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Vasomedical, Inc.'s EECP® Therapy System Model TS3 with Pulse Oximetry is a non-invasive external counterpulsation 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 EECP® Therapy System Model TS3 with Pulse Oximetry 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 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 monitored with an internal pressure sensor and the operator-selected set-point maintained by a closed-loop control system. 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, an internal floppy disk drive is used to record data onto transferable media, and a printer is used to produce hard copy of site and patient identifiers and physiologic data. The Treatment Table accommodates a motorized lifting mechanism, mattress and the pneumatic circuit valve assembly. The motorized lifting mechanism is used to move the mattress up and down, providing a convenient height for 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. External pressure is applied via the patient Cuff Set to the lower extremities of the patient in synchronization with the heart, i.e. the cuffs compress vascular beds in the calves, lower thighs and upper thighs/buttocks on inflation. When the heart is in its relaxed state during the diastolic period, 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 perfusion pressure and coronary blood flow (diastolic augmentation), as well as venous return. 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). Stretchable treatment pants comprised of cotton and Lycra (Spandex) are worn by the patient under the Patient Cuff Set to allow for greater comfort during treatment. The Model TS3 with Pulse Oximetry incorporates a noninvasive sensor and electronic module to acquire and process the patient's oxygen saturation. These same components functions can be used separately or simultaneously.

The provided text describes the Vasomedical EECP® Therapy System Model TS3 with Pulse Oximetry and mentions non-clinical and clinical tests. However, it does not explicitly state acceptance criteria or provide specific quantitative results of a study to demonstrate the device meets those criteria.

Instead, the documentation details:

• Non-clinical tests: Software verification and validation, including functional requirements, boundary values/stress testing, and safety requirements. It also mentions verification of system operation at both system and component levels, and biocompatibility testing. These are primarily focused on device functionality, safety, and software integrity rather than a quantitative performance metric against a defined clinical acceptance criterion.
• Clinical evaluation: A qualitative statement that "Clinical evaluation of EECP® in patients with congestive heart failure has been performed in multi-center, single center and registry-based clinical investigations. Results of these investigations have demonstrated clinical benefit in patients treated with Vasomedical EECP® Therapy Systems. Objective measures such as peak oxygen consumption, exercise duration and pre-load adjusted maximal left ventricular power are improved following EECP® therapy, as well as subjective measures of patient response to therapy, such as quality of life and functional ability measures."

Given this, I cannot construct the table of acceptance criteria and reported device performance as requested, nor can I provide specific details like sample sizes for test sets, data provenance, number/qualifications of experts, or adjudication methods, as these are not present in the provided text for a performance study.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not explicitly stated. The document details types of tests performed (software, safety, biocompatibility, clinical evaluation) but does not provide specific acceptance criteria or corresponding quantitative performance metrics from those tests.

Regarding the study proving the device meets criteria (based on the "Clinical Evaluation" section):

• Type of Study: Clinical evaluation (multi-center, single-center, and registry-based clinical investigations) of EECP® in patients with congestive heart failure.
• Study Purpose: To demonstrate clinical benefit in patients treated with Vasomedical EECP® Therapy Systems.
• Outcomes Measured:
  • Objective: Peak oxygen consumption, exercise duration, pre-load adjusted maximal left ventricular power.
  • Subjective: Quality of life, functional ability measures.
• Reported Finding: "Results of these investigations have demonstrated clinical benefit in patients treated with Vasomedical EECP® Therapy Systems." and that "Objective measures such as peak oxygen consumption, exercise duration and pre-load adjusted maximal left ventricular power are improved following EECP® therapy, as well as subjective measures of patient response to therapy, such as quality of life and functional ability measures."

Missing Information (not found in the provided text):

2. Sample size used for the test set and the data provenance:

• Not specified. The document mentions "multi-center, single center and registry-based clinical investigations" but provides no numbers for patient samples or data provenance (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not specified. For a therapy system like EECP, the "ground truth" relates to clinical outcomes and physiological changes, which are measured directly rather than established by expert review of data/images. The document does not mention experts establishing ground truth in this context.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable/Not specified. This typically applies to studies involving human interpretation (e.g., image reading), which is not the primary focus of the performance evaluation described here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. This is not an AI-assisted diagnostic device, but a therapy system. Therefore, an MRMC study is not relevant.

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

• Not applicable. This is not an algorithm-only device; it's a medical device used in a clinical setting by an operator.

7. The type of ground truth used:

• For the clinical evaluation, the "ground truth" would be the actual physiological measurements (peak oxygen consumption, exercise duration, pre-load adjusted maximal left ventricular power) and patient-reported outcomes (quality of life, functional ability measures) obtained during the investigations.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML algorithm that requires a training set in the conventional sense. The "training" for the device would be its design, engineering, and software development based on medical principles and prior knowledge.

9. How the ground truth for the training set was established:

• Not applicable. See point 8.

In summary, while the document indicates that clinical evaluations were performed and demonstrated clinical benefits, it lacks the specific, quantifiable details regarding acceptance criteria and performance metrics that would typically be found in a robust study summary for a diagnostic or AI-powered device. The emphasis is on overall safety, functionality, and qualitative clinical benefit for a therapy delivery system.

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