The digital systems Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P with Neuron-Spectrum.NET software are intended for use as digital neurophysiological systems intended for recording, processing and display biopotential signals such as Electroencephalography (EEG) and long-latency Evoked Potential (EP). Polysomnography (PSG) derives from Electroencephalography (EEG) by the means of a dedicated software module and dedicated electrodes.

The devices are portable and can register up to 8 (Neuron-Spectrum-1), 16 (Neuron-Spectrum-2), 19 (Neuron-Spectrum-3), 21 (Neuron-Spectrum-4, Neuron-Spectrum-4/P) EEG channels, 1 (Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3 and Neuron-Spectrum-4) or up to 4 polygraphic channels (Neuron-Spectrum-4/P: ECG, EOG), 1 breath channel and 2 direct current channels (Neuron-Spectrum-4/P).

Neuron-Spectrum.NET includes the Evoked potentials averaging function and Quantitative electroencephalography (qEEG) , including specific parameters such as Rhythmicity, FFT power ratio and amplitude metrics.

The devices do not provide alarms, do not provide automated event marking and do not provide to the user any diagnostic conclusion about the patient's condition. They are intended for use in the patient care institutions, diagnostics centers, neurosurgical hospitals experimental laboratories and sleep laboratories.The patient group includes all ages and sexes.

Device Description

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Neurosoft Neuron-Spectrum series of devices (Neuron-Spectrum-1, -2, -3, -4, and -4/P) with Neuron-Spectrum.NET software. The primary purpose of the submission is to demonstrate substantial equivalence to previously cleared predicate devices, rather than to establish new acceptance criteria through a clinical study. Therefore, the document does not contain a typical "acceptance criteria" table with specific performance metrics (e.g., sensitivity, specificity, AUC) and reported device performance against those criteria as would be expected for an AI/ML device seeking de novo authorization or a PMA.

Instead, the submission focuses on comparing the technological characteristics of the subject device to predicate devices to argue for substantial equivalence. The "acceptance criteria" can be inferred to be that the device performs functionally and safely at least as well as the predicate devices, as demonstrated through technical comparisons and compliance with relevant safety and performance standards.

Here's an attempt to structure the information based on the provided text, acknowledging the limitations due to the nature of a 510(k) submission primarily focused on substantial equivalence:

Inferred Acceptance Criteria and Device Performance (Based on Substantial Equivalence to Predicate Devices)

Criterion Category	Inferred Acceptance Criterion (based on predicate)	Device Performance (as stated or implied)
Safety	Compliance with medical device safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26, IEC 60601-1-1, IEC 62304).	The device is in compliance with IEC 60601-1:1988+A1:1991+A2:1995, IEC 60601-1-1:2000, IEC 60601-2-26:2002, IEC 60601-1-2:2007, IEC 60601-1-6-2006 (for subject device), and related predicate standards. "The Neuron-Spectrum-1,2,3,4, 4/P with Neuron-Spectrum.NET is in compliance with both the standards IEC 60601-1-2 and IEC 60601-1 and is safe as the predicate device."
Effectiveness/ Functionality	Performance of core functions for acquiring, processing, and displaying biopotential signals (EEG, EP, PSG) comparable to predicate devices.	The device records, processes, and displays biopotential signals like EEG, EP, and PSG. The document provides detailed comparisons of hardware attributes (number of channels, sampling rate, filters, noise, input impedance, signal types recorded) and software functions (EEG review, archiving, quantitative EEG parameters like Rhythmicity, FFT power ratio, amplitude metrics) to predicate devices, asserting that minor differences do not adversely affect safety and effectiveness. "All the necessary performance tests in support of substantial equivalence determination were conducted and documented in section 18 'Performance testing'. The tests demonstrate that the Neuron-Spectrum-1,2,3,4,4/P with Neuron-Spectrum.NET is effective and performs as well as the predicate device."
No Diagnostic Conclusion	The device does not provide automated diagnostic conclusions about the patient's condition.	"The devices do not provide alarms, do not provide automated event marking and do not provide to the user any diagnostic conclusion about the patient's condition." This is explicitly stated for both the subject device and some predicate devices.
Intended Use Environment/User	Intended for use by trained medical staff in patient care institutions, diagnostics centers, neurosurgical hospitals experimental laboratories, and sleep laboratories. Patient group includes all ages and sexes.	Consistent with the intended use of predicate devices, targeting trained medical professionals in similar clinical and research environments for all patient demographics. E.g., for Cervello: "The devices are intended to be used by physicians, technicians and other medical professions that are trained in EEG and/or PSG." And for Persyst 12: "This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information."

Study Details:

The provided document describes a 510(k) premarket notification, which relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical study establishing new performance claims. Therefore, the details requested about sample sizes, ground truth establishment, expert adjudication, and comparative effectiveness studies are not typically found in this type of submission for this class of device.

Here's what can be inferred or stated based on the document's content:

Sample size used for the test set and the data provenance:
- Test Set Description: The document does not describe a clinical test set of patient data used to evaluate the device's performance against specific acceptance criteria. The evaluation is primarily based on technical specification comparisons and compliance with recognized standards (e.g., IEC tests for electrical safety and electromagnetic compatibility).
- Data Provenance: Not applicable as a traditional clinical test set was not used. The "performance data" refers to validation tests on the device itself (hardware and software) and compliance with standards. The document mentions "Validation tests (Section 16.3), the Software Requirements Specifications (Section 16.4)" but these sections are not provided in the extract.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. As no clinical test set with ground truth was described for independent device evaluation (beyond the intrinsic safety and performance of the device's components and software features), no experts were involved in establishing ground truth for such a test. The evaluation is against predicate device specifications and regulatory standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no clinical test set requiring expert adjudication for ground truth was used.
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 study was done. This device is an Electroencephalograph system for recording, processing, and displaying biopotential signals. It "does not provide alarms, do not provide automated event marking and do not provide to the user any diagnostic conclusion about the patient's condition." Therefore, it does not involve AI for interpretation or diagnostic assistance to human readers, and thus such a study would not be relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance study was done. The device's software (Neuron-Spectrum.NET) performs functions such as signal acquisition, review, editing, storing, and analysis (including quantitative EEG parameters like Rhythmicity, FFT power ratio, and amplitude metrics). However, the document explicitly states that the device "does not provide to the user any diagnostic conclusion about the patient's condition." Its functions are presented as tools for trained medical professionals, implying a human-in-the-loop workflow, where the human interprets the displayed signals and analysis. The document does not describe autonomous algorithmic diagnostic output.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for a clinical test set. The "ground truth" for this submission would relate to whether the device's technical specifications and functional performance meet the engineering and safety standards, and are comparable to predicate devices. This involves engineering measurements and comparisons rather than clinical ground truth diagnoses.
The sample size for the training set:
- Not applicable. The document does not describe a machine learning algorithm that underwent a training phase with a specific dataset.
How the ground truth for the training set was established:
- Not applicable, as no training set for a machine learning algorithm is described.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with the profiles overlapping each other. The profiles are connected by a flowing line that forms the shape of a bird. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 19, 2015

Neurosoft Ltd. c/o Enrico Bisson Studio d'Ingegneria Enrico Bisson Via Marzia n. 9 Abano Terme, Padova 35031 Italy

Re: K133995

Trade/Device Name: Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P with Neuron-Spectrum.NET software Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLT, OLV, GWO Dated: May 11, 2015

Received: May 20, 2015

Dear Mr. Bisson:

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

{1}------------------------------------------------

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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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.

Felipe Aquel -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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K133995

Device Name

Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-4 and Neuron-Spectrum-4 and Neuron-Spectrum-4/P digital systems with Neuron-Spectrum.NET

Indications for Use (Describe)

The digital systems Neuron-Spectrum-1, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P with Neuron-Spectrum.NET software are intended for use as digital neurophysiological systems intended for recording, processing and display biopotential signals such as Electroencephalography (EEG) and long-latency Evoked Potential (EP). Polysomnography (PSG) derives from Electroencephy (EEG) by the means of a dedicated software module and dedicated electrodes.

The devices are portable and can register up to 8 (Neuron-Spectrum-1), 16 (Neuron-Spectrum-2), 19 (Neuron-Spectrum-3), 21 (Neuron-Spectrum-4, Neuron-Spectrum-4/P) EEG channels, 1 (Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3 and Neuron-Spectrum-4) or up to 4 polygraphic channels (Neuron-Spectrum-4/P: ECG, EOG),1 breath channel and 2 direct current channels (Neuron-Spectrum-4/P).

Neuron-Spectrum.NET includes the Evoked potentials averaging function and Quantitative electroencephalography (qEEG), including specific parameters such as Rhythmicity, FFT power ratio and amplitude metrics

The devices do not provide alarms, do not provide automated event marking and do not provide to the user any diagnostic conclusion about the patient's condition. They are in the patient care institutions, diagnostics centers, neurosurgical hospitals experimental laboratories. The patient group includes all ages and sexes.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
----------------------------------------------------------------------------------------------	---------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Section 05 510K Summary

APPLICANT

Company Name:	Neurosoft Ltd
Company Address:	5, Voroninstr.153032, IvanovoRussian Federation
Manufacturing Address:	Neurosoft Ltd.5, Voroninstr.153032, IvanovoRussian Federation
Company Phone:	+7 4932 24-04-34
Company Fax:	+7 4932 24-04-35
Contact Person:	Eugene PolezhaevDirector of quality and information technologiesE-mail: polezhaev@neurosoft.ru
Official Contact for Correspondence:	Enrico Bisson (Consultant)Studio di Ingegneria Enrico BissonVia Marzia, 9 - 35031 Abano Terme (PD) - ITALYPhone: +39 049 8630080Fax: +39 049 8630080E-mail: enrico.bisson@isoplan.org
Date Summary Prepared:	June. 11 2015

DEVICE IDENTIFICATION

Generic Device Name:	Bio-Potential Signal Acquisition System
Trade/Proprietary Name:	Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P with Neuron-Spectrum.NETsoftware
Classification Name:	21 CFR 882.1400 ElectroencephalographClass.IIProduct Code: OLT, OLV, GWQ.
Panel:	Neurology

{4}------------------------------------------------

LEGALLY MARKETED DEVICES (PREDICATE DEVICES)

Predicate Devices	510(K) Holder/Applicant	510(k) No.	Reason.
CERVELLO™ BIO-POTENTIALSIGNALACQUISITIONSYSTEM	Blackrock Neuromed, LLC	K122196	Overall functions
Persyst 12 Eeg ReviewAnd AnalysisSoftware	Persyst Development Corp	K132306	Software functions
Alice 5 System	Respironics , INC.	K040595	Polysomnographyfunction
Focus EMG Device	TELEEMG, LLC	K102610	Auditory stimulator
Neurofax m EEG-9100	Nihon Kohden Corporation	K011204	Photic Stimulator

DEVICE DESCRIPTION

{5}------------------------------------------------

The operation of the device in the video EEG monitoring mode is possible for not more than 30 days.

The general properties, when carrying out EEG or EP study using EEG channels:

•8 (Neuron-Spectrum-1), 16 (Neuron-Spectrum-2), 19 (Neuron-Spectrum-3), 21 (Neuron-Spectrum-4, Neuron-Spectrum-4/P) channels EEG/EP recording in any unshielded room;
•up to 2 direct current channels recording (Neuron-Spectrum-4/P);
·photic, auditory stimulation and stimulation carrying out with the use of reversal checkerboard pattern (Neuron-Spectrum-1,Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P);
·synchronous long-term recording of EEG and video from one, two or three video cameras and recording of audio information from one or two microphones performed using Neuron-Spectrum-Video.NET (Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P);
•long-latency EP recording using EEG channels: flash and reversal pattern visual, auditory and cognitive (P300, MMN, CNV) performed using Neuron-Spectrum-LEP.NET software (Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P);
•amplitude, spectral, exam report generation, export and import of files in the standard European data format (EDF) (Neuron-Spectrum-1,Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P);
•review, store and print of the recorded traces, results of their analysis and exam reports (Neuron-Spectrum-1,Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum-4/P);
·respiratory analysis, heart rate analysis, (Neuron-Spectrum-1,Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P);
·snoring analysis, limb movement analysis during sleep (Neuron-Spectrum- 4/P);
•body position analysis (Neuron-Spectrum- 4/P ), eye movement trends (Neuron-Spectrum-1,Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P);
•EMG amplitude trends and CPAP pressure trends (Neuron-Spectrum-1,Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P).

A patient stimulation can be performed with the use of stimulatorsbuilt in the device.

The main condition for using the digital EEG systems is the good professional skills of the medical staff.

Digital EEG system mode of operation is based on the acquisition and input of brain biopotentials and

{6}------------------------------------------------

other physiological signals into PC for the analysis of brain electrical activity taking into account the influence of the other physiological signals.

Digital EEG system operates under control of PC (IBM PC type) with the mouse, keyboard, laser or ink jet printer and installed licensed Windows XP/Vista/7/8 operational system.Signal processing, displaying and presentation in different modes after mathematical analysis, storing of the EEG traces on the hard disc, exam report generation and their printing is done with the use of PC.

The typical schematics of the equipment location when connecting to the desktop PC is given on the Fia. 1

Image /page/6/Figure/3 description: This image shows a diagram of an EEG (electroencephalogram) setup. The diagram includes a computer system unit connected via USB to an EEG electronic unit. Various components are connected to the EEG unit, including EEG electrodes, ear electrodes, an electrode cap, a breath sensor, a ground electrode, a pattern-stimulator, a pattern-stimulator adapter, a photic stimulator, and an auditory stimulator.

Fig.1 Connection scheme.

All the operation of displaying, and reporting the biopotentials and other physiological signals are demanded to the software Neuron-Spectrum.NET that runs in the PC connected to Neuron-Spectrum device.

Exactly the main operations provided by Neuron-Spectrum.NET software are:

EEG Acquisition
EEG Review, Editing, Storing, Exporting. ●
EEG Analysis ●
. Creation of Exam Reports
. Program Setup

There are then additional software packages:

{7}------------------------------------------------

Optional Software
Neuron-Spectrum-PSG	This software allows performing comprehensive polysomnographystudies (manual sleep stage analysis, analysis of sleep-disorderedbreathing) on digital EEG system Neuron-Spectrum-4/P. All the restmodels of Neuron-Spectrum series provide only manual sleep stageanalysis.
Neuron-Spectrum-Video	This software allows performing the long-term synchronous EEG andvideo recording from one or two video cameras controlled from thecomputer and audio information from one or two microphones. Thereare wide possibilities to review, edit and store the recorded data
Neuron-Spectrum-LEP	This software allows recording long-latency auditory, visual (on flashand pattern), somatosensory and cognitive (P300, MMN, CNV) EPusing EEG channels (up to 21 ones) with brain mapping with theuseboth built-in stimulators.

INTENDED USE /INDICATIONS FOR USE

{8}------------------------------------------------

The Neuron-Spectrum devices with Neuron-Spectrum.NET software bring together similar
functions from a previously cleared for market device; namely CERVELLO™ BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM (K122196). Persyst 12 Eeg Review And Analysis Software(K132306), Alice 5 System (K040595) , Focus EMG Device (K102610) and Neurofax m EEG-9100 (K011204)

SUBSTANTIAL EQUIVALENCE

The Neuron-Spectrum devices with Neuron-Spectrum.NET software are of comparable type and are substantially equivalent to the following predicate device:

Predicate Device	510(K) Holder	510(k) No.	Date Cleared
CERVELLO™ BIO-POTENTIAL SIGNALACQUISTION SYSTEM	Blackrock Neuromed,LLC	K122196	05/02/2013
Persyst 12 Eeg Review AndAnalysisSoftware	Persyst DevelopmentCorp	K132306	11/21/2013
Alice 5 System	Respironics , INC.	K040595	03/18/2004
Focus EMG Device	TELEEMG, LLC	K102610	03/04/2011
Neurofax m EEG-9100	Nihon Kohden Corporation	K011204	05/08/2001

The substantial equivalence determination is discussed in Section 12 Substantial Equivalence Discussion.

Predicate devices indications for use

K122196:The Blackrock NeuroMedCervello™ Bio-Potential Signal Acquisition System contains the following configurations:

Ambulatory: Up to 64 channels with one Cervello hardware device (Amplifier) using the Cervello software. The device is intended to acquire and store physiological signals for EEG and to transfer the data to separate polysomnographic analysis software. The devices are intended to be used by physicians, technicians and other medical professions that are trained in EEG and/or PSG. The Cervello Ambulatory System does not make any judgement of normality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.

Basic: Up to 64 channels with one Cervello hardware device (Amplifier) and up to 128 channels by cascading 2 Cervello devices using the Cervello software. The device is intended to acquire and store physiological signals for EEG and/or PSG, and to transfer the data to separate polysomnographic analysis software. The devices are intended to be used by physicians and other medical professions that are trained in EEG and/or PSG. The Cervello Basic System does not make any judgement of normality or abnormality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.

Elite: Up to 128 with one Neuroport Bio-Potential Recording Systems and up to 256 by cascading two Neuroport systems using the Central and/or Cervello software. The system supports recording, processing and display of bio-potential signals from user-supplied elettrodes. Bio-potential signals include: (EEG), Electrocorticography (ECoG). electroencephalography electromyography (EMG). Electrocardiography (ECG), Electroculography (EOG) and Evoked Potential (EP). Intended users include

{9}------------------------------------------------

Physicians, technicians clinicians or other medical professionals that are trained in bio-potential and/or EEG recording. The Cervello Elite System does not make any judgement of normality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.

K132306: The Persyst Development Corp. Persyst 12 Eeg Review And Analysis Software contains the following indication for use:

1-Persyst 12 EEG Review and Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices using scalp electrodes and to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.

2-The Seizure Detection component of Persyst 12 is intended to mark previously acquired sections of adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic seizures, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with a full scalp montage according to the standard 10/20 system.

3-The Spike Detection component of Persyst 12 is intended to mark previously acquired sections of the patient's EEG recordings that may correspond to spikes, in order to assist qualified clinical practitioners in the assessment of EEG traces. The Spike Detection component is intended to be used in patients at least one month old. Persyst 12 Spike Detection performance has not been assessed for intracranial recordings.

4-Persyst 12 includes the calculation and display of a set of quantitative measures intended to monitor and analyze the EEG waveform. These include FFT, Rhythmicity, Peak Envelope, Artifact Intensity, Amplitude, Relative Symmetry and Suppression Ratio. Automatic event marking is not applicable to the quantitative measures. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveforms.

5-The aEEG functionality included in Persyst 12 is intended to monitor the state of the brain. The automated event marking function of Persyst 12 is not applicabletoaEEG.

6- Persyst 12 provides notifications for seizure detection, quantitative EEG and aEEG that can be used when processing a record during acquisition. These include an on screen display and the optional sending of an email message. Delays of up to several minutes can occur between the beginning of a seizure and when the Persyst 12 notifications will be shown to a user. Persyst 12 notifications cannot be used as a substitute for real time monitoring of the underlying EEG by a trained expert.

7-Persyst AR (Artifact Reduction) is intended to reduce EMG, eye movement, and electrode artifacts in a standard 10-20 EEG recording. AR does not remove the entifact signal, and is not effective for other types of artifacts. AR may modify portions of waveforms representing cerebral activity. Waveforms must still be read by a qualified medical practitioner trained in recognizing artifact, and any interpretation or diagnosis must be made with reference to the original waveforms.

8-This device does not provide any diagnostic conclusion about the patient's condition to the user.

K040595 : TheRespironics , INC. Alice 5 Systemcontains the following indication 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 centres or clinics, or other test environments where adults

{10}------------------------------------------------

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 apnoea monitor.

K102610 :TELEEMG, LLC USA FOCUS EMG DEVICE contains the following indication for use:

The Focus is intended for use by a healthcare provider to perform nerve conductions and EMG studies as an aid in the evaluation of patients with diseases of muscle and nerves. The machine can also use electrical stimulus or sound stimulus for evoked potentials (EP) studies.

K011204: Nihon Kohden Corporation Neurofax m EEG-9100 Operator's manual contains the following information:

The EEG-9100A/G/J/K Electroencephalograph is designed for both clinical and research use. This electroencephalograph realizes the conventional EEG's functions in a GUI (graphical user interface) environment. It provides powerful data filing and easy operation. The EEG waveforms and patient information are saved in a large capacity media (hard disk, MO disk or CD-R/CD-RW disk).

{11}------------------------------------------------

12.3Table . Hardware Comparison with the Predicate Device Cervello™ Bio-Potential Signal Acquisition System

{12}------------------------------------------------

ATTRIBUTE /CHARACTERISTICS	NEURON-SPECTRUM-1,2,3,4,4/P	LEGALLY MARKETED PREDICATE DEVICES OFCervello™ Bio-Potential Signal Acquisition System
	NEUROSOFT Ltd(Submitted Product)	Blackrock NeuroMedLLC
'K" numbers	K133995	K122196
Proprietary / Trade Name	Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3,Neuron-Spectrum-4 and Neuron-Spectrum-4/P with Neuron-Spectrum.NET Software	Cervello™Bio-PotentialSignalAcquisitionSystem
CFR Section	882.1400	882.1400
Pro-code	OLT, OLV, GWQ	GWQ, OLV, GWL, GWK
Classification name	Electroencephalograph	Electroencephalograph
Indications For Use	The digital systems Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P withNeuron-Spectrum.NET software are intended for use as digitalneurophysiological systems intended for recording, processing anddisplay biopotential signals such as Electroencephalography (EEG)and long-latency Evoked Potential (EP). Polysomnography (PSG)derives from Electroencephalography (EEG) by the means of adedicated software module and dedicated electrodes. The devices areportable and can register up to 8 (Neuron-Spectrum-1), 16 (Neuron-Spectrum-2), 19 (Neuron-Spectrum-3), 21 (Neuron-Spectrum-4,Neuron-Spectrum-4/P) EEG channels, 1 (Neuron-Spectrum-1,Neuron-Spectrum-2, Neuron-Spectrum-3 and Neuron-Spectrum-4) orup to 4 polygraphic channels (Neuron-Spectrum-4/P: ECG, EOG), 1breath channel and 2 direct current channels (Neuron-Spectrum-4/P).Neuron-Spectrum.NET includes the Evoked potentials averagingfunction and Quantitative electroencephalography (qEEG), includingspecific parameters such as Rhythmicity, FFT power ratio andamplitude metrics.The devices do not provide alarms,do not provide automated eventmarkingand do not provide to the user any diagnostic conclusion aboutthe patient's condition. They are intended for use in the patient careinstitutions, diagnostics centers, neurosurgical hospitalsexperimental laboratories and sleeplaboratories. The patient group includes all ages and sexes.	The Blackrock NeuroMedCervello Rio-Potential Signal AcquisitionProduct Family contains the following configurations.Ambulatory: Up to 64 channels with one Cervello hardware device(Amplifier) using the Cervello software. The device is intended toacquire and store physiological signals for EEG and/or PSG, and totransfer thle data to separate polysomnographic analysis software.The devices are intended to be used by physicians, technicians andother medical professions that are trained in EEG and/or PSG.The Cervello Ambulatory system does not make any judgment ofnormality or abnormality of the displayed signals or the results of ananalysis. In no way are any of the functions represented as being inand of themselves diagnostic.Basic: Up to 64 channels with one Cervello hardware device(Amplifier) and up to 128 channels by cascading 2 Cervello devicesusing the Cervello software. The device is intended to acquire andstore physiological signals for EEG and/or PSG, and to transfer thedata to separate polysomnographic analysis software. The devicesare intended to be used by physicians, technicians and othermedical professions that are trained in EEG and/or PSG. TheCervello Basic system does not make any judgment of normality orabnormality of the displayed signals or the results of an analysis. Inno way are any of the functions represented as being in and ofthemselves diagnostic.
ATTRIBUTE /CHARACTERISTICS	NEURON-SPECTRUM-1,2,3,4,4/PNEUROSOFT Ltd(Submitted Product)	LEGALLY MARKETED PREDICATE DEVICES OFCervello™ Bio-Potential Signal Acquisition SystemBlackrock NeuroMedLLC
		Elite: Up to 128 with one Neuroport Bio-Potential Recording Systems and up to 256 by cascading two Neuroport systems using the Central and/or Cervello software. The system supports recording., processing and display of bio-potential signals from user-supplied electrodes. Bio-potential signals include: Electrocorticography (ECOG), Electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG), electrooculography (EOG) and Evoked Potential (EP). Intended users include Physicians, technicians, clinicians or other medical professionals that are trained in bio-potential and/or EEG recording. The Cervello Elite System does not make judgement of normality or abnormality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.
ATTRIBUTE /CHARACTERISTICS	NEURON-SPECTRUM-1,2,3,4,4/PNEUROSOFT Ltd(Submitted Product)	LEGALLY MARKETED PREDICATE DEVICES OFCervello™ Bio-Potential Signal Acquisition SystemBlackrock NeuroMedLLC
Intended Use	The digital systems Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P withNeuron-Spectrum.NET software are intended for use as digitalneurophysiological systems intended for recording, processing anddisplay biopotential signals such as Electroencephalography (EEG)and long-latency Evoked Potential (EP). Polysomnography (PSG)derives from Electroencephalography (EEG) by the means of adedicated software module and dedicated electrodes. The devices areportable and can register up to 8 (Neuron-Spectrum-1), 16 (Neuron-Spectrum-2), 19 (Neuron-Spectrum-3), 21 (Neuron-Spectrum-4,Neuron-Spectrum-4/P) EEG channels, 1 (Neuron-Spectrum-1,Neuron-Spectrum-2, Neuron-Spectrum-3 and Neuron-Spectrum-4) orup to 4 polygraphic channels (Neuron-Spectrum-4/P: ECG, EOG), 1breath channel and 2 direct current channels (Neuron-Spectrum-4/P).Neuron-Spectrum.NET includes the Evoked potentials averagingfunction and Quantitative electroencephalography (qEEG) , includingspecific parameters such as Rhythmicity, FFT power ratio andamplitude metrics.The devices do not provide alarms, do not provide automated eventmarking and do not provide to the user any diagnostic conclusionabout the patient's condition. They are intended for use in the patientcare institutions, diagnostics centers, neurosurgical hospitalsexperimental laboratories and sleeplaboratoriesThe patient group includes all ages and sexes-	Ambulatory- Acquire, display, store, and archiveelectroencephalographic signals from the brain using a fullmontage array and user-specified electrode locations.Basic- Acquire, display, store, and archiveelectroencephalographic signals from the brain using a fullmontage array and user-specified electrode locations.Elite- Acquire, amplify, record, display, digitize, retrieval, storeand display bio-potential signals
Clinical applications	Bio-potential signal amplification, recording, display, digitization,retrieval.	Bio-potential signal amplification, recording, display,digitization, retrieval.
Intended Users	Physicians and clinicians or other medical professionals that aretrained in bio-potential recording	Physicians, technicians, clinicians or other medicalprofessionals that are trained in bio-potential recording
Intended UseEnvironment	Care institutions, diagnostic centres, neurosurgical hospitalsexperimental laboratories and sleep laboratories of researchinstitutions	Clinics, hospitals, operating rooms, epilepsy evaluation unitenvironments, sleep laboratories
ATTRIBUTE /CHARACTERISTICS	NEURON-SPECTRUM-1,2,3,4,4/PNEUROSOFT Ltd(Submitted Product)	LEGALLY MARKETED PREDICATE DEVICES OFCervello™ Bio-Potential Signal Acquisition SystemBlackrock NeuroMedLLC
Targetpopulation	Adults and newborns	Adults and paediatrics
Use limitations	The device is not a monitoring system and no physiologic alarms are provided. The acquisition and display of biopotential signals is for the interpretation and use of the clinician. The devices do not make any judgment of normality or abnormality of the displayed signals.	The System is not a monitoring system. No physiologic alarms areprovided. The acquisition and display of biopotential signals is for the interpretation and use of the clinician. The devices do not make any judgment of normality or abnormality of the displayed signals.
Bio-PotentialSignals Recorded	Electroencephalography (EEG)Electrocardiography (ECG)Electrooculography (EOG)Evoked potential (EP),Video EEG, PSGRespiration	Electroencephalography (EEG)Electrocorticography (ECOG)Electrocardiography (ECG)Electromyography (EMG)Electrooculography (EOG)Evoked potential (EP)Video EEG,Respiration, Heart rate, SPO2
Number ofSignal RecordingChannels	up to 8 (Neuron-Spectrum-1), 16 (Neuron-Spectrum-2), 19 (Neuron-Spectrum-3), 21 (Neuron-Spectrum-4, Neuron-Spectrum-4/P) EEG channels,1 breath channel (Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum-4/P)2 direct current channels (Neuron-Spectrum-4/P).	Up to 128 with one device and up to 256 by cascading two NeuroPortBiopotential devices
AnalogInputChannels (perunit)	28	16
Sampling rate	100, 200, 500, 1000, 2000, 5000 Hz	256 Hz Up to 30,000 Hz
ATTRIBUTE /CHARACTERISTICS	NEURON-SPECTRUM-1,2,3,4,4/PNEUROSOFT Ltd(Submitted Product)	LEGALLY MARKETED PREDICATE DEVICES OFCervello™ Bio-Potential Signal Acquisition SystemBlackrock NeuroMedLLC
Power source	Supply voltage:• electronic unit: 5V DC• desktop PC-based system: 220/230 V AC (50 Hz)• notebook PC-based system: 220/230 V AC (50 Hz) / int. battery	Five-channel external power supply with sequencing, 120VAC / 60Hz input or 220VAC / 50Hz input
Software	Neuron-Spectrum.NET Software	Cervello™ and Interface to NeuroExplorer, Spike2, MATLAB, C/C++, and other 3rd-party software
Videocamera	available	available
Alarms	No	no
Digital resolution	32/64 bits	16 bits
Input noise EEG (rms value)	Within 0.5-200 Hz not more than 2 µV(not more than 0.3 µV)	< 3 μν
Input impedance EEG	not less than 400 ΜΩ	1000 ΜΩ (amplifier input impedance)
High pass filter	0.05–10 Hz (step 0.01 Hz)	0.3 to 7.5 Hz (amplifier frequency response)
Low pass filter	5-200 Hz (step 0.1 Hz)	Not stated
Connection to patient	By means of EEG, ECG,EOG, PSG electrodes and sensors(respiratory sensors, snoring sensor, body position sensor, cup electrodes)	User supplied electrodes
Acquired and displayed events:
EEG	Yes (Neuron-Spectrum-1,2,3,4,4/P)	Yes
ECG	Yes(Neuron-Spectrum-1,2,3,4,4/P)	Yes
EOG (eye movement)	Yes (Neuron-Spectrum-1,2,3,4,4/P)	Yes
Evoked potential (EP)	Yes (Neuron-Spectrum-1,2,3,4,4/P)	Yes
Body Position	Yes (Neuron-Spectrum-4/P)	Not stated
Chest movements	Yes(Neuron-Spectrum-4/P)	Not stated
CPAP pressure	Yes(Neuron-Spectrum-4/P)	Not stated
Air Flow	Yes (Neuron-Spectrum-1,2,3,4,4/P)	Yes
Nasal Flow Pressure	Yes(Neuron-Spectrum-4/P)	Not stated
ATTRIBUTE /CHARACTERISTICS	NEURON-SPECTRUM-1,2,3,4,4/PNEUROSOFT Ltd(Submitted Product)	LEGALLY MARKETED PREDICATE DEVICES OFCervello™ Bio-Potential Signal Acquisition SystemBlackrock NeuroMedLLC
Abdominalmovements	Yes(Neuron-Spectrum-4/P)	Not stated
Snoring	Yes(Neuron-Spectrum-4/P)	Not stated
Oximeter	No	yes
Safety StandardCompliance	IEC 60601-1:1988+A1:1991+A2:1995IEC 60601-1-1:2000IEC 60601-2-26:2002IEC 60601-1-2:2007IEC 60601-1-6-2006IEC 62304-2006	IEC 60601-1-1998IEC 60601-1-2:2007IEC 60601-2-26: 2002

{13}------------------------------------------------

{14}------------------------------------------------

{15}------------------------------------------------

{16}------------------------------------------------

{17}------------------------------------------------

{18}------------------------------------------------

12.4 Table . Software Comparison with the Predicate Device Persyst 12 EEG Review and Analysis Software

The functions of the Neuron-Spectrum.NET same as the software of the predicate device Persyst12, that use similar software to collect, store and visualize signals. These functions are generic for all two devices.

ATTRIBUTECHARACTERISTICS	/Neuron-Spectrum.NET(Submitted Product)	Software	NEUROSOFT
"K" numbers	K133995	K132306
Proprietary / TradeName	Neuron-Spectrum.NET Software	Persyst 12 EEG Review And Analysis Software
CFR Section	882.1400	882.1400
Pro-code	OLT, OLV, GWQ	OMB, OLT,OMA
Classification name	Automatic Event Detection Software For Full-MontageElectroencephalograph	Automatic Event Detection Software For Full-MontageElectroencephalograph
ATTRIBUTE /CHARACTERISTICS	NEURON-SPECTRUM.NET SOFTWARENEUROSOFT (Submitted Product)	PERSYST 12 EEG REVIEW ANDANALYSIS SOFTWAREPERSYST DEVELOPMENT CORP.	Why the differences do not adverselyaffect the safety and effectiveness
'K" numbers	K133995	K132306
IndicationsFor Use	The digital systems Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum-4/P with Neuron-Spectrum.NET software are intended for use as digital neurophysiological systems intended for recording, processing and display biopotential signals such as Electroencephalography (EEG) and long-latency Evoked Potential (EP). Polysomnography (PSG) derives from Electroencephalography (EEG) by the means of a dedicated software module and dedicated electrodes.The devices are portable and can register up to 8 (Neuron-Spectrum-1), 16 (Neuron-Spectrum-2), 19 (Neuron-Spectrum-3), 21 (Neuron-Spectrum-4, Neuron-Spectrum-4/P) EEG channels, 1 (Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3 and Neuron-Spectrum-4) or up to 4 polygraphic channels (Neuron-Spectrum-4/P: ECG, EOG), 1 breath channel and 2 direct current channels (Neuron-Spectrum-4/P).Neuron-Spectrum.NET includes the Evoked potentials averaging function and Quantitative electroencephalography (qEEG) , including specific parameters such as Rhythmicity, FFT power ratio and amplitude metrics.The devices do not provide alarms, do not provide automated event marking and do not provide to the user any diagnostic conclusion about the patient's condition.They are intended for use in the patient care institutions, diagnostics centers	1- Persyst 12 EEG Review and Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices using scalp electrodes and to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.2- The Seizure Detection component of Persyst 12 is intended to mark previously acquired sections of adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic seizures, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with a full scalp montage according to the standard 10/20 system.3- The Spike Detection component of Persyst 12 is intended to mark previously acquired sections of the patient's EEG recordings that may correspond to spikes, in order to assist qualified clinical practitioners in the assessment of EEG traces. The Spike Detection component is intended to be used in patients at least one month old. Persyst 12 Spike Detection performance has not been assessed for intracranial recordings.4- Persyst 12 includes the calculation and display of a set of quantitative measures intended to monitor and
ATTRIBUTE /CHARACTERISTICS	NEURON-SPECTRUM.NET SOFTWARENEUROSOFT (Submitted Product)	PERSYST 12 EEG REVIEW ANDANALYSIS SOFTWAREPERSYST DEVELOPMENT CORP.	Why the differences do not adverselyaffect the safety and effectiveness
	neurosurgical hospitals experimentallaboratories and sleeplaboratories-The patient group includes allages and sexes-	analyze the EEG waveform. Theseinclude FFT, Rhythmicity, PeakEnvelope, Artifact Intensity, Amplitude,Relative Symmetry andSuppressionRatio.Automatic event marking is notapplicable to the quantitativemeasures. These quantitative EEGmeasures should always be interpretedin conjunction with review of theoriginal EEG waveforms.5- The aEEG functionality included inPersyst 12 is intended to monitor thestate of the brain. The automatedevent marking function of Persyst 12 isnot applicabletoaEEG.6- Persyst 12 provides notifications forseizure detection, quantitative EEGand aEEG that can be used whenprocessing a record during acquisition.These include an on screen displayand the optional sending of an e-mailmessage. Delays of up to severalminutes can occur between thebeginning of a seizure and when thePersyst 12 notifications will be shownto a user. Persyst 12 notificationscannot be used as a substitute for realtime monitoring of the underlying EEGby a trained expert.7- Persyst AR (Artifact Reduction) isintended to reduce EMG, eyemovement, and electrode artifacts in astandard 10-20 EEG recording. ARdoes not remove the entire artifactsignal, and is not effective for othertypes of artifacts.AR may modifyportions of waveforms representingcerebral activity Waveforms must still
ATTRIBUTE /CHARACTERISTICS	NEURON-SPECTRUM.NET SOFTWARENEUROSOFT (Submitted Product)	PERSYST 12 EEG REVIEW ANDANALYSIS SOFTWAREPERSYST DEVELOPMENT CORP.	Why the differences do not adverselyaffect the safety and effectiveness
Functions
1-EEGReview	Image: Waveform	Image: Waveform	Both windows show EEGwaveforms coming from allthe electrodes positionedon a head. The differencebetween the panels is in theorder and the icons thatenable the visualization andanalysis of any singlechannel. In both cases eachderivation can be analyzedin amplitude and frequency.In both cases the montagecan be selected anddifferent filter applied.So there isn't any differencethat adversely affect thesafety and effectiveness
2-EEG &Archiving	YESNeuron-Spectrum-Video.NETprogram adds the possibility ofvideo and audio recordingsynchronously with EEG beingrecorded. After the examperforming, you can edit therecorded video and audio andsave the most interestingfragments in the exam.	YESArchive Video: if this option isselected then accompanyingvideo will be archived with thefragments of marked EEG with theevent text.	Both softwares perform thevideo recording togetherwith the EEG recording. ButNeuron-Spectrum.NETenables also the audiorecording addingfunctionality with respect toPersyst12. The audiorecording system is safebecause the acquisition isperformed with an audio
		be read by a qualified medicalpractitioner trained in recognizingartifact, and any interpretation ordiagnosis must be made with referenceto the original waveforms.8- This device does not provide anydiagnostic conclusion about thepatient's condition to the user.
ATTRIBUTE /CHARACTERISTICS	NEURON-SPECTRUM.NET SOFTWARENEUROSOFT (Submitted Product)	PERSYST 12 EEG REVIEW ANDANALYSIS SOFTWAREPERSYST DEVELOPMENT CORP.	Why the differences do not adverselyaffect the safety and effectiveness
			connected to the instrumentthrough safe and secureconnections.Thus, there isn't anydifference that adverselyaffect the safety andeffectiveness
3- Off-Line SeizureDetection	NO	YES	In Neuron-Spectrum.NETautomatic tool for seizuredetection is not provided.Neuron-Spectrum.NETensures only manualmarking of epileptiformactivity fragments. All thedetected fragments ofepileptiform activity aremarked by the color on thetraces, displayed in"Navigator", "ExamInspector" and epileptiformactivity analysis windows.In Persyst 12 the seizuredetector runs as a part ofPersyst trending. TheSeizure Detection trenduses a line graph to showthe output of the PersystSeizure Detector. Its valueis one when a seizure isdetected and zero when noseizure is detected. Thereare no user-adjustableparameters. During theprocessing of the currentrecord the software willsimultaneously run seizuredetection, spike detection,and trending. If the recordprocessing was already
ATTRIBUTE /CHARACTERISTICS	NEURON-SPECTRUM.NET SOFTWARENEUROSOFT (Submitted Product)	PERSYST 12 EEG REVIEW ANDANALYSIS SOFTWAREPERSYST DEVELOPMENT CORP.	Why the differences do not adverselyaffect the safety and effectiveness
			started, you can continue itfrom the fragment it was leftoff. It will process new dataas it arrives if the record iscurrently being acquired.Events can be reviewed insuccession by using theComment List. In thiswindow, using the buttonSzDetect, you can seePersyst Seizure Detectionevents only.This function is present onlyin Persyst 12 and is notfundamental to perform theanalysis of EEG fordiagnostic purposes. So theabsence of this function inNeuron-Spectrum.NETdoes not affect the safetyand effectiveness.
4- Off-Line SpikeDetection	NO	YESThe Persyst Spike Detector is runautomatically when the EEGrecording is processed. A SpikeDensity trend generates agraphical depiction of informationshown in Spike text commentsthat were generated duringPersyst Spike Detector'salgorithmic analysis of EEGrecording. An output valueconcerning spike detectionfrequency is plotted as a functionof time.Spike detection is performed bythe SpikeDensityV101 CalculationEngine, which can be viewed byselecting	This function presented only inPersyst 12 is not fundamental toperform the analysis of EEG fordiagnostic purposes. So theabsence of this function in Neuron-Spectrum.NET does not affect thesafety and effectiveness.
ATTRIBUTE /CHARACTERISTICS	NEURON-SPECTRUM.NET SOFTWARENEUROSOFT (Submitted Product)	PERSYST 12 EEG REVIEW ANDANALYSIS SOFTWAREPERSYST DEVELOPMENT CORP.	Why the differences do not adverselyaffect the safety and effectiveness
		Preferences TrendPreferences CaIculation Engines.Image: SpikeDensityV1 Engine settings
5- Notifications	NO	YESVisual and email notifications canbe set to identify events ofinterest. A Notification is triggeredwhen a condition trend becomesTrue.Image: C:\ProgramData\Persyst\Trend Settings Version 2.mmx	This function is only in Persyst12, it is not fundamental toperform the analysis of EEG fordiagnostic purposes. So theabsence of this function inNeuron-Spectrum.NET does notaffect the safety andeffectiveness.
6- Trend Type: ArtifactIntensity	No	YESThe Artifact Intensity trend displays color-scaled indicators representing the	This function presented only inPersyst 12 is not fundamental toperform the analysis of EEG forpag. 05-22
	Confidential	Section 5 rev1
ATTRIBUTE /CHARACTERISTICS	NEURON-SPECTRUM.NET SOFTWARENEUROSOFT (Submitted Product)	12 EEGREVIEWPERSYSTANDANALYSIS SOFTWAREPERSYST DEVELOPMENT CORP.	Why the differences do not adverselyaffect the safety and effectiveness
		presence of three physiologicalnon-cerebral signals (muscle, vertical saccadiceye movement/blink, and lateral saccadiceye movement) in the EEG as a function oftime. The values graphed in this trend areoutputs of intermediate steps in theSeizure Detection and Artifact Reductionalgorithm, and are intended to be used inwithoriginalconjunctiontheEEGwaveforms, and with other EEG trends, foranalysis of the EEG.	Sodiagnosticpurposes.theabsence of this function in Neuron-Spectrum.NET does not affect thesafety and effectiveness.
7-Trend Type: ElectrodeSignal Quality	NO	YESThe Electrode Signal Quality trend displayshorizontal bar indicators representing thepresence of possible electrode artifact inthe montage being used for EEG trendmeasures as a function of time. The valuesgraphed in this trend are outputs ofintermediate steps in the Artifact Reductionalgorithm, and are intended to be used inconjunctionwiththeoriginalEEGwaveforms, and with other EEG trends, foranalysis of the EEG	This function presented onlyinPersyst 12 is not fundamental toperform the analysis of EEG fordiagnosticSopurposes.theabsence of this function in Neuron-Spectrum.NET does not affect thesafety and effectiveness.
8- TrendType:Seizuredetection	NO	YESThe Seizure Detection trend usesa line graph to show the output ofthe Persyst Seizure Detector. Itsvalue is one when a seizure isdetected and zero whennoseizure is detected. There are nouser adjustable parameters.	Thisfunctionpresentedonly in Persyst 12 is notfundamental to perform theEEGanalysisoffordiagnostic purposes.
9-TrendType:RhythmicitySpectrogram	YES"Trend" window is intended toThedisplay the different trends of the record.Using the toolbar it is possible to selectthe trend type: the trend of the frequencyspectrum, the trend of standard EEGConfidential	YESThe Rhythmicity Spectrogram trenddisplays a density spectral array offrequency and power characteristicsof the EEG as a function of time.Time is displayed on the x-axis,frequency on the y-axis, and ameasure of EEG power on the z-axisSection 5 rev1	In both softwares there is aspecial trend to representFrequency spectrum, whichcanshowrhythmicityspectrogramduringexamination.Differences in the mappingdo not affect the safety andpag. 05-23
ATTRIBUTE /CHARACTERISTICS	NEURON-SPECTRUM.NET SOFTWARENEUROSOFT (Submitted Product)	PERSYST 12 EEG REVIEW ANDANALYSIS SOFTWAREPERSYST DEVELOPMENT CORP.	Why the differences do not adverselyaffect the safety and effectiveness
	rhythms indices, the trend of theaverage or maximum EEG amplitude,etc.It is also possible to select Frequencyspectrum trend, which displays a densityspectral array of frequency and powercharacteristics of the EEG as a functionof time. Time is displayed on the x-axis,frequency on the y-axis, and a measureof EEG power on the z-axis as a colorscale. User can set any colors.Density spectral array is calculated asfast Fourier transform for each timeblock of data by formula:$X_k = \sum_{n=0}^{N-1} x_n e^{-i2\pi k \frac{n}{N}} \qquad k = 0,..., N - 1.$Image: The frequency spectrum trend.	as a color scale. The RhythmicitySpectrogram provides a graphicaldepiction of the amplitude of primaryrhythmic EEG components present infour frequency bands spanning 1-25Hz. The Rhythmicity function isintended to be used in conjunctionwith the original EEG waveforms,and with other EEG trends, foranalysis of the EEG.	effectiveness.
10- TrendType:FFTSpectrogramwithSquare-Root(SQRT)Scaling, Left and RightHemisphere	NO	YES	This function presentedonly in Persyst 12 is notfundamental to perform theanalysis of EEG fordiagnostic purposes.So the absence of thisfunction inNeuron-Spectrum.NET does notaffect the safety andeffectiveness.
11- TrendType:EEGAsymmetry Index	NO	YES	This function presentedonly in Persyst 12 is notfundamental to perform theanalysis of EEG fordiagnostic purposes.
	Confidential	Section 5 rev1	pag. 05-24
ATTRIBUTE /CHARACTERISTICS	NEURON-SPECTRUM.NET SOFTWARENEUROSOFT (Submitted Product)	PERSYST 12 EEG REVIEW ANDANALYSIS SOFTWAREPERSYST DEVELOPMENT CORP.	Why the differences do not adversely affect the safety and effectiveness
(EASI)			So the absence of this function in Neuron-Spectrum.NET does not affect the safety andeffectiveness.
12- TrendType:RelativeEEGAsymmetry Index(REASI)	NO	YES	This function presented only in Persyst 12 is notfundamental to perform the analysis of EEG fordiagnostic purposes.
13- TrendType:Asymmetry,RelativeSpectrogram(REASISpectrogram)	NO	YES	So the absence of this fucntion in Neuron-Spectrum.NET does not affect the safety andeffectiveness.
14- TrendTypes:FFTPowerRatio	YESThe spectra IEEG analysis performed with the use of the fastFourier transform(FFT) allows to transfer there recorded signal fromthe time scale to the frequency one. The use of the frequencynotation of the signal is the integral part of the modernmathematical EEG analysis	YESThe FFT Power Ratio trend displays a line graph of a ratio ofpower in two user specified frequency bands of the EEG,derived from a fast Fourier transform analysis, as a functionof time. Time is displayed on the x-axis and the power ratio resulton the y-axis.	In Neuron-Spectrum.NET software there is a specialFrequency spectrum trend, which can show rhythmicityspectrogram during examination. Also there is atrend Rhythm indexes ratio, which can show FFT powerratio by rhythms bands,defined by user.Both softwares perform this function.

{19}------------------------------------------------

{20}------------------------------------------------

{21}------------------------------------------------

{22}------------------------------------------------

{23}------------------------------------------------

{24}------------------------------------------------

{25}------------------------------------------------

{26}------------------------------------------------

{27}------------------------------------------------

{28}------------------------------------------------

ATTRIBUTE /CHARACTERISTICS	NEURON-SPECTRUM.NET SOFTWARENEUROSOFT (Submitted Product)	PERSYST 12 EEG REVIEW ANDANALYSIS SOFTWAREPERSYST DEVELOPMENT CORP.	Why the differences do not adverselyaffect the safety and effectiveness
	Image: Spectra graphsCurrent page: duration 12.2sPower 0.8 FP1-A10,1 FP2-A20,6 FPZ-A11,1 F3-A10.5 F4-A20,6 FZ-A20,8 C3-A10,3 C4-A20,6 CZ-A10,3 P3-A10,4 P4-A20,6 PZ-A20,4 01-A10,5 02-A20,6 OZ-A10,8 F7-A10,2 F8-A20,1 T3-A10,2 T4-A20.1 T5-A10,3 T6-A2uV²/Hz Hz
	In "Trend" window there is aRhythm indexes ratio trend, wichdisplays a line graph of a ratio ofpower in several user specifiedfrequency bands of the EEG,derived from a fast Fouriertransform analysis, as a functionof time. Time is displayed on thex-axis and the power ratio resulton the y-axis. User- specifiedfrequency bands are markedbycolor:

{29}------------------------------------------------

ATTRIBUTE /CHARACTERISTICS	NEURON-SPECTRUM.NET SOFTWARENEUROSOFT (Submitted Product)	PERSYST 12 EEG REVIEW ANDANALYSIS SOFTWAREPERSYST DEVELOPMENT CORP.	Why the differences do not adverselyaffect the safety and effectiveness
	Image: Rhythm indexes ratio trend
15- Trend Types: aEEGLeft + Right	NO	YESThe aEEG trend displays the amplitudecharacteristics of a filtered, rectifiedrepresentation of the EEG signal as afunction of time. Time is displayed on the x-axis and the aEEG amplitude is measuredon the y-axis. The aEEG trend provides asimplified depiction of amplitudecharacteristics of the EEG signal, and isintended to be used in conjunction withother EEG trends, and with the originalEEG waveforms, for analysis of the EEG.	This function presented only inPersyst 12 is not fundamental toperform the analysis of EEG fordiagnostic purposes. So the absenceof this function in Neuron-Spectrum.NET does not affect thesafety and effectiveness.
16- Trend Type:Suppression Ratio	NO	YES	This function presentedonly in Persyst 12 is notfundamental to perform theanalysis of EEG fordiagnostic purposes. So theabsence of this function inNeuron-Spectrum.NETdoes not affect the safetyand effectiveness.
17- Trend Type: SpikeDensity	NO	YESA Spike Density trend generates agraphical depiction of informationcontained in Spike text commentsthat were generated duringPersyst Spike Detector's	This function presentedonly in Persyst 12 is notfundamental to perform theanalysis of EEG fordiagnostic purposes. So theabsence of this function in

{30}------------------------------------------------

ATTRIBUTE /CHARACTERISTICS	NEURON-SPECTRUM.NET SOFTWARENEUROSOFT (Submitted Product)	PERSYST 12 EEG REVIEW ANDANALYSIS SOFTWAREPERSYST DEVELOPMENT CORP.	Why the differences do not adverselyaffect the safety and effectiveness
		algorithmic analysis of an EEGrecording. An output valueconcerning spike detectionfrequency is plotted as a functionof time	Neuron-Spectrum.NETdoes not affect the safetyand effectiveness.
18- Spike Detections(count per 5 sec)	NO	YESSpike Detections (count per 5 sec): ASpike Density trend generates agraphical depiction of informationshown in Spike text comments thatwere generated during Persyst SpikeDetector's algorithmic analysis of anEEG recording. An output valueconcerning spike detection frequency isplotted as a function of time.	This function presentedonly in Persyst 12 is notfundamental to perform theanalysis of EEG fordiagnostic purposes. So theabsence in Neuron-Spectrum.NET does notaffect the safety andeffectiveness.
19- Trend Type: PeakEnvelope 2-20 Hz Left+ Right	NO	YESThe Peak Envelope trend displays atime-smoothed representation of aband-pass-filtered EEG's maximalamplitude envelope as a function oftime. Time is displayed on the x-axisand the Peak Envelope amplitude ismeasured on the y-axis.	This function presentedonly in Persyst 12 is notfundamental to perform theanalysis of EEG fordiagnostic purposes. So theabsence of this function inNeuron-Spectrum.NETdoes not affect the safetyand effectiveness.
20- FFT Spectrogram	YESImage: EEG analysis styles window	YESThe FFT Spectrogram trend displays adensity spectral array of the frequencyand power characteristics of the EEG,derived from a fast Fourier transformanalysis, as a function of time. Time isdisplayed on the x-axis, frequency on they-axis, and a measure of EEG power onthe z-axis as a color scale.	Both softwares perform thisfunction, however thevisualization is different.
	The "Spectral analysis" page contains theparameters of the spectral analysis. It is
	Confidential	Section 5 rev1	pag. 05-28

{31}------------------------------------------------

ATTRIBUTE /	NEURON-SPECTRUM.NET SOFTWARE	PERSYST 12 EEG REVIEW	Why the differences do not adversely
CHARACTERISTICS	NEUROSOFT (Submitted Product)	ANALYSIS SOFTWARE	affect the safety and effectiveness
		PERSYST DEVELOPMENT CORP.
	possible to set the window function (to
	the edge effects), analysissmooth
	parameter (the amplitude or the power),

	the scale of the spectrum graphs. Also for
	the spectrum graphs, it is possible to
	indicate the frequency range which is
	visible on them.
	The Spectra graph analysis window allows
	to review FFT spectrogram by EEG
	derivations.



















	"Spectrumgraphs"window
	In "Trend" window there is a Frequency
	spectrum trend, which displays a density

{32}------------------------------------------------

ATTRIBUTE /CHARACTERISTICS	NEURON-SPECTRUM.NET SOFTWARENEUROSOFT (Submitted Product)	PERSYST 12 EEG REVIEW ANDANALYSIS SOFTWAREPERSYST DEVELOPMENT CORP.	Why the differences do not adverselyaffect the safety and effectiveness
	spectral array of the frequency and powercharacteristics of the EEG, derived from afast Fourier transform analysis, as afunction of time. Time is displayed on the x-axis, frequency on the y-axis, and ameasure of EEGpower on the z-axis as acolor scale.Image: Frequency spectrum trend
21- FFT Power	NO	YESThe FFT Power trend displays a linegraph of power in a user-specifiedfrequency band of the EEG, derived froma fast Fourier transform analysis, as afunction of time. Time is displayed on thex-axis and a measure of EEG power onthe y-axis.	In Neuron-Spectrum.NET softwareonly Total power spectrum trend isavailable, which displays a line graphof power in all frequency band of theEEG, derived from a fast Fouriertransform analysis, as a function oftime. Time is displayed on the x-axisand a measure of EEG power on they-axis.So, in Neuron-Spectrum.NETsoftware user can't specify spectrumbands to calculatepower.
22- FFT Power Ratio	YESIn "Trend" window several trends areavailalbe, which can show FFT powerratio: Alpha and delta index ratio, Alphaand theta index ratio, Alpha and betaindex ratio, Alpha+beta to theta+deltaindex ratio. User can define frequencybands for delta, theta, alpha and betarhythms.This trends display a line graph of aratio of power in two user-specified	YESThe FFT Power Ratio trend displays aline graph of a ratio of power in twouser-specified frequency bands of theEEG, derived from a fast Fouriertransform analysis, as a function oftime. Time is displayed on the x-axisand the power ratio result on the y-axis.	The both softwares performthis function, however thevisualization is different.

{33}------------------------------------------------

ATTRIBUTE /CHARACTERISTICS	NEURON-SPECTRUM.NET SOFTWARENEUROSOFT (Submitted Product)	PERSYST 12 EEG REVIEW ANDANALYSIS SOFTWAREPERSYST DEVELOPMENT CORP.	Why the differences do not adverselyaffect the safety and effectiveness
	frequency bands of the EEG, derivedfrom a fast Fourier transform analysis,as a function of time. Time is displayedon the x-axis and the power ratio resulton the y-axis.Image: Graph
	Alpha+beta to theta+delta index ratiotrend
23- FFT Edge	YESImage: SettingsThe "Spectral analysis" page containsthe parameters of the spectral analysis.It is possible to set the window function(to smooth the edge effects), analysisparameter (the amplitude or the	YESThe FFT Spectral Edge trenddisplays a line graph, as afunction of time, of the frequencybelow which a designatedpercentage of a user-specifiedEEG frequency band's total poweris present. Time is displayed onthe x-axis and the spectral edgefrequency (Hz) on the y-axis. Forexample, for the frequency band0-20 Hz and Edge percentagesetting of 95, a resulting SpectralEdge value of 14 Hz means that95% of the EEG's power in the 0-20 Hz range occurs below afrequency of 14 Hz.	In Neuron-Spectrum.NETsoftware a user can setupFrequency spectrum trend toshow FFT edge, using contextmenu of the Trends window. Alsouser can set spectral edgecalculation percent.Both softwares perform thisfunction, even if the visualizationis different.

{34}------------------------------------------------

ATTRIBUTE /CHARACTERISTICS	NEURON-SPECTRUM.NET SOFTWARENEUROSOFT (Submitted Product)	PERSYST 12 EEG REVIEW ANDANALYSIS SOFTWAREPERSYST DEVELOPMENT CORP.	Why the differences do not adverselyaffect the safety and effectiveness
	power), the scale of the spectrumgraphs. Also for the spectrum graphs, itis possible to indicate the frequencyrange which is visible on them. In"Trend" window on "Density SpectralArray" trend it is possible to show FFTEdge, which displays percentage of auser-specified EEG frequency band'stotal power.Image: Frequency spectrum trend with FFT Edge
24- Trend Type:Amplitude Trend	YESThe "Trend" window is intended todisplay the different trends of therecord. At the calculation of EEGamplitude trends, the current EEGamplitude is represented in the toppart of the current position bar.The boundary values for the trendare given in the right part of thewindow. The boundary values arecalculated automatically but youcan change them. In the top partof the window (on the toolbar) themaximum amplitude, the length ofthe analysis epoch at the trend	YESThe Amplitude trend displaysamplitude, signal slope, zero-crossingfrequency, or statistical informationconcerning amplitude, of the EEGsignal as a function of time. Time isdisplayed on the x-axis and theamplitude is shown on the y-axis. TheAmplitude trend is intended to be usedin conjunction with other EEG trends,and with the original EEG waveforms,for analysis of the EEG.	Neuron-Spectrum.NET softwarecontains EEG average amplitudeand EEG maximum amplitudetrend, which can show EEGamplitudes during examinationby EEG derivations.Both softwares perform thisfunction, even if the visualizationis different.

{35}------------------------------------------------

ATTRIBUTE /CHARACTERISTICS	NEURON-SPECTRUM.NET SOFTWARENEUROSOFT (Submitted Product)	PERSYST 12 EEG REVIEW ANDANALYSIS SOFTWAREPERSYST DEVELOPMENT CORP.	Why the differences do not adverselyaffect the safety and effectiveness
	calculation and the epochsnumber are displayed.Image: EEG graphThe trend of average EEGamplitude
25- Trend Type: ArtifactIntensity	No	YESThe Artifact Intensity trend displayscolor-scaled indicators showing thepresence of three physiological non-cerebral signals (muscle, verticalsaccadic eye movement/blink, andlateral saccadic eye movement) in theEEG as a function of time. The valuesgraphed in this trend are outputs ofintermediate steps in the SeizureDetection and Artifact Reductionalgorithm, and are intended to be usedin conjunction with the original EEGwaveforms, and with other EEG trends,for analysis of the EEG.	This function presented only inPersyst 12 is not fundamental toperform the analysis of EEG fordiagnostic purposes. So theabsence of this function inNeuron-Spectrum.NET does notaffect the safety andeffectiveness.
26- Trend Type:Operation	NO	YES	This function presented only inPersyst 12 is not fundamental toperform the analysis of EEG fordiagnostic purposes. So theabsence of this function in Neuron-Spectrum.NET does not affect thesafety and effectiveness.
27- Trend Type:Combination	NO	YES	This function presented only inPersyst 12 is not fundamental toperform the analysis of EEG fordiagnostic purposes. So theabsence of this function in Neuron-Spectrum.NET does not affect thesafety and effectiveness.
28- Trend Type: Multi-Epoch	NO	YES	This function presented only inPersyst 12 is not fundamental toperform the analysis of EEG for

{36}------------------------------------------------

ATTRIBUTE /CHARACTERISTICS	NEURON-SPECTRUM.NET SOFTWARENEUROSOFT (Submitted Product)	PERSYST 12 EEG REVIEW ANDANALYSIS SOFTWAREPERSYST DEVELOPMENT CORP.	Why the differences do not adverselyaffect the safety and effectiveness
29- Trend Type:VsBkgnd	NO	YES	This function presented only inPersyst 12 is not fundamental toperform the analysis of EEG fordiagnostic purposes. So theabsence of this function in Neuron-Spectrum.NET does not affect thesafety and effectiveness.
30- Trend Type:VsControl	NO	YES	This function presented only inPersyst 12 is not fundamental toperform the analysis of EEG fordiagnostic purposes. So theabsence of this function in Neuron-Spectrum.NET does not affect thesafety and effectiveness.
31- Trend Type:Weighted Sum	NO	YES	This function presented only inPersyst 12 is not fundamental toperform the analysis of EEG fordiagnostic purposes. So theabsence of this function in Neuron-Spectrum.NET does not affect thesafety and effectiveness.
32- Trend Types:Condition Threshold	NO	YES	This function presented only inPersyst 12 is not fundamental toperform the analysis of EEG fordiagnostic purposes. So theabsence of this function in Neuron-Spectrum.NET does not affect thesafety and effectiveness.
33- Trend Types:Condition Boolean	NO	YES	This function presented only inPersyst 12 is not fundamental toperform the analysis of EEG fordiagnostic purposes. So theabsence of this function in Neuron-Spectrum.NET does not affect thesafety and effectiveness.

{37}------------------------------------------------

ATTRIBUTE /CHARACTERISTICS	NEURON-SPECTRUM.NET SOFTWARENEUROSOFT (Submitted Product)	PERSYST 12 EEG REVIEW ANDANALYSIS SOFTWAREPERSYST DEVELOPMENT CORP.	Why the differences do not adverselyaffect the safety and effectiveness
34- Trend Types:Functional Algebra	NO	YES	This function presented only inPersyst 12 is not fundamental toperform the analysis of EEG fordiagnostic purposes. So theabsence of this function in Neuron-Spectrum.NET does not affect thesafety and effectiveness.
35- Trend Types:Functional Constant	NO	YES	This function presented only inPersyst 12 is not fundamental toperform the analysis of EEG fordiagnostic purposes. So theabsence of this function in Neuron-Spectrum.NET does not affect thesafety and effectiveness.
36- Trend Type: EventDensity	YESDuring EEG recording, a lot of events isrecorded. To display these events andnavigate over them, the "Event list" canbe used. The events are divided intoseveral groups:• Service events - the events connectedwith the change of acquisitionparameters (change of sweep speed,scale, montage, filters, etc.). Theservice events, as a rule, are not ofinterest to a user and are hidden bydefault.• User events - the event markersspecified by a user.• Functional tests - the events of thebeginning of the functional testsrecording.• Stimulation events - the eventsconnected with the stimulation during	YESAn Event Density trend generates agraphical depiction of information shownin user-designated comments from thecomments or comment file thataccompanies an EEG recording. Eitherthe presence or presence and duration ofa user-specified comment can begraphed against time, or the presence ofa specified comment and numeric dataassociated with that comment can begraphed against time.	Event list window inNeuron-Spectrum.NETallows to review all eventsmarked during examinationor filtered list of events.Both softwares perform thisfunction, even if thevisualization is different.

{38}------------------------------------------------

ATTRIBUTE /CHARACTERISTICS	NEURON-SPECTRUM.NET SOFTWARENEUROSOFT (Submitted Product)	PERSYST 12 EEG REVIEW ANDANALYSIS SOFTWAREPERSYST DEVELOPMENT CORP.	Why the differences do not adverselyaffect the safety and effectiveness
	an exam (the beginning of thestimulation, the end of the stimulation,the change of stimulation frequency,etc.).To filter the list of events in thewindow, it is possible to use"Show events" menu command.Image: Event ListThe events list.The events list displays the event nameand the time of its beginning. As for theastronomical time. To navigate to anywith the left mouse button
37- Trend Types: EEGrhythms indexes	In "Trend” window it is possible to showtrends for each EEG rhythm index:delta, theta, alpha and beta	NO	These trends only duplicateinformation, which can be shownon "Density Spectral Array" trend,but in another way

{39}------------------------------------------------

ATTRIBUTE /CHARACTERISTICS	NEURON-SPECTRUM.NET SOFTWARENEUROSOFT (Submitted Product)	PERSYST 12 EEG REVIEW ANDANALYSIS SOFTWAREPERSYST DEVELOPMENT CORP.	Why the differences do not adverselyaffect the safety and effectiveness
38- Trend Types: EEGrhythm indexesaspect ratio	Image: EEG trend 15%	NO	These trends only duplicateinformation, which can beshown on "Density SpectralArray" trend, but in anotherway to view rhythms aspectratio.
	Image: EEG trend 52%
	Image: EEG trend 20%
	Image: EEG trend 11%This trends can help to understandfrequency bands, which dominate inexamination.Rhythm indexes are calculated by thisformula:$\frac{\sum_{f=RhythmFreqMin}^{RhythmFreqMax} FFTPower(f)}{\sum_{f=FreqMin}^{FreqMax} FFTPower(f)} * 100%$whereFreqMin and FreqMax – minimumand maximum frequencies of total EEGfrequency band, RhythmFreqMin andRhythmFreqMax minimum andmaximum frequencies of selectedrhythm band. User can define FreqMin,FreqMax, RhythmFreqMin andRhythmFreqMax.In "Trend" window it is possible to showtrends for EEG rhythm indexes aspectratio: alpha and delta index ratio, alphaand theta index ratio, alpha+beta totheta+delta rhythms index ratio, alphaand beta index ratio, rhythms indexesratio.

{40}------------------------------------------------

ATTRIBUTE /CHARACTERISTICS	NEURON-SPECTRUM.NET SOFTWARENEUROSOFT (Submitted Product)	PERSYST 12 EEG REVIEW ANDANALYSIS SOFTWAREPERSYST DEVELOPMENT CORP.	Why the differences do not adverselyaffect the safety and effectiveness
39- Report generatingsystem bytemplates	Rhythm indexes are calculated by thisformula:$\frac{\sum_{f=RhythmFreqMin}^{RhythmFreqMax} FFTPower(f)}{\sum_{f=FreqMin}^{FreqMax} FFTPower(f)} * 100%$ whereFreqMin and FreqMax – minimumand maximum frequencies of total EEGfrequency band, RhythmFreqMin andRhythmFreqMax minimum and maximumfrequencies of selected rhythm band.User can define FreqMin, FreqMax,RhythmFreqMin and RhythmFreqMax.
	"Neuron-Spectrum.NET" softwarecontains examination reportsystem for automatical reportgeneration by templates. In reporttemplate user can select whatinformant about examinationhe/she wants to include to thereport and report will be generatedautomatically.	NO	This tool allows to createexam report by predefinedtemplates that is very fastfor each examination.
	Image: Report template setup window
	Reports template editor windowThis function allows to createexamination reports quickly andeasy.

{41}------------------------------------------------

12.5Table - Comparison of stimulators for NEURON-SPECTRUM-1,2,3,4,4/P, Focus EMG Device and Neurofax m EEG-9100

Characteristics		Predicate device	Predicate device
	Neuron-Spectrum-1,Neuron-Spectrum-2,Neuron-Spectrum-3,Neuron-Spectrum-4,Neuron-Spectrum-4/P(this submission)	Focus EMG DeviceNeurosoft Ltd.TeleEMG LLC.(K102610)	Nihon KohdenNeurofax m EEG-9100(K011204)
Intended Use	The digital systems Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P with Neuron-Spectrum.NET software are intended for use as digital neurophysiological systems intended for recording, processing and display biopotential signals such as Electroencephalography (EEG) and long-latency Evoked Potential (EP). Polysomnography (PSG) derives from Electroencephalography (EEG) by the means of a dedicated software module and dedicated electrodes.The devices are portable and can register up to 8 (Neuron-Spectrum-1), 16 (Neuron-Spectrum-2), 19 (Neuron-Spectrum-3), 21 (Neuron-Spectrum-4, Neuron-Spectrum-4/P) EEG channels, 1 (Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3 and Neuron-Spectrum-4) or up to 4 polygraphic channels (Neuron-Spectrum-4/P: ECG, EOG), 1 breath channel and 2 direct current channels (Neuron-Spectrum-4/P).Neuron-Spectrum.NET includes the Evoked potentials averaging function and Quantitative electroencephalography (qEEG), including specific parameters such as Rhythmicity FFT power ratio and	The Focus is intended for use by a healthcare provider to perform nerve conductions and EMG studies as an aid in the evaluation of patients with diseases of muscle and nerves. The machine can also use electrical stimulus or sound stimulus for evoked potentials (EP) studies.	Neurofax m EEG-9100is intended for useasElectroencephalograph. This Electroencephalograph realizes the conventional EEG's functions in a GUI (graphical user interface) environment. It is designed for both clinical and research use.

{42}------------------------------------------------

Characteristics	Neuron-Spectrum-1,Neuron-Spectrum-2,Neuron-Spectrum-3,Neuron-Spectrum-4,Neuron-Spectrum-4/P(this submission)	Predicate deviceFocus EMG DeviceNeurosoft Ltd.TeleEMG LLC.(K102610)	Predicate deviceNihon KohdenNeurofax m EEG-9100(K011204)
	amplitude metrics..The devices do not provide alarms, donot provide automated event markingand do not provide to the user anydiagnostic conclusion about thepatient's condition. They are intendedfor use in the patient care institutions,diagnostics centers, neurosurgicalhospitals experimental laboratoriesand sleep laboratories.The patient group includes all ages andsexes.
Safety	IEC 60601-1:1988+A1:1991+A2:1995IEC 60601-1-2:2007IEC 60601-2-26:2002IEC 60601-1-1:2000IEC 60601-1-6-2010IEC 62304-2006	IEC 60601-1-1-2000IEC 60601-1-2-2001IEC 62471-2006	IEC 60601-1 (1988)IEC 60601-1 Amd 1 (1991)IEC 60601-1 Amd 2 (1995)IEC 60601-2-26 (1994)EN 60601-1-1 (1992-06) with AMI (1995-10)IEC 60601-1-2 (1993)
General systemapproach	Computer based equipment withdedicated hardwareperipherals/components	Computer based equipment withdedicated hardwareperipherals/components	notebook PC unit
Userinputdevice	Microsoft Windows mouse/keyboarddriven graphic interface	Microsoft Windows mouse/keyboarddriven graphic interface. Built-inkeyboard	Microsoft Windows mouse
Useroutputdevice	No built-in output devices. Computerdisplay and printer	Digital color display Commercialprinters	Printer
Patient inputs	Up to 8 (Neuron-Spectrum-1), 16(Neuron-Spectrum-2), 19 (Neuron-Spectrum-3), 21 (Neuron-Spectrum-4,Neuron-Spectrum-4/P) EEG channels, 1(Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3 andNeuron-Spectrum-4) or up to 4polygraphic channels (Neuron-Spectrum-4/P: ECG, EOG), 1 breathchannel and 2 direct current channels(Neuron-Spectrum-4/P)	2 channels preamplifiers, isolated	25 EEG, 4 Extra, 3 respiration inputs (flow,chest, abdomen), 6 Bipolar, 4 DC inputs

{43}------------------------------------------------

Characteristics	Neuron-Spectrum-1,Neuron-Spectrum-2,Neuron-Spectrum-3,Neuron-Spectrum-4,Neuron-Spectrum-4/P(this submission)	Predicate deviceFocus EMG DeviceNeurosoft Ltd.TeleEMG LLC.(K102610)	Predicate deviceNihon KohdenNeurofax m EEG-9100(K011204)
Trigger input(synchronizationto externalevents)	Yes	Yes	Yes(1 to 5V)
Trigger output(synchronizationfor externaldevices)	Yes	Yes	Yes(3V or more)
Amplifier-Computerinterface	USB	USB	USB
System PowerSupply	Electronic unit: 5V DC System withPersonal Computer: 100-120/200-240V AC (50-60 Hz)System with Notebook: 100-120/200-240 V AC (50-60 Hz)	Electronic unit: 5V DC System withPersonal Computer: 100-120/200-240 V AC (50-60 Hz)System with Notebook: 100-120/200-240 V AC (50-60 Hz)	Power supply unit:2A/250V (AC 100 to 127 V)(50/60Hz)
Size (H/W/D) mm	ElectronicUnit:140x200x45 mm	ElectronicUnit:90x270x50 mm	ElectronicUnit:33.2x388x251 mm
Weight(completesystem-kg)	Electronic Unit: not more than0.9 kgSystem: not more than 12.5 kg	ElectronicUnit: 0.35System: 3.5	PC unit: 2.33 kgPower supply unit: 3 kgCart: 18.5 kg
		Design - Acquisition
Number of channels	Up to 8 (Neuron-Spectrum-1), 16(Neuron-Spectrum-2), 19 (Neuron-Spectrum-3), 21 (Neuron-Spectrum-4,Neuron-Spectrum-4/P) EEG channels, 1(Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3 andNeuron-Spectrum-4) or up to 4polygraphic channels (Neuron-Spectrum-4/P: ECG, EOG), 1 breathchannel and 2 direct current channels(Neuron-Spectrum-4/P)	2 EMG	25 EEG, 4 Extra, 3 respiration inputs (flow,chest, abdomen), 6 Bipolar, 4 DC inputs
CMRR	Not less than 100 dB	>100 dB	105 dB or greater (at 60 Hz)
Noise	<=1 μVrms	< 0. 6 μVrms.	Less than 1.5 μVp-p(0.53 to 60 Hz)
Inputimpedance	> 100 MΩhm< 25pF	> 100 MΩhm< 25pF	100MΩhm

{44}------------------------------------------------

Characteristics	Neuron-Spectrum-1,Neuron-Spectrum-2,Neuron-Spectrum-3,Neuron-Spectrum-4,Neuron-Spectrum-4/P(this submission)	Predicate deviceFocus EMG DeviceNeurosoft Ltd.TeleEMG LLC.(K102610)	Predicate deviceNihon KohdenNeurofax m EEG-9100(K011204)
Lowpassfilter	(-12dB/octave) 5, 10, 15, 35, 75, 100,150, 200, 250, 500 Hz	(-12dB/octave) 10, 20, 35, 50, 75,100, 150, 200, 300, 500, 1000,2000, 3000, 5000, 10000 Hz	0.08, 0.16, 0.27, 0.53, 1.6, 5.3, 53, 159 Hz(-6dB/oct)
High pass filter	(-6dB/octave) 0.05, 0.5, 0.7, 1.5, 2, 5,10 Hz	(-6dB/octave) 0.05, 0.1, 0.2, 0.3, 0.5,1, 2, 3, 5, 10, 20, 30, 50, 100, 200,300, 500, 1000, 2000, 3000 Hz	15, 30, 35, 60, 70, 120(-12 dB/oct)50 (RAPID), 300 Hz (-18 dB/oct)
Notchfilter	50/60 Hzselectable	50/60 Hzselectable	50 or 60 Hz
A/D conversion	16 Bit ADC	16 Bit ADC	16 Bit (97 nV/LSB)
Samplingrate	100 – 5000 Hz	200-80000 Hz	100, 200, 500, 1000 Hz
Analysistime	1s - 30s	2 ms - 5 min
Signaldelay(pre/post)	0-10 s	0-10 s	The time must be set to 10 s or more.
Video Recording	Yes	No	No (digital video software)
ElectricalStimulator	No	Design – StimulatorsType: constant currentN. output 1Max output: 100 mA Pulse width: 0.1- 5 ms Mode: single, train	No
Audio Stimulator	Output mode: click, toneSound pressure: 0-126 dB SPL (TDH-39)Phase: condens., raref, alternateSignal frequency: 100-8000 HzClick width: 100-5000 µsStimulus presen:Left/right/double-sidedHeadset: TDH-39	Output mode: click, toneSound pressure: 0-126 dB SPL(TDH-39)Phase: condens., raref, alternateSignal frequency: 100-8000 HzClick width: 100-5000 µsStimulus presen. Left, right, binauralHeadset: TDH-39	No
Photic Stimulator	Click width: 0.1-3000 µsStimulation frequency 0.1-100 HzStimulus present: Left/right/double-sidedPhotic stimulator (interface:connectorfor photo stimulatorconnection)	Stimulus duration: 2-1500 msStimulation frequency: 0.05—50HzStimulus present: Left / right /double-sided stimulation,LED goggles (interface: connectorfor photo stimulator connection)	Stimulation period: 1 to 99 seconds in 1second stepsPhotic frequency 0.5 Hz, 1 to 33 Hz in 1 Hzsteps, 50 and 60 Hz,Flash lamp assembly (interface: the PHOTICLAMP connector on the rear of the phototcontrol unit)
Somatosensory	No	Basic EP Application ModulesYes	No

{45}------------------------------------------------

Characteristics	Neuron-Spectrum-1,Neuron-Spectrum-2,Neuron-Spectrum-3,Neuron-Spectrum-4,Neuron-Spectrum-4/P(this submission)	Predicate deviceFocus EMG DeviceNeurosoft Ltd.TeleEMG LLC.(K102610)	Predicate deviceNihon KohdenNeurofax m EEG-9100(K011204)
EP
Auditory EP	Yes	Yes	No
Visual EP (flash)	Yes	Yes	Yes
Visual EP(pattern)	Yes	Yes	No

{46}------------------------------------------------

Table 12.6Table - Comparison of outputs for NEURON-SPECTRUM-1,2,3,4,4/P and Alice 5 System

Sensor	Neuron-Spectrum-1(thissubmission)	Neuron-Spectrum-2(this submission)	Neuron-Spectrum-3(this submission)	Neuron-Spectrum-4(this submission)	Neuron-Spectrum-4/P(thissubmission)	Alice 5SystemRespironics Inc.K040595
IFU	The digital systems Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P with Neuron-Spectrum.NET software are intended for use as digitalneurophysiological systems intended for recording, processing and display biopotential signals such asElectroencephalography (EEG) and long-latency Evoked Potential (EP). Polysomnography (PSG)derives from Electroencephalography (EEG) by the means of a dedicated software module anddedicated electrodes.The devices are portable and can register up to 8 (Neuron-Spectrum-1), 16 (Neuron-Spectrum-2), 19(Neuron-Spectrum-3), 21 (Neuron-Spectrum-4, Neuron-Spectrum-4/P) EEG channels, 1 (Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3 and Neuron-Spectrum-4) or up to 4 polygraphicchannels (Neuron-Spectrum-4/P: ECG, EOG), 1 breath channel and 2 direct current channels(Neuron-Spectrum-4/P).Neuron-Spectrum.NET includes the Evoked potentials averaging function and Quantitativeelectroencephalography (qEEG) , including specific parameters such as Rhythmicity, FFT power ratioand amplitude metrics.The devices do not provide alarms, do not provide automated event marking and do not provide to theuser any diagnostic conclusion about the patient's condition. They are intended for use in the patientcare institutions, diagnostics centers, neurosurgical hospitals experimental laboratories and sleeplaboratoriesThe patient group includes all ages and sexes.					The Alice 5 System is aPolysomnography Systemthat is intended to record,display and print informationto clinicians/physicians.These parameters arepresentedgraphically 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 othertest environments whereadults or infant patientsrequire documentation ofvarious sleep or otherphysiological disorders.This device does not providealarms and, Is not intendedfor use as an automatedapnea monitor.
Product code	OLT, OLV, GWQ					OLZ, OLV
CFR section	882.1400					882.1400
Total Channel	8	16	19	21	21	55
EEG inputs	8	16	19	21	21	21
Input impedance	Not less than 400 MΩ					1.66 MΩ per Electrode 3.33differential
Bandwidth	in range from 0.5 up to 60 Hz from -10 up to +5%					0.32 Hz to 106 Hz
Input signal range	1-12000μV					± 3.3 mV
Max sampling rate	5000 Hz					2000 Hz
Max storage rate	5000 Hz					200 Hz, limited 500 Hz
High pass filter	0.05-10 Hz					0.5 to 100 Hz
Low pass filter	5-200 Hz					0.5 to 100 Hz

{47}------------------------------------------------

Sensor	Neuron-Spectrum-1(thissubmission)	Neuron-Spectrum-2(this submission)	Neuron-Spectrum-3(this submission)	Neuron-Spectrum-4(this submission)	Neuron-Spectrum-4/P(thissubmission)	Alice 5SystemRespironics Inc.K040595
Notch filter	not less than 40 dB					50 or 60 Hz
DC inputs	no	no	no	no	yes	yes
EOG	yes	yes	yes	yes	yes	yes
ECG channels	yes	yes	yes	yes	yes	yes
Pressure transducer	no	no	no	no	yes	yes
Effort (chest/abdominal)	no	no	no	no	yes	Piezo,RIP optionalw/additional module
Body position	no	no	no	no	yes	yes
Snore	no	no	no	no	yes	yes
Flow (thermal)	yes	yes	yes	yes	yes	yes
Pulse oximetry	no	yes	yes	yes	yes	yes
Size	140x200x45 (mm)				10L x 4W x 2H (in)
Weight	not more than 0.9 kg				1.6 lb

{48}------------------------------------------------

Conclusion of the hardware equivalence

The Neuron-Spectrum-1,2,3,4,4/P with Spectrum.NET software acquire only a subset of the biopotentials collected by the predicate device Cervellobut this deficiency doesn't affect safety and effectiveness of the system, as demonstrated with the proper IEC tests.

Based on the information and supporting documentation provided in Section 12 Substantial Equivalence Discussion, Neuro-Spectrum-1, 2, 3,4, 4/P devices are substantially equivalent for the applicable features to the predicate devices FOCUS EMG and Neurofax m EEG-9100.

An auditory stimulator adapted for Neurosoft Ltd. is used. TDH-39 headphones are registered together with Focus device as K102610. These auditory stimulators are identical to those used in the subject device.

For photo stimulation a photic stimulator) is used.LED stimulator can be attached to the Neuro-Spectrum-1, 2, 3 ,4, 4/P via photic stimulator connector located on a device panel (the same as Neurofax m EEG-9100)

A thorough comparison of of outputs for NEURON-SPECTRUM-1,2,3,4,4/P and Alice PolysomnographySystemis provided in Section 12 Substantial Equivalence Discussion.

A thorough comparison between the Neuron-Spectrum-1,2,3,4,4/P with Spectrum.NET software and Persyst 12software is shown in a tabular form in theSection 12 Substantial Equivalence Discussion. All the characteristics that affect the safety and effectiveness of the system are compared and presented in a clear format.

All the third party sensors that are recommended to be used in the Neuron-Spectrum-1,2,3,4,4/P have prior 510(k) approval from FDA or they have biosafety tests (see Section 11.9). The specifications meet the requirements of the Draft FDA guidance for 510(k) content for Electroencephalograph Devices.

Discussion of minor differences in software features

The processing functions for both the subject devices are well known and accepted as the conventional tools.

The Neuron-Spectrum.NET software resides on a PC like Persyst 12 and it has indications for use and characteristics that are a subset of the ones of Persyst 12. These functions are generic for all two devices.

As described Section 12 Substantial Equivalence Discussionthe predicate substantially performs the same operations and the minor differences consist in:

graphical appearance of the control icons; 。
graphical appearance on displaying the results.

These minor differences do not raise any new hazard, they don't increase the risk of inappropriate image capture or the risk of an erroneous interpretation of the results by the operator or the risk of an erroneous processing.

TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of Neuron-Spectrum-1.2.3.4.4/P with Neuron-Spectrum.NET software and the predicate devices has been performed through the above comparative tables. The results of

{49}------------------------------------------------

this comparison demonstrate that the Neuron-Spectrum-1,2,3,4,4/P with Neuron-Spectrum.NET software is equivalent to the marketed predicate devices.

PERFORMANCE DATA

The performance data (IEC e ISO tests attached in Section and Validation tests (Section 16.3), the Software Requirements Specifications (Section 16.4) indicate that the Neuron-Spectrum-1.2.3.4.4/P with Neuron-Spectrum.NET software device meets all specified requirements and that it is substantially equivalent to the predicate devices.

CONCLUSION STATEMENT

All the necessary electromagnetic compatibility and electrical safety tests were performed.

The results demonstrate that Neuron-Spectrum-1,2,3,4, 4/P with Neuron-Spectrum.NET is in compliance with both the standards IEC 60601-1-2 and IEC 60601-1 and is safe as the predicate device.

All the necessary performance tests in support of substantial equivalence determination were conducted and documented in section 18 "Performance testing". The tests demonstrate that the Neuron-Spectrum-1,2,3,4,4/P with Neuron-Spectrum.NET is effective and performs as well as the predicate device.

So Neuron-Spectrum-1,2,3,4,4/P with Neuron-Spectrum.NET and CervelloTM can be considered substantial equivalent even if the design is different. In fact, even if the instruments are different, the electrodes have different shapes, the software has some differences in functionalities, they acquire, display and analyse biopotential signals such as Electroencephalography (EEG) , Evoked Potential (EP). AndPolysomnography (PSG).

The Neuron-Spectrum.NET software and Persyst 12 can be considered substantial equivalent even if the windows and the icons, i.e. the design, are different, as demonstrated by the comparison table 5.2. In fact the main core of the functions is the same.

The minor differences in the technological characteristics between the devices do not raise of safety or efficacy.

Based on these results, we conclude that the Neuron-Spectrum-1,2,3,4,4/P with Neuron-Spectrum.NET are substantially equivalent to the existing legally marketed devices CervelloTM Bio-Potential Signal Acquisition System,FOCUS EMG , Neurofax m EEG-9100 and Alice 5 for the hardware configuration, and PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE for the software configuration under Federal Food, Drug and Cosmetic Act.

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).