SYNAMPS2 by NEUROSCAN | FDA 510(k) Summary

The Neuroscan SynAmps2 system is intended for measuring recording of the electrical activity of a patient's brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG. The system is intended for the EEG and long/middle/short-latency EP registration in the research environment. The system is intended to be used by qualified/trained EEG technologists and/or physicians. The data acquired must be interpreted by qualified physicians.

Device Description

The SynAmps2® Amplifier System is an EEG/ERP/EP amplifier and data acquisition system. The amplifier and data acquisition electronics are housed in a small enclosure (Headbox) placed near the patient, and into which individual electrodes, collections of electrodes, may be connected. Additionally a high density electrode cap connector is provided on the Headbox. The Headbox also contains a connector for the interconnect cable to the System Unit.

The System Unit is slightly larger than the Headbox and serves as an interface between up to four Headboxes and the host computer.

The system operates under the software control of a host computer over a USB 2.0 interface. Data flows from the SynAmps2 amplifier over this interface. Multiple System Units may be connected to the host, to obtain systems of up to 512 channels.

AI/ML Overview

This device, the Neuroscan SynAmps2, is an Electroencephalograph (EEG) system and the provided text does not include a study or acceptance criteria in the traditional sense of evaluating an AI model's performance.

The document is a 510(k) summary for a medical device (SynAmps2) that functions as an EEG/ERP/EP amplifier and data acquisition system. The primary goal of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove specific performance metrics against pre-defined acceptance criteria through a study as would be typical for an AI/ML diagnostic device.

Therefore, many of the requested items (e.g., sample sizes for test/training, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable or extractable from this document as these relate to the performance evaluation of a diagnostic or AI algorithm, not an EEG hardware system's substantial equivalence.

Here's an analysis of the provided information in the context of the request, highlighting what is (and isn't) present:

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

Acceptance Criteria: Not explicitly stated in the document in terms of performance metrics for a diagnostic output. The "acceptance criteria" for a 510(k) submission for this type of device is demonstrating substantial equivalence to a predicate device (SynAmps, K001324). This typically involves comparing technical specifications, intended use, and safety aspects.
Reported Device Performance: The document describes the functionality of the SynAmps2 (EEG/ERP/EP amplifier and data acquisition system, up to 512 channels, USB 2.0 interface) and states its intended use (measuring and recording electrical activity of the brain to aid in monitoring and diagnosis). Specific performance metrics like accuracy, sensitivity, or specificity are not provided as this is a hardware device for data acquisition, not an interpretive or diagnostic AI software.

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

Not applicable. This is a 510(k) submission for a hardware device, not an AI/ML algorithm requiring a test set for performance evaluation.

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

Not applicable. No ground truth establishment for a test set is discussed. The device is for acquiring data that would then be interpreted by qualified physicians.

4. Adjudication method for the test set

Not applicable.

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 applicable. No MRMC study or AI assistance is mentioned.

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

Not applicable. This is a hardware acquisition system, not an algorithm.

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

Not applicable. The device acquires raw EEG data; the "ground truth" for diagnosis would be established by a qualified physician interpreting the acquired data.

8. The sample size for the training set

Not applicable.

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

Not applicable.

Summary relevant to the provided document:

The provided document details a 510(k) premarket notification for the Neuroscan SynAmps2, an Electroencephalograph (EEG) system. The core of this submission is to demonstrate substantial equivalence to an existing predicate device (SynAmps, K001324). This involves comparing the new device's technical characteristics, safety, and intended use against the predicate, rather than conducting a clinical study to prove diagnostic performance against specific acceptance criteria for an AI model.

The "acceptance" by the FDA, as indicated by the letter, means they determined the device is substantially equivalent to the predicate, allowing it to be marketed. This is different from meeting performance acceptance criteria from a study for an AI-powered diagnostic device.

Summary

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V. 510(k) Summary

Safety and effectiveness information concerning this device is summarized below. Because this is not a Class III device, the special certification defined in this section is not required.

Submitted by:	Neuroscan7850 Paseo Del Norte, Suite 101El Paso, TX 79912Phone: 915-845-5600 ext 217Fax: 915-845-2965	FEB 06 2003
Contact Person:	Elvira Garcia
Date Prepared:	October 30, 2002
Proprietary Name:	SynAmps2
Common Name:	Electroencephalograph (EEG)
Classification Name:	GWQ, GWP, GWF, GWE, GWJ
Device ClassificationClass II:	21 CFR § 882.1400 Electroencephalograph
Predicate Device:	SynAmps510(k) # K001324

Description of the Device:

The System Unit is slightly larger than the Headbox and serves as an interface between up to four Headboxes and the host computer.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/12 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract image of an eagle with three heads, symbolizing service to the nation. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 6 2003

Neuroscan Elvira Garcia Quality Assurance Manager 7850 Paseo Del Norte, Suite 101 El Paso, Texas 79912

Re: K023771

Trade/Device Name: SynAmps2 Regulation Number: 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWQ Dated: November 6, 2002 Received: November 12, 2002

Dear Ms. Garcia:

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. Iisting 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 such 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.

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Page 2 - Ms. Elvira Garcia

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C Provost

for 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

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IV. Statement of Indications for Use

Applicant:	Neuroscan7850 Paseo Del Norte, Suite 101El Paso, TX 79912Phone: 915-845-5600 ext. 217Fax: 915-845-2965
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KOLS 771 51(k) Number:

Device Name:

Neuroscan SynAmps2

Indications For Use: The Neuroscan SynAmps2 system is intended for measuring recording of the electrical activity of a patient's brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG. The system is intended for the EEG and long/middle/short-latency EP registration in the research environment. The system is intended to be used by qualified/trained EEG technologists and/or physicians. The data acquired must be interpreted by qualified physicians.

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

Concurrence of CDRH, Office of device Evaluation (ODE)

Musiam C. Provost

eral, Restorative Division Neurological Devices

510(k) Number K023771

(Per 21 CFR 801.109)

SynAmps2 510(k) Application

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).