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The NICORE Model NCP-1 is used 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 NICORE Model NCP-1 is a proprietary, 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.

Here's a breakdown of the acceptance criteria and the study details for the NICORE Model NCP-1 External Counterpulsation Device, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

Study Details

• Sample Size for Test Set: 9 healthy volunteers.
• Data Provenance: Not explicitly stated, but implies a prospective study conducted for the purpose of this submission. No country of origin is mentioned for the subjects, but the company is US-based.
• Number of Experts Used to Establish Ground Truth for Test Set & Qualifications: Not applicable. The study did not involve human experts establishing ground truth for the test set in the traditional sense of diagnostic interpretation. Instead, physiological measurements (diastolic augmentation ratios) were directly measured.
• Adjudication Method for Test Set: Not applicable. The study directly measured physiological parameters from the devices, not subjective interpretations requiring adjudication.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, an MRMC study was not performed. This was not a diagnostic imaging device requiring human-in-the-loop performance evaluation.
• Standalone (Algorithm Only) Performance Study: Yes, in effect, this was a standalone performance study comparing the physiological output of the NICORE device directly against the physiological output of the predicate device.
• Type of Ground Truth Used: Physiological measurements (degree of diastolic augmentation, specifically amplitude and area ratios of the pulse pressure wave). The performance was compared to the predicate device, establishing "substantial equivalence" as the ground truth target.
• Sample Size for Training Set: Not applicable. This device does not appear to involve a machine learning algorithm that requires a separate training set. The study directly evaluated the device's physiological output.
• How Ground Truth for Training Set Was Established: Not applicable.

Summary of Clinical Tests and Conclusions

The study aimed to demonstrate substantial equivalence to the predicate device (Vasomedical Model EECP-MC2) by comparing the degree of diastolic augmentation produced by both devices. This was measured as the ratio of peak diastolic pressure to peak systolic pressure, quantified by both amplitude and area of the patient's pulse pressure wave representation.

The results showed that the mean amplitude ratio for the NICORE device was 1.50, compared to 1.51 for the predicate. The mean area ratio for the NICORE device was 1.84, compared to 1.82 for the predicate. Both sets of values were within one standard deviation of the overall combined mean for both devices.

Based on these findings, the study concluded that the data obtained from the NICORE device and the Vasomedical device "belong to the same population and are therefore substantially equivalent."

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