(90 days)
CMS-2000 is intended to be used in the recording of ECG in an ambulatory mode for the diagnosis of various cardiac disorders, which principally include cardiac arrhythmia and myocardial ischemia. This recorder will document and compress the electrocardiograph signal into a memory card during 24 hours recording period with a patient.
Not Found
This is an FDA 510(k) clearance letter for the CMS-2000 device, a medical device for recording ECGs. The provided text does not contain specific acceptance criteria, details of a study proving the device meets acceptance criteria, sample sizes, data provenance, ground truth establishment, or information about MRMC studies.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976."
This indicates that the clearance is based on a demonstration of substantial equivalence to a predicate device, not on a new clinical study with specific acceptance criteria as you've outlined. 510(k) submissions typically compare the new device's performance, technological characteristics, and intended use to a legally marketed predicate device to demonstrate that it is as safe and effective.
Therefore, I cannot populate the table or answer the specific questions you've asked because the provided document does not contain that level of detail for this type of clearance.
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).