(156 days)
The cables are used to transfer monitoring signals from a patient's electrodes, which are connected to leadwires, to a patient's monitor, resulting in no direct contact with the patient. While medical personnel observe the patient, information is received through the cables and is displayed on the monitor. This information can then be used by medical personnel to assess the patient and determine the proper course of medical action.
Not Found
I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for a "Patient Cable" device, indicating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory requirements and the device's indications for use but does not include performance data, study designs, or ground truth establishment details.
§ 870.2900 Patient transducer and electrode cable (including connector).
(a)
Identification. A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.(b)
Classification. Class II (performance standards).