The Ceribell Pocket EEG Device is intended to record and to present the EEG signals in visual and audible formats in real time. The visual and audible signals assist trained medical staff to make neurological diagnoses. The Pocket EEG Device does not provide any diagnostic conclusion about the subject's condition and does not provide any automated alerts of an adverse clinical event. The Pocket EEG Device is intended to be used in a professional healthcare facility environment.

Device Description

The Ceribell Pocket EEG Device (subject) is a portable 8-channel EEG monitoring system. The device connects to 10 patient electrodes (5 left, 5 right), which are used to form the 8 channels, and may be used with any scalp EEG electrodes. The Device includes the following items:

Pocket EEG Device: a portable, battery powered, 8-channel EEG monitoring system. .
Power adapter: 100-240 V AC power adapter used to charge the Pocket EEG Device. ●
. Micro-USB cable: cable used to connect Pocket EEG Device to power adapter for charging and to connect to a computer to transfer EEG recording files. When the Pocket EEG Device is connected to a power adapter of a computer, all EEG acquisition functions are automatically disabled.
EEG Recording Viewer Software: EEG review software for viewing EEG recordings on a . computer.

AI/ML Overview

I am sorry, but based on the provided text, there is no acceptance criteria or study information related to device performance in terms of diagnostic effectiveness or clinical outcomes.

The provided 510(k) summary focuses entirely on:

Technical specifications and safety testing (e.g., electrical safety, electromagnetic compatibility, battery safety, mechanical robustness).
Comparison to a predicate device based on intended use and technological characteristics (e.g., number of channels, digital vs. analog technology).

The device is explicitly stated to not provide any diagnostic conclusion or automated alerts. Its function is to "record and to present the EEG signals in visual and audible formats in real time" to "assist trained medical staff to make neurological diagnoses." Therefore, there would not be an "acceptance criteria" related to diagnostic accuracy for this particular device as it does not perform automated diagnosis.

To directly answer your specific questions based only on the provided text:

A table of acceptance criteria and the reported device performance:
- No acceptance criteria or reported device performance for diagnostic accuracy or clinical outcomes are mentioned. The performance data listed are for safety and technical standards compliance.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable as no clinical performance study involving a test set for diagnostic accuracy is described.
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 as no clinical performance study involving ground truth establishment is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no clinical performance study involving a test set is described.
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 study or AI assistance is mentioned. The device presents raw EEG signals to trained medical staff.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device does not provide "diagnostic conclusions" or "automated alerts." It is explicitly a human-in-the-loop device where trained medical staff make diagnoses based on the presented signals.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable as no clinical performance study requiring ground truth is described.
The sample size for the training set:
- Not applicable as no machine learning algorithm development for diagnostic purposes is described. The device is a data acquisition and presentation tool.
How the ground truth for the training set was established:
- Not applicable as no machine learning algorithm development for diagnostic purposes is described.

In summary, the provided document describes a 510(k) clearance for a medical device that records and presents EEG signals for trained medical staff to interpret, and it focuses on demonstrating the device's technical and safety performance against established standards, not on its diagnostic efficacy or any AI-driven capabilities.

Summary

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Public Health Service

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

May 8, 2017

Ceribell, Inc. Josef Parvizi, MD, Ph.D. Chairman 2483 Old Middlefield Wav. Suite 120 Mountain View, California 94043

Re: K170363

Trade/Device Name: Ceribell Pocket EEG Device Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMC Dated: February 2, 2017 Received: February 6, 2017

Dear Dr. Parvizi:

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

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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 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" (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.

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,

Michael J. Hoffmann -S

Carlos L. Peña, PhD, MS 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) K170363

Device Name Ceribell Pocket EEG Device

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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510(K) SUMMARY

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Applicant Information:

Ceribell, Inc. 2483 Old Middlefield Way Suite 120 Mountain View, California

Contact Person:

Josef Parvizi, MD, PhD, Chairman Telephone: (650) 521-7003 E-mail: josef@ceribell.com

Device Information:

Trade Name:	Ceribell Pocket EEG Device
Common Name:	Reduced-montage standard Electroencephalograph
Classification Name:	Electroencephalograph (21CFR 882.1400)
Device Class:	II
Product Code:	OMC

Predicate Device:

Oxford Medilog 9000 EEG System, K830295

Date Prepared:

February 2nd, 2017

Device Description:

Pocket EEG Device: a portable, battery powered, 8-channel EEG monitoring system. .
Power adapter: 100-240 V AC power adapter used to charge the Pocket EEG Device. ●
. Micro-USB cable: cable used to connect Pocket EEG Device to power adapter for charging and to connect to a computer to transfer EEG recording files. When the Pocket EEG Device is connected to a power adapter of a computer, all EEG acquisition functions are automatically disabled.
EEG Recording Viewer Software: EEG review software for viewing EEG recordings on a . computer.

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Indications for Use:

The Ceribell Pocket EEG Device is intended to record and store EEG signals, and to present the EEG signals in visual and audible formats in real time. The visual and audible signals assist trained medical staff to make neurological diagnoses. The Pocket EEG Device does not provide any diagnostic conclusion about the subject's condition and does not provide any automated alerts of an adverse clinical event. The Pocket EEG Device is intended to be used in a professional healthcare facility environment.

Comparison of Intended Use and Technological Characteristics with the Predicate Device:

The subject and the predicate devices share the same intended use as a portable EEG monitoring system that records, stores, and presents EEG signals in visual and audible formats. The recorded EEG signals assist trained medical staff to make neurological diagnoses. It does not provide any diagnostic conclusion about the subject's condition or any automated alerts of an adverse clinical event.

The subject and predicate device are based on the following same technological elements:

. Portable, battery powered EEG acquisition and recording of 8 channels
. EEG data presented in both visual and audible formats
Review of EEG recordings on an external Replay Module or computer .

Whereas the predicate device uses analog technology for presentation, processing, storage and replay of data, the subject device utilizes digital technology. The predicate uses 16 electrodes to form 8 channels of EEG data; the subject uses 10 electrodes to form 8 channels of EEG data.

Performance Data:

The following performance data were provided to demonstrate safety and efficacy in support of substantial equivalence determination:

. Requirements for the basic safety and essential performance of electroencephalographs per IEC 60601-2-26
Electromagnetic Compatibility and Electrical Safety Testing performed to applicable requirements . of IEC 60601-1 and IEC 60601-1-2
Battery Safety Testing per IEC 62133 ●
Bench testing to verify system performance ●
. Shipping/distribution and vibration testing per ASTM D7386

Summary:

The Ceribell Pocket EEG has the same intended use as the predicate device. In addition, it has similar technological characteristics; performance data demonstrates that any differences in technological characteristics do not raise different questions of safety or effectiveness. Therefore, the Ceribell Pocket EEG Device is substantially equivalent to the cleared predicate device.

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).