(93 days)
This device is intended to assist doctors in checking implanted pacing systems of ambulatory patients. The device transmits the patient's ECG signals, including ambulatory pulse width code, to the remote receiving station via the telephone line.
Card Guard Model CG-4000 Pacemaker Data (PMD®) Transmitter
I am sorry, but the provided text does not contain the detailed information required to answer your request about acceptance criteria and a study proving device performance. The document is a 510(k) clearance letter from the FDA for a medical device (Pacemaker Data Transmitter, Model CG-4000) and primarily focuses on regulatory approval based on substantial equivalence to a predicate device.
The letter does not include:
- A table of acceptance criteria and reported device performance.
- Details about specific studies, sample sizes for test or training sets, data provenance, or ground truth establishment.
- Information on expert involvement, adjudication methods, or MRMC comparative effectiveness studies.
Therefore, I cannot extract the requested information from this document.
§ 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).