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Vasomedical, Inc.'s Enhanced External Counterpulsation (EECP ) Therapy Systems are non-invasive external counterpulsation devices intended for use in the treatment of patients with stable or unstable angina, congestive heart failure, acute myocardial infarction, or cardiogenic shock

Vasomedical's EECP Therapy System Model TS3, Model TS3 with Pulse Oximetry and Model MC-2 have been previously described to FDA. The EECP® Therapy System Model TS4 with/without Pulse Oximetery is comprised of three major components, a Control Console, a Treatment Table, and a patient Cuff Set.

The Control Console accommodates the air compressor and reservoir, a signal module panel, a power module, a microprocessor with touch screen/keyboard interface, data storage drives and printer, and components for acquiring and processing ECG, finger plethysmograph and oxygen saturation signals. The signals are obtained non-invasively. The microprocessor is used to operate and monitor the system by means of proprietary custom software, with the operator using the touch screen/keyboard interface to control its operation. The screen displays information pertinent to operating the system, as well as treatment parameters and patient waveforms during use. Treatment pressure is selected by the operator and then monitored and maintained automatically. The touch screen employs "hardware-less keys" which the operator touches to select a function or execute a command and the keyboard enables alphanumeric text entries. An internal hard disk drive is used to store data on the system a printer is used to produce hard copy of site and patient identification and physiologic data.

The Treatment Table is a padded table assembly and is set at a height convenient for both patient and operator use. The valve assembly consists of three pairs of inflation/deflation valves that open and close on command to inflate or deflate the patient Cuff Set with air. The valve assembly is connected to the air compressor and reservoir components in the Control Console via connecting air hoses.

The electrocardiogram of the patient is detected to initiate triggering of the inflation/deflation valves at appropriate times during the cardiac cycle. External pressure is applied via a patient Cuff Set to the lower extremities of the patient in synchronization with the resting, diastolic phase of the heart cycle, i.e. the cuffs compress vascular beds in the calves, lower thighs and upper thighs/buttocks on inflation. This pressure is applied sequentially from the calves, to the lower thighs, to the upper thighs and buttocks, forcing blood back to the heart, increasing coronary arterial perfusion pressure and coronary arterial blood flow (diastolic augmentation), as well as venous return to the right side of the heart. Immediately before the heart begins to eject blood during the next systolic phase, the cuffs are rapidly deflated and all externally applied pressure is eliminated. The vasculature in the lower extremities reconforms and is able to receive the output of the heart with lessened resistance, thereby reducing systolic pressure and the workload of the heart (decreased afterload).

The provided text is a 510(k) summary for the Vasomedical EECP® Therapy System. It describes the device, its intended use, and states its substantial equivalence to a predicate device. However, this document does not contain information on acceptance criteria, a study proving the device meets those criteria, or any of the detailed performance metrics and study design elements requested in your prompt.

The document is a regulatory submission focused on establishing substantial equivalence, primarily by comparing technological characteristics and intended use to a previously cleared device. It does not include performance data or clinical study results in the manner you are asking for.

Therefore, I cannot fulfill your request for the table of acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, or ground truth information because that data is not present in the provided text.

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