The PSA4000 is indicated for use in the operating room (OR), intensive care unit (ICU), and clinical research laboratory. It is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system includes the Patient State Index (PSI™), a proprietary computed EEG variable that is related to the effect of anesthetic agents.

Device Description

The PSA4000 is an EEG monitor designed for use in the OR, ICU, EEG laboratory and for clinical research. It provides the ability to acquire and display real-time EEG waveforms, process the real time EEG data using digital signal processing techniques, display the processed EEG data in several different formats, and archive the real-time or processed EEG data for future review. The PSA4000 consists of three main components, the monitor, the amplifier and the archive media (optional). The device performs automatic self tests upon power up to ensure that the monitor and its components are functioning properly.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "PSA4000 EEG Monitor with Frontal PSI." However, it does not contain a detailed study with specific acceptance criteria and performance data for the device in the way a clinical trial report would.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (PSA4000 EEG Monitor with PSI K001069) and fulfilling regulatory requirements. It mentions general validation testing but lacks the quantitative details to complete the requested table and answer many of the specific questions about clinical study design and outcomes.

Here's a breakdown of what can be extracted and what is missing, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document states:
"The test results are all positive and indicate that the device meets product requirements and satisfies customer needs and expectations."
However, it does not specify what those "product requirements" or "acceptance criteria" were in a measurable format, nor does it present quantitative performance data. The tests mentioned are:

Software validation testing
Mechanical validation testing
Electrical validation testing
EMC testing
Compliance with UL 2601, CSA 22.2 No. 601-1, IEC 601-1, IEC 601-2-26, and FDA Reviewer Guidance for Premarket Notification Submissions (EMC).

2. Sample size used for the test set and the data provenance

Sample Size: Not specified. The document mentions "test results" but does not detail the number of subjects, cases, or data points involved in any testing, particularly for the performance of the "Frontal PSI" component.
Data Provenance: Not specified. There is no information about the country of origin of the data or whether the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not specified. This information is typically relevant for studies evaluating the accuracy of a diagnostic or prognostic tool against expert judgement. The document does not describe such a study.

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

Not specified. As no expert- Adjudicated test set is detailed, no adjudication method is mentioned.

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 MRMC study was mentioned. The device is an EEG monitor that calculates a "Patient State Index (PSI)". The document does not describe studies where human interpretation of EEG or patient state was compared with and without the aid of the PSA4000's PSI.

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

While the device calculates a proprietary "Patient State Index," the document does not provide a standalone performance evaluation of this algorithm in terms of specific metrics (e.g., sensitivity, specificity, accuracy) against a reference standard. The "Test Results" section refers to engineering and compliance testing, not clinical "standalone" performance.

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

Not specified. Due to the lack of detailed performance studies, the type of ground truth used to validate the accuracy or effectiveness of the PSI is not mentioned.

8. The sample size for the training set

Not applicable/Not specified. The document does not describe the use of machine learning in a way that typically involves distinct "training" and "test" sets for algorithmic development in the context of diagnostic accuracy. The PSI is described as a "proprietary computed EEG variable," implying an algorithm, but no details of its development or training are given.

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

Not applicable/Not specified. See point 8.

Summary

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

KO20671

February 28, 2002

page vii

510(K) SUMMARY

OCT 0 4 2002

Company:	Physiometrix, Inc.Five Billerica Park101 Billerica AvenueN. Billerica, MA 01862
Contact:	Dawn E. FrazerVice PresidentRegulatory Affairs & Quality Assurance(978) 670-2422 x243dfrazer@physiometrix.com
Subject Device:	PSA4000 EEG Monitor with Frontal PSI
Classification:	Class II, 21 CFR Part 882.1400, Electroencephalograph
Intended Use:	The PSA4000 is indicated for use in the operating room (OR), intensive care unit (ICU), and clinical research laboratory. It is intended to monitor the state of thebrain by real-time data acquisition and processing of EEG signals. The systemincludes the Patient State Index (PSI™), a proprietary computed EEG variablethat is related to the effect of anesthetic agents.

Photograph:

Date:

Image /page/0/Picture/7 description: The image shows a medical device used for brain monitoring. The device includes a head mannequin with sensors attached to the forehead, a monitor displaying brain activity, and a processing unit labeled "PSA-4000". The monitor shows a waveform and the number 79, likely indicating a measurement value. The device appears to be used for diagnostic or research purposes related to brain function.

Description:

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

processing techniques, display the processed EEG data in several different formats, and archive the real-time or processed EEG data for future review.

The PSA4000 consists of three main components, the monitor, the amplifier and the archive media (oplional). The device performs automatic self tests upon power up to ensure that the monitor and its components are functioning properly.

Monitor

The monitor provides signal processing and display capabilities for the 4 channels of real-time EEG data acquired from the preamplifier.

The monitor dimensions are 8.5" wide x 6.75" high x 20.75" deep. The color display area is 3.75" high x 5.2" wide. In addition to the display area, the front panel is configured with a number of soft and hard keys to allow for configuration of the display and data acquisition settings.

The processor is a PC-based CPU that processes the EEG data, calculates the processed parameters and displays the real-time EEG data and processed data. Processed parameters include Electromyograph (EMG), Artifact (ART), Suppression Ratio (SR), and the Patient State Index (PSI).

Patient Module

The patient module is an electrically isolated, low noise, high gain, analog to digital signal converter that can process up to 4 channels of real-time data. The preamplifier dimensions are 4.25" wide x 1.75" thick x 5.5" high. The patient module includes a clamp that can be used to secure the unit. The clamp can accommodate a pole of up to 1° in diameter. The preamplifier is connected to the patient and monitor through flexible, shielded cabling.

Archive Media (optional)

The PSA4000 has an optional PCMCIA slot. When a PCMCIA card is detected on start up of the monitor, data will be automatically stored on the PCMCIA Hard Disk Drive.

Predicate Device: PSA4000 EEG Monitor with PSI (K001069)

Similarities: The subject device is similar to the predicate device in the following ways:

Both systems are EEG monitors. a.
b. Both systems provide a variety of processed parameters,
Both systems include a proprietary computed EEG variable that is related to C. the affects of anesthetics.
Both conduct self tests at start up to assure that the device is operating. ರ.
Both systems have two main components, a monitor and a preamplifier. e.

Differences:

The subject device is different from the predicate device in the following way:
- The subject device is intended for use with the PSArray, which consists of 6 a. electrodes located on the forehead while the predicate device is intended for

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

K020671 page J+[}

Physiometrix PSA4000 EEG Monitor with Frontal PSI 510(k) Notification

use with the PSArray, which consists of 7 electrodes located on the forehead, scalp and ears.

Test Results: The following tests have been conducted in order to verify and validate the device: software, mechanical and electrical validation testing and EMC testing.

The PSA4000 has been testing in accordance with the following standards.

UL 2601 .
CSA 22.2 No. 601-1 .
IEC 601-1 ●
IEC 601-2-26 .
FDA Reviewer Guidance for Premarket Notification Submissions, Section 7, . Electromagnetic Compatibility dated November 1993.

The test results are all positive and indicate that the device meets product requirements and satisfies customer needs and expectations.

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

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, with three curved lines forming the body and wings. The bird is facing to the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

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

APR - 9 2012

Ms. Dawn E. Frazer Vice President, Regulatory Affairs and Quality Assurance Physiometrix Five Billerica Park 101 Billerica Avenue North Billerica, MA 01862

Re: K020671

Trade/Device Name: PSA4000 EEG Monitor with Frontal PSI Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLW, OMC, ORT Dated (Date on orig SE ltr): October 1, 2002 Received (Date on orig SE ltr): October 2, 2002

Dear Ms. Frazer:

This letter corrects our substantially equivalent letter of October 4, 2002.

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 (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.

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.

{4}------------------------------------------------

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Kesia Alexander

Malvina B. Evdelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

INDICATIONS FOR USE STATEMENT

Applicant:	Physiometrix, Inc.
510(k) Number (if known)	Not assigned
Device Name	PSA4000 EEG Monitor with Frontal PSI
Indications For Use	The PSA4000 EEG Monitor with Frontal PSI is indicated for use inthe operating room (OR), intensive care unit (ICU), and clinicalresearch laboratory. It is intended to monitor the state of the brainby real-time data acquisition and processing of EEG signals. Thesystem includes the Patient State Index (PSITM), a proprietarycomputed EEG variable that is related to the effect of anestheticagents.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
510(k) Number	K020671
Prescription Use(Per 21 CFR 801.109)	OR Over-The-Counter Use

page x

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).