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The NeuralScan System is intended for the acquisition, display, and storage, of electrical activity of a patient's brain including electroencephalograph (EEG) and Event-related Potentials (ERP), obtained by placing two or more electrodes on the head to aid in diagnosis.

The NeuralScan System is comprised of the NeuralScan Amplifier with embedded firmware for acquisition and transmission of physiological signals, an EEG cap, a Subject Response Device, a laptop computer preloaded with the NeuralScan Evoke software, and a charging kit (that consists of a USB cable, clip kit, and wall adapter).

The NeuralScan Evoke software runs in a Windows Operating System environment and controls the 23 channel (21 EEG and 2 bio channels) NeuralScan EEG amplifier via a USB cable or Wi-Fi connection. The software has a graphical user interface that allows the user to input patient information, create new records, conduct studies to collect EEG and ERP data, view live data streams of the laptop display, record data to a file, analyze resultant test data using standard Frequency EEG analysis and EP display methods and print the results. The software includes a mode to measure the cap electrode impedances which is useful for determining if the electrodes are making a good electrical connection with the scalp at each electrode location. Interpretation of the data is the responsibility of the physician as the software does not provide any diagnosis based on the data.

The patient contacting accessories are commercially sourced and used without modification. The device and the accessories are not sterile and are not intended to be sterilized.

The provided text describes the regulatory clearance for the "NeuralScan System" and includes a summary of non-clinical testing performed to demonstrate its substantial equivalence to predicate devices. However, it explicitly states: "No Clinical testing was necessary to determine substantial equivalence."

Therefore, based on the provided document, the device did not undergo a clinical study involving human subjects to prove its performance against acceptance criteria for diagnostic accuracy or clinical effectiveness. The acceptance criteria and performance data are entirely based on bench testing (non-clinical data) for the device's functional integrity as an electroencephalograph (EEG) and Event-related Potentials (ERP) system.

Given this, I can only provide information derived from the non-clinical testing detailed in the document.

Acceptance Criteria and Reported Device Performance (Non-Clinical Study)

The acceptance criteria and performance measurements for the NeuralScan System are based on bench testing to confirm compliance with recognized medical device standards (primarily IEC 60601-2-26 for electroencephalographs). These tests evaluate the hardware and software's ability to accurately acquire, reproduce, and transmit physiological signals.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

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