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1. Persyst 14 EEG Review and Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices using scalp electrodes and to aid neurologists in the assessment of EEG. The device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.

2. The Seizure Detection component of Persyst 14 is intended to mark previously acquired sections of 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.

3. The Spike Detection component of Persyst 14 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 14 Spike Detection performance has not been assessed for intracranial recordings.

4. Persyst 14 includes the calculation and display of a set of qualitative measures intended to monitor and analyze the EEG waveform. These include FFT, Rhythmicty, Peak Envelope, Artifact Intensity, Amplitude, Relative Symmetry and Suppression Ratio. Automatic event marking is not applicable to the quantitative measures. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveforms.

5. Persyst 14 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 14 is not applicable to patients with pacemaker and/or active implantable devices.

6. The aEEG functionality included in Persyst 14 is intended to monitor the state of the brain. The automated event marking function of Persyst 14 is not applicable to aEEG.

7. Persyst 14 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 14 notifications will be shown to a user. Persyst 14 notifications cannot be used as a substitute for real time monitoring EEG by a trained expert.

8. Persyst 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.

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

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The provided text is an FDA 510(k) clearance letter for the Persyst 14 EEG Review and Analysis Software. It states the indications for use but does not contain the specific acceptance criteria or details of the study that proves the device meets those criteria.

Therefore, I cannot provide the requested information from this document. The document primarily focuses on the regulatory clearance for the device and its intended uses. Details about internal validation studies, acceptance criteria, sample sizes, and expert qualifications are typically found in the Premarket Notification (510(k)) submission itself, which is not included here.

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