(157 days)
I. Persyst 12 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. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.
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The Seizure Detection and Seizure Probability component of Persyst 12 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 tecordings should be obtained with a full scalp montage according to the standard 10/20 system.
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The Spike Detection component of Persyst 12 is intended to mark previously acquired sections of the patient's EEG recordings that may correspond to spikes, in order to assist qualified cinical practitioners in the assessment of EEG traces. The Spike Detection component is intended to be used in patients at least one month old. Persyst 12 Spike Detection performance has not been assessed for intracranial recordings.
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Persyst 12 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, Amplinde, Relative Symmetry and Suppression Ratio. Automatic event marking is not applicative measures. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveforms.
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The aEEG functionality included in the Persyst 12 is intended to monitor the brain. The automated event marking function of Persyst 12 in not applicable to aEEG.
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Persyst 12 provides notifications for seizure detection, quantitative EEG 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 12 notifications will be shown to a user. Persyst 12 notifications cannot be used as a substitute for real time monitoring of the underlying EEG by a trained expert.
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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 entifact signal, and is not effective for other types of artifacts. AR may modify portions of waveloms 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.
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This device does not provide any diagnostic conclusion about the patient's condition to the user.
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The provided document is limited to the FDA's 510(k) clearance letter and the Indications for Use for the Persyst 12 EEG Review and Analysis Software. It does not contain the detailed study information, acceptance criteria, or performance data that would allow for a complete answer to the request.
Therefore, I cannot provide a table of acceptance criteria vs. device performance, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set information based solely on the provided text.
The document only states that the device is "substantially equivalent" to predicate devices, and outlines its intended uses:
- Overall Intent: Review, monitoring, and analysis of EEG recordings to aid neurologists in assessment.
- Seizure Detection and Seizure Probability: Marks previously acquired sections of adult (≥18 years) EEG recordings that may correspond to electrographic seizures.
- Spike Detection: Marks previously acquired sections of patient's EEG recordings that may correspond to spikes, for patients at least one month old.
- Quantitative Measures: Calculates and displays quantitative measures (FFT, Rhythmicity, Peak Envelope, Artifact Intensity, Amplitude, Relative Symmetry, Suppression Ratio) for monitoring and analysis.
- aEEG functionality: Monitors the brain.
- Notifications: Provides notifications for seizure detection and quantitative EEG, but emphasizes these are not a substitute for real-time monitoring.
- Artifact Reduction (AR): Intended to reduce EMG, eye movement, and electrode artifacts in standard 10-20 EEG recordings.
To properly answer your request, the actual 510(k) submission summary or a separate clinical study report would be required.
§ 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).