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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 <90 mmHg or mean arterial pressure (MAP) <70 mmHq) combined with tachycardia (heart rate ≥ 100 bpm).

AHI-PI provides the clinician with physiological insight into a patient's likelihood of a future episode of HI. An episode of HI is defined as 10 continuous minutes or more where HI is present.

The goal of this adjunctive monitoring method is to enable identification of patients who are showing HI or are likely to experience a future episode of HI, and to allow clinicians an opportunity to increase vigilance. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.

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.

2. 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 <90 mmHg or mean arterial pressure (MAP) <70 mmHg) combined with tachycardia (heart rate ≥ 100 bpm)." This operational definition of HI serves as the clinical definition/outcome data that the AHI system aims to detect or predict. It's likely this definition would form the basis of the ground truth if a study were conducted, but the document does not explicitly state how this ground truth was used or established in a specific test set or if it was verified by experts.

8. Sample Size for the Training Set

The provided text does not specify the sample size for any training set used for the algorithm.

9. How the Ground Truth for the Training Set Was Established

The provided text does not explain how the ground truth for any training set was established.

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