The AE-918P EEG Neuro Unit is an 8 channel EEG measuring unit that connects to a Nihon Kohden patient monitor and is intended to monitor brain function. The unit amplifies and analyzes EEG and displays the EEG waveform and the result of analysis on the patient monitor.

The AE-918P EEG Neuro Unit includes the calculation of a set of quantitative measures intended to monitor and analyze the EEG waveform. These include quantitative EEG functions such as SEF, MDF, PPF, TP, CSA, DSA, %Theta, %Alpha, %Beta, %Gamma, Abs Delta, Abs Alpha, Abs Beta, and Abs Gamma. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveform. The aEEG functionality included in the AE-918P EEG Neuro Unit is intended to monitor the state of the brain.

The device is intended for use by medical personnel in any location within a medical facility, physician's office, laboratory, clinic or nursing home under direct supervision of a medical professional.

Device Description

The AE-918P is an 8 channel digital Electroencephalography (EEG) that connects to a Nihon Kohden patient monitor. It receives EEG data from patients and digitizes the signals, the waveforms and analysis are displayed on a Nihon Kohden Patient Monitor.

The AE-918P is contained in a small enclosure that contains the EEG amplifier and digital circuitry. This enclosure is mounted to the bottom of the patient monitor and connects to the patient monitor through the multilink cable.

AI/ML Overview

The Nihon Kohden AE-918P Neuro Unit is an 8-channel EEG measuring unit that connects to a Nihon Kohden patient monitor. It amplifies and analyzes EEG and displays the EEG waveform and analysis results on the patient monitor, intended for monitoring brain function.

Here's an analysis of its acceptance criteria and the study proving its performance, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" in a quantitative manner for specific performance metrics like accuracy, sensitivity, or specificity. Instead, the performance testing focuses on ensuring the device meets established safety and performance standards for electroencephalographs and demonstrating substantial equivalence to predicate devices. The "reported device performance" is largely qualitative, stating that the device "performed within specifications" and was "equivalent in safety and effectiveness" to its main predicate.

Acceptance Criteria (Implied from testing standards and predicate comparison)	Reported Device Performance
Safety and Electrical Performance: Conformance to IEC 60601-1 (various parts) for general requirements, electromagnetic compatibility, and particular requirements for electroencephalographs.	"The AE-918P was subjected to safety and performance testing procedures. The AE-918P has undergone validation and verification testing to ensure conformance to all design requirements.""Testing to the following standards was done: IEC 60601-1 Part1: General requirements for safety 1998-12, Amendment 1 (1991-11), Amendment 2 (1995-03); IEC 60601-1-2 2nd edition (2001-09), Amendment 1 (2004-09); IEC 60601-2-26 Part 2-26: Particular Requirements for the safety of electroencephalograph 2002-11."
Biocompatibility: Electrodes used with the device are biocompatible.	"Electrodes used as accessories with the device are the same as those of the predicate device and have previously been testing for biocompatibility for a surface contacting device of prolonged duration according to ISO 10993-1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing."
Quantitative EEG Measures (SEF, MDF, PPF, TP, CSA, DSA, %Theta, %Alpha, %Beta, %Gamma, Abs Delta, Abs Alpha, Abs Beta, Abs Gamma, aEEG): Calculation and display of trends are substantially equivalent to predicate devices.	"Additionally, the system has undergone comparison testing to ensure the substantial equivalence of the calculation and display of EEG trends. These tests verified that the device performed within specifications."The device includes calculation of these measures, with specific functions like MDF, TP, and aEEG being supported by additional predicates (K051178, K963644, K021185, K120485, K131789).
Overall Equivalence: Safety and effectiveness are equivalent to the main predicate device EEG-1200A.	"Based on the comparison information in the technical comparison chart above and confirmed by verification/validation testing in compliance with the Design Control requirements, the AE-918P was shown to be equivalent in safety and effectiveness to the main predicate device EEG-1200A."

2. Sample Size Used for the Test Set and the Data Provenance

The document explicitly states: "No Clinical testing was required." This indicates that the performance testing for this device primarily relied on bench testing, comparison to predicate devices, and internal validation/verification testing according to design control processes. Therefore, there is no test set of patient data and consequently, no specified data provenance (country of origin, retrospective/prospective).

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

As no clinical testing was performed and no patient-specific "test set" was used, there were no experts used to establish ground truth for such a set. The "ground truth" for the device's technical specifications and performance was based on engineering validation against established standards and comparison to well-characterized predicate devices.

4. Adjudication Method for the Test Set

Since no clinical test set was used, there was no adjudication method employed for a test set.

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 comparative effectiveness study was done. This device is an EEG measuring unit, not an AI-assisted diagnostic tool that would typically involve human readers interpreting AI output. Its function is to amplify, analyze, and display EEG waveforms and quantitative measures for medical personnel to interpret in conjunction with the original waveform.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device's functionality involves "amplifies and analyzes EEG and displays the EEG waveform and the result of analysis on the patient monitor." The quantitative EEG measures "should always be interpreted in conjunction with review of the original EEG waveform." This implies the device provides analytical output that is not intended to be used in a standalone, algorithm-only fashion without human interpretation and review of the raw EEG data. The performance testing verified the device's ability to calculate and display these measures and trends accurately, rather than its diagnostic performance in a standalone mode.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for demonstrating the device's performance was primarily:

Engineering specifications and design requirements: Verifying that the device met its intended technical parameters.
Regulatory standards: Conformance to IEC 60601 series for safety and performance of medical electrical equipment, particularly for electroencephalographs.
Predicate device characteristics: The comparison testing aimed to show "substantial equivalence" of the calculation and display of EEG trends to those of legally marketed predicate devices. This indicates that the established, accepted performance of existing devices served as a benchmark for "ground truth."

8. The Sample Size for the Training Set

The document does not mention any "training set" of data. As previously noted, no clinical testing was required, and the device's validation appears to be based on engineering tests and comparison to existing technologies, not on machine learning or AI models that require specific training data.

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

Since there was no mention of a training set, the method for establishing its ground truth is not applicable to this submission.

Summary

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

March 4, 2015

Nihon Kohden Corporation c/o Natalie Kennel NJK & Associates, Inc 13721 Via Tres Vista San Diego, CA. 92129

Re: K130238

Trade/Device Name: Nihon Kohden AE-918P Neuro Unit Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMA, OLT, OMC Dated: February 3, 2015 Received: February 4, 2015

Dear Ms. Kennel:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Felipe Aquel -S

Carlos Peña, Ph.D., M.S. for 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) K130238

Device Name Nihon Kohden AE-918P Neuro Unit

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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Image /page/3/Picture/0 description: The image shows the logo for NIHON KOHDEN. The logo consists of a blue square on the left side with a white design inside. To the right of the square is the company name, "NIHON KOHDEN", in blue, block letters. The logo is simple and clean, with a focus on the company name.

510(k) Summary

Sponsor:	Nihon Kohden Corporation1-31-4 NishiochiaiShinjuku-ku, Tokyo 161-8560 Japan
Initial Importer/Distributor	Nihon Kohden America, Inc.15353 Barranca ParkwayIrvine, CA 92618
Contact Person:	Ms. Natalie J. KennelConsultantNJK & Associates, Inc.13721 Via Tres VistaSan Diego, CA 92129 USAPhone: (858) 705-0350Fax: (858) 764-9739email: NKennel@njkconsulting.com

Date Revised: March 2, 2015

DEVICE INFORMATION

Proprietary Name:	AE-918P Neuro Unit
Common Name:	Electroencephalograph
Regulation section:	21 CFR 882.1400
Classification:	Class II
Product Code:	OMC
Panel:	Neurological
Predicate Device:	EEG-1200A Series NeurofaxK080546Nihon Kohden

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Additional Predicates:

The following additional predicates support specific functionality in this system (Table 1).

K#	Product	Manufacturer	Aspect
K051178	MEE-1000	Nihon Kohden	MDF function
K963644	A-1050	Aspect	MDF function
K021185	Nervus Monitor	Nervus	Total Power
K120485	QP-160AK	Nihon Kohden	aEEG
K131789	Celebralogik	Mennen	aEEG

Table	1

Product Description:

Electroencephalography (EEG) is the recording of electrical activity along the scalp. EEG measures voltage fluctuations resulting from ionic current flows within the neurons of the brain. In clinical contexts, EEG refers to the recording of the brain's spontaneous electrical activity over a period of time, as recorded from multiple electrodes placed on the scalp.

Indications for Use

The AE-918P EEG Neuro Unit includes the calculation of a set of quantitative measures intended to monitor and analyze the EEG waveform. These include quantitative EEG functions such as SEF, MDF, PPF, TP, CSA, DSA, % Theta, % Alpha, % Beta, % Gamma, Abs Delta, Abs Theta, Abs Alpha, Abs Beta, and Abs Gamma. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveform.

The aEEG functionality included in the AE-918P EEG Neuro Unit is intended to monitor the state of the brain.

AE-918P Neuro Unit

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Comparison to Predicate Devices

The following table compares the technological aspects of the new device with its predicate device (see Table 2). The intended use comparison is given in the conclusion section.

Aspect	AE-918PNew Device	EEG-1200A (K#080546)Configuration with standard JE-921AJunction Box
Number of Channels	8	32
Input Impedance	15 M ohm at 10Hz	100 M ohm
Calibration Check	Step square 50 uV	Step square or Sine wave2 to 1000 uV (9 steps)
Impedance Check	All inputs with Screen	All inputs with Screenand Input box readout
Common-ModeRejection Ratio(CMRR)	110 dB or more (inisolation mode)60 dB or more (inbalance mode)	105 dB or more
Noise Level	< 3 uV p-p (0.53 to 30 Hz)	< 1.5 uV p-p (0.53 to 60 Hz)
Frequency Response	0.08 to 70 Hz	0.08 to 300 Hz
High-pass Filter (Low-cut)	0.08 to 5.3 Hz	0.016 to 159 HzDC standard
Low-pass Filter (High-cut)	15 to 70 Hz	15 to 300 Hz
AC Filter	50 or 60 Hz (rejectionratio > 1/20)	50 or 60 Hz (rejectionratio > 1/25)
ECG Filter	None	Standard
Sensitivity	OFF, 1 to 200 uV/mm(14 steps)	OFF, 1 to 200 uV/mm(15 steps)DC: OFF, 10 to 200mV/mm (10 steps)
A-D Conversion	16 bits	16 bits
Sampling	All channels200 Hz (A-DConversion: 4 kHz)	All channels100, 200, 500, 1000 Hz
Display	N/A	1600 x 1200
Resolution/Channels		64 + Mark Channel
Communication	Serial interface	Analog Input/Output,Networking, Modem
Aspect	AE-918P	EEG-1200A (K#080546)
	New Device	Configuration withstandard JE-921AJunction Box
Power	+12V+/- 5% 500 mA orless+5V+/- 5% 100 mA orless	120 V +/- 10%50 / 60 Hz750 VA
Operating Environment	Temperature: 10 to 40degree CHumidity: 30 to 90 %	Temperature: 10 to 35degree CHumidity: 30 to 80 %
Trend parameter	DSAaEEGFFT powerFFT power ratio	DSAaEEGFFT powerFFT power ratio
Number of trends	8	More than 8
Number of trendwindows	1	2
Time interval of trends	N/A	1 minute/page to 24 hours/page1 cm/hour to 60 cm/hour
Annotation list	No	Annotation list
Annotation trend	No	Annotation trend
MDF (MedianFrequency)	Yes	No
TP (Total Power Value)	Yes	No
aEEG	Yes	No

Table 2 Technological Comparison to Predicate

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Performance Testing

The AE-918P was subjected to safety and performance testing procedures. The AE-918P has undergone validation and verification testing to ensure conformance to all design requirements. Additionally, the system has undergone comparison testing to ensure the substantial equivalence of the calculation and display of EEG trends. These tests verified that the device performed within specifications.

No Clinical testing was required

Testing of the Nihon Kohden AE-918P Neuro Unit was performed in compliance with Nihon Kohden Corporation design control process. Testing to the following standards was done. (See Table 3):

Table 3 Medical Electrical Equipment

IEC 60601-1 Part1: General requirements for safety 1998-12

IEC 60601-1, Amendment 1 Part 1: General Requirements for safety, Amendment 1,

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1991-11

IEC 60601-1, Amendment 2 Part 1: General Requirements for safety, Amendment 2, 1995-03

IEC 60601-1-2 2nd edition Part 1-2: General requirements for safety - Collateral standard. Electromagnetic compatibility, 2001-09

IEC 60601-1-2 2nd edition, Part 1-2: General requirements for safety - Collateral Amendment 1 standard. Electromagnetic compatibility. Amendment 1, 2004-09

IEC 60601-2-26 Part 2-26: Particular Requirements for the safety of electroencephalograph 2002-11

Electrodes used as accessories with the device are the same as those of the predicate device and have previously been testing for biocompatibility for a surface contacting device of prolonged duration according to ISO 10993-1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.

Conclusion:

Based on the comparison information in the technical comparison chart above and confirmed by verification/validation testing in compliance with the Design Control requirements, the AE-918P was shown to be equivalent in safety and effectiveness to the main predicate device EEG-1200A.

The intended use of AE-918P Neuro unit is different from the predicate (EEG-1200A, K080546) because it is a simplified version of the EEG-1200A. thus with a subset of the intended use. The AE-918 has only 8 channels of EEG and used mainly for monitoring brain activity on a patient monitor. The EEG-1200 has up to 256 channels of EEG and can also be used for monitoring brain activity but has additional intended uses such as sleep studies. The technology and materials of the AE-918 are the same as used in the EEG-1200A. The other differences are covered by other predicates as shown in Table 1.

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).