The QP-160AK Trend program is a software-only device intended to be installed on the EEG-1200A series electroencephalograph to record, calculate, and display EEG data obtained from the EEG-1200A system. This device is intended to be used by qualified medical practitioners, trained in Electroencephalography, who will exercise professional judgment when using the information.

The intended use for each of the software's outputs is as follows:

The EEG and aEEG waveforms are intended to help the user monitor the state of the brain.
The user-defined Fast Fourier Transform (FFT) parameters of this software (FFT power) are intended to help the user analyze the EEG waveform.
The burst suppression parameters of this software (interval and bursts per minute) are intended to aid in the identification and characterization of areas of burst-suppression pattern in the EEG.

This device does not provide any diagnostic conclusion about the patient's condition to the user.

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

Device Description

The OP-160AK Trend program is a software-only device intended to be installed on the EEG-1200A series electroencephalograph to record, calculate, and display EEG data obtained from the EEG-1200A system. The QP-160AK EEG Trend program is the same as the previous version of QP-160AK cleared under 510k but has two new trends available (DSA Asymmetry trend and FFT Power Asymmetry trend).

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Nihon Kohden QP-160AK EEG Trend Program, based on the provided 510(k) summary:

This 510(k) submission, K120485, is for an updated version of an existing device (K092573, also Nihon Kohden QP-160AK EEG Trend Program) with the addition of two new trends: DSA Asymmetry trend and FFT Power Asymmetry trend.

The regulatory approach taken is substantial equivalence to the previous version and to other predicate devices (BrainScope Zoom-100DC and Applied Neuroscience NeuroGuide Analysis System) that already include these new trend functionalities.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) submission, where the new features leverage existing, cleared technology, the "acceptance criteria" are primarily based on the functional equivalence and proper operation of these features. There are no explicitly stated numerical performance metrics (e.g., sensitivity, specificity, accuracy) akin to what might be seen for a diagnostic AI device.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance / Justification
Functional Equivalence (New Trends)	The new DSA Asymmetry trend functions equivalently to the DSA Asymmetry trend in the predicate devices (BrainScope Zoom-100DC, Applied Neuroscience NeuroGuide Analysis System).	The submission explicitly states: "The Brainscope-100DC and the Applied Neuroscience Neuroguide Analysis System (K041263) provide the same DSA Asymmetry trend... as the new QP-160AK." This implies a functional comparison was made and found to be equivalent.
	The new FFT Power Asymmetry trend functions equivalently to the FFT Power Asymmetry trend in the predicate devices (BrainScope Zoom-100DC, Applied Neuroscience NeuroGuide Analysis System).	The submission explicitly states: "...and the Applied Neuroscience Neuroguide Analysis System (K041263) provide the same... FFT Power Asymmetry trend as the new QP-160AK." This implies a functional comparison was made and found to be equivalent.
System Integration & Safety	The updated QP-160AK EEG Trend Program integrates safely and correctly with the EEG-1200A series electroencephalograph.	"The QP-160AK EEG Trend Program was subjected to safety and performance testing procedures. The QP-160AK EEG Trend Program has undergone validation and verification testing to ensure conformance to all design requirements."
Calculation & Display Accuracy	The calculations and display of all EEG trends (including new and existing) are accurate and within specifications.	"...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."
Intended Use Compliance	The device continues to meet its stated intended use for monitoring, analyzing, and aiding in identification/characterization of patterns, without providing diagnostic conclusions.	The Intended Use statement remains consistent, and the safety and functional testing would confirm that the device operates within the bounds of this intended use.

Study Information

This submission does not involve a traditional clinical study with patient cohorts or expert assessments in the way an AI diagnostic algorithm might. Instead, the "study" demonstrating performance is primarily non-clinical verification and validation testing, and comparison to predicate devices, focusing on functional equivalence.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not specify the sample size for any test set or the provenance of data used for verification and validation. It only mentions "comparison testing to ensure the substantial equivalence of the calculation and display of EEG trends." This type of testing would typically involve a set of pre-recorded EEG data, but the details are not provided.
- It is not clear if "test set" here refers to specific patient data or internal engineering test cases. Given the context, it's more likely the latter.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. There is no mention of external experts or establishing ground truth based on expert review for specific patient cases in a clinical study context. The "ground truth" for functional verification would be the expected output of the algorithms as derived from engineering specifications and comparison to the predicate device's known outputs.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical adjudication method is described or implied.
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 or reported. This device is an EEG trend program, which assists qualified practitioners in analyzing EEG data, but it is not presented as an AI-powered diagnostic tool that directly "improves" reader performance in a quantifiable clinical trial. It provides visualization tools for interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in a sense. The "comparison testing" and "validation and verification testing" would represent a standalone evaluation of the algorithm and its display capabilities against predefined specifications and the predicate device's output. The device itself is "software-only" and is intended to be installed on an EEG system. However, its intended use is always with a "qualified medical practitioner, trained in Electroencephalography." It does not provide diagnostic conclusions independently.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this type of submission is likely the expected computational output as derived from the established algorithms used in the predicate devices and the mathematical principles of DSA and FFT. It's not a clinical ground truth like pathology or expert consensus on a diagnosis. It's about the accurate calculation and graphical representation of EEG features.
The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set in the typical sense. It implements established signal processing algorithms (DSA, FFT) that do not learn from data.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI/ML algorithm.

Summary

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K120485

510(K) SUMMARY

・・・

. .

Name and Address of Applicant

Nihon Kohden America. Inc. 90 Icon Street Foothill Ranch, CA 92610

Contact: Steve Geerdes Director, Regulatory Affairs (949) 580-1555 ex. 3325 Fax: (949) 580-1550

Date: 2/14/2012

Trade/Device Name: Nihon Kohden QP-160AK EEG Trend Program

Common or usual Name: Electroencephalograph (EEG)

Legally Marketed Predicate:

Nihon Kohden QP-160AK EEG Trend Program (K092573)

Applied Neuroscience NeuroGuide Analysis System (K041263)

Brain Scope Zoom-100DC (K082886)

Intended Use:

The OP-160AK Trend program is a software-only device intended to be installed on the EEG-1200A series electroencephalograph to record, calculate, and display EEG data obtained from the EEG-1200A system. This device is intended to be used by qualified medical practitioners, trained in Electroencephalography, who will exercise professional judgment when using the information.

The intended use for each of the software's outputs is as follows:

The EEG and aEEG wayeforms are intended to help the user monitor the state of the . brain.
The user-defined Fast Fourier Transform (FFT) parameters of this software (FFT power) . are intended to help the user analyze the EEG waveform.
The burst suppression parameters of this software (interval and bursts per . minute) are intended to aid in the identification and characterization of areas of burstsuppression pattern in the EEG.

This device does not provide any diagnostic conclusion about the patient's condition to the user.

MAR 1 6 2012

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A summary of the technological characteristics of the device compared to the predicate device:

The QP-160AK EEG Trend program is the same as the previous version of QP-160AK cleared under 510k but has two new trends available (DSA Asymmetry trend and FFT Power Asymmetry trend).

The QP-160AK EEG Trend program's two new trends (DSA Asymmetry trend and FFT Power Asymmetry trend) are available in the BrainScope Zoom 100 DC (K082886) and the Applied Neuroscience Neuroguide Analysis System (K041263).

Functional Comparision

Nihon Kohden160 Trend program underreview	Nihon KohdenQP -160 TrendProgram ClearedK092573	BrainScope Zoom-100DC clearedK082886	AppliedNeuroscienceNeuroGuideAnalysis SystemCleared K041263
Function
Number of EEG Channels(Dependant on Amplifier)Up to 32/64 EEG Channels	Same	N/A	N/A
Number of DC Channels(Dependant on Amplifier)Up to 8 DC Channels	Same	N/A	N/A
Density Spectral Array (DSA) Trend	Same	N/A	N/A
Density Spectral Array (DSA)asymmetry Trend	None	Same	Same
Spectral Edge Frequency Trend	Same	N/A	N/A
Amplitude Integrated EEG (aEEG)Trend	Same	N/A	N/A
Burst Suppression Ratio (BSR)Trend	Same	N/A	N/A
Inter-burst Interval (IBI) Trend	Same	N/A	N/A
Burst Per Minute (BPM) Trend	Same	N/A	N/A
FFT Power Trend	Same	N/A	N/A
FFT Power Asymmetry Trend	None	Same	Same
FFT Power Ratio (e.g. Alpha /Delta,Alpha/Beta)	Same	N/A	N/A
External input (DC input) display	Same	N/A	N/A
Number of trendsMore than 16	Same	N/A	N/A
User Selectable Trend Groups(Panel)	Same	N/A	N/A
Time interval of trends1 minute/page to 24 hours /page1 cm/hour to 60 cm/hour	Same	N/A	N/A
User Selectable Trends Time Scale	Same	N/A	N/A
Annotation list	Same	N/A	N/A
Raw EEG data display		N/A	N/A
Look-Back while recordingSynchronized Video	Same

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Testing (Non Clinical & Clinical) -

To date no special controls or performance standards are known or established for this . device as required by sections 513(b) and 514 of the Food, Drug and Cosmetic Act as implemented by 21 CFR Part 861.
The device is not sterile. .
The device does not directly contact patients. Therefore, good laboratory practice studies . were not required per 21 CFR Part 58.
The QP-160AK EEG Trend Program was subjected to safety and performance testing . procedures. The QP-160AK EEG Trend Program 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 .

Conclusion of Substantial Equivalence:

The comparison of technological characteristics and performance testing of the QP-. 160AK EEG Trend Program demonstrate that its safety, effectiveness, and performance are equivalent to the specified predicate devices.
This software device is exactly the same as the predicate QP-160AK (K092573) except . for the addition of the two trends (DSA Asymmetry trend and FFT Power Asymmetry trend) that were added to the new QP-160AK. The Brainscope-100DC and the Applied Neuroscience Neuroguide Analysis System (K041263) provide the same DSA Asymmetry trend and FFT Power Asymmetry trend as the new QP-160AK. Therefore, Nihon Kohden believes that the device is substantially equivalent to the stated predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

MAR 1 6 2012

Nihon Kohden America, Inc. c/o Steve Geerdes Director, Regulatory Affairs 90 Icon Street Foothill Ranch, CA 92610

Re: K120485

Trade/Device Name: Nihon Kohden QP-160AK EEG Trend Program Regulation Number: 21 CFR 882.1400 Regulation Name: Amplitude-integrated electroencephalograph Regulatory Class: Class II Product Code: OMA, OLT, ORT Dated: February 14, 2012 Received: February 17, 2012

Dear Mr. Geerdes:

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 of any I vath all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Steve Geerdes

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,

Malvina B. Eydelman, M.D.

Director Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

510(k) Number (if known): _ K120485

Nihon Kohden QP-160AK Trend Program with the addition of DSA Asymmetry trend Device Name: and FFT Power Asymmetry trend

Indications for Use:

The intended use for each of the software's outputs is as follows:

The EEG and aEEG waveforms are intended to help the user monitor the state of the brain. .
The user-defined Fast Fourier Transform (FFT) parameters of this software (FFT power) are . intended to help the user analyze the EEG waveform.
The burst suppression parameters of this software (interval and bursts per minute) are . intended to aid in the identification and characterization of areas of burst-suppression pattern in the EEG.

This device does not provide any diagnostic conclusion about the patient's condition to the user.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kim

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

Page 1 of

510(k) Number K120485

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).