Intended to record and display EEG and EP (evoked potential) data in the clinic and hospital. It is intended to aid in the diagnosis and monitoring of potential disorders of the central and peripheral nervous system.

Device Description

Cognitrace provides a comprehensive EEG/ERP Data acquisition and analysis System. Cognitrace consists of the following components: 1 EEG/ERP amplifier, Power supply for EEG/ERP amplifier, eemagine EEG (K002631) software with Cognitrace extension modules, Stimulation unit. Cognitrace can perform complete sets of measurements for neurology and psychiatry: EEG, Visual Evoked Potential (VEP), Auditory Evoked Potential (AEP), P300 (Auditory oddball paradigm), Visual P300 (Visual oddball paradigm), CNV (Contingent Negative Variation), Option to add protocols using acoustic or visual stimulation. The software components are: eemagine EEG, a novel, user-friendly and efficient software package for the analysis of EEG data and eego, a novel, user-friendly EEG data acquisition system and allows you to record and review EEG, offering different amplifier configurations, eego is seemlessly integrated with the eemagine EEG software, which offers simplicity and efficiency in the analysis of EEG studies.

AI/ML Overview

The provided text describes a 510(k) submission for the Cognitrace device, which is an electroencephalograph with evoked response stimulation. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed device performance metrics in the way an AI/ML device would.

Therefore, many of the requested elements for an AI/ML device study (like sample size for test/training sets, ground truth establishment details, multi-reader multi-case studies, etc.) are not applicable and not present in this document.

However, I can extract the information that is available and present the "acceptance criteria" as implied by the substantial equivalence comparison to the predicate device.

Acceptance Criteria and Device Performance for Cognitrace (Based on Substantial Equivalence)

The Cognitrace device demonstrates its performance by showing substantial equivalence to a legally marketed predicate device, the Nicolet Bravo Multi Modality System (K991054). The "acceptance criteria" are implicitly defined by meeting or exceeding the specifications and functionalities of the predicate device, with a focus on safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Acceptance Criterion (from Predicate)	Cognitrace Performance (as Reported)	Notes/Comparison
Indications For UseRecord and display EEG, EP, EMG, TCD; aid in diagnosis/monitoring of central/peripheral nervous system and muscles.	Record and display EEG and EP (evoked potential) data; aid in diagnosis and monitoring of potential disorders of the central and peripheral nervous system.	Cognitrace has a slightly narrower stated indication (no EMG or TCD mentioned in the table), but it still addresses the core EEG and EP functions. The 510(k) conclusion explicitly states "no new indications for use".
Prescription Use	Yes	Same as predicate.
Testing ModesEEG, EP, EMG	EEG, EP	Cognitrace supports EEG and EP. EMG is not listed as a supported mode for Cognitrace in the table.
Head BoxUses a headbox; fewer channels (32)	Various headboxes available for up to 128 channels	Cognitrace offers more channels than the predicate.
Filters - Low FilterFirst order IIR digital filter	Inside amplifier: Highpass: none	Different processing approach for low-frequency filtering.
Filters - High FilterSecond order IIR digital filter	Inside amplifier: Lowpass digital FIR filter, cutoff frequency = 0.27 * sample frequency	Different processing approach for high-frequency filtering.
Sample Frequencies< 1000 Hz	256 Hz, 512 Hz, 1024 Hz, 2048 Hz	Cognitrace supports higher maximum sampling frequencies.
Noise (0.1 - 100 Hz)< 2 μV (p-p), (0.7 µVrms)	EEG, BIP inputs: noise < 1.0 µVrmsAUX inputs: Noise < 20 µVrms	Cognitrace's EEG noise specification (1.0 µVrms) is comparable to or slightly higher than the predicate's 0.7 µVrms.
Software - Data AnalysisAveraging, Signal Processing, Filtering, Artifact detection, Baseline correction	Averaging, Dipole Fit, Spike Detection, Signal Processing, Filtering, Artifact detection, Baseline correction, Grand averaging, Detrending, Resampling, Spike detector, Dipole Fit, FFT, Coherence, Surface Laplacian	Cognitrace offers a significantly expanded set of data analysis features compared to the predicate.
Software - Data Acquisition	Montage, EEG signal acquisition, Writing of EEG data to file	Explicitly listed for Cognitrace.
Software - Visualization	HTML templates, Screen calibration, EEG view to display EEG traces, Reports and wizards	More detailed visualization and reporting features listed for Cognitrace.
Overall Safety and Effectiveness	Demonstrated through bench, electrical safety, EMC, and user testing	Explicit conclusion of equivalence.

2. Sample Size for the Test Set and Data Provenance

Not Applicable / Not Provided. This document does not describe a clinical study with a specific test set for algorithm performance. The basis for equivalence is primarily technical comparison, bench testing, electrical safety (EMC), and general "user testing." No details on the number of users or the nature of this testing are provided. Data provenance (e.g., country of origin, retrospective/prospective) is also not applicable in this context.

3. Number of Experts used to Establish Ground Truth for the Test Set and Qualifications

Not Applicable / Not Provided. As there's no specific algorithm performance study described, there is no mention of experts establishing a ground truth for a test set.

4. Adjudication Method for the Test Set

Not Applicable / Not Provided. No test set or ground truth adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. No MRMC study or any form of comparative effectiveness study with human readers (with vs. without AI assistance) is mentioned.

6. Standalone (Algorithm Only) Performance Study

Not Applicable / Not Provided. This document describes a medical device system (hardware and software) intended for use by clinicians, not a standalone AI algorithm. The performance evaluation focuses on the entire system's functionality and safety relative to the predicate.

7. Type of Ground Truth Used

Not Applicable / Not Provided. For a substantial equivalence claim based on technical specifications, bench testing, and general user testing of an EEG/EP device, a "ground truth" as you would define for an AI algorithm (e.g., pathology, outcomes data) is not directly applicable or discussed. The "ground truth" for the equivalence claim is the established performance and safety of the legally marketed predicate device.

8. Sample Size for the Training Set

Not Applicable / Not Provided. This device is not described as an AI/ML algorithm that undergoes "training."

9. How the Ground Truth for the Training Set was Established

Not Applicable / Not Provided. As above, no training set or its associated ground truth is discussed.

Summary

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051825 PAGE 1 OF 3

SEP 1 2005

EXHIBIT 2 510(k) Summary Cognitrace (Page 1 of 3) cemagine Medical Imaging Solutions GmbH Rudower Chausse 29 D-12489 Berlin, Germany Phone+ 49 (0)30 63926145 +49 (0) 30 63926146 Fax e-mail: info@eemagine.com May 31, 2005 Contact: Frank Zanow, General Manager

1. Identification of the Device: Proprietary-Trade Name: Cognitrace Classification Name/Product Codes: GWQ, GWE, and GWJ Common/Usual Name: Electroencephalograph with evoked response stimulation
Equivalent legally marketed devices: This product is similar in function to the Nicolet 2. Bravo (K991054) and employs the software for which we obtained clearance in K002631.
1. Indications for Use (intended use) : Intended to record and display EEG and EP (evoked potential) data in the clinic and hospital. It is intended to aid in the diagnosis and monitoring of potential disorders of the central and peripheral nervous system.
1. Description of the Device: Cognitrace provides a comprehensive EEG/ERP Data acquisition and analysis System. Cognitrace consists of the following components:
- 1 EEG/ERP amplifier
  - Power supply for EEG/ERP amplifier 트
  - eemagine EEG (K002631) software with Cognitrace extension modules 트
- Stimulation_unit

Cognitrace can perform complete sets of measurements for neurology and psychiatry:

EEG: ■
Visual Evoked Potential (VEP) 트
Auditory Evoked Potential (AEP)
P300 (Auditory oddball paradigm) 트
Visual P300 (Visual oddball paradigm) 트
트 CNV (Contingent Negative Variation)
Option to add protocols using acoustic or visual stimulation. ■

The software components are:

eemagine EEG, a novel, user-friendly and efficient software package for the . analysis of EEG data and
eego, a novel, user-friendly EEG data acquisition system and allows you to 트 record and review EEG, offering different amplifier configurations, eego is seemlessly integrated with the eemagine EEG software, which offers simplicity and efficiency in the analysis of EEG studies.
Safety and Effectiveness, comparison to predicate device. The results of bench and user 5. testing indicates that the new device is as safe and effective as the predicate devices. The hardware components have been evaluated and found to comply with the same safety and EMC compatibility standards as the predicate.

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K051825 PAGE 2 OF 3

510(k) Summary Cognitrace (Page 2 of 3)

6. Substantial Equivalence Chart

Feature	Nicolet Bravo Multi ModalitySystem (K991054)	Cognitrace
INDICATIONS FORUSE	Intended to record and display EEG, EP,EMG and TCD data in the clinic and hospital(including the hospital room, operating room,emergency room, intensive care unit, neurointensive care unit, critical care unit, etc.), andto import and display data from third-partymonitoring devices such as vital signsmonitors. It is intended to aid the diagnosisand monitoring of potential disorders of thecentral and peripheral nervous system andmuscles.	Intended to record and display EEG and EP (evokedpotential) data in the clinic and hospital. It is intendedto aid in the diagnosis and monitoring of potentialdisorders of the central and peripheral nervous system.
Prescription Use	Yes	Yes
Testing Modes	EEG, EP, EMG	EEG, EP
Head Box	Uses a headbox.Similar to Cognitrace but fewer channels (32)available	EEG: Various headboxes available for up to 128
Filters	Low filter: First order IIR digital filterHigh filter: Second order IIR digital filterAvailable sampling frequencies:< 1000 HzDigital filter applied to display of EEG data	Inside the amplifier following filtering is performed:Highpass: none,Lowpass digital FIR filter,cutoff frequency = 0.27 * sample frequencyAvailable sampling frequencies:256 Hz, 512 Hz, 1024 Hz, 2048 Hz.
Noise:	(0.1 -100 Hz) < 2 μV (p-p), (0.7 µVrms)	EEG, BIP inputs: noise < 1.0 µVrmsAUX inputs: Noise < 20 µVrms
Software	Data Analysis• Averaging• Signal Processing• Filtering (band pass, low pass,• high pass, band stop)• Artifact detection• Baseline correction• AveragingData AcquisitionVisualization	Data Analysis• Averaging• Dipole Fit• Spike Detection• Signal Processing• Filtering (band pass, low pass, highpass, band stop)• Artifact detection• Baseline correction• Averaging• Grand averaging• Detrending• Resampling• Spike detector• Dipole Fit• FFT• Coherence• Surface LaplacianData IO (e.g. EEG data files)DICOM Import (medical Images)Graphical user interfaceData Acquisition• Montage (e.g. montage editor)• EEG signal acquisition• Writing of EEG data to fileVisualizationReports and wizards (e.g. analysis reports)Screen calibrationVisualization (e.g. EEG view to display EEG traces)HTML templates (e.g. for the definition of theacquisition and analysis workflow)
DISPLAY	Various sizes/options of color LCD	SAME

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K051825 PAGE 3CF3

510(k) Summary Cognitrace (Page 3 of 3)

7. Conclusion

After analyzing bench, electrical safety, EMC, and user testing data, it is the conclusion of eemagine Medical Imaging Solutions GmbH that the Cognitrace is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with three heads. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 2 2005

eeMagine Medical Imaging Solutions GmbH c/o Mr. Daniel Kamm, P.E. Kamm & Associates PO Box 7007 Deerfield, Illinois 60015

Re: K051825

Trade/Device Name: Cognitrace Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: GWQ Dated: August 17, 2005 Received: August 26, 2005

Dear Mr. Kamm:

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.

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- Mr. Daniel Kamm, P.E.

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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Milliken

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KOS1825

Indications for Use

510(k) Number (if known):

. 14

Device Name: Cognitrace

Indications For Use: Intended to record and display EEG and EP (evoked potential) data in the clinic and hospital. It is intended to aid in the diagnosis and monitoring of potential disorders of the central and peripheral nervous system.

Prescription Use X (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 CDRH, Office of Device Evaluation (ODE)

Mark A. Mullaun

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

510(k) Number

051825

Page I of I

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).