The ZOOM-100DC is used to measure and record the electrical activity of a patient's brain. The ZOOM-100DC is intended to monitor the state of the brain by acquisition and display of electroencephalogram (EEG) signals and by the calculation of standard quantitative EEG (qEEG) parameters.

Device Description

The ZOOM-100DC records, measures and displays Electroencephalographic (EEG) waveforms which are digitized and processed.

AI/ML Overview

The provided text describes a 510(k) premarket notification for BrainScope's ZOOM-100DC, an Electroencephalograph (EEG). The document focuses on demonstrating substantial equivalence to predicate devices, rather than an independent study proving the device meets specific acceptance criteria based on diagnostic accuracy or clinical outcomes. Therefore, much of the requested information regarding study design, sample sizes, expert adjudication, and ground truth establishment is not present in the provided text.

Here's a breakdown of the available information:

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

The document doesn't explicitly state "acceptance criteria" in the sense of predefined performance targets for diagnostic accuracy or clinical utility. Instead, it relies on demonstrating substantial equivalence to predicate devices by comparing technical characteristics and intended use. The "performance" assessment is based on this comparison.

Characteristic	Predicate Devices (e.g., Nicólet Bravo, Crystal-EEG, BRM3, I-2000) (Range/Example)	ZOOM-100DC	Assessment/Comparison
Intended Use	Measure and record electrical activity of patient's brain, monitor state by acquisition/display of EEG signals and calculation of qEEG parameters (specifics vary slightly by predicate, e.g., BRM3 for neonates)	Measure and record electrical activity of patient's brain, monitor state by acquisition/display of EEG signals and calculation of standard qEEG parameters.	Equivalent: The intended use is directly comparable and within the scope of the predicates.
Modalities	EEG (some predicates also include EP, EMG, CSA)	EEG	Equivalent: ZOOM-100DC offers EEG, consistent with the core modality of the predicates.
Channels	8, 16, 3, 2 channel arrays; 10/20 array capable	10/20 Array (8 single-ended channels, 5 differential concurrently)	Equivalent: Supports standard EEG channel configurations.
Real Time EEG Display	Yes	Yes	Equivalent
Real Time EEG Bandwidth	0.5 - 500 Hz (example from Bravo)	0.5 - 4000 Hz available	Equivalent or Superior: Offers a broader available range, exceeding some predicates.
Processed EEG Bandwidth	0.5 - 500 Hz (example from Bravo)	0.5 - 45 Hz, 50Hz	Comparable: Falls within the typical range for processed EEG.
Amplifier CMRR	≥ 110 dB (Nicolet Bravo)	≥ 100 dB	Comparable: Meets a high standard, though slightly lower than one predicate.
Amplifier Input Impedance	> 100 Meg Ohms (Nicolet Bravo)	≥ 10 Meg Ohms	Comparable: Meets a standard for EEG amplifiers, though lower than one predicate.
Electrode Impedance Test	Yes	Yes	Equivalent
EEG Derived Measures	Yes - Derived from FFT* (Nicolet Bravo)	Yes - Derived from FFT*	Equivalent: Offers similar qEEG parameters.

The conclusion states that "Performance data demonstrate that the device performs equivalently to the predicate devices." This equivalence, rather than a specific numerical acceptance criterion, is the basis for substantial equivalence.

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

The document does not provide information on a test set, sample size, or data provenance from a clinical study for the ZOOM-100DC. The submission relies on a comparison of technical specifications and intended use against existing predicate devices, not on new clinical performance data from a specific study.

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)

This information is not provided as there is no mention of a clinical study involving a test set that required expert-established ground truth.

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

This information is not provided as there is no mention of a clinical study involving a test set that required adjudication.

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

This information is not provided. The ZOOM-100DC is an electroencephalograph, not an AI-assisted diagnostic tool that would typically involve a multi-reader, multi-case study for comparative effectiveness with human readers.

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

This information is not provided. The device is an EEG recording and display system, not an algorithm that operates standalone for diagnostic purposes.

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

This information is not provided as there is no mention of a clinical study that required establishing 'ground truth' for diagnostic outputs. The device measures and records EEG signals and calculates qEEG parameters; its "performance" is assessed by its ability to perform these functions reliably and comparably to predicate devices.

8. The sample size for the training set

This information is not provided. As the submission is for an EEG device and not a machine learning algorithm requiring a "training set," this concept is not applicable in the context of this document.

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

This information is not provided. See point 8.

Summary

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510(k) Summary

AUG 1 0 2009

The following information is provided as required by 21 CFR § 807.87 for BrainScope's 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

BRAINSCOPE COMPANY INC. Sponsor:

1717 Rhode Island Avenue 9th Floor Washington, D.C. 20036

Proprietary Name:	ZOOM-100DC
Common Name:	Electroencephalograph
Regulatory Class:	Class II 21 CFR §882.1400
Product Codes:	OLT & OMC

Predicate Device(s): Nicólet Bravo Multi-Modality System (K991054), Cleveland Medical Crystal-EEG Model 10 (K970672), Brainz Instruments Ltd BRM3 Brain Monitor (K071449) and Infinite Biomedical Technologies, LLC Model I-2000 Monitor (K072382).

Device Description:

The ZOOM-100DC records, measures and displays Electroencephalographic (EEG) waveforms which are digitized and processed.

1717 Rhode Island Avenue 9th Floor Washington, D.C. 20036

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Indications for Use:

Device Comparison Table:

	ZOOM-100DC	Bravo Multi-Modality SystemK991054	Crystal-EEG Model10 (K970672)	BRM3 Brain Monitor(K071449)	Model I-2000Monitor (K072382)
Indication forUse	The ZOOM-100DCis used to measureand record theelectrical activity of apatient's brain. TheZOOM-100DC isintended to monitorthe state of the brainby acquisition anddisplay ofelectroencephalogram(EEG) signals and bythe calculation ofstandard quantitativeEEG (qEEG)parameters.	The Bravo Multi-Modality System isintended to record anddisplay EEG, EP,EMG and TCD datain the clinic andhospital (includingthe hospital room,operating room,emergency room,intensive care unit,neuro intensive careunit, critical care unit,etc.), and to importand display data fromthird party monitoringdevices such as vitalsigns monitors. It isintended to aid thediagnosis andmonitoring ofpotential disorders ofthe central andperipheral nervoussystem and muscles.	The Crystal-EEGModel 10 is a mobile,intermediate range,wireless EEG systemintended to be usedfor measuring andtransmittingelectroencephalogram(EEG) signals.	A device used tomeasure and record theelectrical activity of thepatient's brain obtainedby placing two or moreelectrodes on the head.The BRM3 BrainMonitor isintended for use tomonitor the stateof the brain byacquisition ofelectroencephalogram (EEG)signals, in clinicalenvironmentssuch as theintensive careunit, and forclinical research.The BRM3 BrainMonitor isintended for useonly with neonatalpatients, definedas from birth to 28days post-delivery, andcorresponding to apost-conceptualage of 24 to 46weeks.The BRM3 BrainMonitor does notprovide anydiagnosticconclusion aboutthe patient'scondition.	The 1-2000 Monitoris intended to be usedfor measuring andrecording theelectrical activity of apatient's brain,obtained by placingelectrodes on thehead.The 1-2000 Monitoris indicated for use inmonitoring the stateof the brain byacquisition ofelectroencephalogram(EEG) signals, inresearch and clinicalenvironments.
Modalities	EEG	EEG, EvokedPotential EMG, CSA	EEG	EEG	EEG
Environmentof Use	Hospitals and Clinics	Hospitals and Clinics	Hospitals and Clinics	Hospitals and Clinics	Hospitals and Clinics
Power Source	Li Ion Battery	120 Volt 60Hz AC	Unknown	Unknown	Unknown

1717 Rhode Island Avenue 9t Floor Washington, D.C. 20036

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Device Components	ZOOM-100DCExternal PatientInterface CableExternal Audio CableCF (Compact Flash)CardBattery Charger	PC running Microsoftwindows NTAmplifier UnitPatient InterfaceCablesEvoked Potential UnitEvoked PotentialPatient interfaceCable	Unknown	Sensor Set (EEG skinelectrodes) or SensorAdaptor Set (electrodeadaptor)Data Acquisition Unit(EEG head stage)Data CableMonitorPower Supply Unitand Roll-Pole.	tablet PCbattery poweredwireless headboxheadbox chargerpower conditioner
ElectrodeMaterial	N/A	N/A	N/A	N/A	N/A
	Uses Standard off theShelf EEG electrodes	Uses Standard off theShelf EEG electrodes	Uses Standard off theShelf EEG electrodes	Uses Standard off theShelf EEG electrodes	Uses Standard off theShelf EEG electrodes
ScreenDisplayDetails	Displays:Raw EEG Waveform	Displays:Raw EEG WaveformRaw averaged AEPWaveform	Unknown	Displays:Raw EEG WaveformaEEG parameterSignal Quality	Displays:Raw EEG waveformsEEG powerspectrum95% Spectral EdgeFrequency
Hard copy ofDisplayedData	Yes - through CF(Compact Flash) card	Yes	Unknown	Unknown	Yes
Channels	10/20 Array	10/20 Array	8 channels	3 channels	2 channels
	8 single-endedchannelscorresponding to 8electrodes placedanywhere on thehead, including butnot limited to, alllocations defined bythe International10/20 System. (5differential channelscan be viewedconcurrently).	Up to 16 differentialchannels
Real TimeEEG Display	Yes	Yes	Yes	Yes	Yes
Real TimeEEGBandwidth	0.5-4000 Hzavailable	0.5 - 500 HzAvailable EEG100 - 20kHzAvailable AEP	Unknown	Unknown	Unknown
ProcessedEEGBandwidth	0.5 - 45 Hz50Hz	0.5 - 500 Hz	Unknown	Unknown	Unknown
AutomaticArtifacting		Yes		Unknown		Unknown	Unknown	Unknown

1717 Rhode Island Avenue 9th Floor Washington, D.C. 20036

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AmplifierCommonModeRejectionRatio(CMRR)	≥ 100 dB	≥ 110 dB	Unknown	Unknown	Unknown
AmplifierInputImpedance	≥ 10 Meg Ohms	> 100 Meg Ohms	Unknown	Unknown	Unknown
ElectrodeImpedanceTest	Yes	Yes	Unknown	Unknown	Yes
EEG DerivedMeasures	Yes- Derived fromFFT*	Yes- Derived fromFFT*	N/A	N/A	N/A
	1. Absolute Powera. Monopolar Powerb. Bipolar Power2. Relative Powera. RelativeMonopolar Powerb. Relative BipolarPower3.Mean frequencyvariables (univariateand multivariate)a. Monopolar MeanFrequencyb. Bipolar MeanFrequency4. Coherencea. MonopolarCoherenceb. BipolarCoherence5. Asymmetrya. MonopolarAsymmetry

See comparison of measures in section 12.3.

Conclusion

The ZOOM-100DC, when compared to its predicate devices, has the same intended use and equivalent technological characteristics. Performance data demonstrate that the device performs equivalently to the predicate devices. The ZOOM-100DC is substantially equivalent.

1717 Rhode Island Avenue 9th Floor Washington, D.C. 20036

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Brainscope Company Inc. % Mr. Michael E. Singer 1717 Rhode Island Avenue, 9th Floor Washington, District of Columbia 20036

2009

Re: K082886

Trade/Device Name: ZOOM-100DC Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLT, OMC Dated: July 24, 2009 Received: July 28, 2009

Dear Mr. Singer:

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

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Michael E. Singer

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Mark N. Melkerson Director Division of Surgical, Orthopedic,

Sincerely vours.

and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

K082886 510(k) Number:

Device Name: ZOOM-100DC

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

、

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(Division Sign-Off) (Division Sign-On)
Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K082886

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).