudication method used 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, nor does it provide any effect size of human readers improving with AI vs. without AI assistance. The HPI is an "Adjunctive Predictive Cardiovascular Indicator" providing "additional quantitative information" and is "not intended to make therapeutic decisions solely on the Acumen Hypotension Prediction Index (HPI) parameter," suggesting it is an aid rather than a replacement for human decision-making. However, the exact nature of human-in-the-loop studies, if any, is not detailed.
6. Standalone Performance:
Yes, a standalone (algorithm only) performance evaluation was done through the "Algorithm Verification" section. The verification confirmed that the modified algorithm, with adjustable MAP targets, did not adversely affect safety and effectiveness. This indicates an evaluation of the algorithm's performance independent of real-time human interaction.
7. Type of Ground Truth:
The ground truth used for algorithm verification appears to be based on observed "hypotensive events" defined by Mean Arterial Pressure (MAP) falling below user-defined thresholds (e.g.,
Ask a specific question about this device
(270 days)
QAQ
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
The Acumen Hypotension Prediction Index feature consists of software running on the Edwards Lifesciences HemoSphere Advanced Monitoring Platform paired with the Acumen IQ extravascular blood pressure transducer (K152980) and a peripheral arterial catheter. The monitoring system includes the Acumen Hypotension Prediction Index (HPI), and graphical user interface features displaying hemodynamic parameters relevant to assessing the root cause of a potential hypotensive event. The Acumen Hypotension Prediction Index is an index related to the likelihood of a patient experiencing hemodynamic instability defined as a hypotensive event* within 15 minutes, where zero (0) indicates low likelihood and one hundred (100) indicates a hypotensive event is occurring. The Acumen Hypotension Prediction Index parameter (HPI), should not be used exclusively to treat patients. A review of the patient's hemodynamics is recommended prior to initiating treatment. * A hypotensive event is defined as mean arterial pressure (MAP)
Here is the extracted information regarding the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Primary Effectiveness Endpoint) | Reported Device Performance (HPI Study) |
|---|---|
| Reduce the mean duration of intraoperative hypotension (defined as MAP |
Ask a specific question about this device
(146 days)
QAQ
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
The Acumen Hypotension Prediction Index Feature (DEN160044) consists of software running on the Edwards Lifesciences EV1000 Clinical Platform (DEN160044) and HemoSphere Advanced Monitoring Platform (K180881) paired with the FloTrac IQ or Acumen IQ extravascular blood pressure transducer (K152980) and a radial arterial catheter. The software includes the Acumen Hypotension Prediction Index (HPI), the Dynamic Arterial Elastance Parameter (Eadyn), the Systolic Slope Parameter (dP/dt), and additional graphical user interface features. The Acumen Hypotension Prediction Index is an index related to the likelihood of a patient experiencing a hypotensive event (defined as mean arterial pressure
Here's a breakdown of the acceptance criteria and study information for the Acumen Hypotension Prediction Index based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with specific numerical targets. However, the overall goal of the device, as described in the Indications for Use and Device Description, is to predict hypotensive events (MAP
Ask a specific question about this device
(536 days)
QAQ
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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