Search Results

The AECP-A is a non-invasive external counterpulsation device for treatment of patients suffering from stable or unstable angina pectoris, acute myocardial infarction and cardiogenic shock

Automatic External Counterpulsation Device

This document is a 510(k) clearance letter from the FDA for an Automatic External Counterpulsation Device (AECP-A). It primarily focuses on the regulatory clearance process and does not contain detailed information about the acceptance criteria and the study that proves the device meets them.

Therefore, I cannot provide the requested information based solely on the provided text. The document states that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This implies that the device's performance was compared to existing devices, but the specifics of that comparison, including acceptance criteria, study design, and results, are not included here.

To answer your questions, I would need access to the actual 510(k) premarket notification submission, which would contain the performance data and study details.

Ask a specific question about this device

The AECP-A is a non-invasive external couterpulsation device for The ALCI - 11 to a not suffering from stable or unstable angina pectoris, acute myocardial infarction and cardiogenic shock

Automatic External Counterpulsation Device

I am sorry, but the provided document does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for an Automatic External Counterpulsation Device, which primarily states that the device is substantially equivalent to a legally marketed predicate device. It does not include details about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or ground truth establishment.

Ask a specific question about this device