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1. 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.
2. The Seizure Detection 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 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 12 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 12 Spike Detection performance has not been assessed for intracranial recordings.
4. 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, 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. The aEEG functionality included in Persyst 12 is intended to monitor the state of the brain. The automated event marking function of Persyst 12 is not applicable to aEEG.
6. Persyst 12 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 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.
7. Persyst AR (Artifact Reduction) is intended to reduce EMG, eve 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.
8. This device does not provide any diagnostic conclusion about the patient's condition to the user.

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The provided text discusses the Persyst 12 EEG Review and Analysis Software. While it outlines the indications for use and a general summary of the device, it does not contain the detailed information necessary to fully answer all aspects of your request. Specifically, the document is an FDA 510(k) clearance letter, which focuses on substantial equivalence rather than a full performance study report.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

This information is not present in the provided document. An FDA 510(k) clearance letter typically references that performance data was submitted and found acceptable, but it does not detail the specific acceptance criteria or the numerical results of those tests.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not present in the provided document beyond general statements. The document mentions "previously acquired sections of adult (greater than or equal to 18 years) EEG recordings" for seizure detection and "patients at least one month old" for spike detection, implying retrospective analysis of existing data. However, specific sample sizes, country of origin, or whether it was prospective or retrospective are not detailed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not present in the provided document. The document states the device "aid[s] neurologists in the assessment of EEG" and "assist[s] qualified clinical practitioners," implying expert involvement, but provides no details on the number or qualifications of experts used for establishing ground truth in performance studies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not present in the provided document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not present in the provided document. The document states the device "assist[s] qualified clinical practitioners," but does not provide details about comparative effectiveness studies or effect sizes.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document describes the device's functions (seizure detection, spike detection, quantitative measures) as "intended to mark previously acquired sections" or "calculation and display," implying standalone algorithmic processing. However, it also consistently states that the device is "to aid neurologists" and "assist qualified clinical practitioners" and that "Waveforms must still be read by a qualified medical practitioner." This suggests the performance studies likely evaluated the algorithm's output as an aid, rather than purely standalone diagnostic capability. It does not definitively state that a standalone performance study (evaluating the algorithm's accuracy without any human review or correction) was performed and reported with metrics.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document implies that the ground truth for seizure and spike detection would be based on expert interpretation of EEG recordings. For example, it says the device marks sections "that may correspond to electrographic seizures," suggesting a reference to expert-defined electrographic seizures. However, it does not explicitly state that expert consensus was used, nor does it mention pathology or outcomes data.

8. The sample size for the training set

This information is not present in the provided document.

9. How the ground truth for the training set was established

This information is not present in the provided document.

Summary of what can be inferred or directly stated from the document:

• Device Name: Persyst 12 EEG Review and Analysis Software
• Intended Use: Review, monitoring, and analysis of EEG recordings from scalp electrodes to aid neurologists/qualified medical practitioners.
• Key Components and their intended use:
  • Seizure Detection: Marks sections of adult (>=18 years) EEG recordings that may correspond to electrographic seizures.
  • Spike Detection: Marks sections of EEG recordings that may correspond to spikes (for patients at least one month old; not assessed for intracranial recordings).
  • Quantitative Measures: Calculates and displays FFT, Rhythmicity, Peak Envelope, Artifact Intensity, Amplitude, Relative Symmetry, and Suppression Ratio. These should be interpreted with original waveforms.
  • aEEG functionality: Intended to monitor the state of the brain.
  • Notifications: Provides on-screen and email notifications for seizure detection, QEEG, and aEEG, but notes delays and emphasizes these are not a substitute for real-time human monitoring.
  • Persyst AR (Artifact Reduction): Reduces EMG, eye movement, and electrode artifacts in 10-20 EEG recordings. Warns that AR does not remove entire artifacts, is not effective for other types, and may modify cerebral activity waveforms, requiring interpretation of original waveforms by a qualified practitioner.
• Diagnostic Conclusion: The device does not provide any diagnostic conclusion about the patient's condition to the user.
• User Competency: Intended to be used by qualified medical practitioners.

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