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.

AI/ML Overview

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

Acceptance Criteria	Reported Device Performance
Not explicitly defined in the document for performance metrics. The primary "acceptance criteria" for 510(k) clearance is substantial equivalence (functional and safety equivalence) to a predicate device.	The device identifies spike and seizure events from digitized EEG input.
No diagnostic or effectiveness claims are made.	No performance metrics (e.g., sensitivity, specificity, accuracy) are reported in this document.

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.

Summary

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

Section 2 - Summary of Safety and Effectiveness

Stellate Sensa

The Stellate Sensa (predicate device) is a software only product. It runs on a personal computer and identifies spike and seizure events. These events are then reviewed, possibly deleted, and interpreted by the user.

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.

Persyt Reveal

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.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird in flight, composed of three curved lines.

AUG - 3 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Scott B. Wilson President Persyst Development Corporation 316 Skyline Drive Prescott, Arizona 86303

Re: K011397

Trade/Device Name: Persyst Reveal Regulation Number: 882.1420 Regulatory Class: Class I Product Code: GWS Dated: May 2, 2001 Received: May 7, 2001

Dear Mr. Wilson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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

Page 2 - Mr. Scott B. Wilson

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".

Sincerely yours,

L. Mark A. Wilkinson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

510(k) Number (if known):

011397

Device Name: Persyt Reveal (previously Persyst SpikeDetector)

Indications for Use:

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

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

Concurence of CDRH, Office of Device Evaulation (ODE)

Mark M Millener

(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

510(k) Number

(Optional Format 3-10-98)

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).