The Zmachine Synergy is an EEG and respiratory signal recorder. The device is intended for use by adult patients in the home or clinical environment, under the direction of a qualified healthcare practitioner, to aid in the diagnosis of sleep disorders.

Device Description

The Zmachine Synergy system is a portable, battery operated, medical device housed within an ABS enclosure. The system combines the single-channel EEG recording capability of the Zmachine DT-100 (K101830) with the respiratory signal recording capability of the Resmed ApneaLink Air (K143272). The Zmachine Synergy is thereby capable of recording EEG, respiratory airflow, respiratory effort, blood oxygen saturation, pulse rate, and body position during sleep.

AI/ML Overview

The provided text focuses on establishing substantial equivalence for the Zmachine Synergy device by comparing it to predicate devices (Zmachine DT-100 and ApneaLink Air) through technical and bench testing. It does not contain information about clinical study data, ground truth establishment by experts, or MRMC studies that would typically be associated with AI/algorithm performance claims.

Therefore, many of the requested categories cannot be fully addressed based on the provided document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes "bench comparison testing" where the Zmachine Synergy was compared against predicate devices. The "acceptance criteria" are implied to be "substantially equivalent" or "high agreement" between the Zmachine Synergy and the predicate devices for each measured parameter.

Test	Acceptance Criteria (Implied)	Reported Device Performance
EEG	Substantially equivalent EEG amplifier characteristics.	High agreement with design limits and each other for amplifier gain, highpass/lowpass filter cutoff frequency, DC offset, and noise floor. Found substantially equivalent.
Respiratory Airflow	Strong linear relationship / substantially equivalent signals.	Pearson's correlation coefficient revealed a strong linear relationship. Found substantially equivalent.
Respiratory Effort	Strong linear relationship / substantially equivalent signals.	Pearson's correlation coefficient revealed a strong linear relationship. Found substantially equivalent.
Pulse Oximetry	High agreement and low mean squared error.	Heart rate and oxygen saturation readings were in high agreement with calibrator output levels and showed low mean squared error when comparing the two systems. Found substantially equivalent.
Body Position	Very high agreement with angular reference.	Angular readings and angular reference positions were in very high agreement throughout 360 degrees of rotation. Found substantially equivalent.

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

The study described is bench testing, not a clinical study involving patients or a test set of data in the typical sense for algorithm performance. The "test set" consisted of:

A multi-channel EEG analog playback system for EEG.
A variable pressure air pump for Respiratory Airflow.
Controlled belt stretching and relaxing against a linear scale for Respiratory Effort.
A patient simulator for Pulse Oximetry.
Rotation against an angular reference for Body Position.

Therefore, traditional "sample size" is not applicable, as these were controlled bench tests. Data provenance is specific to the synthetic signals generated by the test equipment.

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

Not applicable. The "ground truth" for these bench tests was established by the precise outputs of the test equipment (e.g., specific frequencies, known pressure values, specific angles) and the design specifications of the devices themselves. No human expert adjudication was involved in establishing this "ground truth."

4. Adjudication Method for the Test Set

Not applicable. There was no human adjudication as the tests were performed against known physical inputs from laboratory equipment.

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

No. The provided text does not describe an MRMC study. The study focuses on comparing the fundamental signal acquisition characteristics of the Zmachine Synergy with its predicate devices at a technical, hardware level, not on assessing how human readers perform with or without AI assistance.

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

Partially applicable, but for hardware performance, not an algorithm's diagnostic output. The "standalone" performance described is the ability of the Zmachine Synergy's hardware components to accurately acquire and record various physiological signals, as compared to predicate devices or known inputs, without human interpretation of derived diagnostic information. The device is an "EEG and respiratory signal recorder" intended to "aid in the diagnosis of sleep disorders," implying subsequent human interpretation of the recorded signals. The described tests confirm the accuracy of the recording capabilities, which is a form of standalone performance for the signal acquisition hardware. Specific algorithm performance for detecting sleep disorders based on these signals is not detailed.

7. The Type of Ground Truth Used

The ground truth used was synthetic signals from laboratory equipment and design specifications/known outputs.

For EEG: Broad spectrum shaped white noise and zero-level output signal.
For Respiratory Airflow: Stepped variable air pressure signal.
For Respiratory Effort: Controlled belt stretching and relaxing against a linear scale.
For Pulse Oximetry: Specified calibrator output levels from a patient simulator.
For Body Position: An angular reference the device was rotated against.

8. The Sample Size for the Training Set

Not applicable. This document describes a pre-market notification for a medical device (Zmachine Synergy), focusing on demonstrating substantial equivalence through technical bench testing of hardware components. It does not involve a training set for an AI or machine learning algorithm.

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

Not applicable. As there is no training set mentioned or implied for an AI/ML algorithm within this document, the method of establishing its ground truth is irrelevant here.

Summary

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December 19, 2017

Consolidated Research of Richmond, Inc. Richard Kaplan, PhD President 26250 Euclid Avenue. Suite 709 Cleveland, Ohio 44132

Re: K172986

Trade/Device Name: Zmachine Synergy Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLV, OMC, MNR Dated: October 25, 2017 Received: October 26, 2017

Dear Dr. Kaplan:

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-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.

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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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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) K172986

Device Name Zmachine Synergy

Indications for Use (Describe)

Type of Use ( Select one or both, as applicable )
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Exportation Use (Per 21 CFR 201.66, Outer Package)
On-Site Compounding (Per 21 CFR 201.66)

|X | Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Zmachine® Synergy 510(k) Notification Consolidated Research of Richmond, Inc.

Date Prepared	December 14, 2017
510(k) Owner	Consolidated Research of Richmond, Inc.
ContactPerson	Richard F. Kaplan, Ph.D., PresidentPhone: (216) 289-2331 Extension 1001E-mail: kaplan@generalsleep.com
Address	26250 Euclid Avenue, Suite 709Euclid, Ohio 44132Phone: (216) 289-2331Fax: (216) 393-0079
Trade Name	Zmachine® Synergy
CommonName	Sleep monitoring system
ClassificationName	Electroencephalograph
ProductCodes	OLV, OMC, and MNR
Indicationsfor Use	The Zmachine Synergy is an EEG and respiratory signal recorder. Thedevice is intended for use by adult patients in the home or clinicalenvironment, under the direction of a qualified healthcare practitioner, to aidin the diagnosis of sleep disorders.
PredicateDevices	Zmachine DT-100 (K101830) – primaryApneaLink Air (K143272)

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Device Description

A healthcare provider will supply a Zmachine Synergy device to a patient. Prior to going to bed, the patient is instructed to clean each mastoid and the back of their neck with a supplied alcohol swab. After allowing a few seconds for the alcohol to dry, the patient then applies the supplied peel-and-stick, disposable, EEG sensor pads onto each mastoid (recording electrodes) and one onto the back of the neck (ground). The EEG cable, with three individual lead wires, is snapped onto the conductive studs of the three EEG sensor pads and the free end of the EEG cable is inserted into the corresponding socket of the Zmachine Synergy device. Respiratory effort is sensed using a thoracic belt which serves double duty in also holding the device onto the patient. The patient is instructed to click the belt onto each of the Zmachine Synergy device, position the device just under the armpits, adjust the tension for a snug but comfortable fit, and snap the belt cables onto the conductive studs of the belt. Respiratory nasal airflow is sensed using a nasal cannula. The patient is instructed to place the cannula in their nostrils, drape over their ears, remove slack with the slider, and screw the free end of the cannula onto the luer fitting of the Zmachine Synergy device. Blood oxygen saturation and pulse are sensed using a finger probe pulse oximeter. The patient is instructed to insert a finger from either hand into finger probe and clip the oximeter module to the effort belt. Body position is sensed by an accelerometer located within the body of the Zmachine Synergy device and no additional patient instructions are requires for this signal. The patient presses the center button of the Zmachine Synergy for approximately one second to start the test before going to sleep, and holding for approximately three seconds to end the test in the morning. LED indicators are used to indicate the status of all sensors.

Data from the overnight recording is streamed to a non-removable microSD memory card located inside the Zmachine Synergy device. When patient returns the Zmachine Synergy device to the healthcare provider, the healthcare provider can access the recorded data by connecting the Zmachine Synergy device to their PC using a supplied USB cable is also used to re-charge the Zmachine Synergy device when connected to a USB wall charger or PC. A fully charged Zmachine Synergy device can be used for approximately 30 hours of recording and can finish re-charging within approximately five hours.

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Technology Overview

Electroencephalograph (EEG)

Both the Zmachine Synergy and Zmachine DT-100 use the same EEG hardware (both technology and design) to acquire a single EEG channel.

Respiratory nasal airflow

Both the Zmachine Synergy and ApneaLink Air use the same pressure transducer to acquire the respiratory nasal airflow signals.

Blood oxygen saturation and pulse

Both the Zmachine Synergy and ApneaLink Air use the same pulse oximeter module to acquire the blood oxygen saturation and pulse signals. However, the Zmachine Synergy and ApneaLink Air operate the module using slightly different data output modes.

Respiratory effort

Both the Zmachine Synergy and ApneaLink Air use a thoracic effort belt to sense chest expansion and contraction during inhalation and exhalation (i.e. respiratory effort). However, the Zmachine Synergy records changes in belt stretch using respiratory inductance plethysmography (RIP), whereas the ApneaLink Air measures changes in belt stretch using an in-line air cell and pressure transducer.

Body position

Both the Zmachine Synergy and ApneaLink Air use solid-state accelerometers to acquire the body position signal.

Substantial Equivalence

The table, starting on the next page, summarizes the technological characteristics of the Zmachine Synergy in comparison to the predicate devices.

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	Zmachine Synergy(New Device)	Zmachine DT-100(Primary Predicate)	ApneaLink Air(Predicate)
Manufacturer	Consolidated Research of Richmond, Inc.	Consolidated Research of Richmond, Inc.	ResMed Germany Inc.
510(k) number	K172986	K101830	K143272
Classification regulation	21 CFR 868.2375	21 CFR 882.1400	21 CFR 868.2375
Product code	MNR	OLV and OMC	MNR
Indications for use	The Zmachine Synergy is an EEGand respiratory signal recorder. Thedevice is intended for use by adultpatients in the home or clinicalenvironment, under the direction of aqualified healthcare practitioner, toaid in the diagnosis of sleepdisorders.	The CRI Zmachine is a single-channel, EEG acquisition andanalysis system, designed for use inthe home or clinical environments.This device is intended to be used byqualified healthcare practitioners tomonitor the wake and sleep states ofadult patients and as an adjunct totheir diagnosis of sleep disorders.	The ApneaLink™ Air device isindicated for use by Health CareProfessionals (HCP), where it mayaid in the diagnosis of sleepdisordered breathing for adultpatients. ApneaLink Air records thefollowing data: patient respiratorynasal airflow, snoring, blood oxygensaturation, pulse, respiratory effortand body position during sleep. Thedevice uses these recordings toproduce a report for the HCP thatmay aid in the diagnosis of sleepdisordered breathing or for furtherclinical investigation. The device isintended for home and hospital useunder the direction of a HCP.
Intendedenvironment(s)	Home or clinical environment	Home or clinical environment	Home or hospital environment
Patient population	Adults	Adults	Adults
Acquired Channels	AirflowPulse OximeterRespiratory EffortBody PositionEEG	n/an/an/an/aEEG	AirflowPulse OximeterRespiratory EffortBody Positionn/a
	Zmachine Synergy(New Device)	Zmachine DT-100(Primary Predicate)	ApneaLink Air(Predicate)
Sensor technology	Airflow: Honeywell solid statepressure transducer (±6 mbar range)Pulse Oximetry: Nonin XPOD LPmoduleRespiratory Effort: Thoracic effortbelt based on respiratory inductanceplethysmography (RIP)Body position: Solid stateaccelerometerZmachine DT-100 EEG technology	n/a	Airflow: Honeywell solid statepressure transducer (±6 mbar range)Pulse Oximetry: Nonin XPOD LPmoduleRespiratory Effort: Thoracic effortbelt based on pneumaticsBody position: Solid stateaccelerometern/a
Display type	LED indicators. A full-color LEDindicator is located beside eachconnector (airflow, effort, oximeter,and EEG) to indicate correct orincorrect hookup/operation. Anotherfull-color LED is located under themain power button to indicate systemstatus.	Zmachine DT-100 EEG technologyLCD display. A full color, 320x240pixel, LCD display with an LEDbacklight is used to present allsystem information.	LED indicators. 3 LED indicatorsare located beside each connector(airflow, effort and oximeter) toindicate correct or incorrect function.Another LED is used to indicate the"test complete" status based onrecording time.
Power source	Internally powered using li-ionrechargeable battery	Internally powered using li-ionrechargeable battery	Internally powered using 2xLR03(AAA) primary or rechargeable
Internal memory / datastorage	Fixed microSD card	Removable microSD card	Fixed microSD card
Communicationinterface	USB	USB card reader	USB
Access to recorded data	Recorded data is stored in the device.When the device is connected to PCvia USB cable the device providesaccess to its internal memory.	Recorded data is stored in the device.The microSD card is removed andconnected to PC via USB card readerto access internal memory.	Recorded data is stored in the device.When the device is connected to PCvia USB cable the device providesaccess to its internal memory.
Recorded data format	Each channel of recorded data isstored in an individual file of theGSC2 data format.	Each channel of recorded data isstored in an individual file of thebinary data format.	All channels of recorded data arestored in EDF+ data format.
	Zmachine Synergy(New Device)	Zmachine DT-100(Primary Predicate)	ApneaLink Air(Predicate)
Device dimensionsLxWxH (mm)	120 x 61 x 24	116 x 68 x 21	61 x 102 x 31

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The table above shows that there are no significant differences between Zmachine devices that adversely affect product safety and effectiveness.

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Testing Summary

Design and verification activities have been performed on the Zmachine Synergy as a result of the risk analysis and product requirements. External tests have been completed for electrical safety (IEC 60601-1:2012), EMC (IEC 60601-1-2:2007), and mechanical and environmental requirements (IEC 60601-1-11:2010). In addition, side-by-side bench comparison testing, summarized in the table below, was performed in which a Zmachine Synergy was compared against a Zmachine DT-100 (K10183) and an ApneaLink Air (K143272).

Test	Test Method Summary	Results
EEG	EEG is sensed by the Zmachine Synergy and the Zmachine DT-100 using the identical EEG amplifier and analog-to-digital conversion hardware. As such, the acquired signals from both systems are expected to be substantially equivalent.	The acquired data from each system was analyzed in order to determine the EEG amplifier gain, highpass filter cutoff frequency, lowpass filter cutoff frequency, DC offset, and noise floor levels at various points across the frequency spectrum.
	To test, a multi-channel EEG analog playback system was connected to the EEG input of a Zmachine Synergy and Zmachine DT-100 device. Broad spectrum shaped white noise and a zero-level output signal were generated and acquired by each system.	The EEG amplifier characteristics were found to be in high agreement with both the design limits and each other for all points of comparison. As such, the EEG recording capabilities were found to be substantially equivalent.
RespiratoryAirflow	Respiratory Airflow is sensed by the Zmachine Synergy and the ApneaLink Air using the identical pressure transducer hardware. As such, the acquired signals from both systems are expected to be substantially equivalent.	The acquired data from each system was analyzed in order to compare the Respiratory Airflow readings.
	To test, a variable pressure air pump was connected to the Respiratory Airflow input of a Zmachine Synergy and ApneaLink Air device. A stepped variable air pressure signal was generated, split, and delivered to both systems.	Because the two systems record airflow using different units of measure, Pearson's correlation coefficient was used to compare the recorded signals.The correlation coefficient between the Zmachine Synergy and ApneaLink Air reveals a strong linear relationship in the Respiratory Airflow signal between the two systems. As such, the Respiratory Airflow characteristics were found to be substantially equivalent

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Test	Test Method Summary	Results
RespiratoryEffort	Respiratory Effort is sensed by theZmachine Synergy and the ApneaLinkAir using a thoracic effort belt toqualitatively record chest expansionand contraction during inhalation andexhalation (i.e. respiratory effort). TheZmachine Synergy senses thisexpansion and contraction bymonitoring changes in belt inductance(RIP), whereas the ApneaLink Airmonitors changes in air pressure withinan in-line air cell. Although the twosystems utilize different techniques formeasuring respiratory effort, they areboth responsive to belt expansion andcontraction and are expected to producesubstantially equivalent output.To test, the Zmachine Synergy andApneaLink Air were subjected tosimulated inhalation and exhalation bycontrolled belt stretching and partialrelaxing against a linear scale.	The acquired data from each systemwas analyzed in order to compare theRespiratory Effort readings.Because the two systems record airflowusing different units of measure,Pearson's correlation coefficient wasused to compare the recorded signals.The correlation coefficient between theZmachine Synergy and ApneaLink Airreveals a strong linear relationship inthe Respiratory Effort signal betweenthe two systems. As such, theRespiratory Effort characteristics werefound to be substantially equivalent.
PulseOximetry	Pulse Oximetry is sensed by theZmachine Synergy and the ApneaLinkAir using the identical pulse oximeterhardware and similar data outputmodes. As such, the acquired signalsfrom both systems are expected to besubstantially equivalent.To test, a patient simulator wasconnected in place of the finger probeof a Zmachine Synergy and ApneaLinkAir device, one-at-a-time, under thesame conditions	The acquired data from each systemwas analyzed in order to compare thePulse Oximeter readings.The heart rate and oxygen saturationreadings were found to be in highagreement with the specified calibratoroutput levels and having a low meansquared error when comparing the twosystems together. As such, the PulseOximeter recording capabilities werefound to be substantially equivalent.

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Test	Test Method Summary	Results
BodyPosition	Body Position is sensed by theZmachine Synergy and the ApneaLinkAir using an accelerometer module.Because each system is measuring theangle of the system with regard togravity, and both systems are worn bythe patient in the same configuration,the acquired signals from both systemsare expected to be substantiallyequivalent if it can be demonstrated thatthe Zmachine Synergy reports anglewith regard to gravity appropriatelyagainst an angular reference.	The acquired data from the ZmachineSynergy was analyzed in order tocompare the Body Position angularreadings against the angular reference.The angular readings and angularreference positions were found to be invery high agreement throughout 360degrees of rotation. As such, the BodyPosition recording capabilities werefound to be substantially equivalent.
	To test, the Zmachine Synergy isrotated through 360 degrees against anangular reference.

All tests confirmed that the Zmachine Synergy device meets the predetermined acceptance criteria for both the external tests and side-by-side comparisons. General Sleep has determined that the Zmachine Synergy is Substantially Equivalent to the predicate devices.

Conclusion

Based on the results of the performance testing for the Zmachine Synergy and the substantial equivalence comparison with the predicate devices, no new concerns about safety and effectiveness were raised. We believe that the presented information is sufficient to determine that the Zmachine Synergy is substantially equivalent to the predicate Zmachine DT-100, K101830, and ApneaLink Air, K143272, devices.

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).