The Neucodia system is an electrophysiological device that generates photic stimuli, and records, processes and analyzes the resultant visual evoked potential (VEP) signals for the study of central visual functions.

Device Description

Visual stimuli are presented to the patient on the stimulus monitor. Visual evoked potentials are extracted from EEG epochs recorded via medical-rated EEG electrodes (not included in the device) attached to the scalp of the patient. Once the recording is complete, the digitized EEG data are processed by the software algorithm for noise filtering, artifact rejection, frequency and time domain analysis. The results are displayed on the user's monitor: EEG epochs, spectrum, Fourier components, and statistical measures (e.g., means, deviations, and signal to noise ratio).

AI/ML Overview

Here's an analysis of the provided information regarding the acceptance criteria and study for the Neucodia device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state quantitative acceptance criteria or detailed performance metrics in the way typically seen for a diagnostic or AI-driven device with specific sensitivity/specificity targets. Instead, the performance and validation section focuses on demonstrating system repeatability and reproducibility of VEP multi-variable statistics and signal-to-noise ratio.

Since no specific numerical acceptance criteria are given, the second column reflecting "Reported Device Performance" cannot be filled with quantitative values. The 510(k) focuses on demonstrating equivalence to predicate devices and the functionality of its components.

Acceptance Criteria (Implied)	Reported Device Performance
Software Verification and Validation	Performed (stated)
Safety Testing (UL 60601-1, IEC 60601-2-26, EN60601-1-2, ISO15004-2)	Performed (stated)
Bench Testing (power supply, amplifier gain, CMRR)	Performed (stated)
System Repeatability (VEP multi-variable stats & SNR)	Data obtained from 10 repeated sequential tests on each subject. (Detailed results are stated to be in Section 4.2.18, User's Manual and Section 5.2.3, Device Description, which are not provided in this excerpt).
System Reproducibility (VEP multi-variable stats & SNR)	Data obtained from each subject having three visits for the same repeated tests using different devices, different operators, and reapplication of electrodes. (Detailed results are stated to be in Section 4.2.18, User's Manual and Section 5.2.3, Device Description, which are not provided).

2. Sample Size Used for the Test Set and Data Provenance

The text mentions:

"10 repeated sequential tests were performed on each subject to obtain repeatability performance data."
"each subject had three visits for the same repeated tests using different devices and with different operators and reapplication of electrodes to obtain reproducibility performance data."

The total number of subjects (the sample size) used for these clinical tests is not specified in the provided document excerpt.

The data provenance (e.g., country of origin, retrospective/prospective) is also not specified. However, given it's a 510(k) submission to the FDA, it is likely that the study was conducted to support regulatory approval in the US, but the geographic location is not explicitly stated. The nature of the testing (repeated sequential tests, multiple visits) strongly indicates a prospective study design.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The device, an electrophysiological (EEG) test system, processes signals for objective measurements (VEPs), and the "ground truth" here likely refers to the accurate capture and processing of these physiological signals rather than an expert interpretation of an image or clinical condition. Therefore, clinical expert consensus on a 'diagnosis' may not be the primary ground truth method for demonstrating system repeatability and reproducibility.

4. Adjudication Method for the Test Set

This is not applicable/not specified for the type of testing described. The study focuses on the device's ability to consistently measure electrophysiological signals, not on the interpretation of clinical outcomes where adjudication would typically be needed (e.g., for disagreements among expert readers).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This is not specified and appears not to have been performed in the context of human readers improving with AI vs. without AI assistance. The Neucodia system is described as an electrophysiological measurement device, not an AI-assisted diagnostic aid for human interpretation. The study focused on the device's own measurement consistency.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is an "electrophysiological device that generates photic stimuli, and records, processes and analyzes the resultant visual evoked potential (VEP) signals for the study of central visual functions." The data processing is described as being performed by a "software algorithm for noise filtering, artifact rejection, frequency and time domain analysis." The results are then "displayed on the user's monitor."

While the device's software performs processing, the description doesn't explicitly frame it as a "standalone algorithm performance" study in the context of AI-driven diagnostic accuracy (e.g., classifying a disease state). It does demonstrate the standalone processing capabilities of the algorithm in generating "VEP multi-variable statistics and signal to noise ratio" as part of its normal operation, but without an explicit "ground truth" diagnosis it aims to achieve, it's difficult to categorize it as a typical "standalone algorithm performance" in the context of a diagnostic AI. The closest analogous measure is the repeatability and reproducibility of its signal processing outputs.

7. The Type of Ground Truth Used

The "ground truth" in this context is the consistent and accurate measurement of VEP signals by the device itself. The clinical testing aims to demonstrate the device's ability to repeatedly and reproducibly produce "VEP multi-variable statistics and signal to noise ratio." The underlying biological phenomenon of Visual Evoked Potentials is the de facto ground truth that the device seeks to accurately capture and quantify.

8. The Sample Size for the Training Set

The document does not mention a training set in the context of a machine learning or AI model that requires training data. The "software algorithm" for signal processing (noise filtering, artifact rejection, frequency and time domain analysis) is presented as a deterministic algorithm rather than a learned model.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned in the context of a machine learning model, this information is not applicable.

Summary

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K081591

Page 1 of 2

Premarket Notification 510(k) Submission

VeriSci Corp.

04/24/2009

510(k) Summary 2

Submitter:	VeriSci Corporation106 Anderson StreetRaritan, New Jersey 08869-1514Telephone: (908) 725-5213Fax: (908) 725-4617 MAY 15 2009
Contact Person:	George Hu, Ph.D.CEO
Trade Name:	Neucodia
Classification Name:	Stimulator, Photic, Evoked Response
Regulation Number:	882.1890
Classification Product Code:	GWE
Regulatory Class:	II

Identification of Legally Marketed Predicate Devices 2.1

The Neucodia system is substantially equivalent to Roland Consult's RETI-Port-Scan (K023525) and LACE Elettronica's GLAID Ocular Electrophysiology Device (K043367). The Neucodia device features are substantially equivalent to the predicate devices with respect to the device's general design concept, operational procedure, data processing methodology, data acquisition conditions, and indications for use. All the devices are electrophysiological (EEG) test systems that consist of electrical hardware and software to produce visual stimuli, EEG signal recording and processing for extraction of visual evoked potentials (VEPs). All the devices are intended to be used by trained medical professionals for the study of central visual functions.

2.2 Device Description

Indications for Use 2.3

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VeriSci Corp.

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04/24/2009

Substantial Equivalence 2.4

	Predicate Devices		Submission Device
Product Name	Roland ConsultRETI-Port-Scan(K023525)	LACE ElettronicaGLAID Ocular(K043367).	VeriSciNeucodia
Indications for useElectrophysiological device thatmeasures and processeselectroencephalographic signalselicited by visual stimuli presentedon electronic display for the studyof visual function	Yes	Yes	Yes
	Intended usersVision researchers, neurologists,eye-care professionals, and trainedmedical technicians	Yes	Yes	Yes
		Intended populationNormal observers,individuals at-risk for visualpathway dysfunction or withconfirmed ophthalmic disorders	Yes	Yes	Yes
			Site of useHospital, clinics, physicians'offices, and research laboratories	Yes	Yes	Yes
				Data collectedEEG signals	Yes	Yes
	StimuliPatterns on screen displayed inperiodical functions			Yes	Yes	Yes
			Data processingFrequency domain and timedomain analysis, statisticalanalysis	Yes	Yes	Yes
		Hardware for signalamplification and AD converting(Filter bandwidth, sampling rate,AD converting accuracy, Gain,CMRR, input impedance,input/output voltage range)		Yes	Yes	Yes

Performance and Validation 2.5

Software: Verification and validation

Safety test: UL 60601-1, IEC 60601-2-26, EN60601-1-2, ISO15004-2 System: Bench testing for power supply requirement, amplifier gain and CMRR Clinical testing:

VEP multi-variable statistics and signal to noise ratio were measured to produce system repeatability and reproducibility. 10 repeated sequential tests were performed on each subject to obtain repeatability performance data. In addition, each subject had three visits for the same repeated tests using different devices and with different operators and reapplication of electrodes to obtain reproducibility performance data. The clinical test results are described in Section 4.2.18, User's Manual and Section 5.2.3, Device Description.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.

MAY 15 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

VeriSci Corporation % George Hu, Ph.D. 106 Anderson Street Raritan, New Jersey 08869

Re: K081591

Trade/Device Name: NEUCODIA Regulation Number: 21 CFR 882.1890 Regulation Name: Evoked response photic stimulator Regulatory Class: II Product Codc: GWE Dated: April 24, 2009 Received: April 29, 2009

Dear Dr. Hu:

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 he 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- George Hu, Ph.D.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding 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/cdrl/industry/support/index.html.

Sincerely yours,

Mark H. Milken

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

Enclosure

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Premarket Notification 510(k) Submission

VeriSci Corp.

04/24/2009

1 Indications for Use

Device Name: NEUCODIA

Indications for Use:

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Use × AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Orthopedic, Division or Sugies and Restorative D. rices

§10(k) Number K081541

Regulation Number and Section

§ 882.1890 Evoked response photic stimulator.

(a)
Identification. An evoked response photic stimulator is a device used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye for use in evoked response measurements or for electroencephalogram (EEG) activation.(b)
Classification. Class II (performance standards).