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510(k) Data Aggregation
(171 days)
Cerebral Adaptive Index (CAI) Algorithm
Cerebral Adaptive Index (CAI) Algorithm is an informational index to help assess the level of coherence or lack thereof between Mean Arterial Pressure (MAP) and the Absolute Levels of Blood Oxygenation (StO2) in patient's cerebral tissue. MAP is acquired by the HemoSphere Pressure Cable and StO2 is acquired by the ForeSight Oximeter Cable.
CAI is intended for use in patients over 18 years of age receiving advanced hemodynamic monitoring.
CAI is not indicated to be used for treatment of any disease or condition and no therapeutic decisions should be made based solely on the Cerebral Adaptive Index (CAI) Algorithm.
Cerebral Adaptive Index (CAI) Algorithm is a derived parameter that quantifies the dynamic relationship between two existing hemodynamic parameters, Mean Arterial Pressure (MAP) and the Absolute Levels of Blood Oxygenation Saturation (StO2) in the cerebral tissue. CAI is intended to show the level of coherence between MAP and cerebral StO2. The output will be represented as an index value and a trended graph.
MAP is acquired from the HemoSphere Pressure Cable (initially cleared in K180881 on November 16, 2018). StO2 used for computing CAI is acquired from the ForeSight Oximeter Cable (cleared in K201446 on October 1, 2020).
The CAI parameter can enhance clinician's understanding of the underlying hemodynamic changes behind cerebral desaturation events. It helps the clinician recognize/ identify possible causes of, for example, decrease in StO2 and clinical events related to StO2 decrease (e.g., hypotension as opposed to inadequate oxygen content).
CAI will be continuously displayed at 20-second rate. The parameter will not have any alarm ranges and will only be represented as a number with a range between 0 to 100. A high CAI value (CAI ≥45) means that MAP and StO2 have a greater coherence and informs the clinician that alterations in MAP may result in concomitant changes in cerebral oxygen saturation Whereas a low CAI value (CAI
Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria and Device Performance Study for Cerebral Adaptive Index (CAI) Algorithm
The Cerebral Adaptive Index (CAI) Algorithm is an informational index designed to assess the coherence between Mean Arterial Pressure (MAP) and Absolute Levels of Blood Oxygenation (StO2) in cerebral tissue.
1. Acceptance Criteria and Reported Device Performance
The performance goals for the CAI algorithm were established using a CAI threshold of 45.
| Acceptance Criteria | Reported Device Performance at CAI Threshold of 45 |
|---|---|
| Sensitivity ≥ 80% | 0.84 [0.78, 0.88] (84%) |
| Specificity ≥ 80% | 0.80 [0.76, 0.85] (80%) |
| ROC AUC (summarizes overall performance) | 0.88 [0.85, 0.90] |
Conclusion: The device met all pre-defined acceptance criteria for sensitivity, specificity, and ROC AUC at the specified CAI threshold of 45.
2. Sample Size and Data Provenance for Test Set
- Sample Size: 145 subjects aged 18 or older.
- Data Provenance: Retrospectively obtained from four different clinical sites within the US:
- Northwestern University, Chicago
- UC Davis, Sacramento
- University of Minnesota, Minneapolis
- Stanford University, Stanford
- Patient Characteristics: Adult surgical patients (cardiac surgery, general surgery, and surgical ICU) whose StO2 (via Foresight Sensors) and MAP (via Flotrac Sensors) were being monitored. Patients were randomly selected.
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state the number of experts or their qualifications used to establish the ground truth.
4. Adjudication Method for Test Set
The document does not explicitly state an adjudication method. The ground truth was based on the Pearson's Correlation Coefficient (Corr) between MAP and StO2 from the clinical data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not mentioned in the provided text. The study focused on the standalone performance of the algorithm.
6. Standalone (Algorithm Only) Performance
Yes, a standalone performance study was conducted. The reported sensitivity, specificity, and ROC AUC values are for the CAI Algorithm operating without human intervention, based on the retrospective clinical data.
7. Type of Ground Truth Used
The ground truth was established by classifying the relationship between MAP and StO2 using the Pearson's Correlation Coefficient (Corr) from the utilized time-series clinical data.
- Weak/Moderate MAP-StO2 association: 0
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