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The Mobile External Counter Pulsation System AngioNew-V is a mobile noninvasive external counter pulsation device for the treatment of patients suffering from congestive heart failure, stable or unstable angina pectoris, acute myocardial infarction and cardiogenic shock.

The Mobile External Counter Pulsation System AngioNew-V is a mobile noninvasive external counter pulsation device for the treatment of patients suffering from congestive heart failure, stable or unstable angina pectoris, acute myocardial infarction and cardiogenic shock.

The Living Data Technology AngioNew-V system consists of a central control unit and three pairs of inflatable cuffs that are wrapped respectively around a patient's calves, thighs and buttocks. External pressure is applied via the cuffs to the lower extremities of the patient in synchronization with the heartbeat. When the heart is in the relaxed state during diastolic period, pressure is applied sequentially from the distal to proximal extremities to force blood back to the heart, increase coronary perfusion pressure (diastolic augmentation) and, at the same time, increases coronary blood flow and enhances the development of coronary collateral circulation. Just before the heart starts ejecting blood during systolic period, air is quickly withdrawn from all cuffs simultaneously to remove all the external applied pressure, leaving behind empty vasculature in the lower extremities to receive the output of the heart, thereby reducing systolic pressure (systolic unloading) and the workload of the heart.

The AngioNew-V device, an external counterpulsation system, underwent non-clinical testing to demonstrate its substantial equivalence to a predicate device, AngioNew-IV. The provided summary focuses on safety and performance testing rather than a comparative effectiveness study involving human readers or a standalone algorithm performance study in the context of medical image analysis.

Here's an analysis based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy, or specific physiological thresholds). Instead, the acceptance criteria appear to be met by demonstrating compliance with various safety and design specifications, and by showing that the modified features of AngioNew-V do not introduce new questions of safety or effectiveness compared to the predicate device.

The reported device performance is qualitative, indicating that the device "meets all safety and EMC requirement, as well as all design specifications." Specifically, the non-clinical tests covered:

2. Sample Size for Test Set and Data Provenance

The document describes "non-clinical tests" and "bench testing" but does not specify a "test set" in the context of a dataset of patient cases. This implies a focus on device functionality and safety through engineering and laboratory testing rather than performance on a clinical dataset. Therefore, no sample size for a test set of patient data is provided, nor is data provenance (country of origin, retrospective/prospective) relevant here.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This study is not evaluating an AI or diagnostic device that relies on expert interpretation of medical data for ground truth establishment. It's a device safety and performance evaluation.

4. Adjudication Method

Not applicable. As the study does not involve expert interpretation of cases, no adjudication method is relevant.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes non-clinical and bench testing of the device's technological and functional characteristics, not a study evaluating human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Not applicable in the conventional sense of an algorithm's diagnostic performance. While the device incorporates a "control loop" and "software updates the inflation timing," a standalone study in the context of diagnostic algorithms (e.g., sensitivity, specificity of an AI identifying a condition) was not conducted or reported. The tests focused on the device's operational performance and safety.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests would have been established through engineering specifications, direct measurements, and compliance with recognized safety and performance standards (e.g., IEC, EN standards). For example:

• Safety standards: Direct verification that the device components and operation meet defined safety thresholds (e.g., electrical leakage, temperature limits).
• Design specifications: Measurement of device outputs (e.g., pressure, timing, heart rate detection accuracy) against predetermined design targets.
• Bench test results: Physical measurement of the device's response under various conditions (e.g., inflation/deflation timing accuracy, pressure regulation).

8. Sample Size for the Training Set

Not applicable. This document is for a medical device clearance (510(k)) that focuses on substantial equivalence for an external counterpulsation system, not on an AI algorithm that requires a "training set" for machine learning. The "software updates the inflation timing" suggests an internal algorithm, but the details of its development (and thus, a training set) are not provided in this summary.

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

Not applicable. As a training set for an AI algorithm is not discussed, the method for establishing its ground truth is also not mentioned.

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