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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.

Not Found

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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The PressOn™ electrode is intended for use in the recording of the electroencephalogram (EEG), the evoked potential (EP), or as ground and reference in an EEG or EP recording.

The PressOn electrode is a single-use, disposable EEG electrode. The electrode is very small, with a footprint of approximately 0.6 cm and a very thin (~0.004 inch) height profile. It is made from a super-elastic Nitinol and is flexible. The electrode has 3 legs (a tri-pod configuration) that each terminate in micro-teeth that penetrate the top layers of the scalp dermis during subdermal electrode placement.

The PressOn electrode is used in conjunction with an accessory PressOn lead that is provided non-sterile and is reusable. The lead is approximately 48" in length and is used to connect one of the PressOn electrodes to a commercially available EEG monitor. The EEG monitor/ equipment is not part of the PressOn device offering.

This a 510(k) Premarket Notification for the PressOn™ electrode. The document states that the device is "substantially equivalent to legally marketed needle electrodes that are in commercial distribution". Therefore, no specific acceptance criteria or studies proving device performance against such criteria are explicitly detailed in this document, as the FDA has determined it is substantially equivalent to a predicate device.

The document indicates that the device underwent "biocompatibility, bench and performance testing and demonstrated acceptable results in all testing." However, the details of what these acceptable results were, the specific acceptance criteria, or the study methodologies and data, are not provided for the electrode.

Therefore, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: Not available.
2. Sample size used for the test set and the data provenance: Not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
4. Adjudication method: Not available.
5. MRMC comparative effectiveness study: Not applicable, as this is a physical medical device (electrode), not an AI-assisted diagnostic tool.
6. Standalone performance study: Not available, "performance testing" is mentioned but no details.
7. Type of ground truth used: Not applicable as there is no diagnostic outcome being evaluated.
8. Sample size for the training set: Not applicable as there is no mention of a training set or a machine learning algorithm.
9. How the ground truth for the training set was established: Not applicable.

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This software is intended for use by a trained EEG technician or neurologist.

The Persyst Reveal is a software only product. It runs on a personal computer and requires no specialized hardware. It identifies spike and seizure events are then reviewed, possibly deleted, and interpreted by the user. The digitized EEG input is read from a file on the personal computer (or available across the network).

Neither the computer nor the software control the delivery of energy, the administration of parenteral drugs, or another form of life sustaining function to the patient.

No diagnostic or effectiveness claims are made.

The provided text is a 510(k) clearance letter for the Persyst Reveal device, which is a software product that identifies spike and seizure events in EEG data. The clearance is based on substantial equivalence to a predicate device, the Stellate Sensa.

It's important to note that the provided text is a regulatory clearance document, not a detailed technical study report. As such, it does not contain the specific performance metrics, study designs, or detailed data typically found in a clinical study proving device effectiveness against acceptance criteria.

The document explicitly states: "No diagnostic or effectiveness claims are made." This strongly implies that the clearance was based on demonstrating functional equivalence to the predicate and meeting general controls, rather than rigorous performance metric-based studies against pre-defined acceptance criteria for diagnostic efficacy.

Therefore, many of the requested details about acceptance criteria and study particulars cannot be extracted from this document.

Here's what can be inferred and what cannot:

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

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

• Not available in the document. The document does not describe a performance study with a test set.

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)

• Not available in the document. Since no performance study is described, there's no mention of experts establishing ground truth for a test set. The software is intended for review and interpretation by a "trained EEG technician or neurologist."

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

• Not available in the document. No test set or adjudication method is described.

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

• No, it was not done and is not described in the document. The document states "No diagnostic or effectiveness claims are made," indicating that such a study (which would aim to prove improved effectiveness) was not part of this submission for clearance.

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

• Not explicitly described as a formal standalone performance study. The device "identifies spike and seizure events are then reviewed, possibly deleted, and interpreted by the user." This implies it's intended as an assistive tool, not for standalone diagnostic use without human-in-the-loop. Given "No diagnostic or effectiveness claims are made," a rigorous standalone performance study against clinical ground truth is highly unlikely to have been conducted for this submission.

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

• Not available in the document. No ground truth definition is provided, as no performance study is detailed.

8. The sample size for the training set

• Not available in the document. The document does not provide details about algorithm training or development.

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

• Not available in the document. No information regarding training set ground truth is present.

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This product is intended for use by a trained EEG reader.
This software is intended for use by a trained EEG technician or neurologist.

The Persyst Prism is a software only product. It runs on a personal computer and requires no specialized hardware. It displays digitized EEG signals, power spectra, topographic maps, etc. These functions are all controlled and interpreted by the digitized EEG input is read from a file on the personal computer (or available across the network).

Neither the computer nor the software control the delivery of energy, the administration of parenteral drugs, or another form of life sustaining function to the patient.

The provided text is a 510(k) summary for the PERSYST PRISM device, submitted in 1997. Unfortunately, it does not contain the detailed information required to answer many of the questions. The document primarily focuses on demonstrating substantial equivalence to a predicate device (STELLATE RHYTHM) based on descriptive characteristics and intended use, rather than presenting a performance study with acceptance criteria and results.

Here's a breakdown of what can be extracted and what information is missing:

Description of the Device

The Persyst Prism is a software-only product that runs on a personal computer. It displays digitized EEG signals, power spectra, topographic maps, etc. It requires the EEG signal to be digitized by a separate EEG acquisition system. It is intended for use by a trained EEG reader.

Missing Information Based on Source Document:

The provided 510(k) summary does not include any information regarding:

• Acceptance criteria for device performance.
• A performance study or clinical trial demonstrating the device meets specific criteria.
• Sample sizes for test or training sets.
• Data provenance (country of origin, retrospective/prospective).
• Number or qualifications of experts used for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Effect size of AI assistance for human readers.
• Standalone algorithm performance.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• How ground truth for any set was established.

Based on the provided document, the only aspect that remotely touches upon "performance" is the comparison of technological characteristics to a predicate device. This is not a performance study in the manner typically expected for acceptance criteria.

Therefore, a table of "acceptance criteria" and "reported device performance" as requested cannot be constructed from this document. The document states:

"Both Prism and Rhythm support the following digital EEG plots: average power spectrum, compressed spectral arrays, topographic spectrum, topographic voltage plots, and correlation and lag. Neither product utilizes a normative database. Rhythm is capable of digitizing an analog signal while Prism requires that the signal be digitized by a separate EEG acquisition system. Both are software only products."

This describes features, not performance metrics against acceptance criteria.

Summary of available and missing information:

1. Table of acceptance criteria and reported device performance: Not provided in the document. The document describes functional characteristics but not performance metrics or acceptance criteria.
2. Sample size used for the test set and the data provenance: Not provided in the document. No performance study details are included.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided in the document. No ground truth establishment is described.
4. Adjudication method for the test set: Not provided in the 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: Not provided in the document. The device is a "software only product" for displaying EEG signals, not an AI-assisted diagnostic tool in the modern sense.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not provided in the document. The device is intended "for use by a trained EEG reader."
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not provided in the document.
8. The sample size for the training set: Not provided in the document.
9. How the ground truth for the training set was established: Not provided in the document.

Conclusion:

The provided 510(k) summary from 1997 is a demonstration of substantial equivalence based primarily on a comparison of intended use, technological characteristics, and predicate device classification. It does not include the detailed performance study information, acceptance criteria, or ground truth establishment methodologies that are typically found in more recent regulatory submissions for devices that involve AI or machine learning algorithms with specific performance claims. At the time of this submission, the regulatory requirements and the nature of the device (a display and analysis tool, not an automated diagnostic system) likely did not necessitate such extensive performance data in the summary.

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