The Blackrock NeuroPort Biopotential Signal Processing System supports recording, processing and display of biopotential signals from user supplied electrodes. Biopotential signals include: Electrocorticography (ECoG), electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG), electrooculography (EOG) and Evoked Potential (EP).

Device Description

The Blackrock NeuroPort Biopotential Signal Processing System (System), when connected to customer supplier bio-potential electrodes or the NeuroPort Electrode Array (K042384), supports recording and display of bio-potential signals. Bio-potential signals that can be recorded by the System include:

Electrooculography (EOG),
Electrocorticography (ECoG),
electroencephalography (EEG),
electromyography (EMG),
electroencephalography (ECG) and
evoked potential (EP).
The System is not a monitoring system. No physiologic alarms are provided. The acquisition and display of bio-potential signals is for the interpretation and use of the clinician.

AI/ML Overview

The provided 510(k) summary for the Blackrock NeuroPort Biopotential Signal Processing System does not contain the detailed information typically found in a clinical study report that proves a device meets specific acceptance criteria using a test set. This document is a premarket notification for a medical device to demonstrate substantial equivalence to existing predicate devices.

Instead, it focuses on comparing the new device's technical specifications and intended use with previously cleared (predicate) devices to argue that it raises "no new questions of safety or effectiveness."

Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not available in this document.

Here's an attempt to extract and infer information based on the provided text, while making explicitly clear what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the sense of predefined performance targets for a clinical study. Instead, it compares the device's technical specifications to those of predicate devices. The implicit acceptance criterion is that the device's performance characteristics are equivalent to or better than the predicate devices, and that it adheres to relevant safety standards.

Feature	Predicate NeuroPort Instrument (K060523) Performance (Implicit Acceptance Criteria)	Device Under Review Performance
Intended Use, Indications for Use	Recording, processing and display of biopotential signals (EEG, ECoG, ECG, EMG, EOG, EP)	Equivalent
Typical Biopotential Signals Recorded	EEG, ECoG, ECG, EMG, EOG, EP	Equivalent
Number of Signal Recording Channels	96	Up to 128 (cascadable to 256)
Amplifier Input Impedance	1000 Megohm	1000 Megohm
A/D Conversion	16 Bit	16 Bit
Sampling Rate	Up to 30,000 Hz	Up to 30,000 Hz
CMRR	> 90 dB	> 90 dB
Analysis Software	Embedded, commercially available and user defined (e.g., Persyst Insight™, NeuroPlex™, Matlab™, Spike 2™)	Equivalent, same examples
Power	110 VAC	110 VAC
Alarms	No	No
Safety Standards Compliance	IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26	Same

Note on "Reported Device Performance": The reported performance is essentially a restatement of the technical specifications, demonstrating they match or exceed the predicate devices. There is no independent "study" performance data presented in this 510(k) summary that would provide statistical measures like sensitivity, specificity, accuracy, or other metrics typically seen in diagnostic device studies.

2. Sample size used for the test set and the data provenance

Not Provided. This document does not describe a "test set" in the context of a clinical study with human or animal subjects, nor does it mention data provenance (country of origin, retrospective/prospective). The assessment appears to be based on direct technical specification comparison and perhaps internal engineering testing (referred to as "system testing" and "software documentation" in Section 4.0).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable/Not Provided. Since there is no "test set" or clinical study described for ground truth establishment, this information is not present.

4. Adjudication method for the test set

Not Applicable/Not Provided. No adjudication method is mentioned as there's no described test set or expert evaluation process.

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

Not Applicable/Not Provided. This device is a signal processing system for acquiring and displaying biopotential signals. It is not an AI-assisted diagnostic tool for human readers, and therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device description and was not performed.

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

Not Applicable/Not Provided. The device itself is a hardware and software system for signal acquisition and display. It does not perform automated interpretations or diagnoses requiring a standalone "algorithm only" performance evaluation in the typical sense of AI/ML devices. Its performance is defined by its ability to accurately acquire and condition the biopotential signals. The "software testing" mentioned in Section 6.0 likely refers to verification and validation of the software's functionality within the system.

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

Not Applicable/Not Provided. Given the nature of a signal processing system, "ground truth" would typically relate to the accuracy of the signal acquisition and conditioning itself, which is assessed through engineering tests against known input signals, not clinical ground truth like pathology or outcomes data. The document does not specify how the performance metrics (e.g., CMRR, impedance, sampling rate) were verified, but it would logically involve calibrated electronic test equipment.

8. The sample size for the training set

Not Applicable/Not Provided. This device is not an AI/ML device that requires a "training set" in the context described.

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

Not Applicable/Not Provided. As there's no training set, this is not applicable.

Summary of the "Study" (as described in the 510(k) Summary):

The "study" described in this 510(k) summary is not a clinical trial or performance study against predefined clinical acceptance criteria involving human subjects or expert readers. Instead, it is a technical comparison and verification process.

Purpose: To demonstrate "substantial equivalence" of the Blackrock NeuroPort Biopotential Signal Processing System to legally marketed predicate devices (K042626, K060803, K040113).
Methodology:
- Comparison of Intended Use/Indications for Use: Showing the new device's intended use is equivalent to or falls within the scope of predicate devices.
- Comparison of Technological Characteristics: A detailed feature-by-feature comparison of specifications (e.g., number of channels, input impedance, A/D conversion, sampling rate, CMRR) between the new device and predicate devices.
- Hardware Modifications Verification: Mention of verifying new interface cables and a passive splitter box through "continuity of the single pathway" and "continuity of the signal pathways."
- Software Testing: Indication that "software testing" was performed for new functionalities like syncing with external EEG instruments and cascading two systems.
- Standards Compliance: Affirmation of compliance with relevant safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26).
Conclusion: The modifications to the predicate NeuroPort System "raise no new questions of safety or effectiveness," indicating that the device is considered safe and effective based on its equivalence to existing cleared devices.

In essence, this document is a regulatory submission demonstrating technical equivalence rather than a report of a scientific study with clinical performance endpoints.

Summary

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510(k) Summary

Device Name: Blackrock NeuroPort Biopotential Signal Processing System

510(k) Sponsor: I2S Micro Implantable Systems, LLC, d/b/a Blackrock Microsystems 391 Chipeta Way, Suite G Salt Lake City, UT 84108

510(k) Contact: Chris DeCaria Director of Product Development Blackrock Microsystems 391 Chipeta Way, Suite G Salt Lake City, UT 84108

Summary Date: May 15, 2009

Trade Name: Blackrock NeuroPort Biopotential Signal Processing System

Common Name: Bio-potential Signal Acquisition System

Classification Name: CFR 882.1835 Physiologic Signal Amplifier, Product Code: GWL CFR 882.1845 Physiological Signal Conditioners, Product Code: GWK

Predicate Devices:

510{k) Number: K042626

Trade Name: NeuroPort™ Neural Signal Processing (NSP) System

510(k) Number: K060803 Trade Name: g.USBamp

510(k) Number: K040113 Trade Name: Sandman SD20 Amplifier

1.0 Description of Device

1. Electrooculography (EOG),
Electrocorticography (ECoG), 2.

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electroencephalography (EEG), 3.
1. electromyography (EMG),
న్న electroencephalography (ECG) and
evoked potential (EP). 6.

The System is not a monitoring system. No physiologic alarms are provided. The acquisition and display of bio-potential signals is for the interpretation and use of the clinician.

1.2 Clinical Application

The System is used in research institution, clinic, hospital, operating room and epilepsy evaluation environments to acquire (record) bio-potential signals from user supplied electrodes or the NeuroPort Array. All of these electrodes require a high input impedance amplifier to acquire and display the bio-potential signal from the human body the electrodes contact.

2.0 Intended use of Device

3.0 Technological Characteristics

The only hardware modifications to the predicated NeuroPort System are:

1. The addition of interface cables to support connection of user supplied electrodes to the amplifier. These interface cables are verified by the continuity of the single pathway, commercial electrode input connector to the amplifier output connector.
1. A passive signal splitter box allows the user supplied electrodes to connect to the System Amplifier and the user's own equipment. This passive box will be verified by continuity of the signal pathways between the user supplied electrode input connector and the two signal connector outputs (System Amplifier output connector and User defined equipment connector).
Sync to an external EEG instrument, such as the X-CEL TEK device is addressed in 3. the software testing, see Section 6.0.

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1. The syncing of two Systems to be capable of recording up to 256 input channels is supported in the software testing, see Section 6.

3.1 Comparison to Predicates

Feature	SystemUnder Review	PredicateNeuroPortInstrument(K060523)	Predicateg.USBamp(K060803)	PredicateSandman SD20Amplifier(K0040113)	Comments
IntendedUse,Indicationsfor Use	The Blackrock NeuroPortBiopotential SignalProcessing Systemsupports recording,processing and display ofbiopotential signals fromuser supplied electrodes.Biopotential signalsinclude, but are not limitedto: Electrocorticography(ECOG),electroencephalography(EEG), electromyography(EMG),electrocardiography(ECG), electrooculography(EOG) and EvokedPotential (EP).	The intended use ofthe CyberkineticsNeurotechnologySystems, Inc.NeuroPort NeuralSignal ProcessorSystem is fortemporary (< 30days) recording andmonitoring of brainelectrical activity.	Measuring,recording andanalysis ofelectrical activity ofthe brain and/orthrough theattachment ofmultiple electrodesat various locationsto aid in morningand diagnosis asroutinely found inclinical settings ofEEG.	The SD20Amplifier isintended to be useby or under thedirections of aphysician foracquisition of EEG,polygraphy andpolysomnographysignals andtransmission ofthese signals to aPC duringrecording ofneurophysiologyexaminations.	EquivalentThe BlackrockNeuroPortBiopotentialSignalProcessingSystem underreview acquires,conditions andsupports analysisof the same typesof biopotentialsignals as thepredicatedevices.Polygraphy andpolysmnographyincludes EEG,EMG, ECG,EOG,biopotentialsignals.
TypicalBiopotentialSignalsRecorded	Electroencephalography(EEG)Electrocorticography(ECOG)Electrocardiography (ECG)Electromyography (EMG)Electrooculography (EOG)Evoked potential (EP)	EEG	EEGECoGECGEMGEOG	EEGECGEMGEOGEP	Equivalent
Number ofSignalRecordingChannels	Up to 128 with onedevice;Up to 256 by cascadingtwo devices	96	Up to 128	Up to 128	Equivalent
AmplifierInputImpedance	1000 Megohm	1000 Megohm	> 100 Megohm	Unknown	Same aspredicateNeuroPortInstrument.
A/DConversion	16 Bit	16 Bit	24 Bit	16 Bit	Equivalent
SamplingRate	Up to 30,000 Hz	Up to 30,000 Hz	Up to 38,400 Hz	Up to 32,000 Hz	Equivalent
CMRR	> 90 dB	> 90 dB	> 100 dB	> 100 dB	Equivalent

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Feature	SystemUnder Review	PredicateNeuroPortInstrument(K060523)	Predicateg.USBamp(K060803)	PredicateSandman SD20Amplifier(K0040113)	Comments
AnalysisSoftware	Embedded, commerciallyavailable and userdefined.Examples:Persyst Insight™NeuroPlex™Matlab™Spike 2™and others.	Embedded,commerciallyavailable and userdefined.Examples:Persyst Insight™NeuroPlex™Matlab™Spike 2™and others.	Embedded andcommerciallyavailable.Examples:Matlab™and others.	Embedded andcommerciallyavailable	EquivalentThephysician/clinicianmay apply theirown analysissoftware as aresearch tool orothercommerciallyavailablesoftwaresupportinganalysis.
Power	110 VAC	110 VAC	USB Port	Unknown	Safety of thepower source isverified bystandardscompliance.
Alarms	No	No	No	Unknown	Same
SafetyStandardsCompliance	IEC 60601-1:1998IEC 60601-1-2:2001IEC 60601-2-26	IEC 60601-1IEC 60601-1-2IEC 60601-2-26	IEC 60601-1IEC 60601-1-2IEC 60601-2-26	IEC 60601-1IEC 60601-1-2	Same

4.0 Data Summary

Software documentation, system testing and standards compliance were provided to support the substantial equivalence, safety and effectiveness of the System.

5.0 Conclusions

The modifications to the Predicate NeuroPort System to create the Blackrock NeuroPort Biopotential Signal Processing System were evaluated and raise no new questions of safety or effectiveness.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, with stylized lines forming the wings and body.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

I2S Micro Implantable Systems, LLC c/o Gary Syring, Principal Consultant Quality & Regulatory Associates, Inc. 800 Levanger Lane Stoughton, WI 53589

MAY 2 8 2009

Re: K090957

Trade/Device Name: Blackrock NeuroPort Biopotential Signal Processing System Regulation Number: 21 CFR 882.1835 Regulation Name: Physiologic Signal Amplifier Regulatory Class: II Product code: GWL (and GWK) Dated: April 2, 2009

Received: April 6, 2009

Dear Mr. Syring:

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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/cdrh/industry/support/index.html.

Sincerely yours.

Malvina B. Eglehnus, mD.

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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690957

Indications for Use

510(k) Number (if known):

Device Name: Blackrock NeuroPort Biopotential Signal Processing System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

E.K. Rhm

(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices

510(k) Number K090957

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Regulation Number and Section

§ 882.1835 Physiological signal amplifier.

(a)
Identification. A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).(b)
Classification. Class II (performance standards).