Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))

1. Persyst 15 EEG Review and Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.

2. The Seizure Detection and Seizure Probability component of Persyst 15 is intended to mark previously acquired sections of the adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic seizures, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with a full scalp montage according to the standard 10/20 system. Alternatively, the Seizure Detection can operate using reduced set of electrodes including Fp1, F7, T3, T5, O1, Fp2, F8, T4, T6, O2, but will have decreased sensitivity for seizures due to its limited spatial sampling.

3. The Persyst software's Electrographic Status Epilepticus (ESE) component is indicated for the diagnosis of Electrographic Status Epilepticus in patients greater than or equal to 18 years of age who are at risk for seizure. The (ESE) Component analyzes EEG waveforms and identifies patterns that may be consistent with electrographic status epilepticus as defined in the "(American Clinical Neurophysiology Society's Guideline 14)". EEG recordings used with this feature should be obtained with a full scalp montage (10/20 system) or a reduced set of electrodes (Fp1, F7, T3, T5, O1, Fp2, F8, T4, T6, O2). Using the reduced set of electrodes will result in some decrease in sensitivity and specificity for the detection of ESE in comparison to the full montage due to decreased spatial sampling.

The (ESE) Component is intended to be used as an aid for determining patient treatment in acute-care environments. Detections from the (ESE) Component provide one input for the clinician that is intended to be used in conjunction with other elements of clinical practice to determine the appropriate treatment course for the patient. The (ESE) Component is intended for detection of electrographic status epilepticus only. The (ESE) Component does not substitute for the review of the underlying EEG by a qualified clinician with respect to any other types of pathological EEG patterns. The (ESE) Component is not intended for use in Epilepsy Monitoring Units or non-acute care environments.

4. The Neonatal Seizure Detection component of Persyst 15 is intended to mark previously acquired sections of neonatal patients’ (defined as near-term or term neonates of conceptional age between 36 and 44 weeks and less than two weeks of chronologic age) EEG recordings that may correspond to electrographic seizures, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with scalp-recorded EEG using the standard International 10-20 system electrode placement, modified for neonates (this includes electrode sites Fp1/2 or alternate F1/2, C3/4, T3/4, O1/2, and Cz, optionally including Fz). Alternatively, the Neonatal Seizure Detection component can operate using a more reduced set of electrodes including C3/4, Fp1/2 (F1/2), and O1/2 (recorded in such a manner to allow creation of montage C3-4, Fp1-O1, Fp2-O2), or an even more simplified electrode set including only C3/4 and Cz (arranged as C3-Cz and C4-Cz), but the three-electrode montage will have decreased sensitivity for seizures due to its limited spatial sampling.

5. The Spike Detection component of Persyst 15 is intended to mark previously acquired sections of the patient’s EEG recordings that may correspond to spikes, in order to assist qualified clinical practitioners in the assessment of EEG traces. The Spike Detection component is intended to be used in patients at least one month old. Persyst 15 Spike Detection performance has not been assessed for intracranial recordings.

6. Persyst 15 EEG Review and Analysis Software includes the Persyst Imaging Workflow (PIW), an imaging viewer. It is intended for use by qualified clinical practitioners on both adult and pediatric subjects at least 12 years of age to interpret EEG data in conjunction with any type of neuroimaging including magnetic resonance imaging (MRI) or computed tomography scans (CT). Persyst Imaging Workflow is not intended to provide diagnostic information.

7. The Persyst ESI component of Persyst 15 is intended for use by a trained/qualified EEG technologist or physician on both adult and pediatric subjects at least 3 years of age for the visualization of human brain function by fusing a variety of EEG information with rendered images of an individualized head model and an individualized MRI image.

8. The Persyst 15 sleep state feature provides the user with output concerning wake-sleep states (wake or sleep,) present in an EEG recording as an aid in assessing which states are present and when they are present. The EEG being assessed for sleep state should utilize standard 10-20 system electrode recording positions and contain the expected EEG patterns of typical wake and sleep, with no major persistent pathological alterations. The sleep state output is subject to user confirmation via EEG waveform review and is not intended for the diagnosis of sleep disorders (e.g.: sleep apnea, narcolepsy, restless leg syndrome). The sleep state feature is intended for adult and pediatric subjects at least 13 years and older.

9. Persyst 15 includes the calculation and display of a set of quantitative measures intended to monitor and analyze the EEG waveform. These include FFT, Rhythmicity, Peak Envelope, Artifact Intensity, Amplitude, Relative Symmetry, and Suppression Ratio. Automatic event marking is not applicable to quantitative measures. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveforms.

10. Persyst 15 displays physiological signals, including the calculation and display of a heart rate measurement based on the ECG channel in the EEG recording, which are intended to aid in the analysis of an EEG. Heart rate measurement of Persyst 15 is not applicable to patients with pacemaker and/or active implantable devices.

11. The aEEG functionality included in Persyst 15 is intended to monitor the state of the brain. The automated event marking function of Persyst 15 is not applicable to aEEG.

12. Persyst 15 provides notifications for seizure detection, quantitative EEG and aEEG that can be used when processing a record during acquisition. These include an on screen display and the optional sending of an email message. Delays of up to several minutes can occur between the beginning of a seizure and when the Persyst 15 notifications will be shown to a user. Persyst 15 notifications cannot be used as a substitute for real time monitoring of the underlying EEG by a trained expert.

13. Persyst 15 AR (Artifact Reduction) is intended to reduce EMG, eye movement, and electrode artifacts in a standard 10-20 EEG recording. AR does not remove the entire artifact signal, and is not effective for other types of artifacts. AR may modify portions of waveforms representing cerebral activity. Waveforms must still be read by a qualified medical practitioner trained in recognizing artifact, and any interpretation or diagnosis must be made with reference to the original waveforms.

14. This device does not provide any diagnostic conclusion about the patient's condition to the user.