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CardioSmart is intended to be used for resting ECG and for recording ECG in realtime with and without arrhythmia detection.

CardioSmart is intended to be used by trained operators when ECG records are required in the judgement of a physician.

The arrhythmia detection portion of CardioSmart is provided to the user for the convenience of automatic documentation.

CardioSmart does not provide alarms for arrhythmia detection.

CardioSmart is not intended for use as a vital signs physiological monitor.

CardioSmart offers no diagnostic opinion to the user. Instead, it provides interpretive statements for which the physician renders his/her own medical opinion.

CardioSmart is not designed for intracardial use.

CardioSmart is not intended for home use.

The intended use of CardioSmart is a subset of the intended use of the predicate device. CardioSmart is a low cost alternative for all users who are not required to perform stress test ECGs.

CardioSmart is a portable ECG data acquisition and recording system designed and manufactured by HELLIGE GmbH.

CardioSmart allows to:

• record resting ECGs,
• measure and interprete the ECGs.

This looks like a 510(k) summary for a medical device called "CardioSmart" from HELLIGE GmbH. This document describes the device, its intended use, and its equivalence to a predicate device.

However, the provided text does not contain the specific acceptance criteria or the study details that prove the device meets those criteria, as requested in the prompt.

The document states that:

• "CardioSmart complies with the voluntary standards ANSI/AAMI EC11-1991, ANSI/AAMI ECAR-1987, IEC 601-1, IEC 601-1-2 and IEC 601-2-25."
• "CardioSmart passed the EC type-examination and thus bears the CE mark."
• "The results of these measures demonstrated that CardioSmart is as safe, as effective, and performs as well as the predicate device CARDIOGNOST EK 26."

These statements indicate that performance studies were conducted and the device met certain standards or demonstrated equivalence, but they do not provide the detailed acceptance criteria or the study methodology (like sample size, ground truth, expert qualifications, etc.).

Therefore, I cannot populate the requested table and answer the study-specific questions based on the provided text. The document is a summary and points to compliance with standards and equivalence, rather than detailing the actual performance study results and acceptance criteria.

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