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The Mobile External Counter Pulsation System AngioNew-IV is a non-invasive external counter pulsation device intended for use in the treatment of patients with congestive heart failure, stable or unstable angina pectoris, acute myocardial infarction or cardiogenic shock.

The Mobile External Counter Pulsation System AngioNew-IV 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 Technologies AngioNew-IV system consists of a central control unit and three pairs of inflatable/deflatable 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 diatolic period, pressure is applied sequentially from calves to thighs and then to buttocks to force blood back to the hear, increase coronary perfusion pressure (diatolic and augmentation) and, at the same time, increases coronary blood flow and enchances the development of coronary collateral circulation. Just before the heart starts eiecting blood during systolic period, air is quickly withdrawn from all cuffs simultaneously to remove all the external applied pressure, leaving behind empty vasculature in the lower extremities to receive the output of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.

Here's an analysis of the provided text regarding the acceptance criteria and study for the AngioNew-IV device:

1. Table of Acceptance Criteria & Reported Device Performance

The provided 510(k) summary focuses on non-clinical testing to demonstrate substantial equivalence, rather than a clinical study with detailed performance metrics against specific acceptance criteria. The "acceptance criteria" are more implicitly defined by the successful completion of these non-clinical tests and the device operating within expected parameters.

Study That Proves the Device Meets Acceptance Criteria:

The study described is primarily a non-clinical bench testing study, not a clinical trial. The purpose was to demonstrate substantial equivalence to predicate devices (Vasogenics EECP-MC2, Vasomedical EECP®MC-2, Beit Hapa'amon AECP-A) by showing that differences in certain components (inflation/deflation timing control, valves, cuff dimensions, and use of artery plethysmography) do not result in changes to safety, effectiveness, intended use, precautions, or contraindications.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify a "sample size" in terms of patients or a dataset for clinical evaluation. The testing performed was bench testing of the device's functional components.
• Data Provenance: Not applicable as it was non-clinical bench testing. There is no information about country of origin or whether it was retrospective/prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

• This information is not provided as the study was non-clinical bench testing. Ground truth, in the sense of expert consensus on patient data, was not established for this type of test. The "ground truth" for these tests would be the established engineering specifications and performance of the predicate devices.

4. Adjudication Method for the Test Set

• An adjudication method is not applicable as the study was non-clinical bench testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission focuses on engineering and performance testing for substantial equivalence to predicate devices, not on a clinical comparison of human reader performance with and without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This is not an AI device in the context of image analysis or diagnostic algorithms. Therefore, the concept of "standalone performance" of an algorithm is not directly applicable. The device's critical functions (ECG signal processing, QRS detection, timing of inflation/deflation) can be seen as the "algorithm only" aspects, and their performance was tested on the bench.

7. The Type of Ground Truth Used

• The "ground truth" for this non-clinical testing was based on:
  • Engineering specifications and operational parameters of the predicate devices.
  • Established standards for electrical safety (IEC 60601-1) and EMC (IEC 60601-1-2, EN 55011, etc.).
  • The expected output and timing of the device's critical functions as designed to mimic the predicate devices.

8. The Sample Size for the Training Set

• This is not applicable. The AngioNew-IV device is not described as utilizing machine learning or AI that requires a "training set" in the conventional sense. Its functionality is based on pre-programmed logic for physiological monitoring and control.

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

• This is not applicable for the same reasons as #8.

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