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The TTM For Windows + is used for Transtelephonic Cardiac Monitoring. It provides the ability to download, present and store the ECG signal via a phone using commercially available transtelephonic cardiac monitoring devices. It only presents the data such as one, two or twelve lead ECG and pacer spikes. There is no age or other physiological limitations using this device TTM For Windows +. It is intended that TTM For Windows + will be used only by a physician and trained technicians. It also acts as a database for patients with or without pacemakers or implantable cardioverter defibrillators.

The TTM For Windows + system is designed and manufactured by Rozinn Electronics Inc. It is a PC based computer that is used for Transtelephonic cardiac monitoring. It consists of a standard PC computer, monitor, printer and proprietary download module. It provides the ability to download, present and store the ECG signal via a phone using commercially available transtelephonic cardiac monitoring devices. TTM For Windows + does not come in contact with the patient. TTM For Windows + does not perform any diagnostic functions. It only presents the data. There is no age or other physiological limitations using this device TTM For Windows +.

The provided 510(k) summary for the TTM For Windows + device does not contain information regarding acceptance criteria or a study that proves the device meets those criteria.

The document explicitly states that the "TTM For Windows + does not perform any diagnostic functions. It only presents the data." The FDA's substantial equivalence determination is based on the device's function as a transtelephonic cardiac monitoring station for downloading, presenting, and storing ECG signals, similar to legally marketed predicate devices.

Therefore, I cannot provide the requested table or answer the questions related to performance studies, ground truth, or expert involvement because this information is not present in the provided text. The device's nature as a data presentment and storage tool means that clinical performance metrics typically associated with diagnostic or therapeutic devices (like sensitivity, specificity, or reader improvement with AI) are not applicable or detailed in this document.

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