PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE by PERSYST DEVELOPMENT CORP.

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

Device Description

Not Found

AI/ML Overview

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.

Summary

{0}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human figures connected by flowing lines, representing the department's focus on health and human well-being. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 21, 2013

Persyst Development Corp. c/o Mr. Dari Darabbeigi Vice President of Quality and Regulatory Affairs 12625 High Bluff Drive Suite 213 San Diego. CA 92130

Re: K132306

Trade/Device Name: Persyst 12 EEG Review and Analysis Software Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMB Additional Product Codes: OLT, OMA Dated: October 18, 2013 Received: October 22, 2013

Dear Mr. Dari Darabbeigi:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you however, that device labeling must be truthful and not misleading.

If your device is classified (sec above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may . publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act

{1}------------------------------------------------

Page 2 - Mr. Dari Darabbeigi

or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Victor Krauthamer -A

Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known): K132306

Device Name: Persyst 12 EEG Review and Analysis Software

Indications For Use:

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.
1. 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.

(Continue on next page.)

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

Victor Krautha 2013.11.2119:15

Page 1 of 2

{3}------------------------------------------------

1. 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.
1. 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.
1. 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.
1. 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.
1. 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.
1. This device does not provide any diagnostic conclusion about the patient's condition to the user.

Page 2 of 2

Regulation Number and Section

§ 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).