The EyeBOX is intended to measure and analyze eye movements as an aid in the diagnosis of concussion, also known as mild traumatic brain injury (mTBI), within one week of head injury in patients 5 through 67 years of age in conjunction with a standard neurological assessment of concussion.

A negative EyeBOX classification may correspond to eye movement that is consistent with a lack of concussion.

A positive EyeBOX classification corresponds to eye movement that may be present in both patients with or without concussion.

Device Description

Oculogica's EyeBOX model EBX-4 uses eye-tracking technology and a data processing algorithm to detect subtle changes in eye movements resulting from concussion. The eye tracking task takes about 4 minutes to complete and involves watching a video move around the perimeter of an LCD monitor positioned in front of the patient while a high speed near-infrared (IR) camera, positioned just below the screen, records eye movements. The data are then analyzed to produce one or more outcome measures.

The patient sits in front of the device with their head secured in a chinrest about 40 cm from the middle of the display. A face tracking camera, positioned above the screen, assists the patient and operator with proper placement of the patient by providing a second set of eye coordinates in three-dimensional space to calculate the patient's distance from the screen and the patient face's position relative to the display.

The device contains a rechargeable battery, which makes it possible to use without a direct connection to an active power source.

The device has Wi-Fi and Ethernet capabilities, which optionally can provide the user with the ability to send reports to a remote printer and/or file storage location.

AI/ML Overview

No clinical data was collected to prove the device meets acceptance criteria. The submission states, "No new clinical data were collected."

The document states that the EyeBOX Model EBX-4 is substantially equivalent to its predicate device, EyeBOX Model OCL 02.5. The rationale for this substantial equivalence is based on the fact that the EBX-4 has the same intended use, similar technological characteristics, and principles of operation as the predicate device. The changes implemented in the EBX-4 (e.g., removal of integrated headrest/chinrest, updated camera system, electronic component changes) are considered minor and do not raise new questions of safety or effectiveness.

To support this claim of substantial equivalence, Oculogica, Inc. performed performance testing rather than clinical efficacy studies. These tests focused on verifying the functionality and safety of the modified hardware and software.

Here's a breakdown of the requested information based on the provided document:

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

The document does not provide a specific table of acceptance criteria with corresponding performance metrics from a clinical study. Instead, the acceptance criteria appear to be addressed through a series of verification and validation activities showing that the device "functioned as intended" and that changes did not "adversely impact device performance."

Acceptance Criteria (Implied)	Reported Device Performance
Device functions as intended.	"In all instances, the EyeBOX Model EBX-4 functioned as intended."
Device does not have adverse impact on performance due to changes.	"Results of this comprehensive testing demonstrates these changes do not adversely impact device performance."
Meets electrical safety standards.	"Electromagnetic emissions, immunity, and safety testing according to IEC 60601-1-2:2014 (4TH EDITION)..." "In all instances, the EyeBOX Model EBX-4 functioned as intended."
Hardware integrity and functionality.	"Hardware verification testing," "Hardware specification testing." "In all instances, the EyeBOX Model EBX-4 functioned as intended."
Eye-tracking functionality.	"Eye-tracking functional testing," "Eye-tracking bench testing." "In all instances, the EyeBOX Model EBX-4 functioned as intended."
Software integrity and functionality.	"Software verification," "User acceptance testing." "In all instances, the EyeBOX Model EBX-4 functioned as intended."
Ophthalmic safety (light hazard).	"Light hazard testing for ophthalmic devices." "In all instances, the EyeBOX Model EBX-4 functioned as intended."

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

Test Set Sample Size: Not applicable. No new clinical data or test set was used for clinical performance evaluation. The performance testing focused on hardware and software verification.
Data Provenance: Not applicable. No new clinical data was collected.

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)

Not applicable. No clinical test set with human-established ground truth was used for this submission, as it relied on substantial equivalence and performance testing.

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

Not applicable. No clinical test set was used.

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

No MRMC comparative effectiveness study was done. The submission explicitly states, "No new clinical data were collected."

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

No standalone clinical performance study was done for this submission. The device is referred to as an "aid in the diagnosis of concussion... in conjunction with a standard neurological assessment of concussion," implying a human-in-the-loop use case. However, its performance was assessed through technical verification tests, not a clinical trial.

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

For the technical performance testing, the ground truth would be defined by engineering specifications and expected functional behavior, verified against established standards (e.g., IEC standards for electrical safety, internal specifications for eye-tracking accuracy).
For the original predicate device, the ground truth for clinical validation would have been established through clinical assessments of concussion (e.g., standard neurological assessments, potentially outcomes data or expert diagnosis), but details of the predicate device's clinical validation are not provided in this specific document. This submission does not provide information about the ground truth for the predicate device.

8. The sample size for the training set

Not applicable. The document describes a device with "a data processing algorithm," but it does not specify if or how a machine learning model was trained with a dataset. The emphasis is on the EyeBOX system's "principles of operation" remaining unchanged from the predicate device, suggesting the core algorithm (and any associated training) was already established.

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

Not applicable. Information regarding a training set or its ground truth establishment is not provided in this 510(k) summary, as the submission relies on substantial equivalence and verification testing of hardware/software changes.

Summary

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December 22, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Oculogica, Inc. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia, Pennsylvania 19103

Re: K212310

Trade/Device Name: EyeBOX (Model EBX-4) Regulation Number: 21 CFR 882.1455 Regulation Name: Traumatic Brain Injury Eye Movement Assessment Aid Regulatory Class: Class II Product Code: QEA Dated: November 29, 2021 Received: November 29, 2021

Dear Janice Hogan:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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,

for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: June 30, 2023 See PRA Statement on last page

510(k) Number (if known)

Device Name

EyeBOX

Indications for Use (Describe)

The EyeBOX is intended to measure and analyze eye movements as an aid in the diagnosis of concussion, also known as mild traumatic brain injury (mTBD), within one week of head injury in patients 5 through 67 years of age in conjunction with a standard neurological assessment of concussion.

A negative EyeBOX classification may correspond to eye movement that is consistent with a lack of concussion.

A positive EyeBOX classification corresponds to eye movement that may be present in both patients with or without concussion.

Type of Use (Select one or both, as applicable) □ Over-The-Counter Use (21 CFR 801 Subpart C) x Prescription Use (Part 21 CFR 801 Subpart D)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number. "

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510(k) SUMMARY Oculogica's EyeBOX Model EBX-4

Date Prepared:Submitted by:	11/19/2021Oculogica Inc.33 IRVING PLACENEW YORK, NY 10003ROSINA SAMADANI, PH.D.484-393-2694
Subject Device Name:Predicate Device Name:Regulation Number:Regulation Name:Regulatory Class:Product Code:Review Panel:Manufacturer:	EyeBOX Model EBX-4Oculogica, Inc. EyeBOX, Model OCL 02.5, K2018421 CFR 882.1455Traumatic brain injury eye movement assessment aidClass IIQEANeurologyOculogica Inc.33 IRVING PLACENEW YORK, NY 10003
Registration Number:Manufacturer Contact:	301453677ROSINA SAMADANI, PH.D.484-393-2694ROSINA@OCULOGICA.COM

Intended Use / Indications for Use

The EyeBOX is intended to be used as an aid in diagnosis of concussion.

A negative EyeBOX classification may correspond to eye movement that is consistent with a lack of concussion.

A positive EyeBOX classification corresponds to eye movement that may be present in both patients with or without concussion.

Device Description

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The device contains a rechargeable battery, which makes it possible to use without a direct connection to an active power source.

The device has Wi-Fi and Ethernet capabilities, which optionally can provide the user with the ability to send reports to a remote printer and/or file storage location.

Technological Characteristics

Oculogica's EveBOX uses eve-tracking technology and a data processing algorithm to detect subtle changes in eye movements resulting from concussion. The EyeBOX principles of operation have not changed. The principles of operation are identical to its predicate device. The technological characteristics important to device function as an aid in diagnosis of concussion are not changed; the eye tracking performance and proprietary EyeBOX algorithm, which processes the eye tracking data and outputs the BOX score, are not changed.

The following technological modifications have been implemented compared to the predicate.

The integrated headrest and chinrest have been removed. ●
. The eye tracking camera is replaced with a camera system having equivalent function.
Electronic components have been replaced to accommodate form factor changes.
Minor changes have been made to the user interface to simplify user interaction.
. Minor changes have been made to the EyeBOX report to assist interpretation of results.

None of the changes in technology raise new questions of safety or effectiveness. The hardware provides the same functionality as the predicate. Therefore, the safety and effectiveness of the final device is the same as the predicate. The following table presents a comparison of this submission to the predicate device.

	Predicate Device	Subject Device
510(k) Number	K201841	K212310
Trade Name	EyeBOX	Same
Model	OCL 02.5	EBX-4 / DMR-0004
Manufacturer	Oculogica, Inc.	Same
Product Code	QEA	Same
Regulation	21 CFR 882.1455 Traumatic braininjury eye movement assessment aid	Same
Indications for Use	The EyeBOX is intended to measureand analyze eye movements as an aid inthe diagnosis of concussion, also knownas mild traumatic brain injury (mTBI),within one week of head injury inpatients 5 through 67 years of age inconjunction with a standardneurological assessment of concussion.A negative EyeBOX classification maycorrespond to eye movement that isconsistent with a lack of concussion.	Same
	Predicate Device	Subject Device
	A positive EyeBOX classificationcorresponds to eye movement that maybe present in both patients with orwithout concussion.
Overall form factor	The predicate device (OCL 02.5) hastwo ends, one for the patient and one forthe operator. The patient end contains achinrest and a dedicated screen is usedto display the video stimulus to thepatient. A moveable operator console isused by the technician to control thedevice and enter data. The device'sdimensions are approximately 21" x 20"x 26" (h, w, d) and it weighs about 34pounds. Since it does not have aninternal battery, it must be connected toA/C power.	The EBX-4 is similar in shape to an all-in-one PC but without a keyboard. The screenis mounted on a pedestal that can be tiltedup or down. The device's dimensions areapproximately 19" x 12" x 8" (h, w, d) andit weighs about 12 pounds. A separatechinrest must be used with the device.Because it includes a rechargeable battery,it can be used with or without a connectionto A/C power.
Biocompatibility	The patient's head is stabilized by thechinrest and headrest. The user manualinstructs that an appropriate drape beused to avoid direct patient contact, sono biocompatibility is claimed.	There is no patient contact with theEyeBOX EBX-4, so no biocompatibility isclaimed.
Eye tracking	An IR machine vision camera operatesat 500 fps and calculates gazecoordinates from the image data. 3-frame smoothing (filtering) is used toremove high frequency noise. No headmovement compensation is employed.The eye-tracking system has a spatialresolution of < 0.01°.	Same
Patient positioning	Seated only. A fixed headrest/chinrestassembly is used to position thepatient's head at the correct positionfrom the camera.	Seated only, cameras are used to calculatethe distance between the display and thepatient's eyes to establish the correctposition for the patient and chinrest.
Computer and otherelectronics	Contains a general-purpose computer,two LCD screens (1 for the stimulusdisplay and 1 for the operator console),an infrared light illuminator, machinevision camera, and related powercomponents.	Similar. The device uses a single LCDtouchscreen, two cameras, and a chargeablebattery.
Principle of Operation	The data processing algorithm detectssubtle changes in eye movementsresulting from concussion. The eyetracking task takes about 4 minutes tocomplete and involves watching a videomove around the perimeter of an LCDmonitor positioned in front of thepatient while a high speed near-infrared	Same
	Predicate Device	Subject Device
	(IR) camera records gaze positions 500times per second. The post-processeddata are analyzed automatically toproduce a BOX score.
WiFi Functionality	Provided	Same
Enclosure	Table-top	Same

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Summary of Clinical Testing

No new clinical data were collected.

Summary of Performance Testing

The following verification / validation activities were performed subsequent to a risk assessment evaluation of the device modifications per the Oculogica Quality Management System. Results of this comprehensive testing demonstrates these changes do not adversely impact device performance.

. Electromagnetic emissions, immunity, and safety testing according to IEC 60601-1-2:2014 (4TH EDITION) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
. Hardware verification testing
. Hardware specification testing
Eye-tracking functional testing
Eye-tracking bench testing
. Software verification
User acceptance testing
. Light hazard testing for ophthalmic devices

In all instances, the EyeBOX Model EBX-4 functioned as intended.

Substantial Equivalence

The EyeBOX Model EBX-4 is as safe and effective as the EyeBOX Model OCL 02.5. The EyeBOX Model EBX-4 has the same indication for use and similar technological characteristics, and principles of operation as its predicate device. Performance data demonstrate that the EyeBOX Model EBX-4 is as safe and effective as EyeBOX Model OCL 02.5. Therefore, the minor technological differences between the EyeBOX Model EBX-4 and its predicate device raise no new issues of safety or effectiveness. Thus, the EyeBOX Model EBX-4 is substantially equivalent.

Conclusions

The EyeBOX Model EBX-4 has the same intended use and principle of operation as the previously cleared EyeBOX Model OCL 02.5 device. In addition, the EyeBOX Model EBX-4 device has similar technological characteristics as its predicate. None of the changes in technology raise new questions of safety or effectiveness, and comprehensive testing demonstrates that these changes also do not adversely impact performance. Thus, the EyeBOX Model EBX-4 device is substantially equivalent to its predicate device.

Regulation Number and Section

§ 882.1455 Traumatic brain injury eye movement assessment aid.

(a)
Identification. A traumatic brain injury eye movement assessment aid is a prescription device that uses a patient's tracked eye movements to provide an interpretation of the functional condition of the patient's brain. This device is an assessment aid that is not intended for standalone detection or diagnostic purposes.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance data under anticipated conditions of use must evaluate tracked eye movement in supporting the indications for use and include the following:
(i) Evaluation of sensitivity, specificity, positive predictive value, and negative predictive value using a reference method of diagnosis;
(ii) Evaluation of device test-retest reliability; and
(iii) A description of the development of the reference method of diagnosis, which may include a normative database, to include the following:
(A) A discussion of how the clinical work-up was completed to establish the reference method of diagnosis, including the establishment of inclusion and exclusion criteria; and
(B) If using a normative database, a description of how the “normal” population was established, and the statistical methods and model assumptions used.
(2) Software verification, validation, and hazard analysis must be performed. Software documentation must include a description of the algorithms used to generate device output.
(3) Performance testing must demonstrate the electrical safety and electromagnetic compatibility (EMC) of the device.
(4) The patient-contacting components of the device must be demonstrated to be biocompatible.
(5) A light hazard assessment must be performed for all eye-tracking and visual display light sources.
(6) Labeling must include:
(i) A summary of clinical performance testing conducted with the device, including sensitivity, specificity, positive predictive value, negative predictive value, and test-retest reliability;
(ii) A description of any normative database that includes the following:
(A) The clinical definition used to establish a “normal” population and the specific selection criteria;
(B) The format for reporting normal values;
(C) Examples of screen displays and reports generated to provide the user results and normative data;
(D) Statistical methods and model assumptions; and
(E) Any adjustments for age and gender.
(iii) A warning that the device should only be used by trained healthcare professionals;
(iv) A warning that the device does not identify the presence or absence of traumatic brain injury or other clinical diagnoses;
(v) A warning that the device is not a standalone diagnostic; and
(vi) Any instructions to convey to patients regarding the administration of the test and collection of test data.