The Retitrack™ is intended for recording, viewing, and analyzing temporal characteristics of fixation and saccadic responses when viewing a visual stimulus. The Retitrack™ is intended for use by healthcare practitioners in healthcare settings (e.g., physician's office, clinic, laboratory).

Device Description

The Retitrack™ is a monocular, bench-top saccadometer that incorporates scanning laser ophthalmoscope (SLO) technology and eye tracking software to record, view, measure, and analyze eye motion. The Retitrack™ is comprised of an optical head containing an illumination system and an optical system; a base unit with a computer, electronics, and a power distribution system; connections for external input/output devices (e.g., monitor, keyboard, mouse, and storage media); a patient forehead and chin rest; and operational software.

The Retitrack™ interacts with the patient by directing light from an infrared (840 nm) superluminescent diode (SLD) into the patient's eye. The only parts of the device that contact the patient are the forehead and chin rest with adjustable temple pads and an optional attachable head strap to stabilize the patient's head.

The Retitrack™ uses the SLD light to scan the patient's retina in two dimensions while the patient is viewing a visual stimulus. The optical imaging system detects the reflected (or returned) light from the retina and creates high-resolution, digital retinal video sequences over time. The eye tracking software uses eye motion corrected frames to measure the translational retinal movement over time. The device displays the analysis of the eye motion results and saves the retinal video and a report. The Retitrack™ does not provide a diagnosis or treatment recommendation.

The Retitrack™ has separate tests that measure fixation stability (including microsaccades and drift) and visually guided horizontal saccade tracking. The Retitrack™ can be programmed by the user with specific visual stimuli presentations, including a single fixed stimulus to measure fixation stability or two alternating stimuli in different orientations to measure horizontal saccades. For the fixation stability test, the Retitrack™ analyzes the fixation responses, including microsaccade amplitude, microsaccade frequency, microsaccade velocity, drift velocity, and drift ratio over time. For the saccade tracking tests, the Retitrack™ analyzes the saccadic responses, including duration, amplitude, target accuracy, latency, and velocity.

AI/ML Overview

The provided text describes the Retitrack™ device and its performance testing to demonstrate substantial equivalence to a predicate device. However, it does not explicitly state "acceptance criteria" in the format of a table or provide specific values for the device to meet. Instead, it describes various performance tests and their outcomes, implying that successful completion of these tests serves as the criteria for acceptance.

Therefore, the following information is extracted and presented based on what is available in the text, and where specific acceptance criteria are not provided, the reported performance is described as the outcome of the validation.

Acceptance Criteria and Device Performance

Since explicit quantitative acceptance criteria for all aspects are not provided, the "Acceptance Criteria" column will describe the objective of the test, and the "Reported Device Performance" will detail the findings.

Acceptance Criteria (Objective of Test)	Reported Device Performance
Verify compliance with safety standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60825-1, ANSI Z80.36)	Device demonstrated compliance with all listed standards, including IEC 60601-1:2005 + AMD2:2012 + AMD2:2020, IEC 60601-1-2:2014, IEC 60825-1:2014, and ANSI Z80.36-2021. It is classified as Group 1 scanning instrument (light hazard $\leq$ 1.32 mW at the eye) and Class 1 laser product.
Software verification and validation (function, GUI, analysis algorithm, usability)	Software functions, graphical user interface (GUI), analysis algorithm, and usability were verified and validated with representative intended users in a simulated use environment. (No specific metrics provided, but implied successful).
Eye movement measurement accuracy and tracking performance (bench testing)	Demonstrated accuracy and tracking performance. (No specific metrics provided, but implied successful). Spatial resolution reported as < 1.2 arc min.
Optical subsystem and visual stimulus/fixation display performance (bench testing)	Verified performance. (No specific metrics provided, but implied successful).
Mechanical and electrical hardware safety and reliability (bench testing)	Demonstrated safety and reliability. (No specific metrics provided, but implied successful).
Performance under environmental operating, storage, and transport conditions (bench testing)	Verified performance. (No specific metrics provided, but implied successful).
Validate intended use for recording, viewing, measuring, and analyzing temporal characteristics of fixation and saccadic responses	Fixation and saccade measurements were successfully measured for all 21 human subjects. A linear relationship with excellent correlation was found between the expected and measured retinal response for saccade amplitude and velocity measurements.
Compare retinal and pupil tracking methods for saccade measurement	Linear regression and agreement analyses demonstrated good agreement between pupil and retinal tracking methods for saccade amplitude, latency, and velocity measurements. Retitrack™ (480 Hz) velocity measurement was, on average, 1.5 times (95% CI of 1.2 to 1.8 times) faster than a conventional pupil-based system (60 Hz).

Study Details:

Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: 21 human subjects (ages 21-55 for the intended use validation, ages 19-53 for retinal vs. pupil comparison).
  - For the intended use validation: The study used 10-second human eye movement videos, with >200 videos for fixation stability and >300 videos for horizontal saccade tracking.
- Data Provenance: The document does not specify the country of origin for the human subject data. It also does not explicitly state whether the study was retrospective or prospective, but the description of "human subjects" and "recorded... while pupil videos were recorded simultaneously" implies a prospective data collection.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set. The ground truth appears to be based on the device's ability to accurately measure expected responses or on comparative analysis with another tracking method, rather than expert consensus on a diagnosis or interpretation.
Adjudication Method for the Test Set:
- The document does not specify any adjudication method for the test set. The validation seems to rely on quantitative measurement comparisons and correlations rather than subjective interpretations requiring adjudication.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done in the context of human readers improving with AI vs. without AI assistance. The device is an "Eye Movement Monitor" and the studies reported focus on its measurement accuracy and equivalence to other tracking methods, not on assisting human interpretation of images or data.
Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):
- Yes, standalone performance was assessed. The device itself is an automated measurement tool. The performance tests described (e.g., "Fixation and saccade measurements were successfully measured for all subjects," "linear relationship... found between the expected response and the measured retinal response," "good agreement between the pupil and retinal tracking methods") refer to the algorithm's direct measurement capabilities without human interpretation as part of the primary output.
Type of Ground Truth Used:
- The ground truth appears to be based on:
  - Expected responses: For saccade amplitude and velocity, the device's measurements were compared against "expected response" (likely defined by the stimulus presented).
  - Comparative method: For retinal vs. pupil tracking, the ground truth for comparison was the "pupil videos... processed with a standalone pupil tracking algorithm."
- This is not typical "expert consensus" or "pathology" ground truth as might be seen for diagnostic imaging devices. It's an engineering and physiological measurement validation.
Sample Size for the Training Set:
- The document does not provide information on the sample size used for the training set.
How the Ground Truth for the Training Set Was Established:
- The document does not provide information on how the ground truth for an implied training set (if any for the analysis algorithm's development) was established.

Summary

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May 9, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

C. Light Technologies, Inc. % Christy Coleman Regulatory Consultant Blur Product Development 260 James Jackson Avenue Cary, North Carolina 27513

Re: K222484

Trade/Device Name: Retitrack Regulation Number: 21 CFR 886.1510 Regulation Name: Eye Movement Monitor Regulatory Class: Class II Product Code: HLL Dated: March 31, 2023 Received: April 3, 2023

Dear Christy Coleman:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Elvin Y. Ng -S

Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222484

Device Name Retitrack

Indications for Use (Describe)

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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Image /page/3/Picture/0 description: The image contains the logo for C. Light Technologies. The logo consists of an eye-shaped icon on the left, with a series of small squares emanating from the top right corner of the eye. To the right of the icon is the text "C. LIGHT" in a bold, sans-serif font, with the word "TECHNOLOGIES" in a smaller font size underneath.

510(k) SUMMARY

Preparation Date:	May 8, 2023
Submitter:	C. Light Technologies, Inc.84 High St., Suite 303Medford, MA 02155Contact: Christy K. Sheehy-Bensinger, Ph.D., CEOPhone: 518-339-2895
Device Information:
Trade Name:	Retitrack™
Common/Classification Name:	Eye Movement Monitor
Device Classification:	Class II (21 CFR 886.1510)
Product Code:	HLL
Predicate Device:	Saccadometer Plus (K152890)Class II (21 CFR 886.1510); Product Code HLLApplicant: Ober Consulting Sp. Z.o.o.
Reference Devices:	RightEye Vision System (K181771)Class II (21 CFR 882.1460); Product Code GWNApplicant: RightEye LLCCenterVue COMPASS (K150320)Class II (21 CFR 886.1570); Product Codes MYC and HPTApplicant: CenterVue S.p.A.

Device Description:

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The Retitrack™ is classified as a Group 1 scanning instrument, which poses no potential light hazard during device operation, per the American National Standards Institute (ANSI) Z80.36-2021, Light Hazard Protection for Ophthalmic Instruments standard. In addition, the Retitrack™ is classified as a Class 1 laser product per the International Electrotechnical Commission (IEC) 60825-1:2014 (Ed 3.0) Safety of laser products – Part 1: Equipment classification and requirements standard.

Intended Use/Indications for Use:

The Retitrack™ is intended for recording, viewing, measuring, and analyzing temporal characteristics of fixation and saccadic responses when viewing a visual stimulus. The Retitrack™ is intended for use by healthcare practitioners in healthcare settings (e.g., physician's office, clinic, laboratory).

The Retitrack™ has the same intended use as the predicate device to measure and record temporal characteristics of saccadic responses when viewing a visual stimulus.

Comparison of Technological Characteristics:

The Retitrack™ shares many of the same technological characteristics as the Saccadometer Plus. Both the Retitrack™ and the predicate device direct infrared light into the eye and use the reflected light to track the eye for the purpose of measuring eye movement. Although their light sources are different, both devices conform to voluntary consensus standards for light safety and laser safety.

The Retitrack™ device tracks eye movement by measuring the translational retinal movement observed between video frames over time, whereas the predicate device tracks eye movement based on anterior eye landmarks. The method of retinal tracking to measure eye movement is substantiated by the COMPASS reference device, which uses retinal tracking to measure fixation stability.

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While the temporal resolution of the Retitrack™ differs from the predicate device, the published literature on the temporal resolution needed to track fixational and saccadic movements along with the temporal resolution of the reference devices reflect that this difference does not raise new or different questions of safety or effectiveness.

The Retitrack™ collects monocular eye movement data while the predicate device collects binocular data. Due to the conjugacy and synchronicity of saccadic eye movements, the predicate device adds and averages the data for both eyes. Therefore, the difference between monocular and binocular data collection does not affect the effectiveness to measure saccades.

Both the Retitrack™ and the predicate device measure visually-guided horizontal saccades using multiple displaced visual stimuli to generate eye movements. The Retitrack™ has additional functionality to measure fixational stability, which is also measured by the RightEye reference device.

The Retitrack™ uses an internal monitor to display visual stimuli to generate eye movements, similar to the RightEye reference device, and corrects for the patient's refractive error, similar to the COMPASS reference device. Conversely, the predicate device presents visual stimuli using laser projectors that are mounted to the forehead and does not provide refractive error correction. These differences do not affect the ability of the device to present visual stimuli to generate eye movement and accurately measure saccadic responses. Therefore, these differences do not raise new or different safety and effectiveness questions.

Both devices record, analyze, and report temporal characteristics of eye movements and use software algorithms to detect saccades. The Retitrack™ has integrated software with a graphical user interface used to record, view, measure, and analyze eye movement, whereas the predicate device has separate hardware to record movement and software to analyze the data. The difference in integrated vs. separate hardware/software applications does not affect the effectiveness of the device to record, view, or analyze data. In addition, both the RightEye and COMPASS reference devices provide a software user interface like the Retitrack™.

Both the Retitrack™ and the predicate device contact the patient's intact skin/hair over a limited contact duration and are designed to be biocompatible for their intended use. Additionally, both devices conform to consensus standards for electrical safety and electromagnetic compatibility (EMC). The conformance to these standards supports that the difference between the AC-power of the Retitrack™ vs. battery power of the predicate device does not raise new or different safety questions.

The technological differences between the Retitrack™ and the predicate device are substantiated by similar technological characteristics in the technological reference devices. Furthermore, the technological differences do not raise new or different questions of safety and effectiveness, as demonstrated by performance testing of the Retitrack™ device.

Table 1 compares the Retitrack™ with the predicate and reference devices.

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Table 1. Predicate and Reference Device Comparison Table
Feature	PROPOSEDSUBJECT DEVICERetitrack™	PREDICATE DEVICEK152890Saccadometer Plus	REFERENCE DEVICEK181771RightEye Vision System	REFERENCE DEVICEK150320COMPASS
Device andProduct CodeClassification	Eye Movement Monitor (HLL)21 CFR 886.1510, Class II	Eye Movement Monitor (HLL)21 CFR 886.1510, Class II	Nystagmograph (GWN)21 CFR 882.1460, Class II	Ophthalmoscope, Laser Scanningand Perimeter (MYC and HPT)21 CFR 886.1570, Class II21 CFR 886.1605, Class I
Intended Use/Indications for Use	The Retitrack™ is intended forrecording, viewing, measuring,and analyzing temporalcharacteristics of fixation andsaccadic responses when viewinga visual stimulus.	The Saccadometer Plus is intendedfor measuring temporalcharacteristics of saccadicrefixation responses when viewinglateral visual stimulus andidentifying the individual timedelays of moving the eyes towardthe stimuli.	The RightEye Vision System isintended for recording,viewing, and analyzing eyemovements in support ofidentifying visual trackingimpairment in human subjects.	The CenterVue COMPASS isintended for taking digital imagesof a human retina without theuse of a mydriatic agent and formeasuring retinal sensitivity,fixation stability and the locus offixation. It contains a referencedatabase that is a quantitativetool for the comparison of retinalsensitivity to a database of knownnormal subjects.
Rx Only/OTCEye MovementTracking Method	Prescription Device• Analyzes reflected infraredlight to track eye movements• Retinal Tracking• Pupil camera used foralignment purposes	Prescription Device• Analyzes reflected infrared lightto track eye movements• Anterior eye (corneal bulge,limbus, iris/pupil) tracking• Fixation target used to definethe initial eye position	Prescription Device• Analyzes reflected infraredlight to track eye movements• Pupil tracking• Includes a remote camera	Prescription Device• Analyzes reflected infraredlight to track eye movements• Retinal Tracking• Pupil camera used for alignmentpurposes
PerformanceSpecifications	Spatial Resolution: $< 1.2$ arc minTemporal Resolution: 480 Hz	Spatial Resolution: $< 5$ arc minTemporal Resolution: 1,000 Hz	Spatial Resolution: UnknownTemporal Resolution: 60 Hz	Spatial Resolution: UnknownTemporal Resolution: 25 Hz
Eye MovementMeasurements	• Monocular• Visually Guided HorizontalSaccades• Fixational Stability	• Binocular (added and averaged)• Visually Guided HorizontalSaccades	• Binocular• Visually Guided Horizontaland Vertical Saccades• Fixational Stability	• Monocular• Fixational Stability
Visual Stimuli toGenerate EyeMovement	• Built-in stimulus presentationusing a display monitor• User can program specificstimuli presentations/durations• Multiple displaced stimulio Horizontal positiono Single center fixed target	• Built-in stimulus presentationusing laser projectors• User can program specific stimulipresentations/durations• Multiple displaced stimulio Horizontal positiono Center fixed target	• Stimulus presentation usingmonitor as projection source• User can program differentstimuli presentationso Multiple displaced stimulio Horizontal/vertical positiono Single fixed target	• Fixation target projectorprojects green LED target• User cannot program differentstimuli presentationso Single fixed target• Refractive error compensation
Table 1. Predicate and Reference Device Comparison Table
Feature	PROPOSEDSUBJECT DEVICERetitrack™	PREDICATE DEVICEK152890Saccadometer Plus	REFERENCE DEVICEK181771RightEye Vision System	REFERENCE DEVICEK150320COMPASS
Software andData Analysis	• Automatic saccade detectionalgorithm• Software records, views, andanalyzes eye movement data• Graphical User Interface	• Automatic saccade detectionalgorithm• Separate software application(LatencyMeter) views andanalyzes eye movement data	• Automatic saccade detectionalgorithm• Software records, views, andanalyzes eye movement data• Graphical User Interface	• Analysis of fixationcharacteristics, allowing activecompensation of the positionof perimetric stimuli• Graphical User Interface• Fixation stability
Eye MovementMeasurementOutput	• Latency (promptness)• Duration• Velocity• Amplitude (Position)• Target accuracy• Fixation Stability	• Latency (promptness)• Duration• Velocity• Amplitude (Position)	• Latency (promptness)• Duration• Velocity• Amplitude (Position)• Target accuracy• Fixation Stability
Patient ContactComponents	• Biocompatible for limitedduration, intact skin/hair contact• Cleaned with medical gradedisinfectant wipe	• Biocompatible for limitedduration, intact skin/hair contact• Cleaned with medical gradedisinfectant wipe	Not applicable – no patientcontact	• Biocompatible for limitedduration, intact skin contact• Cleaned with medical gradedisinfectant wipe
Light Safety	• Infrared (840nm)Superluminescent Diode (SLD)• Complies with ANSI Z80.36-2021 for Group 1 scanninginstruments (weighted power$\leq$ 1.32 mW at the eye)• Class 1 Laser (finished device)complies with IEC 60825-1:2014	• Infrared (940 nm) LED(irradiance <1mW/cm2)• Complies with IEC 62471standard for light safety• Class 2 lasers, 655 nm, <1mW• Complies with IEC 60825-1:2007for laser safety	• Near infrared light source• Complies with IEC 62471	• Infrared (825-870 nm) imagingsystem with scanning mirror• Infrared LEDs and visible (440-650) LED illumination sources• Complies with ISO 15004-2:2007 for light hazardprotection
Electrical Safety/ElectromagneticCompatibility(EMC)	• AC-powered• Complies with IEC 60601-1and IEC 60601-1-2	• Battery-powered• Complies with IEC 60601-1 andIEC 60601-1-2	• AC-powered• Complies with IEC 60601-1and IEC 60601-1-2	• AC-powered• Complies with IEC 60601-1 andIEC 60601-1-2

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Image /page/7/Picture/0 description: The image shows the logo for C. Light Technologies. The logo features a stylized eye graphic on the left, rendered in a light blue color. To the right of the eye is the company name, "C. LIGHT," in a dark gray sans-serif font. Below the company name, in smaller letters, is the word "TECHNOLOGIES," also in dark gray.

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Performance Testing:

The following non-clinical performance testing was conducted for the Retitrack™:

. Verification of compliance to the following standards:
- o IEC 60601-1:2005 + AMD2:2012 + AMD2:2020 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- o IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- o IEC 60825-1:2014 Safety of laser products Part 1: Equipment classification and requirements
- ANSI Z80.36-2021 Ophthalmics Light Hazard Protection for Ophthalmic Instruments o
. Software verification and validation testing of the function, graphical user interface, analysis algorithm, and usability with representative intended users in a simulated use environment.
Bench performance testing for verification of:
- o Eye movement measurement accuracy and tracking performance;
- o Optical subsystem and visual stimulus/fixation display performance;
- Mechanical and electrical hardware safety and reliability; and
- o Performance under environmental operating, storage, and transport conditions.

The following performance testing was conducted using human subjects to evaluate the performance of the Retitrack™ to measure and analyze eye movements:

. The intended use for recording, viewing, measuring, and analyzing the temporal characteristics of fixation and saccadic responses when viewing a visual stimulus was validated using 21 human subjects (ages 21-55). This sample contained 10-second human eye movement videos with > 200 videos for fixation stability and > 300 videos for horizontal saccade tracking. Fixation and saccade measurements were successfully measured for all subjects. Furthermore, a linear relationship with an excellent correlation was found between the expected response and the measured retinal response for the saccade amplitude and velocity measurements.
A comparison of retinal and pupil tracking methods was performed using 21 human subjects (ages 19-53). For each subject, 10-second retinal videos were recorded with the Retitrack™, while pupil videos were recorded simultaneously with the alignment camera. The pupil videos were processed with a standalone pupil tracking algorithm. Measurements of horizontal saccades at different stimulus target separations were performed with the analysis of amplitude, latency, and velocity. Linear regression and agreement analyses demonstrated good agreement between the pupil and retinal tracking methods for saccade amplitude, latency, and velocity measurements.

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Image /page/9/Picture/0 description: The image shows the logo for C. Light Technologies. The logo features a stylized eye graphic on the left, rendered in a light blue color. To the right of the eye is the company name, "C. LIGHT," in a dark gray sans-serif font. Below the company name is the word "TECHNOLOGIES," also in dark gray and a smaller font size.

The testing showed that the velocity measurement is, on average, 1.5 times (95% Cl of 1.2 to 1.8 times) faster with the Retitrack™ (sampling at temporal resolution of 480 Hz) as compared to a conventional pupil-based eye tracking system (sampling at a temporal resolution of 60 Hz). This information was updated accordingly in the Instructions for Use to inform users how to compare the Retitrack™ to other pupil-based tracking methods.

Conclusions:

Performance testing demonstrated that the Retitrack™ meets all design requirements for safety and performance. Performance testing validated the Retitrack™ for its intended use and demonstrated that retinal tracking is an equivalent method to anterior eye/pupil tracking for measurement of saccadic responses.

Based on the collective performance test results, the Retitrack™ is as safe and effective as the predicate device for the intended use. In conclusion, C. Light Technologies, Inc. has demonstrated that the Retitrack™ is substantially equivalent to the predicate device in intended use and technological characteristics.

Regulation Number and Section

§ 886.1510 Eye movement monitor.

(a)
Identification. An eye movement monitor is an AC-powered device with an electrode intended to measure and record ocular movements.(b)
Classification. Class II.