The Alice 5 System is a Polysomnography System that is intended to record, display and print physiological information to clinicians/physicians. These parameters are presented graphically on a computer screen for diagnostic review, similar in application to the use of a traditional paper based polygraph recorder. The device will be used in hospitals, institutions, sleep centers or clinics, or other test environments where adults or infant patients require the documentation of various sleep or other physiological disorders. This device does not provide alarms and, is not intended for use as an automated apnea monitor.

Device Description

The Alice 5 is a multi-functional recording device. The system is used for the recording, monitoring, storage and transfer of up to 55 channels of biophysical parameters such as brain, heart and muscle activily, eye movement, blood pressure, breathing, body movements and oximelry. In addition it has 5 auxiliary channels and 2 serial channels for connection of external devices. Electrodes and sensors from the patient are connected to Alice 5 head box which in turn is connected to the Alice 5 base station (recording unit) for data processing and recording. Patient studies recorded using the Alice 5 head box and the base station are viewed, printed, summarized, and analyzed using the Alice Sleepware Soltware.

AI/ML Overview

The provided documentation describes the Alice 5 System, a Polysomnography System, and its acceptance criteria as demonstrated through various performance tests and comparisons to predicate devices.

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

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Standard	Reported Device Performance/Status
Safety	IEC 60601-1: 1988 + A1: 1991 + A2: 1995 (Medical Electrical Equipment Part 1: General Requirements for Safety)	Conforms (Declaration of conformance provided).
	ISO-10993-1: Biological Evaluation of Medical Devices - Evaluation and Testing	Conforms (Declaration of conformance provided).
	FDA Reviewer's Guidance (#G95-1, 5/1/95) Biological Evaluation of Medical Devices; Use of ISO-10993	Guidance adopted.
Electromagnetic Compatibility (EMC)	IEC 60601-1-2: 2001 (Medical Electrical Equipment Part 1-2: Collateral Standard: Electromagnetic Compatibility - Requirements and tests)	Conforms (Declaration of conformance provided).
Performance (Functional Equivalence)	Alice 4R to Alice 5 Bench test comparison report; assesses event (breath) detection capability and autoscoring algorithm. (Input: known set of inputs depicting apneas/hypopneas)	Assessed for equivalence: Compared Alice 5 to Alice 4R for event (breath) detection and autoscoring. The report implies successful comparison given the overall conclusion of substantial equivalence.
	Devilbiss Sleep Recorder Pulse Transit Time vs. Alice 5 PTT waveform recording assessment (equivilance of PTT measurement)	Assessed for equivalence: Determined equivalence in PTT measurement between Alice 5 and Devilbiss Sleep Recorder.
	Devilbiss Sleep Recorder Snore channel/signal to Alice 5 Snore recording assessment (equivalence in data collection and waveform presentation)	Assessed for equivalence: Determined equivalence in data collection and waveform presentation for snore channel.
	Devilbiss Sleep Recorder Pressure Based Flow channel/signal to Alice 5 Pressure Based Flow waveform recording assessment (equivalence in data collection and waveform presentation)	Assessed for equivalence: Determined equivalence in data collection and waveform presentation for pressure-based flow channel.
	Alice 4R vs Alice 5 thermistor channel/signal comparison (equivalence in data collection and waveform presentation)	Assessed for equivalence: Determined equivalence in data collection and waveform presentation for thermistor channel.
System Functionality	Alice 5 System Requirements Test Procedure/Report; assesses compliance with System level requirements.	Assessed for compliance: Ensures features of Alice 5 meet system-level requirements. The successful completion of this test implies compliance.
Durability/Environmental	Alice 5 Shock & Vibration Test Report; assesses compliance to IEC 68-2-34 & 2-26 standards.	Assessed for compliance.
	Alice 5 Temperature & Humidity Report; assesses compliance to Operational and Storage test conditions stated in 1993 FDA Reviewers Guidance.	Assessed for compliance.
Software Life Cycle	ANSI/AAMI SW68: 2001 Medical Device Software Software Life Cycle Processes	Conforms (Declaration of conformance provided). This implies that unit, module, and functional testing of the device (firmware) and Alice Sleepware Software were completed, although reports were not submitted, as per the standard.
General Equivalence	Comparison to predicate devices (Respironics Alice 4R, Masimo SET Oximeter, Devilbiss Sleep Recorder) in terms of intended use, technological characteristics (e.g., number of channels, data input types, study modes, data collection/analysis)	Substantially Equivalent: The submission demonstrates that the Alice 5 system is substantially equivalent to the combination of the predicate devices, with the primary modification being the extension of existing claims to include additional channels (51 for Alice 5 vs. 35 for Alice 4R and 9 for Devilbiss). It is noted that the Alice 5 adds "Radio LAN Capabilities" not present in the predicates, but this is presented as a minor difference not affecting safety or effectiveness. The conclusion states no new concerns about safety and effectiveness compared to predicate devices. The device expands channel count from 35 to 51, and adds Radio LAN capabilities.
Intended Use	Polysomnography System to record, display, and print physiological information for diagnostic review by clinicians/physicians for adults/infants in various sleep or physiological disorders. Not for alarms or automated apnea monitoring.	Maintained equivalence and expanded usability: The intended use is virtually identical to the Alice 4R, and encompasses elements of the Devilbiss Sleep Recorder, but explicitly states it does not provide alarms or act as an automated apnea monitor, similar to the Alice 4R.

Study Details:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document describes bench testing using a "known set of inputs (depicting apneas/hypopneas) was simulated as an input" for the Alice 4R to Alice 5 breath detection comparison. For other comparisons (PTT, Snore, Pressure Based Flow, thermistor channels), the term "assessment" or "comparison" is used for the predicate devices.
- No specific human subject "test set" sample sizes or patient data provenance (country of origin, retrospective/prospective) are explicitly mentioned for clinical performance evaluation. The comparisons are primarily focused on equivalence of technical signal acquisition and processing with predicate devices through bench testing.
- The term "performance testing" here primarily refers to engineering and non-clinical bench tests.
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):
- Given the nature of the testing (bench comparisons with simulated inputs or direct signal comparisons with predicate devices), the concept of "experts establishing ground truth for a test set" in the context of clinical performance is not directly applicable.
- The "ground truth" for the bench tests would have been the "known set of inputs" or the established performance of the predicate device signals as processed and presented.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as the tests described are technical bench comparative assessments rather than clinical performance studies requiring adjudication of human-interpreted results.
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 conducted or mentioned. This device is a data acquisition and display system for physiological signals, not an AI-assisted diagnostic or interpretation tool. Its function is to record, display, and print physiological information for clinicians to review, similar to a traditional polygraph, without automated alarms or apnea monitoring.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device itself, the Alice 5 System, is essentially a standalone data acquisition system. Its "performance" is based on its ability to accurately record, display, and print physiological data. The bench tests evaluated this standalone performance and its equivalence to predicate devices. There's an "autoscoring algorithm" mentioned for the Alice 4R to Alice 5 comparison, implying some automated analysis capability, but the document doesn't delve into its specific standalone performance metrics or comparative studies for clinical interpretation. The device's indications for use emphasize diagnostic review by clinicians/physicians, implying a human-in-the-loop for interpretation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the bench test comparisons appears to be:
  - Simulated Inputs: For the breath detection (apneas/hypopneas) test, "a known set of inputs" was used.
  - Predicate Device Performance: For other channel comparisons (PTT, Snore, Pressure Based Flow, thermistor), the predicate devices (Alice 4R and Devilbiss Sleep Recorder) served as the reference for equivalent data collection and waveform presentation.
- There is no mention of ground truth established via expert consensus, pathology, or outcomes data related to clinical diagnosis.
The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the traditional sense. It's a hardware system with associated software for data acquisition and display. Software validation (ANSI/AAMI SW68:2001) was performed for the firmware and Alice Sleepware Software, which is more about ensuring proper function and reliability through a defined software life cycle process rather than machine learning training.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for this type of device.

Summary

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K 040595

. .

MAR 1 8 2004

... .. .. .. .. ..

Date of Submission	11 February 2004
Official Contact / Address of Manufacturing facility	Zita A. YurkoManager, Regulatory AffairsRespironics Inc.1001 Murry Ridge LaneMurrysville, PA 15668
	Phone: 724-387-4120Fax: 724-387-4216Zita.yurko@respironics.com
Proprietary Name	Alice 5 System
Common/Usual Name	Electroencephalograph/Polysomnography System
Device Classification Name	Electroencephalograph/Polysomnography System
Classification Reference	21 CFR 882.1400
Classification	Class II
Appropriate Classification Panel	Neurology
Product Code	OLZ, OLV
Predicate Devices	Respironics Alice 4R (K971867)
	Masimo SET Oximeter (K990966)
	Devilbiss Sleep Recorder (K012437)
Reason for submission	Modified design

Substantial Equivalence

This premarket notification submission demonstrates that the Alice 5 system is substantially equivalent to a combination of the Respironics Alice 4R (K971867), Masimo SET Oximeter (K990966), and the Devilbiss Sleep Recorder (K012437).

・・・・

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The design of the Alice 5 was verified through the use of design verification and validation testing. The Hazards Control Measures Traceability Matrix provided in the Risk Analysis assured that all hazards identified by the risk analysis were successfully mitigated.

This submission is seeking to extend the existing claims of the Alice system to include additional channels to process and record physiologic information.

Indications for Use

The Alice 5 System is a Polysornography System that is intended to record, display and print physiological information to clinicians/physicians. These parameters are presented graphically on a computer screen for diagnostic review, similar in application to the use of a traditional paper based polygraph recorder. The device will be used in hospitals, institutions, sleep centers or clinics, or other test environments where adults or infant patients require the documentation of various sleep or other physiological disorders.

This device does not provide alarms and, is not intended for use as an automated apnea monitor.

Device Description

Electrodes and sensors from the patient are connected to Alice 5 head box which in turn is connected to the Alice 5 base station (recording unit) for data processing and recording.

Patient studies recorded using the Alice 5 head box and the base station are viewed, printed, summarized, and analyzed using the Alice Sleepware Soltware.

Technological characteristics, comparison to predicate devices

Like the predicate devices, the Alice 5 system is intended to detect physiological signals from various points on the patient's body, individually or as a signal measured between selected electrodes and to record those signals in accordance with preset parameters (in a montage) for analysis by a clinician.

@2004 Respironics Inc.

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Abbreviated 510(k)

Tab 10 – 510(K) Summary

Abbreviated 510(k)Tab 10 - 510(K) Summary
Characteristic	Alice 4R (K97xx)	Devilbiss Sleep Recorder,Model RM60 (K012437)	Alice 5
Intended Use	The Alice 4 System is apolysomnography system thatis intended to record, displayand print EEG and otherphysiological information toclinicians/physicians. Thedevice will be used inhospitals, institutions, sleepcenters or clinics or other testenvironments where adult orinfant patients require thedocumentation of varioussleep or other physiologicaldisorders.	The Devilbiss Sleep Recorderis intended for screeningpatients suspected of orexhibiting symptoms of sleepdisorders. The DevilbissSleep Recorder can be usedwith an autotitrating CPAP torecord the results of CPAPtreatment for adults diagnosedwith sleep apnea syndrome.Patients suffering fromexcessive daytime sleepinessshould be referred to a sleepdisorder specialist. Theresults of an unattendedscreening are insufficient toidentify all possible medicaldisorders that may producethese symptoms. This deviceis intended to aid thephysician in diagnosing adultsleep apnea. A qualifiedmedical professional shouldscore the device's recordedsignals to determinerespiratory events. TheDevilbiss Sleep Recorder orany of its components shouldnot be used as a life supportdevice, life support system, oras a critical component of alife support device or lifesupport system.	The Alice 5 System is aPolysomnographic Systemthat is intended to record,display and print physiologicalinformation toclinicians/physicians. Theseparameters are presentedgraphically on a computerscreen for diagnostic review,similar in application to theuse of a traditional paperbased polygraph recorder.The device will be used inhospitals, institutions, sleepcenters or clinics, or other testenvironments where adults orinfant patients require thedocumentation of varioussleep or other physiologicaldisorders.This device does not providealarms and, is not intended foruse as an automated apneamonitor.
Configuration	Desktop	Wearable	Desktop
Number of patients canmonitor simultaneously	1 per unit	Same	Same
Portable Design	Yes	Samo	Same
Data Collection	Yes	Yes	Yes
Data Analysis	Optional (always present, buta clinician may choose to useit or not)	Optional	Optional (always present, buta clinician may choose to useit or not)
Report Generation	Optional (always present, buta clinician may choose to useit or not)	Optional	Optional (always present, buta clinician may choose to useit or not)
Capable of Data Transfer forAnalysis and ReportGeneration	Yes	Yes	Yes
Channels	35	9	51
Data input types	ECG, Neurological,Respiratory	ECG, respiratory	ECG, Neurological,Respiratory
Remote Capability to Monitor	Yes	Yes	Yes
Lead Quality
Electrode Impedance check	Yes	Yes	Yes
Calibration Check	Yes	Yes	Yes
Selectable MontageConfiguration	Yes	Yes	Yes
Annotations on study	Yes	Yes	Yes
Raw data storage	Yes, Hard Disk	Yes, Flash	Yes, Hard Disk
Study Modes	Polysomnography RecordingLong term Monitoring,Retrieval and Replay	Overnight at-home study	Polysomnography RecordingLong term Monitoring,Retrieval and Replay
Optional equipment	Time Sync Video, Digitalvideo, printer	Not Available	Digital video, printer
Radio LAN Capabilities	No	No	Yes

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Abbreviated 510(k)

Tab 10 ~ 510(K) Summary

Performance testing

An extensive collection of tests has been conducted and successfully completed, including safety, performance and comparative tests. Declarations of conformance to the FDA Recognized list of consensus standards, as well as FDA reviewers guidance and Applicable voluntary standards have been provided in support of the safety and effectiveness of the Alice 5 System. This list of performance testing included in the submittal is as follows:

IEC 60601-1: 1988 + A1: 1991 + A2: 1995, Medical Electrical Equipment Part 1: General . Requirements for Safety - Tab 11A
. IEC 60601-1-2: 2001 Medical Electrical Equipment Part 1-2: Collateral Standard: Electromagnetic Compatibility - Requirements and tests - Tab 11B
. ISO-10993-1: Biological Evaluation of Medical Devices - Evaluation and Testing - Tab 9

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Tab 10 -- 510(K) Summary

FDA Reviewer's Guidar ce (#G95-1, 5/1/95) Biological Evaluation of Medical Devices; Use of ISO-. 10993 - Tab 9
Alice 4R to Alice 5 Bench test comparison report; assesses the event (breath) detection capability . of the Alice 4R vs. Alice 5 and the autoscoring algorithm. For this testing a known set of inpuls (depicting apneas/hypopneas) was simulated as an input to the Alice 4R and the Alice 5.
Devilbiss Sleep Recorder Pulse Transit Time vs. the Alice 5 PTT waveform recording assessment . to determine equivalence in the PTT measurement between the Alice 5 and the Devilbiss Sleep Recorder.
Devilbiss Sleep Recorder Snore channel/signal to the Alice 5 Snore recording assessment to . determine equivalence in the data collection and waveform presentation between the Alice 5 and the Devilbiss Sleep Recorder.
Devilbiss Sleep Recorder Pressure Based Flow channel/signal to the Alice 5 Pressure Based . Flow waveform recording assessment to determine equivalence in the data collection and waveform presentation between the Alice 5 and the Devilbiss Sleep Recorder.
Alice 4R vs Alice 5 thermistor channel/signal comparison to determine equivalence in the data ◆ collection and waveform presentation between the Alice 4R and the Alice 5 systems.
Alice 5 System Requirements Test Procedure/Report; assesses the features of the Alice 5 to . ensure compliance with the System level requirements.
Alice 5 Shock & Vibration Test Report; assesses compliance of the Alice 5 system to the IEC 68-. 2-34. & 2-26 standards.
Alice 5 Temperature & Humidity Report; assesses compliance of the Alice 5 Head Box and base . Station to the Operational and Storage test conditions stated in the 1993 FDA Reviewers Guidance.

Additional testing has been performed in to ensure safety & effectiveness of the Alice 5 System. This testing involves the unit, module, and functional testing of the device (lirmware) and the Alice Sleepware Software. Since we are able to declare compliance to AAMI: SW68:2001 Medical Device software – Software life cycle processes, these test protocols and reports are not required to be submitted as part of this submittal, but are available upon request. Additionally the following set of standards and guidance documents have been used in the design of the Alice 5 System. These include:

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Required Standards – A Declaration of Conformity for each of these standards is provided in the submiltal:

. ...

ANSI/AAMI SW68: 2001 Medical Device Software Software Life Cycle Processes. ●
IEC 60601-1: 1988 + A1: 1991 + A2: 1995, Medical Electrical Equipment Part 1: General . Requirements for Safety
IEC 60601-1-2: 2001 Medical Electrical Equipment Part 1-2: Collateral Standard: Electromagnetic . Compatibility - Requirements and tests
ISO-10993-1: Biological Evaluation of Medical Devices Evaluation and Testing .

Voluntary Standards - Guidance, when applicable, has been adopted from the following standards.

IEC 60601-2-25: 1993 + A1: 1999 Medical Electrical Equipment Part 2-25: Particular requirements . for the safety of electrocardiographs.
IEC 60601-2-26: 2002 Medical Electrical Equipment -- Part 2-26: Particular requirements for the safety . of electroencephalographs.
IEC 60601-2-40: 1998 Medical Electrical Equipment Part 2-40: Particular requirements for the safety . of electromyographs and evoked response equipment.
IEC 60601-2-49: 2001 Medical Electrical Equipment Part 2-49: Particular requirements for the salety ● of multifunction patient monitoring equipment.

Reviewers Guidance - Guidance, when applicable, has been adopled from each of the FDA Reviewers Guidance documents

FDA Guidance Document, Electroencephalograph Devices Guidance for 510(k) Content, Draft ● Document, Version 1.0.
FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, ● May 1998
FDA Reviewer's Guidance (#G95-1, 5/1/95) Biological Evaluation of Medical Devices; Use of ISO-. 10993
FDA Reviewer's Guidance for Premarket Notification Submissions, Appendix A, November 1993 .
FDA Reviewer's Guidance General Principles of Software Validation; Final Guidance for Industry and . FDA Staff, January 2002

Conclusion

It is the conclusion of Respirorics that the Alice 5 system is substantially equivalent to devices already on the market (cleared by the 510(k) process) and presents no new concerns about salely and effectiveness.

(End of Tab.)

Alice C

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

Respironics, Inc. c/o Mr. Ned E. Devine, Jr. Entela, Inc. 3033 Madison Avenue, SE Grand Rapids, Michigan 49548

Re: K040595

Trade/Device Name: Alice 5 System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLZ, OLV Dated (Date on orig SE 1tr): March 3, 2007 Received (Date on orig SE Itr): March 8, 2004

APR - 9 2012

Dear Mr. Devine:

This letter corrects our substantially equivalent letter of March 18, 2004.

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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,
Kesia Alexander

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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

510(k) Number (if known): _ K 040 595

Device Name:

Indications for Use:

The Alice 5 System Is a Polysomnography System that is intended to record, display and print physiological Information to clinicians/physicians. These parameters are presented graphically on a computer screen for diagnostic review, similar in application to the use of a traditional paper based polygraph recorder. The device will be used in hospitals, institutions, sleep centers or clinics, or other test environments where adults or infant patients require the documentation of various sleep or other physiological disorders.

This device does not provide alarms and, is not intended for use as an automated apnea monitor.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_K 040595

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).