(80 days)
System for recording electroencephalogram of brain electrical activity to Host Digital EEG Machine.
The NeuroLink NeuroMonitoring System (predicate device) consists of a set of components that work together to acquire and present EEG signal to any existing EEG recording and analysis equipment. The components include Biosensor electrodes, e-Net headpiece, Patient Module, battery module, fiber optic cable, and DSP Interface Card. Changes in the Patient Module and power supply are described in this submission. An electrode headbox has been added to the Patient Module and an AC power supply is available as an alternate to the battery module. The Patient Module is a small battery powered or AC powered amplifier. The EEG signals are transmitted from the head via conventional electrodes that are input into the attached headbox or e-Net that has a mating connector on the patient module. Power is enabled when the Patient Module is plugged into the DSP Card via the fiber optic cable, the host digital EEG computer is in the powered state and the Patient Module is enabled by pressing the control button located on the Patient Module. A five meter fiber optic cable is standard. The fiber optic cable provides patient isolation and flexible patient EEG Record Station placement options. Self test, calibration and impedance tests are remotely activated from the Host Digital EEG Machine through the DSP Interface Card or locally by depressing the appropriate test button on the Patient Module. A visual indication of control button function, system status and out of range impedance can be provided on the LCD display as controlled from the Host Digital EEG Machine.
The provided text describes a 510(k) premarket notification for the Physiometrix. Inc. Model 1320 NeuroLink II NeuroMonitoring System. This device is a physiological signal amplifier designed to acquire and present EEG signals to existing EEG recording and analysis equipment. The submission highlights changes to a previously cleared predicate device (K962157, NeuroLink Model 1310).
Based on the provided text, there is no acceptance criteria or detailed study information presented that would allow for the completion of the requested table and answers. The document is a regulatory approval letter and a summary of the device's description and indications for use, not a study report or a performance validation document.
Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
The document mainly focuses on:
- Device Description: What the NeuroLink II does and how it's constructed, noting changes from its predicate.
- Regulatory Approval: The FDA's determination of substantial equivalence to a legally marketed predicate device.
- Indications for Use: Recording electroencephalogram of brain electrical activity to a Host Digital EEG Machine.
To provide the requested information, a different type of document, such as a test report, clinical study protocol, or performance validation report, would be necessary.
§ 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).