(280 days)
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.
Not Found
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.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).