The NEMUS system is intended to monitor, record and display the bioelectric signal produced by the muscles, to stimulate peripheral nerves, and to monitor, record and display the electrical activity produced by nerves to aid the clinician in the diagnosis and prognosis of neuromuscular diseases (EMG). The device may use electrical stimulus or sound stimulus for use in evoked response measurements (EP).

Device Description

There are two configurations of NeMus: NeMus System and NeMus PC Peripheral.

The "Nemus system" is a complete system provided with a cart (expressly designed for this device and equipped with isolation transformer, the base unit support mobile arm, places for computer, keyboard, footswitch, printer, and dedicated keyboard and so on. The complete system provided of all the part ordered by the customer is completely wired, assembled and tested in factory before to ship to the final user. Like the hardware parts, all the needed software is installed and configured in factory.

The "Nemus PC Peripheral" is a base kit (constituted by the NeMus 1 Amplifier the AC/DC adapter, cables and GALILEO NT management software) which, by adding a Personal Computer, becomes a digital electromiograph system. This configuration is developed and verified in order to allow a Distributor or the User to "build" an acquisition/processing EMG signal system by using the NeMus 1 acquisition module, the GALILEO NT/MYTOWIN management software and their own Personal Computer (and peripherals). However the PC must be compliant with EBNeuro specified minimum requirements. Of course the "system builder" must follow all the indications detailed in the related User Manual provided with the system. In this kind of system configuration, the "base kit" provided by EBNeuro is a sort of "peripheral" of a PC system. This configuration allows the Distributor or the User to use its own PC, cart or other "system" arrangement of its choice.

NeMus systems are diagnostic medical systems able to detect the electric signals produced by the peripheral nerve system and by skeletal muscles.

The Nemus system is intended to monitor, record and display the bioelectric signal produced by the muscles, to stimulate peripheral nerves, and to monitor, record and display the electrical activity produced by nerves to aid the clinician in the diagnosis of neuromuscular diseases (EMG). The device may use electrical stimulus or sound stimulus for use in evoked response measurements (EP).

AI/ML Overview

The provided text is a 510(k) summary for the Nemus System and Nemus PC Peripheral, which are electromyographs. This summary primarily focuses on establishing substantial equivalence to predicate devices and describes the device's technical characteristics and intended use.

Crucially, this document does NOT contain information about specific acceptance criteria or a study designed to prove the device meets those criteria, as typically found in clinical validation studies. The information provided is for regulatory clearance based on substantial equivalence to existing devices, not a de novo clinical performance study against pre-defined performance metrics.

Therefore, many of the requested points cannot be answered from the provided text. I will indicate where the information is not available.

Acceptance Criteria and Device Performance (Not applicable directly from the provided text):

The document does not specify quantitative acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy, or specific thresholds for physiological signal capture). Instead, it relies on demonstrating that the device has similar technological characteristics to its predicate devices, implying comparable performance.

The table below summarizes some key performance characteristics from the provided comparison table, but these are typically specifications, not acceptance criteria against which a clinical study would be measured in this context.

Product Characteristic (Performance-Related)	Acceptance Criteria (Not Explicitly Stated as such in the document)	Reported Device Performance (Nemus System)
Acquisition
CMRR (Common Mode Rejection Ratio)	Comparable to predicate (>100 dB for PHASIS, >110 dB for Sinergy LT)	>100 dB
Noise	Comparable to predicate (<0.9 µVrms for PHASIS, <0.7 µVrms for Sinergy LT)	<0.3 µVrms (0.1 - 00 Hz), < 20 nV/Hz^1/2 (10 Hz - 10 kHz )
Input impedance	Comparable to predicate (>100 MOhm for PHASIS, >1000 MOhm for Sinergy LT)	> 1000 MOhm / 8 pF
A/D conversion	Comparable to predicate (16 bit for both predicates)	24 bit Sigma-Delta
Sampling rate	Comparable to predicate (0.5 µs max for PHASIS, 50 kHz for Sinergy LT)	4.194 MHz
Ohmmeter range	Comparable to predicate (0-100 kOhm for PHASIS, 0-32 kOhm for Sinergy LT)	0-100 kOhm (auto full scale)
Stimulators
Max output (Somatosensory Elec. Stimulator)	Comparable to predicate (100 mA for both predicates)	100 mA
Pulse width (Somatosensory Elec. Stimulator)	Comparable to predicate (0.01-1 ms for PHASIS, 0.05-1 ms for Sinergy LT)	0.05 - 1 ms
Sound pressure (Audio Stimulator)	Comparable to predicate (20-132 dB SPL for PHASIS, 0-122 dB SPL for Sinergy LT)	0-132 dB SPL

1. A table of acceptance criteria and the reported device performance:

As mentioned above, the 510(k) summary does not define specific "acceptance criteria" in the way one might expect for a clinical performance study. Instead, the "performance" is presented as technical specifications and compared to predicate devices for the purpose of demonstrating substantial equivalence. The table above provides the most relevant performance characteristics available.

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

Not Applicable. The provided document is a 510(k) summary for regulatory clearance based on substantial equivalence. It does not describe a clinical performance study with a test set of patient data. The "testing" involved appears to be related to engineering specifications and safety standards (e.g., IEC 60601-1).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not Applicable. No ground truth establishment is described, as there is no mention of a clinical test set or human interpretation being evaluated.

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

Not Applicable. No adjudication method is described, as there is no mention of a clinical test set or human interpretation being evaluated.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable. This document pre-dates widespread AI integration in medical devices (2008) and does not describe any MRMC studies or AI assistance features. It is purely an electromyograph device.

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

Not Applicable. This device is an electromyograph, which assists clinicians in diagnosis, but it is not an AI algorithm performing diagnostic tasks in a standalone capacity. Its performance is measured by its ability to accurately acquire and display bioelectric signals.

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

Not Applicable. No ground truth is described, as the document focuses on the device's technical specifications and substantial equivalence, not a clinical validation study against a pre-defined diagnostic gold standard.

8. The sample size for the training set:

Not Applicable. There is no mention of a training set, as the device is not based on machine learning or AI that would require such data.

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

Not Applicable. No training set is mentioned in the document.

Summary

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K073 4/5

MAY 2 3 2008

510(k) Summary

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(a).

807.92(a)(1)

Submitter Information

Allison Scott Official Correspondent The Anson Group 11460 N. Meridian St. Suite 150 Carmel, IN 46032

Phone: (317) 569-9500 x 106 Facsimile: (317) 569-9520

Contact Person: Allison Scott

Date: December 3, 2007

807.92(a)(2)

Trade Names:	Nemus System
	Nemus PC Peripheral

Common Name: Electromyograph

Classification Name(s): Electromyograph

IKN Classification Number:

807.92(a)(3)

Predicate Device(s)

Esaote Biomedica	PHASIS	K922488
Oxford Instruments PLC	Sinergy LT	K981405

Additional Substantial Equivalence Information is provided in the following Substantial Equivalence Comparison Table.

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807.92 (a)(4)

Device Description

There are two configurations of NeMus: NeMus System and NeMus PC Peripheral.

NeMus systems are diagnostic medical systems able to detect the electric signals produced by the peripheral nerve system and by skeletal muscles.

807.92(a)(5)

Intended Use(s)

NEMUS systems are diagnostic medical systems able to detect the electric signals produced by the peripheral nerve system and by skeletal muscles.

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Technological Characteristics Substantial Equivalence Comparison Table

ProductCharacteristic	Nemus System(submission device)	PHASIS(predicate device)	Sinergy LT
Regulatory
Manufacturer	EBNeuro S.p.A.	Esaote Biomedica	Oxford Instrumentsplc
510(k) number	Not assigned	K922488	K981405
Device class	Class II	Class II	Class II
Product code	IKN	IKN	GMF
Device type	Electromyograph	Electromyograph	Stimulator, Electrical,Evoked response
Regulation Number	890.1375	890.1375	882.1870
ProductCharacteristic	Nemus System(submission device)	PHASIS(predicate device)	Sinergy LT
Labeling
Intended use	The NEMUS system isintended to monitor,record and display thebioelectric signalproduced by the muscles,to stimulate peripheralnerves, and to monitor,record and display theelectrical activityproduced by nerves to aidthe clinician in thediagnosis and prognosis ofneuromuscular diseases(EMG). The device mayuse electrical stimulus orsound stimulus for use inevoked responsemeasurements (EP).	The PHASISelectomyograph isintended for medicalpurposes, such as tomonitor and display thebioelectric signalsproduced by muscles, tostimulate peripheralnerves, and to monitor anddisplay the electricalactivity produced bynerves for the diagnosisand prognosis ofneuromuscular disease	2 channelelectromyograph whichprovides facilities forEMG and EvokedPotentials testing for arange of clinicalapplication.Synergy LT is designedto enable reliablerecording display anddocumentation ofelectrophysiologicalinformation from thehuman nervous andmuscular system in aclinical environment.
Warnings	Items related to off-label use.	Items related to off-label use.	Items related to off-label use.
Contraindication	Items related to designand indicated uselimitations, such as notfor use in the presenceof flammableanesthetics or inconjunction withdefibrillationequipment.	Items related to designand indicated uselimitations, such as notfor use in the presenceof flammableanesthetics	Items related todesign and indicateduse limitations, suchas not for use in thepresence offlammableanesthetics.
Target population	Pediatric through adult	Pediatric through adult	Pediatric throughadult
Environment of use	Hospitals, institutions,or other testenvironments.	Hospitals, institutions,or other testenvironments	Hospitals,institutions, or othertest environments
Prescription status	Available only on theorder of a physician.	Available only on theorder of a physician.	Available only on theorder of a physician.
User Service	No user service allowed	No user service allowed	No user service allowed
ProductCharacteristic	Nemus System(submission device)	PHASIS(predicate device)	Sinergy LT
Design - General
General systemapproach	Computer basedequipment with dedicatedhardwareperipherals/components	Computer basedequipment with dedicatedhardwareperipherals/components	Computer basedequipment withdedicated hardwareperipherals/components
User input device	Microsoft Windowsmouse/keyboard drivengraphic interface.Dedicated externalkeyboard (optional)	ASCII keyboard withapplication specificfunction key.Re-definable "soft" keyswith on-screen indication	Microsoft Windowsmouse/keyboard drivengraphic interface.
User output device	Digital color displayCommercial printers	Digital color displayCommercial printers	Digital color displayCommercial printers
Patient inputs	2 channels preamplifiers,isolated	2-4 channelspreamplifiers, isolated	2 channelspreamplifiers, isolated
Signal acquisition	Analog-to-digitalconversion at variablesampling rate	Analog-to-digitalconversion at variablesampling rate	Analog-to-digitalconversion at variablesampling rate
Trigger input(synchronization toexternal events)	YES	YES	YES
Trigger output(synchronization forexternal devices)	YES	YES	YES
Footswitch forhands-freeoperation	YES (optional)	YES	YES
Use of standardsoftware platform(Operating System)	YES - MicrosoftWindows	YES - Motorola Versados	YES - MicrosoftWindows
Customization ofclinical protocols	Via storage / retrieval ofuser-defined settings	Via storage / retrieval ofuser-defined settings	Via storage / retrievalof user-defined settings
Applicationflexibility /expandability	Via software update	Via software update	Via software update
Safety Standards	IEC 60601-1IEC 60601-1-1IEC 60601-2-26	IEC 60601-1	IEC 60601-1
	IEC 60601-2-40IEC 60601-1-2
Patient circuitryisolation	optic	optic	optic
SystemComponents	Nemus 1 Base Unit(Amplifier)Host Computer (PC)Printer (optional)Cart (optional)Dedicated Keyboard(optional)	Headbox (Amplifier)ComputerCartPrinter (optional)	Headbox (Amplifier)Computer (PC)CartPrinter (optional)
Amplifier-Computer interface	LAN Ethernet 100 Mbit	proprietary	proprietary
System PowerSupply	From mains (110-240VAC) trough isolationtransformer	From mains (110-240VAC)	From mains (110-240VAC)
Amplifier PowerSupply	15 VDC from medicalapproved AC/DCconverter	Internal power supply	Internal power supply
Size (H/W/D) mm	Nemus System :1250/750/850 (completesystem, with cart, monitor,arm )	238/457/413	500/209/321( cart : 720/640/780 )
Weight(complete system -kg)	Nemus System : 90(complete system, withcart, monitor, arm)	80 (with cart)	55 (with cart)

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ProductCharacteristic	Nemus System(submission device)	PHASIS(predicate device)	Sinergy LT
Design - Acquisition
Number of channels	2	2/4	2
CMRR	>100 dB	>100 dB	> 110 dB
Noise	<0.3 µVrms (0.1 - 00 Hz)$ < 20 nV/Hz^{\frac{1}{2}} $(10 Hz - 10 kHz )	<0.9 µVrms(0.1 Hz - 10 kHz)	<0.7 µVrms(0.1 Hz-10 kHz)
Input impedance	> 1000 MOhm / 8 pF	> 100 MOhm / 15 pF	> 1000 MOhm / 30 pF
Low pass filter	20 Hz - 16 kHz (15step)	10 Hz - 20 kHz (11step)	50 Hz - 16 kHz (10step)
High pass filter	0.01 - 500 Hz (11 step)	0.01 - 500 Hz (13 step)	DC, 30 – 2000 Hz
Notch filter	50/60 Hz selectable	50/60 Hz selectable	50/60 Hz selectable
A/D conversion	24 bit Sigma-Delta	16 bit	16 bit
Sampling rate	4.194 MHz	0.5 µs max	50 kHz
Analysis time	5 ms - 10 s	1 ms - 20 s	5 ms - 10s
Time base	Single	Single, dual	single
Trigger mode	Free, Auto, Internal,External	Recurrent, manual, self,external	Auto, Internal, External
Signal delay(pre/post)	0-5 div	0-5 div	0-9 div
Ohmmeter	0-100 kOhm (auto fullscale)	0-100 kOhm (auto fullscale)	0 - 32 kOhm
ProductCharacteristic	Nemus System(submission device)	PHASIS(predicate device)	Sinergy LT
Design - Stimulators
Somatosensory(electrical) Stimulator	Type: constant currentN. output : 1Max output : 100 mAPulse width: 0.05 -1msMode: single, train	Type: constantcurrent/voltageN. output : 1Max output:100 mAPulse width: 0.01 - 1 msMode: single, recurrent,paired, trains	Type: constantcurrent/voltageN. output : 1Max output: 100 mAPulse width: 0.05-1 msMode: single, double,train
Audio Stilmulator	Output mode: click,toneSound pressure: 0-132dB SPLPhase: condens., raref.,alternateSignal frequency: 125-8000 HzPlateau time: 1-200 msRise/fall time: 1-100msMask level: -40 - +10dB (relative)Click width: 1-100 μsStimulus presen. Left,right, binauralHeadset: TDH 39	Output mode: click, pip,toneSound pressure: 20-132dB SPLPhase: condens., raref.,alternateSignal frequency: 125-8000 HzPlateau time: 0-200 msRise/fall time: 0-200 msMask level: 0-90 dBClick width: 50-500 μsStimulus presen. Left,right, binauralHeadset: TDH 50P	Output mode: click.pip, toneSound pressure: 0-122dB SPLPhase: condens., raref.,alternateSignal frequency: 125-8000 HzPlateau time: 1-999 msRise/fall time: 1-255 msMask level: -40 - +10dB (relative)Click width: 0.05-1msStimulus presen. Left,right, binauralHeadset: TDH 39
Basic EMG applicationmodules :Free run acquisitionNerve conduction studySelf triggered acquisitionSpontaneous activitySingle fiber EMGMotor Unit Analysis	YESYESYESYESYESYES	YESYESYESYESYESYES	YESYESYESYESYESYES
F wave analysisBasic EP applicationmodulesSomatosensory EPAuditory EP	YESYESYES	YESYESYES	YESYESYES
Visual EP (flash)	NO	YES	YES
Visual EP (pattern)	NO	YES	YES

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,、中

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/9/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 3 2008

Eb Neuro S.p.A % The Anson Group Ms. Allison Scott Official Correspondent 11460 North Meridian Street, Suite 150 Carmel, Indiana 46032

Re: K073415 Trade/Device Name: Nemus System and Nemus PC Peripheral Regulation Number: 21 CFR 890.1375 Regulation Name: Diagnostic Electromyograph Regulatory Class: Class II Product Code: IKN, GWF, GWF, JXE Dated: May 9, 2008 Received: May 12, 2008

Dear Ms. Scott:

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.

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.

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Page 2 - Ms. Allison Scott

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

NeMus system & NeMus PC Peripheral Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

NEMUS systems are diagnostic medical systems able to detect the electric signals produced by the peripheral nerve system and by skeletal muscles.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.P. Oueda for mkm

Division Sign-Of Division of General, Restorative, and Neurological Devices

510(k) Number K073415

Regulation Number and Section

§ 890.1375 Diagnostic electromyograph.

(a)
Identification. A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.(b)
Classification. Class II (performance standards).