The Visionsearch1 System consists of specialist software and the supporting computer and peripherals. The System displays multifocal visual patterns to evoke response in the retina which are transmitted to the visual cortex. The System then detects responses in the visual cortex using specific, validated third party EEG electrodes and biological amplifier. After analyzing the EEG, the System displays the electrical response from each segment of the retina. It also allows the user to compare the response time between eyes and compare an individual's measurements to those from a set of data that the user has compiled as reference.

AI/ML Overview

The Visionsearch1 System is an electrophysiological test unit intended for quantifying responses to visual stimulation by measuring Visual Evoked Potentials (VEP).

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria or a specific study to prove the device meets these criteria in the traditional sense of a clinical trial with performance metrics like sensitivity, specificity, or accuracy.

Instead, the submission for the Visionsearch1 System focuses on demonstrating substantial equivalence to a predicate device, the RETIScan/RETIPort (K023525). The effectiveness is asserted through compliance with established standards and comparison of technological characteristics.

Feature / Criterion	Acceptance Criteria (Implied by Substantial Equivalence to Predicate)	Reported Device Performance / Justification
Intended Use	Generate photic signals and measure and display the electrical response signals generated by the retina and the visual nervous system, particularly for mfVEP measurement.	"Same as predicate" - Electrophysiological Test Unit for quantifying the response to visual stimulation by measuring the Visual Evoked Potential (mfVEP functionality subset).
Indications for Use	Electrophysiological Test Unit for quantifying the retinal response and measuring parameters (VEP and ERG) related to retinal response.	"Same as Predicate for mfVEP functionality subset" - The Visionsearch1 System is specifically for "...quantifying the response to visual stimulation by measuring the Visual Evoked Potential." (from Indications for Use statement). It does not perform ERG.
Technological Characteristics	Similar principle of operation, physiological data collected (VEP), stimulus characteristics (luminance, chromaticity, field of view), and software functions for data display, analysis, and comparison to the predicate device.	Principle of operation: "Same as predicate, except: Only 56 segments are used (nasal field segments are not included). More advanced patient fixation – a wireless device is used for patient feedback instead of verbal communication, and a 'multi response' /' multi button' fixation system is supported."Physiological data collected: VEP waveforms (Predicate also collects ERG).Stimulus: "Stimulus provided is essentially identical (in terms of luminance, chromaticity and size of the stimulated visual field) to that of the predicate."Software Functions: "Same as predicate" including stimulus provision, acquisition, waveform display, noise detection, scaling/correlation for amplitude/latency, numerical/graphical display, comparisons, export/import, and printing.
Safety	Compliance with applicable electrical and biological safety standards (IEC 60601-1-2, IEC 60601-1), design control (ISO 13485, 21 CFR 820.30), and software lifecycle processes (IEC 62304:2006).	"The Visionsearch1 device complies with applicable standards for electrical and biological safety." Developed in accordance with design control requirements of ISO 13485:2003 and 21 CFR 820.30. Software development per IEC 62304:2006. Electrical components in contact with patient conform to IEC60601-1-2:2007. Isolation transformer complies with IEC 60601-1.
Effectiveness (Validation)	Independent verification of software functionality and data capture/analysis effectiveness.	"The effectiveness of data capture and analysis is validated through development under IEC 62304 software life cycle controls and independent laboratory verification of software functionality."

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

The document does not describe a clinical performance study with a specific "test set" in terms of patient data. The validation discussed is primarily related to software functionality and technical equivalence.

No "test set" of patient data is explicitly mentioned for performance evaluation.
The data provenance is not applicable as no specific patient data test set is used to demonstrate performance.

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

Not applicable. No clinical test set with ground truth established by experts is described in this submission.

4. Adjudication method for the test set

Not applicable. No clinical test set requiring adjudication is described.

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. The Visionsearch1 System is a diagnostic device for measuring VEP, not an AI-assisted diagnostic tool for interpretation by human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device's submission.

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

This submission does not detail a standalone performance study in the context of an algorithm's diagnostic output. The device itself is standalone in terms of generating and analyzing electrophysiological signals. Its "performance" is assessed through its technical specifications, compliance with standards, and functional equivalence to the predicate, rather than an independent diagnostic accuracy study using a clinical dataset. The "independent laboratory verification of software functionality" implies a form of standalone testing, but not clinical performance.

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

Not applicable in the context of a clinical performance study for diagnostic accuracy. The "ground truth" for the device's development and validation appears to be the established technical and functional performance of the predicate device and compliance with regulatory standards for medical device software and safety.

8. The sample size for the training set

Not applicable. The Visionsearch1 System measures physiological responses, it is not an AI/ML algorithm that is "trained" on a dataset of patient images or clinical data.

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

Not applicable, as there is no training set for an AI/ML algorithm described.

Summary

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K120104

510(k) Summary : Visionsearch1 System

MAY 2 1 2012 Contact Person: Dr. Arthur Brandwood Brandwood Biomedical Pty. Ltd. Suite 408, 460 Pacific Highway St Leonards, NSW 2065, AUSTRALIA Tel: +61 2 9906 2984 Fax: +61 2 8580 4613 arthur@brandwoodbiomedical.com Brand Name: Visionsearch1 System Common Name: Multi focal visual evoked potential (mfVEP) device Classification Name: (21CFR 882.1890) Evoked Response Photic Stimulator Product Code: GWE Predicate Device: RETIScan/RETIPort (K023525). Date Prepared: 11 May 2012 Device Description: The Visionsearch1 System consists of specialist software and the supporting computer and peripherals. The System displays multifocal visual patterns to evoke response in the retina which are transmitted to the visual cortex. The System then detects responses in the visual cortex using specific, validated third party EEG electrodes and biological amplifier. After analyzing the EEG, the System displays the electrical response from each segment of the retina. It also allows the user to compare the response time between eyes and compare an individual's measurements to those from a set of data that the user has compiled as reference. Indications for Use: Electrophysiological Test Unit for quantifying the response to visual stimulation by measuring the Visual Evoked Potential.

Summary of Basis for Substantial Equivalence:

The Visionsearch1 is substantially equivalent to the RETIScan/RETIPort (K023525) for mfVEP measurement. Equivalence is based on both devices having the same intended use and technological characteristics as summarized in the following Comparison Table.

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Feature	Predicate RETiscan (K023525)	Visionsearch1
Intended use	Generate photic signals and measureand display the electrical responsesignals generated by the retina and thevisual nervous system.	Same as predicate
Intended users	Ophthalmologists and trained medicaltechnicians and professionals	Same as predicate
Indications for use	Electrophysiological Test Unit forquantifying the retinal response andmeasuring parameters (VEP and ERG)related to retinal response.	Same as predicate for mfVEPfunctionality subset
IntendedPopulation	Patients with ophthalmic conditions	Same as predicate
Intended Useenvironment	Hospitals, clinics and physician offices	Same as predicate
Physiological datacollected	Electroretinogram and Visual EvokedPotential (VEP) waveforms	VEP waveforms
Principle ofoperation	Display multi-focal, light/dark patterns ,read resultant waveforms, filter andcorrelate against stimulus patterns toproduce response measurements.Key features:Dartboard layout with 58segments for mfVEP (1innermost ring with 8 segments,4 rings with 12 segments, 2 extrasegments in nasal field. Displayed on standard LCDmonitor (60:000 to 1 contrast,1.5 or greater LUX) at 24 degreefield of view when patient iscorrectly positioned. Uses m-sequence for temporalsequence generation. Supports 60Hz stimulation rate. Pattern reversal stimulation with4*4 checkerboard in eachsegment. Patient fixates on fixed icon orchanging pattern (where theycount the number of events andverbally inform the operator at	Same as predicate, except:Only 56 segments are used(nasal field segments are notincluded). More advanced patient fixation– a wireless device is used forpatient feedback instead ofverbal communication, and a'multi response' /' multi button'fixation system is supported.
Feature	Predicate RETIscan (K023525)	Visionsearch1
	the end).
Materials ofconstruction	Enterprise grade PC with stimulus qualitymonitor and/or Ganzfeld-stimulatorand/or Miniganzfeld-stimulator andintegrated bio amplifier (2-8 channels).	Enterprise grade PC with stimulus qualitymonitor attached to 3rd party(independently certified) clinical bioamplifier (4 channels).
Functions offeredby the software	Provision of stimulus patterns viacomputer monitor.Acquisition of evoked response througha bio amplifier.Display of waveforms captured by theamplifier during recording.Detection of noise and artifacts in theacquired response.Scaling and correlation of the responseto the stimulus to produce amplitudeand latency measurements.Resulting measurements are displayed innumerical and 2d/3d graphical formats.Comparisons between measurementsand against user supplied reference setsare possible.Recordings can be exported andimported between systems.Measurements and graphs can beprinted.	Same as predicate

Comments of the country

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Safety:

The Visionsearch1 device complies with applicable standards for electrical and biological safety. It was developed in accordance with design control requirements of 15013485:2003 and 21 CFR- 820.30. Software development was conducted in accordance with requirements of IEC 62304:2006 "Medical device software – Software lifecycle processes" and software validation was performed by an independent laboratory accredited by the Australian National Association of Testing Authorities (NATA) for testing and validation of medical device software. Electrical components in contact with the patient conform to IEC60601-1-2:2007. The isolation transformer powering all other electrical components complies with IEC 60601-1.

Effectiveness: Stimulus provided is essentially identical (in terms of luminance, chromaticity and size of the stimulated visual field) to that of the predicate. The effectiveness of data capture and analysis is validated

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through development under IEC 62304 software life cycle controls and independent laboratory verification of software functionality.

Substantial equivalence conclusion

The new device, the Visionsearch1 System, is considered to be substantially equivalent to the predicate device based on:

. equivalent technological characteristics
identical intended use .
. identical indications for use
identical users ●
identical patient population .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. The eagle is facing to the right.

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

MAY 2 1 2012

Brandwood Biomedical Pty. Ltd. c/o Mr. Norbert Stuiber TÜV SÜD America 1775 Old Hwy. 8 NW, Ste. 104 New Brighton, MN 55112-18914

Re: K120104

Trade/Device Name: Visionsearch1 System Regulation Number: 21 CFR 882.1890 Regulation Name: Evoked Response Photic Stimulator Regulatory Class: Class II Product Code: GWE Dated: May 15, 2012 Received: May 17, 2012

Dear Mr. Stuiber:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becases of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments, or to conninered prior to rialy 20, sire) in accordance with the provisions of the Federal Food, DNA de necs that have been roomsonied in assire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, merciolo, manel the act include requirements for annual registration, listing of general controls provisions of ractice, labeling, and prohibitions against misbranding and uevices, good manufacturing practices and evaluate information related to contract liability adulteration. Trease note: ODFET assement 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 If your device is classified (600 above). Existing major regulations affecting your device can be finay of subject to additional controls. Inc. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Norbert Stuiber

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.

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 (301) 796-7100 or at its Internet address

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

Sincerely yours,

Quk. Kum m fa

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

Enclosure

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Indications for Use

510(k) Number (if known):

K120104

Device Name: _

Visionsearch1 System

Electrophysiological Test Unit for quantifying the response Indications For Use: to visual stimulation by measuring the Visual Evoked Potential.

Prescription Use _

AND/OR

Over-The-Counter Use

(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)

Quynt Hoang

(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, 1 Nose and Throat Devices

Page 1 of 1

510(k) Number KL20104

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).