The Apnea Risk Evaluation System (ARES™), Model 610 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, and airflow. Additionally, a physiological signal from the forehead used to stage sleep or respiratory effort signal obtained from an optional piezo respiratory effort belt can be acquired. The battery powered Unicorder provides sufficient capacity to record two nights of data. 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, residing on a local PC or a physical or virtual server controls the uploading and downloading of data to the Unicorder, processes the sleep study data and generates a sleep study report. The ARES™ can auto-detect positional and non-positional obstructive and mixed apneas and hypopneas similarly to polysomnography. It can detect sleep/wake and REM and non-REM. After the sleep study has been completed, data is transferred off the Unicorder is prepared for the next study. The downloaded sleep study record is then processed with the ARES™ Insight software to transform the raw signals and derive and assess changes in oxygen saturation (SpO2), pulse rate, head movement, head position, snoring sounds, airflow, and EEG or respiratory effort. The red and IR signals are used to calculate the SpO2 and pulse rate. The actigraphy signals are transformed to obtain head movement and head position. A clinician can convert an auto-detected obstructive apnea to a central apnea based on visual inspection of the waveforms. ARES™ Screener can predict pre-test probability of obstructive sleep apnea (OSA). The ARES™ can also assist the physician to identify patients who will likely have a successful OSA treatment outcome, including CPAP and oral appliance therapies. ARES™ can help identify patients who would benefit from a laboratory PAP titration.

AI/ML Overview

The provided FDA 510(k) summary for the Apnea Risk Evaluation System (ARES™), Model 610 (K112514) primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in a standalone performance evaluation. The changes in the modified device are related to software platform, improved filtering of the SpO2 signal, and new claims in the report messages.

Here's an attempt to extract and organize the information based on your request, with significant caveats that much of the requested detail is not explicitly provided in the document for the performance of the modified device in the way you've outlined:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily for the SpO2 accuracy after the filtering changes. The document explicitly states that the accuracy in all ranges is less than 3.5% as recommended by draft FDA guidance.

Acceptance Criteria (Modified Device)	Reported Device Performance (Modified Device)
SpO2 Accuracy (Arms) for various ranges:
60-100%	< 3.0%
90-100%	< 3.0%
80-90%	< 3.0%
70-80%	< 3.0%
60-70%	< 3.0%
Up to 32% of reading may fall outside listed range for all	Up to 32% of reading may fall outside listed range
Accuracy in all ranges is less than 3.5% (as per FDA Draft Guidance)	Confirmed to be < 3.5%
Equivalence to original ARES™ accuracy for SpO2 signal	Confirmed to be equivalent
Software operates properly from cloud server	Confirmed

Note: The document states "The Arms has changed due to the filtering changes but labeling will reflect specification of < 3.0%. Accuracy in all ranges is less than 3.5% as recommended in Draft Guidance..." This implies < 3.0% is the target specification for labeling, and the performance meets the broader FDA guidance of < 3.5%.

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

The document mentions validation of the SpO2 filtering changes using "clinical data previously acquired in two clinical studies" but does not specify the sample size for these studies. The data provenance is described as "clinical data previously acquired," suggesting it was retrospective analysis of existing data. The country of origin is not specified.

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

This information is not provided in the document. For the new claims regarding treatment messages and PAP titration identification, it states these are "supported by published literature," but it doesn't detail the ground truth establishment process for this specific device's testing.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

A Multi Reader Multi Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not mentioned in the document. The study described focuses on the device's SpO2 accuracy and the functionality of the new software platform and report messages.

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

A standalone performance evaluation of the algorithm's core diagnostic capabilities (e.g., apnea/hypopnea detection accuracy compared to PSG) is not detailed as a new clinical study for this 510(k) submission. The clinical tests mentioned specifically relate to the filtering changes to the SpO2 signal. The document states: "The ARES™ can auto-detect positional and non-positional obstructive and mixed apneas and hypopneas similarly to polysomnography," which implies standalone performance, but the K112514 document primarily refers back to the predicate device (K111194) for such claims and only describes validation of the SpO2 filtering for the current submission.

7. The Type of Ground Truth Used

For the SpO2 accuracy validation:

Original breathe down data: This typically involves controlled desaturation events where arterial blood gas measurements or a highly accurate reference pulse oximeter serve as ground truth for SpO2.
Breath hold data: This involves evaluating performance during dynamic SpO2 changes, again implying a reference standard for SpO2 measurements.
For the new claims (treatment planning messages, PAP titration): The ground truth is cited as published literature.

8. The Sample Size for the Training Set

The document does not specify the sample size for the training set. It mentions "previously acquired clinical data" being used for validation, but not for training.

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

The document does not provide information on how ground truth was established for any training set for the modified device, as it primarily focuses on validating changes to an already cleared device.

Summary

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K112514

Apnea Risk Evaluation System (ARES™), Model 610

JAN - 9 2012

510(K) SUMMARY

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

January 5, 2012

SUBMITTER:

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 Member Pathway Regulatory Consulting, LLC T 262-290-0023

SECONDARY CONTACT PERSON:

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

DEVICE:

TRADE NAME: Apnea Risk Evaluation System (ARES™), Model 610

COMMON/USUAL NAME: ARES

CLASSIFICATION NAMES: 868.2375 Ventilatory Effort Recorder

PRODUCT CODE: MNR

PREDICATE DEVICE(S):

K111194 Apnea Risk Evaluation System (ARES), Model 610

K082968 ApneiCare Connection Center /Internet Analysis, ApneiCare, LLC

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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, residing on a local PC or a physical or virtual server controls the uploading and downloading of data to the Unicorder, processes the sleep study data and generates a sleep study report. The ARES™ can auto-detect positional and non-positional obstructive and mixed apneas and hypopneas similarly to polysomnography. It can detect sleep/wake and REM and non-REM.

After the sleep study has been completed, data is transferred off the Unicorder is prepared for the next study. The downloaded sleep study record is then processed with the ARES™ Insight software to transform the raw signals and derive and assess changes in oxygen saturation (SpO2), pulse rate, head movement, head position, snoring sounds, airflow, and EEG or respiratory effort. The red and IR signals are used to calculate the SpO2 and pulse rate. The actigraphy signals are transformed to obtain head movement and head position. A clinician can convert an auto-detected obstructive apnea to a central apnea based on visual inspection of the waveforms.

ARES™ Screener can predict pre-test probability of obstructive sleep apnea (OSA). The ARES™ can also assist the physician to identify patients who will likely have a successful OSA treatment outcome, including CPAP and oral appliance therapies. ARES™ can help identify patients who would benefit from a laboratory PAP titration.

INTENDED USE:

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TECHNOLOGY:

The ARES™ Model 610 being submitted is identical to the predicate ARES™ Model 610 (K111194) with the changes:

1. Modification to run ARES™ software from a cloud server, which may be a physical or virtual server, and is accessed using web-portal software.
1. Modification to ARES Insight software to improve filtering of the SpO2 signal.
1. New claims, supported by published literature, are added to the ARES™ labeling and the ARES™ report:
- o The ARES report provides messages to help physicians plan for treatment and/or followup care.
- o ARES can help identify patients who would benefit from a laboratory PAP titration.

DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

COMPARISON TO PREDICATE DEVICES

The modified ARES™ Model 610 has the same intended use and fundamental scientific technology as the cleared ARES™ Model 610. All features are identical except those described in the table below.

Feature	Original Device(Model 610, K111194)	Modified Device(Model 610)	Reason for Change
Software Platform	All software operates on a local PC.	Software operates on a PC, or via a web portal.	Equivalent. The Portal Software was designed to emulate existing ARES software that communicates with the ARES Unicorder, allows for data entry, and manages the workflow of an ARES sleep study. The portal software and server configuration is similar to ApneiCare Connection Center /Internet Analysis which analyzes sleep data over the internet (K082968).
Derived Signals	SpO2 Pulse rate Apneas and hypopneas Hypopnea severity Snoring loudness Head movement and position Sleep/wake Stages rapid eye movement (REM) vs. non-REM	SpO2 Pulse rate Apneas and hypopneas Hypopnea severity Snoring loudness Head movement and position Sleep/wake Stages rapid eye movement (REM) vs. non-REM	Equivalent. Improved filtering has been added in the processing of the SpO₂ signal prior to identification of desaturation events. The raw signal acquired from the Unicorder is unchanged.

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Feature	Original Device(Model 610, K111194)		Modified Device(Model 610)		Reason for Change
SaturationAccuracy	SpO2 range	Arms (%)	SpO2 range	Arms (%)	Equivalent. The Arms has changed dueto the filtering changes but labelingwill reflect specification of <3.0%.Accuracy in all ranges is less than 3.5%as recommended in Draft Guidancefor Industry and FDA Staff - PulseOximeters - Premarket NotificationSubmissions [510(k)s] July 19, 2007.
	60-100%	2.4	60-100%	< 3.0
	90-100%	1.5	90-100%	< 3.0
	80-90%	2.6	80-90%	< 3.0
	70-80%	2.6	70-80%	< 3.0
	60-70%	2.7	60-70%	< 3.0
	* Up to 32% of the reading may falloutside the listed error range		* Up to 32% of the reading may falloutside the listed error range
Reports	Multiple report formats available.		Multiple report formats available.Treatment considerations messagesare updated to help physicians planfor treatment and/or follow-up careand ARES can help identify patientswho would benefit from a laboratoryPAP titration.		Equivalent. The new statement isbased on and supported by studiesdescribed in Section 20. Thetreatment messages are optional, andare presented in a report generatedafter the signals have been reviewedby the interpreting physician. Thetreatment consideration messages arenot an automated diagnosis, but assistthe physician in providing standardtext for common messages in theirreports. These messages are derivedfrom published literature.

SUMMARY OF NON-CLINICAL TESTS:

Support for the substantial equivalence of the ARES™ Model 610 was provided as a result of risk management and software validation, which confirmed.

All features of the ARES™ Model 610 were compliant with the system level requirements. .
. The ARES™ software operates properly from a cloud server which is accessed using web-portal software.

SUMMARY OF CLINICAL TESTS:

The filtering changes to the SpO2 signal were validated by analysis of clinical data previously acquired in two clinical studies. The first study analyzed original breathe down data and demonstrated steady-state accuracy is equivalent before and after implementation of the filtering changes. The second study analyzed breath hold data to evaluate performance of ARES™ during dynamic SpO2 changes, as are typical in sleep disordered breathing. Both studies confirmed that the accuracy of the ARES " after the implementation of the filtering changes is equivalent to the original ARES "" accuracy.

Evaluation of published literature was also used to support the new claims and report messages introduced for ARESTM.

CONCLUSION:

The conclusions drawn from the nonclinical tests demonstrate equivalent performance of the Apnea Risk Evaluation System (ARES™), Model 610 and the legally marketed devices. The Apnea Risk Evaluation System (ARES'"), Model 610 is 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

Advanced Brain Monitoring, Incorporation C/O Ms. Adrienne Lenz Regulatory Affairs Consultant Pathway Regulatory Consulting, LLC 2511 Fox River Circle Waukesha. Wisconsin 53189

JAN - 9 2012

Re: K112514

Trade/Device Name: Apnea Risk Evaluation System (ARES) Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: December 29, 2011 Received: January 3, 2011

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,

Susan Quinn

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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510(k) Number (if known):

Apnea Risk Evaluation System (ARES) Device Name:

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)

L Schilttin

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

510(k) Number: K112574

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).