PERSYST 13 (P13) EEG REVIEW AND ANALYSIS SOFTWARE by PERSYST DEVELOPMENT CORPORATION

Persyst 13 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 13 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 13 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 13 Spike Detection performance has not been assessed for intracranial recordings.
Persyst 13 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 13 is intended to monitor the state of the brain. The automated event marking function of Persyst 13 is not applicable to aEEG.
Persyst 13 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 13 notifications will be shown to a user. Persyst 13 notifications cannot be used as a substitute for real time monitoring EEG by a trained expert.
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.
This device does not provide any diagnostic conclusion about the patient's condition to the user.

Device Description

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AI/ML Overview

Here's an analysis of the provided text to fulfill your request, focusing on acceptance criteria and supporting studies for the Persyst 13 device.

It's important to note that the provided document is a 510(k) clearance letter and an "Indications for Use" statement. It does not contain the detailed study results or explicit acceptance criteria tables that would typically be found in a full submission or a clinical trial report. The FDA 510(k) clearance process primarily evaluates substantial equivalence to a legally marketed predicate device rather than requiring de novo efficacy studies with specific performance metrics and acceptance criteria.

Therefore, the response below will extract what can be inferred or found directly from the text and highlight what information is not present.

Acceptance Criteria and Device Performance Study (Based on Provided Document)

The provided document (FDA 510(k) clearance letter K151929 for Persyst 13) is a regulatory approval, not a detailed scientific study report. As such, it does not explicitly state specific acceptance criteria (e.g., minimum sensitivity, specificity, or AUC thresholds) or present a table of quantitative performance metrics from a clinical study. The FDA's 510(k) clearance process relies on demonstrating "substantial equivalence" to a predicate device, which implies the device performs at least as well as, or comparably to, the predicate.

The document indicates that certain components of Persyst 13 have specific intended functionalities, for which performance would have been assessed to support the 510(k) submission. However, the actual performance values or the detailed study design (including acceptance criteria) are not included in this public-facing clearance letter.

We can infer the types of performance relevant to the device's claims, specifically for "Seizure Detection" and "Spike Detection."

Table 1: Acceptance Criteria (Inferred from Indications for Use) and Reported Device Performance (Not Stated in Document)

Feature / Performance Metric Type	Acceptance Criteria (Not Explicitly Stated in Document)	Reported Device Performance (Not Explicitly Stated in Document)
Seizure Detection	Likely related to sensitivity and specificity in marking electrographic seizures.	The document states it's "intended to mark... sections of... EEG recordings that may correspond to electrographic seizures." No quantitative performance is reported.
Spike Detection	Likely related to sensitivity and specificity in marking spikes.	The document states it's "intended to mark... sections of the patient's EEG recordings that may correspond to spikes." No quantitative performance is reported.
Artifact Reduction (AR)	Likely related to efficacy in reducing EMG, eye movement, and electrode artifacts while preserving cerebral activity.	The document states AR "is intended to reduce EMG, eye movement, and electrode artifacts" but "does not remove the entire artifact signal" and "may modify portions of waveforms representing cerebral activity." No quantitative performance is reported.
Other Quantitative Measures	Likely related to accuracy/reliability of FFT, Rhythmicity, Peak Envelope, Artifact Intensity, Amplitude, Relative Symmetry, and Suppression Ratio calculations.	The document states these are "intended to monitor and analyze the EEG waveform." No quantitative performance is reported.
aEEG Functionality	Likely related to reliability in monitoring the state of the brain.	The document states it "is intended to monitor the state of the brain." No quantitative performance is reported.
Notification Delays	Likely a maximum acceptable delay for notifications.	The document states "Delays of up to several minutes can occur between the beginning of a seizure and when the Persyst 13 notifications will be shown to a user." This implies an upper bound on delay, but an explicit criterion is absent.

Study Information (Where Available or Inferable from the Document)

Since the document does not provide a detailed study report, much of the requested information is not explicitly stated. Where information can be inferred or is directly mentioned, it is noted.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not explicitly stated in the document. The document is a regulatory clearance, not a study report. Details about the test set size, data origin, or whether it was retrospective/prospective would be in the original 510(k) submission, which is not provided.
- Implicitly, for Seizure Detection: "previously acquired sections of adult (greater than or equal to 18 years) EEG recordings."
- Implicitly, for Spike Detection: "previously acquired sections of the patient's EEG recordings... in patients at least one month old." Performance for intracranial recordings was not assessed.
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 explicitly stated in the document. This level of detail would be in the study design section of the 510(k) submission. However, the "Indications for Use" repeatedly mentions "qualified medical practitioners," "neurologists," and "trained expert" as the intended users and interpreters, implying that ground truth would be established by such qualified individuals, likely neurologists or epileptologists.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not explicitly stated in the document.
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 explicitly stated in the document. The device is cleared as an assistive tool ("to aid neurologists," "to assist qualified clinical practitioners"). This phrasing implies that human readers are still central to the interpretation. Whether a formal MRMC study was done to quantify improvement with AI assistance is not described in this clearance letter.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The "Seizure Detection" and "Spike Detection" components "mark previously acquired sections." This implies an algorithm-only function to identify and highlight these events, which are then presented to a human for review. The indications for use emphasize that the device does not provide diagnostic conclusions and is intended to assist practitioners, suggesting the algorithm's output is not final without human review.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Inferred to be expert consensus/review of EEG waveforms. For seizure and spike detection, the most common ground truth in EEG analysis is expert annotation by neurologists or epileptologists. The document explicitly states that quantitative EEG measures "should always be interpreted in conjunction with review of the original EEG waveforms," and for AR, "any interpretation or diagnosis must be made with reference to the original waveforms." This strongly suggests that human interpretation of raw EEG is the ultimate ground truth.
The sample size for the training set
- Not explicitly stated in the document.
How the ground truth for the training set was established
- Not explicitly stated in the document. As with the test set, it's highly probable it involved expert annotation of EEG data.

Summary of Document Limitations:

The provided document is an FDA clearance letter and an "Indications for Use" statement. It serves to inform that the device has been deemed substantially equivalent to a predicate and what its approved uses are. It does not typically contain the detailed technical and clinical study reports that would include specific acceptance criteria, performance metrics, sample sizes, ground truth methodologies, or granular study results (like those from MRMC studies for AI effect size). Such detailed information would reside in the original 510(k) submission document, which is not publicly available in this format.

Summary

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

August 12, 2015

Persyst Development Corporation Dari Darabbeigi Vice President of Quality and Regulatory Affairs Persyst Development Headquarters 12625 High Bluff Drive Suite 213 San Diego, CA 92130

Re: K151929

Trade/Device Name: Persyst 13 Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMB, OLT, OMA Dated: July 10, 2015 Received: July 14, 2015

Dear Ms. 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 (see 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 or any Federal statutes and regulations administered by other Federal agencies. You must

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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 of medical devicerelated 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education 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.

Carlos L. Pena -S

Carlos Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K151929

Device Name Persyst 13

Indications for Use (Describe)

Persyst 13 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 13 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 13 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 13 Spike Detection performance has not been assessed for intracranial recordings.
Persyst 13 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 13 is intended to monitor the state of the brain. The automated event marking function of Persyst 13 is not applicable to aEEG.
Persyst 13 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 13 notifications will be shown to a user. Persyst 13 notifications cannot be used as a substitute for real time monitoring EEG by a trained expert.
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.
This device does not provide any diagnostic conclusion about the patient's condition to the user.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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).