(79 days)
The AHI System is intended for use by healthcare professionals managing patients 18 years or older who are receiving continuous physiological monitoring with electrocardiography (ECG) in hospitals.
AHI provides a frequently updated binary output over time based on pattern analysis of a lead-II ECG waveform intended to describe a patient's hemodynamic status and indicate if a patient is showing signs of hemodynamic stability or instability. Signs of hemodynamic instability (HI) are defined as hypotension (systolic blood pressure
The AHI System is a multiparameter system designed to meet clinicians' need to identify patient hemodynamic status and predict patient hemodynamic instability episodes using two analytics:1. Analytic for Hemodynamic Instability (AHI): Utilizing data from a single existing lead of a non-invasive electrocardiograph (ECG), AH analyzes heart rate variability (HRV) and ECG morphology features to rapidly detect signs of hemodynamic stability and categorize each window of data as either "AHI Stable" or "AHI Unstable." Time trending of AHI outputs is also provided.
- Analytic for Hemodynamic Instability Predictive Indicator (AH-P); Utilizing AH outputs from up to the most recent 30 minutes of EG data, AH-PI indicates the likelihood of a future episode of hemodynamic instability, defined as ten continuous minutes or more where signs of hemodynamic instability are present.
The provided text details the FDA clearance for the AHI System (v 2.2.0) and references a previous version (K212219) as the predicate device. However, the document primarily focuses on regulatory approval and equivalence, not on a detailed study proving the device meets specific acceptance criteria with performance metrics, sample sizes, expert qualifications, or ground truth establishment.
Therefore, many of the requested details about the study proving the device meets acceptance criteria are not present in the provided text. The text only vaguely refers to "Software: Software verification and validation testing were conducted and documentation was provided... Testing was conducted to ensure the AHI System works as designed." This is insufficient to populate the requested table and further study details.
Based on the provided text, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not include a table of acceptance criteria or reported device performance metrics such as sensitivity, specificity, or AUC for the AHI System (v 2.2.0) or its predicate. It only states the device "works as designed" following software V&V.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample size used for any test set or the provenance (e.g., country of origin, retrospective/prospective) of the data.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
The provided text does not mention the number or qualifications of experts used to establish ground truth for any test set.
4. Adjudication Method for the Test Set
The provided text does not describe any adjudication method (e.g., 2+1, 3+1, none) for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided text does not indicate that an MRMC comparative effectiveness study was done, nor does it provide any effect size for human reader improvement with or without AI assistance.
6. Standalone Performance Study
While the device's function (AHI and AHI-PI) is described as "pattern analysis of a lead-II ECG waveform" to indicate hemodynamic status and predict instability, the document does not provide the results of a standalone (algorithm only) performance study with specific metrics. It states "Testing was conducted to ensure the AHI System works as designed," which is a high-level statement without data.
7. Type of Ground Truth Used for the Test Set
The "Signs of hemodynamic instability (HI)" are defined within the Indications for Use as "hypotension (systolic blood pressure
§ 870.2220 Adjunctive hemodynamic indicator with decision point.
(a)
Identification. An adjunctive hemodynamic indicator with decision point is a device that identifies and monitors hemodynamic condition(s) of interest and provides notifications at a clinically meaningful decision point. This device is intended to be used adjunctively along with other monitoring and patient information.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Software description, verification, and validation based on comprehensive hazard analysis and risk assessment must be provided, including:
(i) Full characterization of technical parameters of the software, including algorithm(s);
(ii) Description of the expected impact of all applicable sensor acquisition hardware characteristics on performance and any associated hardware specifications;
(iii) Specification of acceptable incoming sensor data quality control measures;
(iv) Mitigation of impact of user error or failure of any subsystem components (signal detection and analysis, data display, and storage) on output accuracy; and
(v) The sensitivity, specificity, positive predictive value, and negative predictive value in both percentage and number form for clinically meaningful pre-specified time windows consistent with the device output.
(2) Scientific justification for the validity of the hemodynamic indicator algorithm(s) must be provided. Verification of algorithm calculations and validation testing of the algorithm must use an independent data set.
(3) Usability assessment must be provided to demonstrate that risk of misinterpretation of the status indicator is appropriately mitigated.
(4) Clinical data must support the intended use and include the following:
(i) The assessment must include a summary of the clinical data used, including source, patient demographics, and any techniques used for annotating and separating the data;
(ii) Output measure(s) must be compared to an acceptable reference method to demonstrate that the output represents the measure(s) that the device provides in an accurate and reproducible manner;
(iii) The data set must be representative of the intended use population for the device. Any selection criteria or limitations of the samples must be fully described and justified;
(iv) Where continuous measurement variables are displayed, agreement of the output with the reference measure(s) must be assessed across the full measurement range; and
(v) Data must be provided within the clinical validation study or using equivalent datasets to demonstrate the consistency of the output and be representative of the range of data sources and data quality likely to be encountered in the intended use population and relevant use conditions in the intended use environment.
(5) Labeling must include the following:
(i) The type of sensor data used, including specification of compatible sensors for data acquisition, and a clear description of what the device measures and outputs to the user;
(ii) Warnings identifying factors that may impact output results;
(iii) Guidance for interpretation of the outputs, including warning(s) specifying adjunctive use of the measurements;
(iv) Key assumptions made in the calculation and determination of measurements; and
(v) A summary of the clinical validation data, including details of the patient population studied (
e.g., age, gender, race/ethnicity), clinical study protocols, and device performance with confidence intervals for all intended use populations.