The device is intended to record the physiological data required for EEG and sleep studies (Polysomnography or PSG). These data, may be used by clinicians in Sleep Disorders, Epilepsies and other disorders as a diagnostic aid.
The device is intended to record cerebral, extracerebral and other bio-potential activities for EEG and Sleep Studies via legally marketed PSG reading software. These data may be used by clinicians in sleep disorders, Epilepsies and other related disorders as a diagnostic ald.

Device Description

The device is intended to record the physiological data required for EEG and sleep studies (Polysomnography or PSG).

AI/ML Overview

The provided text describes a Special 510(k) Notification for the Nihon Kohden PSG Input Box, Model JE-912AK. However, the document primarily focuses on regulatory compliance, substantial equivalence to a predicate device, and general performance testing rather than a detailed study with specific acceptance criteria and performance metrics described in the way you've outlined.

Based on the provided text, I can infer the following:

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

The document does not provide a table of specific quantitative acceptance criteria or detailed reported device performance in the format of accuracy, sensitivity, specificity, or similar metrics typically associated with AI/algorithm performance. Instead, it states:

Acceptance Criteria Category	Reported Device Performance
Regulatory Compliance & Standards adherence	The device complies with IEC 601-1 sub-clause 56.3(c) implemented by 21 CFR Part 898. It also conforms to voluntary industrial standards: IEC 60601-1 (1988), Amendment 1 (1991), Amendment 2 (1995), IEC 60601-1-1 (1992), Amendment 1 (1995), IEC 60601-1-2 (1993), CISPR11 Group 1, Class B, IEC 60601-2-26 (1994).
Product Specifications	"The completed testing showed that the device met its product specifications."
Safety & Reliability	Verified conformance to safety and reliability.
Software Functionality	"Software verification and validation tested the operation of the software functions of the device. The results confirmed that the device performed within specifications."
Environmental Testing	Subjected to temperature/humidity stress testing.
Electromagnetic Compatibility	Subjected to electromagnetic interference / electromagnetic compatibility testing.
Design Controls	Developed in accordance with design controls.

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" with a particular sample size for evaluating algorithmic performance. The testing described is for hardware and software functionality, safety, and compliance, not for diagnostic accuracy evaluated against a specific dataset of patient cases. Thus, data provenance (country, retrospective/prospective) is not applicable in this context.

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

Not applicable. The ground truth concept as described (e.g., expert consensus for diagnostic accuracy) does not apply to the type of performance testing reported in this submission for an EEG/PSG amplifier. The ground truth for electrical and safety performance would be established by engineering standards and test equipment.

4. Adjudication method for the test set

Not applicable, as there is no mention of a diagnostic performance test set requiring adjudication.

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 such study was conducted or reported. This device is an amplifier for recording physiological data, not an AI-powered diagnostic tool. It records data that may be used by clinicians as a diagnostic aid with "legally marketed PSG reading software."

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

No standalone algorithm performance was conducted or reported. The device itself is hardware.

7. The type of ground truth used

For the reported performance testing (safety, electrical, software functionality), the ground truth is based on engineering specifications, regulatory standards (e.g., IEC), and design control documents. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this device's performance evaluation as described.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable for the same reason as above.

Summary

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K02121

Special 510(K) Notification PSG input Box

· ... .. .. ..

UUL 2 9 2002

SECTION 2 - 510(K) SUMMARY

Name and Address of Applicant Nihon Kohden America. Inc. Attn: Regulatory Affairs 90 Icon Street Foothill Ranch, California 92610 Phone: (949) 580-1555 Fax: (949) 580-1550

Device Name and Classification: PSG amplifier and accessories. The device classification is unchanged. The device is classified by the Neurology Panel under 21 CFR Part 882.1400 "Electroencephalograph" per GWQ. Common names for the device include Electroencephalograph (EEG) and Polysomnograph (PSG).

'Legally Marketed Predicate: Nihon Kohden EEG 9100, cleared under 510K, K011204

There are no significant changes in function, biocompatibility, performance or manufacturability compared to the predicate device that would affect the safety and effectiveness of the device as intended for use, Therefore, Nihon Kohden believes that the new PSG amplifier is substantially equivalent to the predicate EEG device. The device has the same intended use and indications for use as the existing marketed device and uses the same fundamental scientific technology.

Description and Intended Use: The device is intended to record the physiological data required for EEG and sleep studies (Polysomnography or PSG). These data, may be used by clinicians in Sleep Disorders, Epilepsies and other disorders as a diagnostic aid. This device is intended for use by medical personnel and will be available for use within a medical facility or outside of a medical facility under direct supervision of a medical professional on all patient populations.

Performance Testing

. The device complies with IEC 601-1 sub-clause 56.3(c) implemented by 21 CFR Part 898 Performance Standard for Electrode Lead Wires and Patient Cables. To other special controls or performance standards are known or established for this device. The device is designed to comply with the following voluntary industrial standards: IEC 60601-1 (1988-12). Amendment 1 (1991-11), Amendment 2 (1995-03), IEC 60601-1-1 (1992-06), Amendment 1 (1995-10), IEC 60601-1-2 (1993-05), CISPR11 Group 1, Class B, IEC 60601-2-26 (1994)
The PSG unit is not sterile. .
. The device does not directly contact patients. Accessories that contact patients, such as the EEG electrodes and SP02 probes are the same as current available component materials and accessories legally cleared and marketed in the USA (see accessories list). Therefore, good laboratory practice studies were not required per 21 CFR, part 58.
The device was developed in accordance with design controls and operation of the device was appropriately verified and validated using test methods as with all other existing devices. The device was subjected to environmental testing including temperature/humidity stress testing, electromagnetic interference / electromagnetic compatibility testing and safety standards testing

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Special 510(K) Notification PSG input Box

and performance testing procedures. Test criteria are established prior to testing based upon product specifications and applicable standards. The completed testing showed that the device met its product specifications and verified conformance to safety, reliability, and applicable standards. Software verification and validation tested the operation of the software functions of the device. The results confirmed that the device performed within specifications (see Attachment # 6).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

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

Ms. Serrah Namini Regulatory Affairs Associate Director Nihon Kohden America, Inc. 90 Icon Street Foothill Ranch, California 92610

APR - 9 2012

Re: K022121

Trade/Device Name: PSG Input Box, Model JE-912AK Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLV, GWQ Dated (Date on orig SE Itr): June 28, 2002 Received (Date on orig SE ltr): July 1, 2002

Dear Ms. Namini:

This letter corrects our substantially equivalent letter of July 29, 2002.

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.

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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 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/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/ReportalProblem/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,
Kesia Alexander

Image /page/3/Picture/7 description: The image shows a black and white drawing of a signature. The signature is stylized and cursive. The signature appears to start with a loop at the bottom and then has a line that goes up and to the right.

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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Special 510(K) Notification PSG Input Box

G. Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: PSG input Box

Indications for Use:

The device is intended to record cerebral, extracerebral and other bio-potential activities for EEG and Sleep Studies via legally marketed PSG reading software. These data may be used by clinicians in sleep disorders, Epilepsies and other related disorders as a diagnostic ald.

The device is intended for use by medical personnel in any location within a medical facility, physician's office, laboratory, clinic or nursing home or outside of a medical facility under direct supervision of a medical professional. The device will be available on all patient populations (including adults and children) as determined by a trained professional.

for Mark A. Milburn

.f General, Restorative Ne ... rological Devices

510(k) Number -

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).