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510(k) Data Aggregation
(265 days)
Hypertension Prediction Index (HePI) Algorithm
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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