The eego amplifier is intended to be used by or under the direction for acquisition of EEG signals and to transmit them digitally to a computer. The device is intended for use on humans. The device is intended for use in a clinical environment (e.g., hospital, physician's office, etc). The device is not intended for use in life support systems.

Device Description

The eego amplifier is a multi-channel, plastic enclosed EEG amplifier. There are two ranges for the variations of amplifiers (models):

1. EE-2xx, and
1. EE-4xx.
  In total, there are 8 models. The EE-411 and EE-430 amplifiers are built using identical components and share identical internal structure, functionality and performance. The eego amplifier electroencephalography (EEG) input is from commercially available EEG electrodes from the Waveguard™ EEG Cap cleared in K110223. The eego amplifiers support EEG acquisition and storage by:
1. referential DC input channels,
1. parallel trigger input channel.
  Electrode Impedance values can be measured for all referential electrodes, reference and patient ground electrode. Signal sampling rate and gain are set through the user interface of the Software Development Kit (SDK). The EE-2XX series of eego amplifier is powered by a built-in, rechargeable battery. The battery provides a minimum of 4 hours of operation time. The amplifier can be applied for data acquisition with the 12 V battery charger source applied. The USB port supports interface to the computer running the SDK. The EE-4XX series of eego amplifier is powered by the USB port connection to a computer.

AI/ML Overview

This document describes the premarket notification for the eego amplifiers, focusing on its substantial equivalence to a predicate device rather than a study proving the device meets specific acceptance criteria for a diagnostic algorithm.

Therefore, many of the requested points regarding diagnostic performance, ground truth, sample sizes for training/test sets, expert adjudication, and comparative effectiveness with AI assistance cannot be extracted Directly from the provided text. The document primarily concerns the safety and performance of a medical device (EEG amplifier) and its compliance with general medical device standards.

Here's an attempt to answer the questions based on the available information:

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

The document does not provide specific acceptance criteria or quantitative performance metrics for a diagnostic task. Instead, it refers to compliance with international safety and performance standards for medical electrical equipment.

Acceptance Criteria Category	Reported Device Performance (Compliance)
Safety Standards
IEC 60601-1:2005 (DIN EN 60601-1:2007)	Device complies with standards for basic safety and essential performance.
IEC 60601-1-2:2007/2014 (EMC)	Device complies with electromagnetic compatibility requirements.
IEC 60601-2-26:2012	Device complies with particular requirements for basic safety and essential performance of electroencephalographs.
IEC 62133 Ed. 2.0 2012-12 (Batteries)	Device complies with safety requirements for portable sealed secondary cells and batteries (for EE-2XX series).
Functional Equivalence to Predicate
Intended Use	Equivalent to predicate (electrically amplify signals derived from EEG).
Indications for Use	Equivalent to predicate (acquisition of EEG signals and digital transmission to computer).
Type of Use	Same (Prescription Use).
Modes of Operation	Both acquire EEG signals (subject device focuses on EEG, predicate broader).
Environment of Use	Same (Clinical environment).
Data Storage	Same (Yes).
Electrode Impedance Measurement	Same (Yes).
Filter	Same (Low pass filtering in amplifier).
Patient Contact	Equivalent (No direct patient contact by amplifier, uses external electrodes).
Sampling Rate	Equivalent (Subject device: up to 16384 Hz for EE-2XX, up to 2048 Hz for EE-4XX; Predicate: up to 20000 Hz).
Video	Option to allow video (subject device) vs. No (predicate) - considered an acceptable difference.
Amplifier Active Shielding	Same (Yes).
Amplifier CMRR (referential)	>100 dB (subject device) vs. 90 dB (predicate) - subject device performs better, considered equivalent or superior.
Amplifier Input Channels	Up to 64 (subject device) vs. Up to 64 (special mode supports 128) (predicate) - considered equivalent.
Amplifier Input Impedance (referential)	>10^9 Ohm (subject device) vs. >10^12 Ohm (predicate) - considered equivalent for low impedance physiological signal inputs.
Amplifier Power	Subject device: Rechargeable battery (EE-2XX), USB (EE-4XX) vs. Predicate: AC Mains - considered equivalent in function.
Amplifier Operating Time on Battery	Up to 4 hours (EE-2XX Series) - N/A for predicate (AC powered).
Amplifier Referential DC Input Channels	Yes (8, 16, 32, or 64 channels) vs. Yes (16, 32, 64 or 128 channels) - considered equivalent.
Amplifier Trigger Input	Equivalent (Optional TTL, varying bits).
Amplifier Trigger Input Channel	Same (Yes, Parallel).
Amplifier USB Interface	Same (Yes).

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

This information is not provided in the document. The document describes performance testing for compliance with technical standards, not a diagnostic study involving patient data.

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

This information is not provided. Ground truth in the context of diagnostic algorithms is not relevant to this type of device submission, which focuses on hardware performance and safety standards.

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

This information is not provided as it is not applicable to the type of device and testing 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, an MRMC comparative effectiveness study was not done. The eego amplifier is a device for signal acquisition, not an AI-powered diagnostic algorithm.

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

No, a standalone algorithm performance study was not done. The device itself is not an algorithm, but hardware for signal acquisition.

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

This information is not provided in the context of diagnostic accuracy. The "ground truth" for the performance testing mentioned would be the established specifications and requirements of the referenced IEC standards.

8. The sample size for the training set

This information is not provided. Training sets are relevant for machine learning algorithms, which is not the primary subject of this submission.

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

This information is not provided.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

March 30, 2018 eemagine Medical Imaging Solutions GmbH % Gary J. Syring Principal Consultant Ouality & Regulatory Associates, LLC 800 Levanger Lane Stoughton, Wisconsin 53589

Re: K172312

Trade/Device Name: eego amplifiers Regulation Number: 21 CFR 882.1835 Regulation Name: Physiological Signal Amplifier Regulatory Class: Class II Product Code: GWL, GWQ, OMC Dated: July 25, 2017 Received: March 1, 2018

Dear Gary J. Syring:

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 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

William J. Heetderks -S 2018.03.30 16:43:21 -04'00"

for Carlos L. 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) K172312

Device Name eego™ amplifiers

Indications for Use (Describe)

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

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

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K173312 510(k) Summary

Submitter Information

Submitter's Name:	eemagine Medical Imaging Solutions GmbH
Submitter's Address:	Gubenerstr. 47, Fabrik
	D-10243, Berlin, Germany
Submitter's Phone:	Phone: +49 30 29 04 84 04
Contact Person:	Frank Zanow, Chief Executive Officer
	or Ralf Hauffe, PhD, Chief Operations Executive Officer
Date Summary

March 29, 2018

Subject Device

Prepared:

Trade Name:	eego™ amplifiers
Common Name:	Physiological signal amplifier
Classification Name:	21 CFR 882.1835 Physiological signal amplifierClass II
Product Code:	GWL, amplifier, physiological signal
Subsequent Code:	GWQ, full-montage standard electroencephalographOMC, reduced- montage standard electroencephalograph

Predicate Device

510(k) Number:	K060374
Trade Name:	REFA, Physiological Amplifier
Submitter Name:	TMS International BV
Classification Name:	21 CFR 882.1835
Product Code:	GWL

Device Description

The eego amplifier is a multi-channel, plastic enclosed EEG amplifier. There are two ranges for the variations of amplifiers (models):

1. EE-2xx, and
1. EE-4xx.

In total, there are 8 models, as follows:

Model	EEGChannels(Referential)	Sampling rate configuration(down sampling in API software,internal 32 kHz for all)	Power Source
EE-211	64	2 kHz	Rechargeable battery
EE-212	32	2 kHz
EE-213	16	2 kHz
EE-221	32	16 kHz
EE-222	64	16 kHz
EE-224	32	16 kHz
EE-411	8	2 kHz	USB Connection toComputer
EE-430	8	0.5 kHz

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The EE-411 and EE-430 amplifiers are built using identical components and share identical internal structure, functionality and performance.

The eego amplifier electroencephalography (EEG) input is from commercially available EEG electrodes from the Waveguard™ EEG Cap cleared in K110223.

The eego amplifiers support EEG acquisition and storage by:

1. referential DC input channels,
1. parallel trigger input channel.

Electrode Impedance values can be measured for all referential electrodes, reference and patient ground electrode. Signal sampling rate and gain are set through the user interface of the Software Development Kit (SDK).

The EE-2XX series of eego amplifier is powered by a built-in, rechargeable battery. The battery provides a minimum of 4 hours of operation time. The amplifier can be applied for data acquisition with the 12 V battery charger source applied. The USB port supports interface to the computer running the SDK.

The EE-4XX series of eego amplifier is powered by the USB port connection to a computer.

Statement of Intended Use

The eego amplifier is intended to be used by or under the direction of a physician for acquisition of EEG signals and to transmit them digitally to a computer. The device is intended for use on humans. The device is intended for use in a clinical environment (e.g., hospital, physician's office, etc). The device is not intended for use in life support systems.

Summary of Technological Characteristics & Comparison to Predicate

The following table provides a comparison the eego amplifiers to the predicate device identified to demonstrate substantial equivalence.

Table 1: Substantial Equivalence Technical Characteristics
Feature	eego™ amplifiersSubject Device K172312	REFA Physiological AmplifierPredicate K060374	Comment
Intended Use	Used to electrically amplify signalsderived from electroencephalogram.	Used to electrically amplify signalsderived from various physiologicalsources, including theelectroencephalogram.	Both devices areamplifiers of signalsderived from physiologicsources.
Indications for Use	The eego amplifier is intended to beused by or under the direction of aphysician for acquisition of EEG signalsand to transmit them digitally to acomputer. The device is intended foruse on humans. The device is intendedfor use in a clinical environment (e.g.,hospital, physician's office, etc). Thedevice is not intended for use in lifesupport systems.	The REFA Physiological Amplifierfamily is intended to be used by orunder the direction of a physicianfor acquisition of EEG, polygraphyand polysomnography signals andtransmission of the signals to a PCduring recording of neurophysical /physiological research and exams.Polygraphy and Polysomnographymay besides EEG, includephysiological information such asEMG, ECG, EOG, EGG, PH,Respiration, Temperature andOxygen Saturation.	Amplifiers are intendedfor acquisition of EEGsignals to a computer.
Type of use	Prescription Use	Prescription Use	Same
Modes of Operation	Electroencephalography (EEG)	EEG, EMG, ECG, EOGEGG, PHRespiration, Temperature,	Both acquire EEG signals.
Table 1: Substantial Equivalence Technical Characteristics
Feature	eego™ amplifiersSubject Device K172312	REFA Physiological AmplifierPredicate K060374	Comment
		Oxygen Saturation
Environment of Use	Clinical environment(Example: hospital, physician's office,etc)	Clinical environment(Example: hospital, physician'soffice, etc)	Same
Data Storage	Yes	Yes	Same
Electrodeimpedancemeasurement	Yes	Yes	Same
Filter	Low pass filtering in amplifier	Low pass filtering in amplifier	Same
Patient Contact	NoPatient contact is made by theWaveguard™ EEG Cap (K110223).	NoPatient contact is made bycommercially available electrodesand transducers.	Equivalent
Sampling rate	EE-2XX Series:Up to 16384 Hz Set through the userinterface of the Software DevelopmentKit (SDK) softwareEE-4XX Series: Up to 2048 Hz	Up to 20000 Hz	Equivalent
Video	Optional	No	Option to allow video
Amplifier activeshielding technique	Yes(Protects the referential EEG inputs fromenvironmental noise)	Yes	Same
Amplifier CMRR(referential)	>100 dB	90 dB	Equivalent
Amplifier InputChannels	Up to 64	Up to 64Special mode supports 128 EEGinputs	Equivalent
Amplifier inputimpedance(referential)	>109 Ohm	>1012 Ohm	Equivalent for lowimpedance ofphysiological signalinputs.
Amplifier power	EE-2XX Series: Rechargeableintegrated batteryEE-4XX Series: USB from Computer	AC Mains	DC power source for eegoamplifiers.
Amplifier operatingtime on batterypower	EE-2XX Series: Up to 4 hours	Not Applicable	DC power source for eegoamplifiers.
Amplifier referentialDC input channels	Yes8, 16, 32, or 64 channels	Yes16, 32, 64 or 128 channels	Equivalent
Amplifier triggerinput	Yes,EE-2XX Series: Optional 8 bit TTLEE-4XX Series: Optional 2 bit TTL	Yes,Optional 8 bit TTL	Equivalent
Amplifier triggerinput channel	Yes(Parallel)	Yes	Equivalent
Amplifier USBinterface	Yes	Yes	Same

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Table 1: Substantial Equivalence Technical Characteristics
------------------------------------------------------------	--	--

Feature	eego™ amplifiersSubject Device K172312	REFA Physiological AmplifierPredicate K060374	Comment
Safety standards applied	IEC 60601-1IEC 60601-1-2IEC 60601-2-26IEC 62133	IEC 60601-1IEC 60601-1-2	Appropriate standards applied

Performance Testing

To establish the equivalency of the eego amplifiers, evaluations were conducted to confirm compliance with performance requirements and standards including:

IEC 60601-1:2005 (DIN EN 60601-1:2007), Medical electrical equipment Part 1: General 0 requirements for basic safety and essential performance.
. IEC 60601-1-2:2007, Medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility requirements and tests.
IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for basic . safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests.
. IEC 60601-2-26: 2012 Medical electrical equipment, Particular requirements for the basic safety and essential performance of electroencephalographs.
IEC 62133 Edition 2.0 2012-12. Secondary cells and batteries containing alkaline or other . non-acid electrolytes - safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications.

Conclusion

The eego amplifiers meet performance requivalent to the predicate device. The intended use and technology of the eego amplifiers are equivalent to the predicate device.

Regulation Number and Section

§ 882.1835 Physiological signal amplifier.

(a)
Identification. A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).(b)
Classification. Class II (performance standards).