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 is an eye-tracking device with custom software. The device is comprised of a host PC with integrated touchscreen interface for the operator, eye tracking camera, LCD stimulus screen and head-stabilizing rest (chin rest and forehead rest) for the patient, and data processing algorithm. The data processing algorithm detects 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 records gaze positions 500 times per second. The post-processed data are analyzed automatically to produce one or more outcome measures.

AI/ML Overview

The provided text describes the Oculogica EyeBOX, Model OCL 02, a device intended to aid in the diagnosis of concussion (mild traumatic brain injury, mTBI). Since this is a 510(k) submission for a modified device (OCL 02) that is deemed substantially equivalent to a previously cleared device (OCL 01), the document focuses on demonstrating that the changes do not raise new questions of safety or effectiveness. Therefore, detailed information about the original clinical study that proved the device met its acceptance criteria is not explicitly repeated in this 510(k) summary; rather, it refers back to the data from the predicate device (DEN170091).

Based on the information provided, here's what can be extracted and inferred:

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

The provided 510(k) summary for OCL 02 does not explicitly state acceptance criteria or device performance metrics for this specific submission because it's a modification focusing on substantial equivalence. It asserts that the EyeBOX algorithm which processes the eye tracking data and outputs the BOX score is not changed. This implies that the performance established for the predicate device (OCL 01 under DEN170091) is maintained.

To fully answer this, one would typically need access to the original DEN170091 submission. However, we can infer the type of performance metrics that would have been evaluated: sensitivity and specificity for concussion diagnosis. The "Indications for Use" statement gives a clue:

"A negative EyeBOX classification may correspond to eye movement that is consistent with a lack of concussion." (Implies high negative predictive value/sensitivity for ruling out concussion)
"A positive EyeBOX classification corresponds to eye movement that may be present in both patients with or without concussion." (Implies that a positive result needs to be interpreted in conjunction with other clinical assessments and not as a definitive diagnosis, suggesting emphasis might be on sensitivity rather than high specificity as a standalone diagnostic.)

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

The 510(k) for OCL 02 does not provide details about the test set sample size or data provenance, as it refers to the predicate device's data. For the predicate device (OCL 01, DEN170091), a clinical study would have been conducted. This information is not present in the provided text.

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)

This information is also not present in the provided text for the OCL 02 submission, as it relies on the predicate device's data, which is not detailed here. For concussion diagnosis, the ground truth would typically be established by a consensus of neurologists, sports medicine physicians, or other specialists experienced in concussion diagnosis, likely based on a combination of clinical assessment (e.g., SCAT5, BESS, neurocognitive testing), imaging (if applicable for other purposes), and follow-up.

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

This information is not present in the provided text. Adjudication methods would have been part of the clinical study design for the predicate device to establish the ground truth for concussion diagnosis.

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

The EyeBOX is described as an "aid in the diagnosis," not a standalone diagnostic that replaces human assessment. The text states it is used "in conjunction with a standard neurological assessment of concussion." This implies that it is meant to assist clinicians. However, the provided document does not contain information regarding an MRMC comparative effectiveness study or the effect size of human reader improvement with AI assistance. Such a study might have been part of the predicate device's clinical evidence, but it's not detailed here.

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

The device provides a "BOX score" and a "classification" (positive or negative). The statement "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." implies the algorithm generates a classification on its own. However, the overriding indication for use is "as an aid in the diagnosis... in conjunction with a standard neurological assessment." This strongly suggests that a standalone, algorithm-only diagnosis is not the intended use or claim, and therefore, a standalone performance study as a definitive diagnosis without human-in-the-loop for the final diagnostic decision would be inconsistent with the stated indication. The algorithm produces a result, but that result is an aid to a human clinician making the final diagnosis.

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

The type of ground truth used for the predicate EyeBOX (OCL 01) would almost certainly have been expert clinical consensus of concussion diagnosis, based on standard neurological assessment, symptom questionnaires, and potentially neurocognitive testing. Concussion diagnosis is primarily clinical, so pathology is not a typical ground truth for this condition, and while outcomes data is important, the initial diagnostic ground truth typically relies on expert assessment at the time of diagnosis. This is inferred, as it is not explicitly stated in the provided document.

8. The sample size for the training set

The provided 510(k) summary for OCL 02 focuses on the current device and its substantial equivalence to its predicate. It explicitly states that "The EyeBOX algorithm which processes the eye tracking data and outputs the BOX score is not changed." This suggests the algorithm was developed and trained prior to the OCL 01 submission. The sample size for the training set for the original algorithm development is not provided in this document.

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

Similar to the test set, the ground truth for the training set would have been established through expert clinical consensus based on comprehensive neurological assessments. This information is not provided in this document but is inferred based on standard practices for clinical AI/ML device development in this field.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

Oculogica, Inc. Rosina Samadani CEO 33 Irving Place New York, New York 10003

Re: K191183

Trade/Device Name: EyeBOX Regulation Number: 21 CFR 882.1455 Regulation Name: Traumatic Brain Injury Eye Movement Assessment Aid Regulatory Class: Class II Product Code: QEA Dated: May 2, 2019 Received: May 2, 2019

Dear Rosina Samadani:

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

{1}------------------------------------------------

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 medical devices and radiation-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,

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

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Druq Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K191183

Device Name

EyeBOX

Indications for Use (Describe)

A neqative EyeBOX classification may correspond to eve 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)

区 Prescription Use (Part 21 CFR 801 Subpart D)

[ ] Over-The-Counter Use (21 CFR 801 Subpart C)

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 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."

{3}------------------------------------------------

510(k) Summary [21 CFR 807.92]

Date Prepared:Submitted by:	July 29, 2019Oculogica Inc.33 IRVING PLACENEW YORK, NY 10003ROSINA SAMADANI, PH.D.484-393-2694
Subject Device Name:Predicate Device Name:Regulation Number:Regulation Name:	EyeBOX, Model OCL 02EyeBOX, Model OCL 01, DEN17009121 CFR 882.1455Traumatic brain injury eye movement assessment aid
Regulatory Class:Product Code:Review Panel:	Class IIQEANeurology
Manufacturer:	Oculogica Inc.33 IRVING PLACENEW YORK, NY 10003
Registration Number:Manufacturer Contact:	PendingROSINA SAMADANI, PH.D.484-393-2694ROSINA@OCULOGICA.COM

The company's EyeBOX Model OCL 02 device is a modification to the EyeBOX Model OCL 01 device, which was granted marketing authorization under De Novo request DEN170091 in December 2018. The EyeBOX Model OCL 02 device has the same intended use, the same principles of operation, and similar technological characteristics as the previously cleared EyeBOX Model OCL 01 device. Thus, the EyeBOX Model OCL 02 device is substantially equivalent to its predicate.

The following table presents a comparison of this submission to the device granted marketing authorization under DEN170091.

	Predicate Device	Subject Device
510(k) Number	DEN170091	TBD
Trade Name	EyeBOX	Same
Model Number	OCL 01	OCL 02
Manufacturer	Oculogica, Inc.	Same
Product Code	QEA	Same
Regulation	21 CFR 882.1455 Traumatic brain injuryeye movement assessment aid	Same
Indicationsfor Use	The EyeBOX is intended to measure andanalyze eye movements as an aid in thediagnosis of concussion within one week ofhead injury in patients 5 through 67 yearsof age in conjunction with a standardneurological assessment of concussion.A negative EyeBOX classification maycorrespond to eye movement that isconsistent with a lack of concussion.A positive EyeBOX classificationcorresponds to eye movement that may bepresent in both patients with or withoutconcussion.	The EyeBOX is intended to measure andanalyze eye movements as an aid in thediagnosis of concussion, also known asmild traumatic brain injury (mTBI), withinone week of head injury in patients 5through 67 years of age in conjunctionwith a standard neurological assessmentof concussion.A negative EyeBOX classification maycorrespond to eye movement that isconsistent with a lack of concussion.A positive EyeBOX classificationcorresponds to eye movement that maybe present in both patients with orwithout concussion.
DeviceDescription	Oculogica's EyeBOX is an eye-trackingdevice with custom software. The device iscomprised of a host PC with integratedtouchscreen interface for the operator, eyetracking camera, LCD stimulus screen andhead-stabilizing rest (chin rest andforehead rest) for the patient, and dataprocessing algorithm. The data processingalgorithm detects subtle changes in eyemovements resulting from concussion.The eye tracking task takes about 4minutes to complete and involves watchinga video move around the perimeter of anLCD monitor positioned in front of thepatient while a high speed near-infrared(IR) camera records gaze positions 500times per second. The post-processeddata are analyzed automatically toproduce one or more outcome measures.	Same
Principle ofoperation	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 the patientwhile a high speed near-infrared (IR)camera records gaze positions 500 timesper second. The post-processed data areanalyzed automatically to produce a BOXscore.	Same
WiFi Functionality	None	Provided
Enclosure	Wheeled Chassis	Table-top
Patient position	Seated and recumbent	Seated only

{4}------------------------------------------------

{5}------------------------------------------------

Intended Use and Indications for Use Statement

No change is made to the intended use of the device. The company proposes to modify the Indications for Use statement to recognize that mild traumatic brain injury (mTBI) is used interchangeably with concussion in clinical practice and the medical literature. This does not change the intended use population. The proposed wording of the Indications for Use statement is provided below. The phrase ", also known as mild traumatic brain injury (mTBI)." (shown in italicized and bolded text for ease of review only) has been added; no wording is deleted.

The EveBOX is intended to measure and analyze eve 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.

Although this results in a minor modification to the Indications for Use wording, it does not alter the intended diagnostic effect of the device.

Technological Characteristics

The technological characteristics of the EyeyeBOX Model OCL 02 device are very similar to that of the EyeBOX Model OCL 01 authorized under DEN170091. The principles of operation are not changed. The technological characteristics which are important to device function as an aid in diagnosis of concussion are not changed; these include the following characteristics:

The principles of operation are not changed; .
The eye tracking camera is not changed;
The optical path is not changed; ●
The EyeBOX alqorithm which processes the eye tracking data and outputs the BOX score is . not changed:

Thus, the device is identical to that of DEN170091 in all aspects important to its use as an aid in diagnosis of concussion. The following changes have been implemented but do not affect the safety and effectiveness of the EyeBOX device.

Change from a wheeled chassis to a tabletop model
Change to use with seated patients only
. Provide WiFi functionality
. Software changes to allow for licensing of device use.

Performance Testing

The following verification / validation activities were performed as required by the risk assessment of the changes according to the same well-established methods and procedures presented in DEN170091.

{6}------------------------------------------------

. Safety testing according to ANSI/AAMI ES60601-1: 2005 / A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
Electromagnetic emissions and immunity 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
. Software validation

Conclusion

the EyeBOX Model OCL 02 device has the same intended use and principle of operation as the previously authorized EyeBOX Model OCL 01 device. In addition, the EyeBOX Model OCL 02 device has very similar indications and technological characteristics as its predicate. Although there are minor differences between the EyeBOX Model OCL 02 device and its predicate devices, those differences do not raise new questions of safety or effectiveness and nonclinical testing demonstrates the device function is equivalent to the legally marketed predicate device. Thus, the EyeBOX Model OCL 02 device is substantially equivalent.

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.