(57 days)
The ADAM amplifier system is intended for recording routine EEG and EEG associated with long term monitoring for epilepsy. This device is intended to be used only by physicians, technicians, or other medical professionals that are trained in electroencephalography.
The ADAM amplifier system is an EEG Amplifier System.
The provided text is a 510(k) summary for the Grass-Telefactor ADAM EEG Amplifier System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.
Therefore, I cannot populate the table or answer the questions you've posed based on the given input text. The 510(k) summary is primarily concerned with establishing substantial equivalence, not with detailing performance studies with specific statistical metrics and ground truth methods.
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).