The NeuroWorks is EEG software that displays physiological signals. The intended user of this product is a qualified medical practitioner trained in Electroencephalography. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.

-The NeuroWorks EEG software allows acquisition, display, archive, review and analysis of physiological signals.
-The Seizure Detection component of NeuroWorks is intended to mark previously acquired sections of the 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 full scalp montage according to the standard 10/20 system.

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

-The aEEG functionality included in NeuroWorks is intended to monitor the state of the brain. The automated event marking function of NeuroWorks is not applicable to aEEG.

-NeuroWorks also includes the display of a quantitative EEG plot, Compressed Spectrum Array (CSA), which is intended to help the user to monitor and analyze the EEG waveform. The automated event marking function of NeuroWorks is not applicable to CSA.

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

Device Description

Natus NeuroWorks is electroencephalography (EEG) software that displays physiological signals. The software platform is designed to work with Xltek and other select Natus amplifiers (headboxes). Software add-ons and optional accessories let you customize your system to meet your specific clinical EEG monitoring needs.

AI/ML Overview

The provided text describes the Natus NeuroWorks EEG software and its FDA 510(k) clearance application. However, it does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and the study proving the device meets them.

Specifically, the document states:

"The NeuroWorks software was designed and developed according to a robust software development process, and was rigorously verified and validated."
"Results indicate that the NeuroWorks software complies with its predetermined specifications, the applicable guidance documents, and the applicable standards."
"Verification and validation activities were conducted to establish the performance and safety characteristics of the device modifications made to the NeuroWorks software. The results of these activities demonstrate that the NeuroWorks software is as safe, as effective, and performs as well as or better than the predicate device."

While these statements confirm that performance testing was done and the device met its specifications, the actual acceptance criteria (e.g., sensitivity, specificity, F-score targets for seizure/spike detection) and the detailed results of those tests are not explicitly provided in this summary.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Acceptance Criteria: Not explicitly stated in terms of quantitative metrics (e.g., target true positive rate, false positive rate for seizure/spike detection). The text broadly states compliance with "predetermined specifications" and "applicable standards."
Reported Device Performance: Not explicitly stated in terms of quantitative metrics against specific acceptance criteria. The text concludes that the device "performs as well as or better than the predicate device."

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

Sample Size: Not specified for any performance evaluation.
Data Provenance: Not specified.

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

Not specified. The document mentions "qualified clinical practitioners" as the intended users, but doesn't detail their involvement in establishing ground truth for testing.

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

Not specified.

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

A MRMC comparative effectiveness study is not explicitly mentioned. The "Seizure Detection" and "Spike Detection" components are described as intended to "assist qualified clinical practitioners," implying a human-in-the-loop scenario. However, the study design and results of such assistance are not detailed.

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

A standalone performance study focused solely on the algorithm's performance (without human interaction) is not explicitly mentioned as a separate activity with results. The device's indications for use emphasize assisting "qualified clinical practitioners," suggesting an integrated workflow.

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

Not specified. Given the nature of EEG analysis, expert consensus would be the most probable method, but it is not stated in the document.

8. The sample size for the training set

Not specified.

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

Not specified.

In summary: The provided 510(k) summary focuses on the regulatory aspects, intended use, technological comparison to the predicate, and adherence to software development and general performance standards. It lacks the specific clinical performance metrics, study designs, and detailed data provenance typically found in a comprehensive clinical validation study report for an AI/ML medical device. Further details would likely be found in the complete 510(k) submission, which is not fully provided here.

Summary

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March 14, 2018

Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) Sanjay Mehta Director Regulatory Affairs 2568 Bristol Circle Oakville, L6H 5SI CA

Re: K180421

Trade/Device Name: Natus NeuroWorks Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMB, OMA, OLT Dated: February 15, 2018 Received: February 16, 2018

Dear Sanjay Mehta:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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

Sincerely,

Michael J. Hoffmann -S

Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180421

Device Name Natus NeuroWorks

Indications for Use (Describe)

-The NeuroWorks EEG software allows acquisition, display, archive, review and analysis of physiological signals. -The Seizure Detection component of NeuroWorks is intended to mark previously acquired sections of the 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 full scalp montage according to the standard 10/20 system.

-The aEEG functionality included in NeuroWorks is intended to monitor the state of the brain. The automated event marking function of NeuroWorks is not applicable to aEEG.

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

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)

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NEUROWORKS 510(K) SUMMARY

monitoring needs.

K180421

Submission Date:	13 March 2018
Submitter:	Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)2568 Bristol CircleOakville, Ontario, L6H 5S1Canada
Submitter andApplicationCorrespondent	Mr. Sanjay MehtaPhone: +1 (905) 287-5055Fax: +1 (905) 829-5304Email: sanjay.mehta@natus.com
Manufacturing Site:	Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)2568 Bristol CircleOakville, Ontario, L6H 5S1Canada
Trade Name:	Natus NeuroWorks
Common andClassificationName:	Automatic Event Detection Software For Full-MontageElectroencephalograph
ClassificationRegulation:	21 CFR §882.1400
Product Code:	OMB (primary), OMA, OLT
SubstantiallyEquivalent Devices:	New Model	Predicate 510(k)Number	PredicateManufacturer / Model
	NeuroWorks	K090019	Natus Medical IncorporatecDBA Excel-Tech Ltd.(XLTEK)2568 Bristol CircleOakville, Ontario, L6H 5S1Canada
Device Description:	Natus NeuroWorks is electroencephalography (EEG) software that displays physiological signals. The software platform is designed to work with Xltek and other select Natus amplifiers (headboxes). Software add-ons and optional accessories let you customize your system to meet your specific clinical EEG

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The NeuroWorks is EEG software that displays physiological signals. The Intended Use: intended user of this product is a qualified medical practitioner trained in Electroencephalography. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.

. The NeuroWorks EEG software allows acquisition, display, archive, review and analysis of physiological signals.
. The Seizure Detection component of NeuroWorks is intended to mark previously acquired sections of the 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 full scalp montage according to the standard 10/20 system.
The Spike Detection component of NeuroWorks is intended to mark previously acquired sections of the adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic spikes, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with full scalp montage according to the standard 10/20 system.
The aEEG functionality included in NeuroWorks is intended to monitor the state of the brain. The automated event marking function of NeuroWorks is not applicable to aEEG.
NeuroWorks also includes the display of a quantitative EEG plot, Compressed Spectrum Array (CSA), which is intended to help the user to monitor and analyze the EEG waveform. The automated event marking function of NeuroWorks is not applicable to CSA.

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

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Technology Comparison:

The NeuroWorks employs the same technological characteristics as the predicate device.

System Characteristic	Natus Medical Inc DBA Excel-Tech Ltd.Natus NeuroWorks(K090019)	Natus MedicalIncorporated DBAExcel-Tech Ltd.Natus NeuroWorks(Proposed Device)
Intended Use	The NeuroWorks is EEG software thatdisplays physiological signals. Theintended user of this product is a qualifiedmedical practitioner trained inElectroencephalography. This device isintended to be used by qualified medicalpractitioners who will exerciseprofessional judgment in using theinformation.The NeuroWorks EEG software allowsacquisition, display, archive, review andanalysis of physiological signals.The Seizure Detection component ofNeuroWorks is intended to markpreviously acquired sections of the adult(greater than or equal to 18 years) EEGrecordings that may correspond toelectrographic seizures, in order to assistqualified clinical practitioners in theassessment of EEG traces. EEG recordingsshould be obtained with full scalp montageaccording to the standard 10/20 system.The Spike Detection component ofNeuroWorks is intended to markpreviously acquired sections of the adult(greater than or equal to 18 years) EEGrecordings that may correspond toelectrographic spikes, in order to assistqualified clinical practitioners in theassessment of EEG traces. EEG recordingsshould be obtained with full scalp montageaccording to the standard 10/20 system.The aEEG functionality included inNeuroWorks is intended to monitor thestate of the brain. The automated eventmarking function of NeuroWorks is notapplicable to aEEG.NeuroWorks also includes the display of aquantitative EEG plot, CompressedSpectrum Array (CSA), which is intendedto help the user to monitor and analyze theEEG waveform. The automated eventmarking function of NeuroWorks is notapplicable to CSA.This device does not provide anydiagnostic conclusion about the patient'scondition to the user.	Same.
Personal ComputerOperating System	Microsoft® Windows XP	Microsoft® Windows 7Microsoft® Windows 10
System Compatibility(for using NeuroWorksduring corticalstimulation proceduresonly)	None	Natus Quantum amplifier inconjunction with NicoletCortical StimulatorControl Unit
Cortical Stimulation	External stand-alone device	Yes, Nicolet CorticalStimulator controlledfrom NeuroWorkssoftware in conjunctionwith stimulus switching.

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Summary of Performance Testing:

Software

The NeuroWorks software was designed and developed according to a robust software development process, and was rigorously verified and validated. Software information is provided in accordance with internal requirements and the following FDA guidance documents and standards:

The content of premarket submissions for software contained in medical devices, 11 May 05.
Off-the-shelf software use in medical devices, 09 Sep 99. ●
General principles of software validation; Final guidance for industry . and FDA staff, 11 Jan 02.
. Content of premarket submissions for management of cybersecurity in medical devices, 02 Oct 14.
Cybersecurity for networked medical devices containing off-the-shelf ● (OTS) software, 14 Jan 05
IEC 62304: 2006, Medical device software Software life cycle . processes

Results indicate that the NeuroWorks software complies with its predetermined specifications, the applicable guidance documents, and the applicable standards.

Performance Testing – Bench The NeuroWorks software was verified for performance in accordance with internal requirements and the applicable clauses of the following standards:

IEC 60601-1-6: 2010, Am1: 2013, Medical electrical equipment Part . 1-6: General requirements for basic safety and essential performance -Collateral standard: Usability
. IEC 62366: 2007, Am1: 2014, Medical devices – Application of usability engineering to medical devices.

Results indicate that the NeuroWorks software complies with its predetermined specifications and the applicable standards.

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Verification and validation activities were conducted to establish the Conclusion performance and safety characteristics of the device modifications made to the NeuroWorks software. The results of these activities demonstrate that the NeuroWorks software is as safe, as effective, and performs as well as or better than the predicate device.

Therefore, the NeuroWorks software is considered substantially equivalent to the predicate device.

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).