(33 days)
The device is intended for receiving the signal, transmitted by the Card Guard personal transtelephonic transmitters and transferring the signal to PC equipped with the TM2000 Receiving program or compatible.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "CG-3250 TM MiniReceiver." It states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
However, the provided text does not contain specific information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for either training or test sets.
The document is purely a regulatory clearance notice and does not elaborate on the technical performance or testing methodology of the device beyond stating its intended use.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or details about the study that proves the device meets those criteria based on the information provided.
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).