(269 days)
The COGNISION System is for use by qualified clinical professionals in private practice offices or small clinical settings for the acquisition, display, analysis, storage, reporting and management of electroencephalograph (EEG) and auditory evoked potentials (AEP) information.
The COGNISION™ EEG/EP System is a combination device for reduced montage recording and display of electroencephalographic (EEG) and evoked potentials (EP) test data. The system uses elastic bands to accurately position 10 electrode pods around the head (7 recording channels, 2 linked mastoids, and 1 common). EEG signal amplification, conditioning, and A/D conversion is performed by electronic circuits closely coupled to the electrode pods through short flexible printed wires. The headset is connected by a cable to a handheld control unit and data acquisition box (HCU). A lithium-ion battery in the HCU is used to power the system. The HCU communicates via a wireless data link to a Windows PC to stream EEG data. HydroDot® Biosensors (from HydroDot Inc., and not included as part of this submission) are inserted into each electrode pod to electrically couple the electrode pods to the subjects scalp. Software on the PC is used to setup the tests and view and evaluate the resultant test data using standard EEG/EP display methods. Calibrated audiometric earphones (from E-A-R Auditory Systems) can be plugged in to the amplifier A/D converter box to deliver various auditory stimuli to produce evoked potential EEG responses.
The provided text describes the COGNISION™ EEG/EP System and its equivalence to predicate devices, but it does not contain detailed information about a study proving the device meets specific acceptance criteria in the manner of a clinical or comparative effectiveness study. Instead, it focuses on non-clinical performance data (bench testing) and general statements about design validation.
Here's an breakdown of the information that is available and what is missing based on your request:
Acceptance Criteria and Device Performance
The document presents non-clinical (bench) acceptance criteria and states that the device passed these tests. It does not provide "reported device performance" in terms of clinical outcomes or performance metrics against specific acceptance thresholds in a clinical study.
Table of Acceptance Criteria and Stated Device Performance (Non-Clinical):
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Current Draw | -420 to -525mA | Passed (Implied, as the Conclusion states all tests were passed according to established specifications) |
| Cal Tones | Low Cal Frequency: 13.50 - 14.50 Hz | |
| Low Cal Power: 31.5 - 33.5 dB μV | ||
| High Cal Frequency: 27.00 - 28.00 Hz | ||
| High Cal Power: 31.5 - 33.5 dB μV | Passed | |
| Baseline Noise | Noise VRMS: 60 dB @ 10 Hz, 730 mv pk-pk input on driven CH | Passed |
| CMMR | Min Attenuation : |
§ 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).