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The Paceart System is intended for use as a 12-lead electrocardiograph, pacemaker artifact analyzer, and transtelephonic ECG monitor. It also acts as a database for pacemaker and implantable cardioverter defibrillator patients.

The Medtronic Paceart® System is a personal computer based pacemaker-testing system, a 12-lead electrocardiograph, and a transtelephonic receiving station. It provides data that can be used to analyze implanted pacemaker performance based on electrocardiographic measurements, either taken directly from the patient or programmer. The system can measure, store, and display any of the 12 standard leads. Reports and charts are available by means of a laser printer. The system also includes a database that collects and stores patient data. Optional software allows the device to function as an unattended transtelephonic receiving station.

The provided text is a 510(k) summary for the Medtronic Paceart System. It describes the device, its intended use, and states that it has been found substantially equivalent to predicate devices. However, this document does not contain specific acceptance criteria or the details of a study demonstrating that the device meets those criteria.

Therefore, I cannot provide the requested information from this document. The sections you asked for, such as sample sizes, expert qualifications, adjudication methods, and details of standalone or MRMC studies, are not present in this regulatory submission summary. These types of details would typically be found in a separate study report or a more detailed technical file for the device.

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