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The CardioStation-100 is intended to be used as an aid to diagnosis by means of analysis of cardiac electrical signals in the frequency domain, the power spectral estimate.

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The provided document is an FDA 510(k) clearance letter for the CardioStation-100 device. While it indicates that the device has been cleared based on substantial equivalence to a predicate device, it does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications.

The letter primarily focuses on:

• Acknowledging the 510(k) premarket notification.
• Stating that the device is substantially equivalent to legally marketed predicate devices.
• Outlining the regulatory classification (Class II).
• Reminding the manufacturer of general controls provisions and other applicable regulations.
• Stating the intended use of the device.

Therefore, I cannot provide the requested table and details from this document. The information typically needed to answer these questions would be found in the 510(k) submission itself or a separate clinical study report, which is not part of this clearance letter.

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Cardiostation is a transtelephonic cardiac monitoring station intended to provide the reception and evaluation of the ECG signal, transmitted via standard telephone lines, using commercially available transtelephonic cardiac monitoring devices. It is intended that the Cardiostation will be used by physicians and cardiac laboratories supervised by physicians.

Cardiostation is a transtelephonic cardiac monitoring station intended to provide the reception and evaluation of the ECG signal, transmitted via standard telephone lines, using commercially available transtelephonic cardiac monitoring devices.

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, sample sizes, expert qualifications, or study details. This document appears to be an FDA 510(k) clearance letter for a device called "Cardiostation," primarily focusing on its substantial equivalence to a predicate device and its indications for use. It does not include a study report or performance data.

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