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The External Counterpulsation System, Soulaire device is intended for the treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization. In addition, it is intended for use in healthy patients to provide improvement in vasodilation, and increased blood flow. It is intended for use under the oversight of a healthcare professional.

The External Counterpulsation System, Soulaire device has similar design to the External Counterpulsation System Model ECP-MC3.

The Soulaire system is computer-controlled system that inflates and deflates three pairs of air cuffs in synchronization with the patient's cardiac cycle. The three pairs of cuffs are wrapped around the calves, lower thighs, and upper thighs/buttocks of the patients. As diastde begins, the cuffs inflate separately in sequence from the calves, to the lower thighs, to the upper thighs including the lower buttocks. This inflation sequence generates and impels a counter-pulsation wave, increasing diastolic blood pressure (diastolic augmentation), coronary perfusion pressure and coronary blood flow, and raising cardiac output.

The start of inflation, deflation and cuff pressure can be adjusted by the operator. The system will deflate simultaneously before systole, this will reduce the heart's workload and resistance of blood vessel.

Before ECP treatment, ECG electrodes and Finger Clip plethysmograph Sensor are placed on the patient. The ECG waveform is used to generate triggering signals for cuff inflation and deflation. The plethysmograph waveform is used to monitor the proper timing of the inflation cycle and to indicate the effect of ECP treatment on patient homodynamic.

This FDA 510(k) summary does not contain information about acceptance criteria or specific study results for the Soulaire External Counterpulsation System.

The document indicates that the Soulaire device is a modification of a previously cleared predicate device (ECP-MC3, K190683). The modifications described are primarily related to external structure (adding storage drawers, a keyboard tray, an integrated cool air outlet), changes in dimensions and weight, and a software company logo change.

Crucially, the document states that these modifications did not result in changes to the technological characteristics or performance of the device. Therefore, the submission leverages performance and electrical testing from the previous submission (K190683) and concludes that "Clinical performance is not deemed necessary."

This means:

1. Acceptance criteria and reported device performance: Not applicable from this document, as no new performance data was generated for the modified device. The document asserts that the modified device's performance is equivalent to the predicate.
2. Sample size for test set and data provenance: No new test set data or studies are presented.
3. Number and qualifications of experts for ground truth: Not applicable.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not conducted or reported in this document.
6. Standalone (algorithm only) performance: Not applicable, as this device is not an algorithm-only diagnostic device. It's a therapeutic medical device for physical counterpulsation.
7. Type of ground truth used: Not applicable.
8. Sample size for training set: Not applicable.
9. How ground truth for training set was established: Not applicable.

In essence, the Soulaire device's clearance is based on its similarity to a previously cleared device, with the argument that the minor changes do not impact safety or effectiveness. Therefore, no new clinical or performance studies were provided for this specific 510(k) submission. To understand the original acceptance criteria and studies for the predicate device (ECP-MC3, K190683), one would need to refer to its 510(k) submission documentation.

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The ECP-MC3 device is intended for the treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization. It is intended for use in healthy patients to provide improvement in vasodilation, and increased blood flow. It is intended for use under the oversight of a healthcare professional.

ECP-MC3 is the most updated designed External Counter Pulsation System for non-invasive treatment of certain cardiovascular and other ischemia related diseases. The ECP-MC3 system is computer-controlled system that inflates and deflates three pairs of air cuffs in synchronization with the patient's cardiac cycle. The three pairs of cuffs are wrapped around the calves, lower thighs, and upper thighs/buttocks of the patients. As diastole begins, the cuffs inflate separately in sequence from the calves, to the lower thighs, to the upper thighs including the lower buttocks. This inflation sequence generates and impels a counter-pulsation wave, increasing diastolic blood pressure (diastolic augmentation), coronary perfusion pressure and coronary blood flow, and raising cardiac output. The start of inflation, deflation and cuff pressure can be adjusted by the operator. The system will deflate simultaneously before systole, this will reduce the heart's workload and resistance of blood vessel. Before ECP treatment, ECG electrodes and Finger Clip plethysmograph Sensor are placed on the patient. The ECG waveform is used to generate triggering signals for cuff inflation and deflation. The plethysmograph waveform is used to monitor the proper timing of the inflation cycle and to indicate the effect of ECP treatment on patient homodynamic.

The provided text describes the 510(k) premarket notification for the "External Counter Pulsation System; Model ECP-MC3". This document focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than proving the device's efficacy through clinical trials or detailed performance metrics against defined acceptance criteria typically seen for AI/ML devices. As such, the standard information requested for AI/ML device acceptance criteria and study design is not present in this document.

Here's a breakdown of why this document doesn't contain the requested information:

• Device Type: The ECP-MC3 is an External Counterpulsation System, a mechanical medical device, not an AI/ML diagnostic or therapeutic device.
• Regulatory Pathway: A 510(k) submission primarily relies on demonstrating substantial equivalence to a predicate device, meaning it has the same intended use, technological characteristics, and safety/effectiveness profile, or if there are differences, they do not raise new questions of safety or effectiveness. This is different from the rigorous performance testing and clinical trials often required for novel or AI/ML-driven devices.
• Focus of Testing: The non-clinical testing mentioned focuses on reliability, pressure control timing, pressure range accuracy, electrical safety, electromagnetic compatibility (EMC), and software verification/validation. These are standard engineering and safety tests for this type of device, not an assessment of AI algorithm performance.
• Lack of AI/ML Specifics: There is no mention of algorithms, machine learning models, training data, ground truth establishment, expert readers, or MRMC studies, which are all pertinent to AI/ML device evaluations.

Therefore, I cannot provide the requested information in the format of a table for acceptance criteria and reported performance, nor can I detail the specifics of an AI/ML study (sample size, experts, adjudication, MRMC, standalone performance, training data) because this information is not applicable to or contained within the provided 510(k) summary for the ECP-MC3 device.

The document explicitly states: "Clinical data were not required in this submission to support a finding of substantial equivalence." and "Clinical performance is not deemed necessary." This further emphasizes that direct performance measurement against clinical outcomes or a specific ground truth, as would be expected for an AI/ML device, was not part of this regulatory submission.

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