The Apnea Risk Evaluation System (ARES™) is indicated for use in the diagnostic evaluation by a physician of adult patients with possible sleep apnea. The ARES can record and score respiratory events during sleep (e.g., apneas, hypopneas, mixed apneas and flow limiting events). The device is designed for prescription use in home diagnosis of adults with possible sleep-related breathing disorders.

Device Description

The Apnea Risk Evaluation System (ARES) includes a device called a Unicorder which records oxygen saturation, pulse rate, snoring level, head movement and head position, airflow, respiratory effort, and a physiological signal from the forehead used to stage sleep. The battery-powered Unicorder provides sufficient capacity to record for 18-hours of continuous use. The device monitors signal quality during acquisition and notifies the user via voice messages when adjustments are required. A standard USB cable connects the Unicorder to a USB port on a host computer when patient data is to be uploaded or downloaded. The USB cable provides power to the Unicorder during recharging from the host computer or from a USB wall charger. The Unicorder cannot record nor can it be worn by the patient when connected to the host computer or the wall charger. Software controls the uploading and downloading of data to the Unicorder, processes the sleep study data and generates a sleep study report. Algorithms are applied to the physiological data to automatically detect apneas and hypopneas, distinguish sleep from awake and rapid eye movement sleep from non-rapid eye movement sleep. A full disclosure recording is provided, allowing a clinician to edit any of the events detection algorithms. The software includes the capability to assign a pre-test probability of a patient having OSA based on questionnaire responses. Six disposable components must be replaced and the forehead sensor must be cleaned before reuse.

AI/ML Overview

The provided text describes the Apnea Risk Evaluation System (ARES) Model 600. It details various performance tests conducted to establish substantial equivalence to predicate devices, but it does not provide specific acceptance criteria or an explicit study that quantifies device performance against those criteria in a table format with numerical results.

However, based on the text, we can infer some aspects related to acceptance criteria and the nature of the validation.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present a table of acceptance criteria with corresponding performance metrics. Instead, it indicates that "Design verification and validation tests were performed on the ARES Unicorder Model 600 to ensure it meets the specified product requirements," and states that the accuracy of automated detection was "assessed and compared to the predicate device." This phrasing suggests a comparative approach to acceptance rather than pre-defined numerical thresholds.

Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Safety	Conformity to IEC 60601-1 and related standards	Achieved (supported by "risk analysis" and "extensive testing")
Software	Conformity to FDA Guidance for Software in Medical Devices	Achieved (listed as a performance test item)
Head Position/Movement Measurement	Equivalence to ARES Model 500 (predicate)	Achieved ("bench comparison report")
Airflow, Respiratory Effort, Pulse Rate, SpO2 Measurement	Equivalence to ARES Model 500 (predicate)	Achieved ("channel/signal comparisons")
EEG, EOG, EMG Measurement	Equivalence to Sandman Digital (predicate)	Achieved ("channel/signal comparisons")
Accuracy of Automated Detection (Awake, Sleep, REM vs. non-REM)	Comparable to predicate device's performance against technician scoring (gold-standard)	"Accuracy... was assessed and compared to the predicate device." (No specific metrics provided in this document).

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set for performance evaluation of automated detection. It mentions "laboratory PSG" as the gold standard, suggesting the data originated from sleep lab studies. The provenance (country of origin) is not specified, but the submission is to the US FDA, so it's likely US data. The data appears to be retrospective, as it's used for comparison against technician scoring.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document states that "The technician scoring was considered the gold-standard for purposes of assessing accuracy."

Number of experts: Not specified (implied to be one or more technicians per PSG).
Qualifications of experts: "Technician scoring" implies trained polysomnography technicians. No specific experience level (e.g., "10 years of experience") is mentioned.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method like 2+1 or 3+1. The ground truth for automated detection was based on "technician scoring," which implies a single-reader assessment per PSG record, rather than a consensus or adjudicated reading.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study is not described. The documentation focuses on the device's standalone performance compared to technician scoring and other predicate devices, not on human readers' improvement with AI assistance.

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

Yes, a standalone performance assessment was done. The document states: "The accuracy of the automated detection of awake and sleep and REM vs. non-REM compared to technician scoring of laboratory PSG was assessed and compared to the predicate device." This directly refers to the algorithm's performance without human intervention.

7. The Type of Ground Truth Used

The ground truth used for assessing the automated detection of sleep stages (awake, sleep, REM vs. non-REM) was expert consensus / technician scoring (specifically stated as "technician scoring of laboratory PSG was considered the gold-standard").

8. The Sample Size for the Training Set

The document does not provide any information regarding the sample size of a training set for the algorithm. It focuses on the validation of the ARES Model 600, not its development.

9. How the Ground Truth for the Training Set Was Established

Since no information regarding a training set is provided, there is also no information on how its ground truth was established.

Summary

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K071230

510(k) Summary

Date of submission	May 2, 2007	OCT 3 2007
Official contact/addressof manufacturing facility	Daniel J. Levendowski
	President
	Advanced Brain Monitoring, Inc.
	2237 Faraday Avenue, Suite 100
	Carlsbad, CA 92008
	Tel: 760.720.0099 x 6040
	Fax: 760.720.3337
Proprietary name	Apnea Risk Evaluation System - Model 600
Common/Usual name	ARES™
Device classification name	Ventilatory Effort Recorder
Classification reference	21 CFR 868.2375
Classification	Class II
Appropriate classification panel	Anesthesiology
Product code	MNR
Predicate Devices	Advanced Brain Monitoring ARES (Model 500)(K041662)Sandman Digital (K003154), Watch_Pat 100S (K042916)
Reason for submission	Modified design

Substantial Equivalence

Design verification and validation tests were performed on the ARES Unicorder Model 600 to ensure it meets the specified product requirements. As a result of its risk analysis, Advanced Brain Monitoring has determined that the modifications have no impact on safety and effectiveness of the device. In summary, the device described in the submission is substantially equivalent to the predicate devices.

Indications for Use

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events). The device is designed for prescription use in home diagnosis of adults with possible sleep-related breathing disorders.

Device Description

A standard USB cable connects the Unicorder to a USB port on a host computer when patient data is to be uploaded or downloaded. The USB cable provides power to the Unicorder during recharging from the host computer or from a USB wall charger. The Unicorder cannot record nor can it be worn by the patient when connected to the host computer or the wall charger.

Software controls the uploading and downloading of data to the Unicorder, processes the sleep study data and generates a sleep study report. Algorithms are applied to the physiological data to automatically detect apneas and hypopneas, distinguish sleep from awake and rapid eye movement sleep from non-rapid eye movement sleep. A full disclosure recording is provided, allowing a clinician to edit any of the events detection algorithms. The software includes the capability to assign a pre-test probability of a patient having OSA based on questionnaire responses. Six disposable components must be replaced and the forehead sensor must be cleaned before reuse.

Characteristic	ARES Model 500K041662	Sandman Digital 32K003154	ARES Model 600K071230	Watch Pat 100SK042916
Intended Use	The Apnea RiskEvaluation System(ARESTM) isindicated for use inthe diagnosticevaluation by aphysician of adultpatients with possiblesleep apnea. TheARES can record andscore respiratoryevents (c.g., apneas,hypopneas, mixedapneas and flowlimiting events). Thedevice is designedfor prescription usein home screening ofadults with possiblesleep disorders.	The Sandman digitalsystem is aPolysomnographicSystem intended to beused by or under thedirection of a physicianfor acquisition of EEG,polygraphy andpolysomnographysignals and transmissionof these signals to a PCduring recording ofneurophysiologyexaminations.	The Apnea RiskEvaluation System(ARESTM) isindicated for use inthe diagnosticevaluation by aphysician of adultpatients with possiblesleep apnea. TheARES can record andscore respiratoryevents during sleep(e.g., apneas,hypopneas, mixedapneas and flowlimiting events). Thedevice is designed forprescription use inhome screening ofadults with possiblesleep disorders.	The Watch_PAT isa diagnostic aid forthe detection ofsleep relatedbreathing disordersand rapid eyemovement (REM)sleep staging. TheWP100S generatesa peripheral arterialtonometry,respiratorydisturbance andPAT REM sleepstage identification

Comparison to Predicate Devices

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	Portable Design
Battery powered	Yes	No	Yes	Yes
Data collection	Yes	Yes	Yes	Yes
Present collected data	Yes	Yes	Yes	Yes
Automated data analysis	Optional (always present, but a clinician may choose to use it or not)	Same	Same	Same
Capable of data transfer for analysis and report generation	Yes	Yes	Yes	Yes
Data input types	Respiratory	Respiratory,neurological, ECG	Respiratory,neurological,actigraphy	Peripheral arterialtonometry,oximetry, pulserate, actigraphy
Channels	7	51	10	4
Raw data storage	Yes, flash	Yes, hard disk	Yes, flash	Yes, flash
Study modes	Over-nightrecordings at home,retrieval and replay	Polysomnographyrecordings, long termmonitoring, retrievaland replay	Over-night recordingsat home, retrieval andreplay	Over-nightrecordings at home.retrieval and replay

Materials

All materials used in the manufacture of the device are suitable for this use and have been used in numerous previously cleared products.

Performance Testing

Support for the safety and efficacy of the ARES Unicorder (Model 600) was provided as a result of extensive testing which included safety, performance and comparative tests. This testing includes conformity to the FDA recognized list of consensus standards and voluntary standards. The list of performance testing conducted prior to this submission is as follows:

IEC 60601-1: 1988+A1: 19991 + A2: 1995 + CAN/CSA-C22.2+ UL60601-1:2003, ୍ Medical Electrical Equipment - Part 1" General requirements for Safety
IEC 60601-1-2: 2001 Medical Electrical Equipment Part 1-2: Collateral Standard: o Electromagnetic compatibility - requirements and tests
্ত FDA Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices - May 2005
ARES 600 System Requirements Test Procedure/Report; assesses the features of the o ARES 600 to ensure compliance with the System level requirements
ARES 600 and ARES 500 bench comparison report for the measurement of head position 0 and head movement
ARES 600 and ARES 500 airflow, respiratory effort, pulse rate and SpO2 channel/signal o comparisons to determine the equivalence in the data collection and the waveform presentation between the ARES 500 and ARES 600.
ARES 600 and Sandman Digital EEG, EOG and EMG channel/signal comparisons to 0 determinc the equivalence in the data collection and waveform presentation between the ARES 600 and Sandman Digital.

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The accuracy of the automated detection of awake and sleep and REM vs. non-REM o compared to technician scoring of laboratory PSG was assessed and compared to the predicate device. The technician scoring was considered the gold-standard for purposes of assessing accuracy.

Summary of Substantial Equivalence

It is the conclusion of Advanced Brain Monitoring, Inc. that the ARES - Model 600 is substantially equivalent to devices already on the market (cleared by the 510(k) process) and presents no new concerns about safety and effectiveness.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol on the right and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The symbol is composed of three curved lines that resemble a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Daniel J. Levendowski President Advanced Brain Monitoring, Incorporated 2237 Faraday Avenue, Suite 100 Carlsbad, California 92008

OCT 3 2007

Re: K071230

Trade/Device Name: Apnea Risk Evaluation System (ARESTAS) Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: September 6, 2007 Received: September 7, 2007

Dear Mr. Levendowski:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Mr. Levendowski

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Ching-ju, Ph.D.

Chiu Lin, Ph.D. 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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INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

This application

Device Name:

Apnea Risk Evaluation System (ARESTM)

Indications for Use:

The Apnea Risk Evaluation System (ARES) is indicated for use in the diagnostic evaluation by a physician of adult patients with possible sleep apnea. The ARES can record and score respiratory events during sleep (e.g., apneas, hypopneas, mixed apneas and flow limiting events). The device is designed for prescription use in home diagnosis of adults with possible sleep-related breathing disorders.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓
OR
Over-The-Counter Use

(Per 21 CFR 801.109)

(Division Sign-Off)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

Optional Format 1-2-96)

510(k) Number: K071230

Regulation Number and Section

§ 868.2375 Breathing frequency monitor.

(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).