The X4 System is intended for prescription use in the home, healthcare facility, or clinical research environment to acquire, record, transmit and display physiological signals from adult patients. The X4 System acquires, records, transmits and displays electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG), accelerometer, acoustical and photoplethesmographic signals. The X4 system only acquires and displays physiological signals, no claims are being made for analysis of the acquired signals with respect to the accuracy, precision and reliability.

Device Description

The X4 system is used for configurable acquisition of physiological signals. Model X4-E provides for acquisition of three channels of electroencephalography (EEG) and one photoplethesmographic (PPG) signal from a head strip, with an optional channel connected to two sensors via a dual-lead connector with twice the gain. Model X4-M provides four channels of EEG with the dual-lead connector providing the input for reference sensors. Both models measure sound via an acoustic microphone, and movement and position measured via a 3-D accelerometer. The device is designed so it can be affixed by the patient and to record data. Alternatively, a technician can affix the device and display the signals via a wireless connection during acquisition. The X4 system firmware monitors signal quality to ensure that the sensors are properly applied and that high quality signals are being acquired.

The X4 software provides a means to: a) initiate a study and track patient information, b) acquire and save signals to the memory of the device, c) acquire and wirelessly transmit signals from the device, d) upload data saved in the memory of the device to a PC, and e) visually inspect the signal quality.

The acquired signals are saved in a universal data format (European Data Format – EDF) that is intended to be analyzed with third party software, including Advanced Brain Monitoring's Sleep Profile Software (K120450).

AI/ML Overview

The provided text describes the X4 System, a device for acquiring physiological signals. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and a limited clinical study.

Here's an analysis of the acceptance criteria and study information provided:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the X4 System, as articulated in the clinical tests, is based on the interpretability of the acquired signals and the ease of device application.

Acceptance Criteria	Reported Device Performance
Non-Clinical:
Compliance with system-level requirements	All features of the X4 System were compliant with the system level requirements.
Electrical, biological safety, performance, and software tests	Confirmation of conformity to FDA recognized consensus standards and voluntary standards (IEC 60601-1-1, IEC 60601-1-2, ISO 10993-1, IEC 60601-1-11, IEC 60601-2-26).
Signals provide similar information to predicate device for physician interpretation	Signals acquired with the X4 System provide similar information as compared to the predicate device that would allow a physician to interpret the signals. (Specific metrics or comparison data are not provided in this summary.)
Clinical:
Over 90% of overnight studies recorded with the X4 are interpretable and behave as expected	Result: Over 90% of studies recorded overnight with the X4 are interpretable and behave as expected.
Device instructions can be applied without difficulty by patients in the home	Result: The X4 instructions were applied without difficulty, allowing all subjects to properly apply the device so that it remained in the proper position and allowing any problems that triggered an audio alarm to be properly resolved. (No specific quantitative metric for "difficulty" or "proper application" is given beyond the qualitative statement.)

Study Details for Acceptance Criteria

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

Test set sample size: While a specific number for the sample size for the clinical test is not explicitly stated, it refers to "all subjects" and "over 90% of studies recorded overnight." This suggests a prospective clinical study involving multiple subjects.
Data provenance: Not explicitly stated, but the context of a 510(k) submission to the FDA for a US company suggests it would likely involve data from the US, potentially a prospective clinical trial.

3. 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)

The summary states that "signals acquired with the X4 System provide similar information as compared to the predicate device that would allow a physician to interpret the signals." and that "over 90% of studies recorded overnight with the X4 are interpretable."
This implies that physicians are the experts who would interpret the signals to determine interpretability. However, the number of experts and their specific qualifications (e.g., board-certified sleep physicians, neurologists, years of experience) are not specified in the provided text.

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

The text does not specify an adjudication method. It mentions that "physicians" would interpret the signals, but it does not detail how potential disagreements among interpreters would be resolved or if multiple interpreters were used for each case.

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 X4 System is described as a device for acquiring, recording, transmitting, and displaying physiological signals, with "no claims being made for analysis of the acquired signals with respect to the accuracy, precision and reliability." This indicates that the device itself does not perform AI-assisted analysis and therefore, a study on human reader improvement with AI assistance would not be applicable to this submission.

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

No, a standalone (algorithm only) performance study was not done.
The device's intended use is to acquire, record, transmit, and display physiological signals. It explicitly states "no claims are being made for analysis of the acquired signals." Thus, there is no standalone algorithm being evaluated for diagnostic or analytical performance.

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

The ground truth for the clinical study appears to be expert interpretation (physician interpretability) of the acquired signals. The study aimed to demonstrate that the signals are "interpretable" and "behave as expected," which would rely on a physician's assessment.

8. The sample size for the training set

Not applicable / Not provided. The X4 System is a signal acquisition and display device, not an analytical or AI-driven system. Therefore, it does not involve a "training set" in the context of machine learning algorithms.

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

Not applicable. As a signal acquisition device without analytical claims, there is no training set or associated ground truth establishment process for algorithm training.

Summary

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510(k) Summary

(120447

In accordance with 21 CFR 807.92 the following summary of information is provided:

DATE: May 25, 2012

SUBMITTER:

ﻷﻛﺴ

Advanced Brain Monitoring 2237 Faraday Avenue, Suite 100 Carlsbad, CA 92008 T 760.720.0099 F 760.720.3337

PRIMARY CONTACT PERSON:

Adrienne Lenz, RAC Founder Pathway Regulatory Consulting, LLC T 262-290-0023

SECONDARY CONTACT PERSON:

Dan Levendowski President and Co-founder Advanced Brain Monitoring, Inc.

DEVICE:

TRADE NAME: X4 System

COMMON/USUAL NAME: X4

CLASSIFICATION NAMES: 882.1400 Electroencephalograph

PRODUCT CODE: OMC

PREDICATE DEVICE(S):

K112514 Apnea Risk Evaluation System (ARES), Model 610

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DEVICE DESCRIPTION:

INTENDED USE:

TECHNOLOGY:

The X4 System uses the same fundamental technology as the ARES Model 610 for most features including the electrophysiological (EEG), photoplethesmographic (PPG) and actigraphy signals. Acquisition of the electrocardiograph signal requires minor modification to the band pass filters and is equivalent to the Compumedics Somte. Wireless acquisition of the physiological signals is equivalent to the Infinite Biomedical Technologies 1200 two-channel EEG system. The technologies used in the X4 are used in the same manner as the predicate products and do not raise new questions of safety and effectiveness.

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DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

SUMMARY OF NON-CLINICAL TESTS:

Support for the substantial equivalence of the X4 System was provided as a result of risk management and testing which included electrical and biological safety, performance and software tests. This testing includes conformity to FDA recognized consensus standards and voluntary standards as follows:

Standard Number	Standard Title
IEC 60601-1-1:1988+A1:1991+A2: 1995	Medical Electrical Equipment - Part 1: General requirements for safety
IEC 60601-1-2: 2007	Medical Electrical Equipment Part 1-2: Collateral standard: Electromagneticcompatibility - requirements and tests
ISO 10993-1: 2009	Biological evaluation of medical devices Part 1
IEC 60601-1-11: 2010	Medical electrical equipment - Part 1-11: General requirements for basicsafety and essential performance - Collateral Standard: Requirements formedical electrical equipment and medical electrical systems used in thehome healthcare environment
IEC 60601-2-26:2002	Particular requirements for the safety of electroencephalographs

Additional verification and validation testing confirmed:

All features of the X4 System were compliant with the system level requirements. .
Signals acquired with the X4 System provide similar information as compared to the predicate . device that would allow a physician to interpret the signals.

SUMMARY OF CLINICAL TESTS:

The X4 has been the subject of clinical testing to demonstrate it can be used by patients in the home. The results support that over 90% of studies recorded overnight with the X4 are interpretable and behave as expected. The X4 instructions were applied without difficulty, allowing all subjects to properly apply the device so that it remained in the proper position and allowing any problems that triggered an audio alarm to be properly resolved.

CONCLUSION:

Advanced Brain Monitoring considers the X4 System to be as safe, as effective, and substantially equivalent to the predicate devices.

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

JUN 2 0 2012

Advanced Brain Monitoring, Inc. C/O Ms. Adrienne Lenz Pathway Regulatory Consulting, LLC Regulatory Affairs Consulting W324 S3649 County Road E Dousman, Wisconsin 53118

Re: K120447

Trade/Device Name: X4 System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OMC Dated: May 25, 2012 Received: May 30, 2012

Dear Ms. Lenz:

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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Page 2 - Ms. Lenz

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/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,

hr for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Advanced Brain Monitoring, Inc. X4 System

510(k) Number (if known):

Device Name: X4 System

Indications for Use:

Prescription Use_ X

AND/OR

Over-The-Counter Use_

(Part 21 CFR 801 Subpart D)

(Part 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)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K120447

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).