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Currem Indication for use includes patients with: Stable Angina Pectoris

The NICORE™ model ESP-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 calves, lower thighs, and upper thighs/buttocks to achieve the desired therapy.

The provided text is related to a 510(k) submission for a medical device called the NICORE™ ESP-1™ External Counterpulsation Device. It describes the device, its intended use, and the FDA's clearance of the device as substantially equivalent to a predicate device.

However, the provided document does not contain the detailed study information, acceptance criteria, or performance data that would allow me to populate the requested table and answer questions 2 through 9.

The document mainly covers:

• Premarket Notification (510(k)) Summary details (submitter, contact, trade name, common name, classification name).
• Identification of the legally marketed predicate device (Vasomedical Model EECP-MC2).
• Description of the NICORE™ ESP-1™ device.
• Intended Use (Stable Angina Pectoris).
• The FDA's decision letter confirming substantial equivalence.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, study details (sample sizes, ground truth, expert qualifications, adjudication, MRMC, standalone performance, training set details) because this information is not present in the provided text.

To answer your request, I would need a section of the 510(k) submission (or a separate study report) that specifically details:

• The clinical or performance testing conducted.
• The acceptance criteria defined for that testing.
• The results of the testing against those criteria.
• Information about the study design, data collection, and ground truth establishment.

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