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The intended use of the ScottCare Genesis ECP device is to provide external counterpulsation (ECP) therapy, and is indicated for use in the treatment of stable or unstable angina pectoris, congestive heart failure, cardiogenic shock, and acute myocardial infarction.

The "Genesis" is a non-invasive medical device for performing external, sequential counterpulsation. It is a microprocessor-controlled system that inflates and deflates three pairs of air cuffs, which compress vascular beds in the muscles of the calves, thighs, and buttocks to achieve the desired therapy. The microprocessor's primary function is to serve as an R-wave detector, calculate the R-wave rate (heart rate), and deliver triggering signals to actuate valves that allow the cuffs to be filled during the diastolic period and then emptied prior to systole. The secondary function of the microprocessor is to output, through a serial port, information necessary for displaying patient treatment data on a video monitor. This data allows a trained operator to finetune the inflation/deflation signals to optimize a patient's diastolic augmentation. The cuffs are snugly wrapped around the patient's calves, thighs, and buttocks to allow compression of vascular beds in these body areas. To prevent skin irritation the patient is typically dressed in tight fitting, stretchable treatment pants prior to being fitted with the cuffs. As diastole begins, the cuffs inflate sequentially proceeding from the calves, to the thighs, to the buttocks, with the inflation sequence taking a total of approximately 200ms. The inflation sequence generates and drives an arterial counter pulsation wave creating an increase in coronary perfusion pressure and coronary blood flow. The compression sequence also increases venous return, which increases stroke volume and cardiac output. At the end of diastole, and just before the next QRS complex, the cuffs are evacuated simultaneously over a period of approximately 120ms. The course of treatment is typically 35 1-hour treatments administered 5 days a week. The device automatically stops compression of the cuffs and releases all pressure in the cuffs upon completion of the pre-set treatment timer. The system consists of two major assemblies: 1) the patient bed that houses the electronic pneumatic controls / valves, compressor / vacuum pump and associated power supplies and 2) the operator's console that consists of an all-in-one computer/monitor, computer peripherals (keyboard and pointing device) and a control panel.

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) summary for the "ScottCare Genesis ECP Device," primarily focused on demonstrating substantial equivalence to a predicate device.

It lists:

• Device Description: How the ECP device works.
• Indications for Use: The medical conditions the device is intended to treat.
• Substantial Equivalence Comparison: A table comparing features of the new "Genesis" model with the predicate device "NCP-1 Counter Pulsation Device."
• Conclusion: States that testing (without details on specific acceptance criteria or results) demonstrated the device functioned as designed and complied with IEC60601 safety and EMC requirements. It concludes substantial equivalence to the predicate device.
• FDA Clearance Letter: Confirms the 510(k) clearance based on substantial equivalence.

There is no mention of:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets or data provenance.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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