(259 days)
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), in patients 5 through 67 years of age in conjunction with a standard neurological assessment of concussion.
A negative BOX Score classification may correspond to eye movement that is consistent with a lack of concussion within one week of injury.
A positive BOX Score classification corresponds to eye movement that may be present in both patients with or without concussion within one week of injury.
The EyeBOX provides a set of eye-tracking metrics in relation to a reference database of uninjured individuals.
Oculogica's EyeBOX EBX-4.1 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 a screen 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. 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 upload scans to a remote server, provide over-the-air software updates, and assist with customer support.
The provided FDA 510(k) Clearance Letter for EyeBOX EBX-4.1 (K242116) primarily focuses on demonstrating substantial equivalence to a predicate device (EyeBOX EBX-4, K212310) rather than presenting a detailed clinical study for novel acceptance criteria. The document states that the EyeBOX EBX-4.1's core diagnostic algorithm (BOX score) and hardware are "exactly the same" as its primary predicate. Therefore, the "acceptance criteria" and "device performance" in relation to a new clinical study are not explicitly defined or rigorously proven as they would be for a de novo device or a device with significant changes affecting its diagnostic performance.
However, the document does describe some performance testing related to additional eye-tracking metrics and software updates. It does NOT include a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or a standalone algorithm performance study for the primary diagnostic function (BOX score).
Based on the provided text, here's an attempt to outline the requested information, acknowledging the limitations inherent in a 510(k) submission focused on substantial equivalence:
Acceptance Criteria and Device Performance (Based on "Additional Eye-tracking Metrics Performance Testing")
The document describes testing for newly included eye-tracking metrics. While not explicit "acceptance criteria" in the strict sense for diagnostic performance, the following table summarizes the reported performance for these new metrics, which are stated to be for "contextual clinical information" and "not intended to aid in diagnosis." The key acceptance criterion for these metrics appears to be their reliability as demonstrated by test-retest performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Accuracy & Precision (General eye-tracking measurements) | Functioned as intended (qualitative statement) | Accuracy and precision testing completed for timestamp, gaze position, pupil size (diameter), and blink duration. Accuracy testing also conducted for blink count and saccade detection. (No quantitative results provided) |
| Reliability (Test-Retest for Eye-tracking Metrics) | Expected variation between repeated tests represented by Bland-Altman 95% limits of agreement (LoA); "functioned as intended." | Bland-Altman 95% LoA values were determined for each metric. These values are incorporated into the device output. "In all instances, the EyeBOX Model EBX-4.1 functioned as intended." (No specific LoA values provided) |
2. Sample Size and Data Provenance
- Test Set Sample Size: 30 healthy individuals.
- Data Provenance: Retrospective, drawn "from the EyeBOX normative database." (No specific country of origin mentioned, but implies data collected during previous EyeBOX studies for normative data). The study itself was prospective in design for the "test-retest" aspect (i.e., participants underwent two tests for this specific study).
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable (N/A) for this specific testing. The "Additional Eye-tracking Metrics Performance Testing" described is primarily a technical validation (accuracy, precision, test-retest reliability) of the eye-tracking measurements themselves, not a diagnostic performance study requiring expert ground truth on concussion. The device's diagnostic capability (BOX score) is deemed substantially equivalent to the predicate, K212310, and thus, its ground truth establishment would refer to the studies for that earlier clearance.
4. Adjudication Method for the Test Set
- None. As this was a technical validation of eye-tracking metrics and not a diagnostic accuracy study, expert adjudication was not relevant.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study was not described in this 510(k) submission. The document focuses on demonstrating that changes (software updates, additional output metrics) don't adversely impact the performance established by the predicate device. The primary diagnostic algorithm (BOX score) is stated to be identical to the predicate.
6. Standalone (Algorithm Only) Performance
- Not explicitly highlighted as a separate study in this document. The BOX score algorithm's performance as a standalone diagnostic aid would have been established during the clearance of the predicate device (K212310). This 510(k) asserts that the BOX score algorithm itself is "exactly the same" and its "principles of operation have not changed." The "Output Report Metric Selection for Concussion" is mentioned as a performed activity, but details of a standalone study for the EBX-4.1's diagnostic performance are not provided.
7. Type of Ground Truth Used
- Not explicitly detailed for the EBX-4.1 in this document. For the diagnostic performance (BOX score), the ground truth for the predicate device's studies (K212310) would have been crucial for establishing its effectiveness as an "aid in the diagnosis of concussion." The current submission emphasizes the stability of the BOX score algorithm and its output compared to the predicate.
- For the additional eye-tracking metrics (Pupil Size, Blinks, Disconjugacy, etc.) that are for "contextual clinical information" and "not intended to aid in diagnosis," the "ground truth" for the performance testing cited would be the true physical eye movements/features being measured (e.g., actual blink duration, actual pupil diameter for accuracy). This often involves calibrated phantoms or controlled experimental setups to assess measurement correctness. The "test-retest" reliability used the same healthy individuals observed twice.
8. Sample Size for the Training Set
- Not provided in this document. The document states that the EyeBOX EBX-4.1's diagnostic algorithm (BOX score) and hardware are "exactly the same" as the predicate (EyeBOX EBX-4). Therefore, the training data for the BOX score algorithm would be associated with the development and validation of the K212310 device, not explicitly detailed here.
- The "reference database of uninjured individuals" mentioned for the new output metrics is based on 30 healthy individuals for the test-retest study, but this is the testing set for reliability, not a training set for an algorithm. The actual size of the "normative database" (a "reference database of uninjured individuals") for contextual comparison is not specified as a training set, but as a general reference for physicians.
9. How the Ground Truth for the Training Set Was Established
- Not provided in this document for the reasons stated in point 8. This information would be critical for the original K212310 submission for the EyeBOX EBX-4.
- For the newly added "reference database of uninjured individuals," the "ground truth" is simply that these individuals were uninjured. This likely involved a screening process to confirm their healthy status, but no details are given.
FDA 510(k) Clearance Letter - EyeBOX EBX-4.1
Page 1
April 4, 2025
Oculogica, Inc.
℅ Janice Hogan
Partner
Hogan Lovells US LLP
1735 Market Street, Floor 23
Philadelphia, Pennsylvania 19103
Re: K242116
Trade/Device Name: EyeBOX EBX-4.1
Regulation Number: 21 CFR 882.1455
Regulation Name: Traumatic Brain Injury Eye Movement Assessment Aid
Regulatory Class: Class II
Product Code: QEA
Dated: July 19, 2024
Received: July 19, 2024
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 (the 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 available 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.
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K242116 - Janice Hogan Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K242116 - Janice Hogan Page 3
assistance/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,
Patrick Antkowiak -S
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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K242116
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 (mTBI), in patients 5 through 67 years of age in conjunction with a standard neurological assessment of concussion.
A negative BOX score classification may correspond to eye movement that is consistent with a lack of concussion within one week of injury.
A positive BOX score classification corresponds to eye movement that may be present in both patients with or without a concussion within one week of injury.
The EyeBOX provides a set of eye-tracking metrics in relation to a reference database of uninjured individuals.
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)
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:
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FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
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510(K) SUMMARY
Oculogica's EyeBOX
K242116
Submitter
Oculogica Inc.
1477 S. Knowles Ave. #110F
New Richmond, WI 54017
Phone: 484-393-2694
Contact Person: Rosina Samadani, Ph.D.
Date Prepared: 4/02/2025
Name of Device: EyeBOX Model EBX-4.1
Common or Usual Name: EyeBOX
Classification Name: Neurology
Regulatory Class: Class II
Product Code: QEA
Predicate Devices
Device Description
Oculogica's EyeBOX EBX-4.1 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 a screen 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.
The device contains a rechargeable battery, which makes it possible to use without a direct connection to an active power source.
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The device has Wi-Fi and Ethernet capabilities, which optionally can provide the user with the ability to upload scans to a remote server, provide over-the-air software updates, and assist with customer support.
Intended Use / Indications for Use
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), in patients 5 through 67 years of age in conjunction with a standard neurological assessment of concussion.
A negative BOX Score classification may correspond to eye movement that is consistent with a lack of concussion within one week of injury.
A positive BOX Score classification corresponds to eye movement that may be present in both patients with or without concussion within one week of injury.
The EyeBOX provides a set of eye-tracking metrics in relation to a reference database of uninjured individuals.
Summary of Technological Characteristics
- Eye-tracking is the technological principle for both the subject and predicate devices. The EyeBOX uses eye-tracking technology and a data processing algorithm to detect subtle changes in eye movements resulting from concussion. The eye tracking takes 220 seconds to complete, is non-invasive 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 data are analyzed automatically to produce one or more outcome measures in the form of a report. This report, in conjunction with other standard of care assessments, are used to aid in the diagnosis of concussion. A BOX score is the main diagnostic outcome measure and ranges between 0 and 20, with scores below 10 associated with lower risk of concussion and scores equal to or greater than 10 suggestive of possible concussion. The BOX Score may be used within one week of the known head injury. In addition to the BOX Score, a number of measurements are presented in relation to a normative database of uninjured individuals. The normative database allows physicians to compare ocular motor function of the patient being tested to the normal population. The measurements include pupil size and dynamics, saccades, horizontal/vertical disconjugacy, path departure from stimulus, average gaze displacement ("travel"), and blinks. The addition of more available eye tracking parameters does not raise new questions of safety or effectiveness, and the available testing demonstrates that the addition of these parameters does not adversely impact performance with respect to accuracy.
At a high level, the subject and predicate devices are based on the following same technological elements:
- The hardware for the EyeBOX Model EBX-4.0 and Model EBX 4.1 are exactly the same. This includes all components, and the form factor
- The algorithm for the BOX Score is exactly the same as the EyeBOX Model EBX-4.0
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Oculogica's EyeBOX uses eye-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 differences exist between the subject and predicate devices:
Output report changes, including:
- Additional eye-tracking and pupillometry metrics
- Inclusion of a reference database of healthy subjects
- Display "Not Computed" for spurious metric values
Upgrades to third party software components to remove cyber security vulnerabilities.
None of the changes in technology raise new questions of safety or effectiveness. The hardware provides the same functionality as the predicate. The inclusion of additional pupillometric metrics in the EyeBOX Model EBX-4.1 (i.e., pupil size, pupil dynamics) for contextual clinical information does not raise different questions of safety and effectiveness because both devices use multiple eye tracking parameters. Although the specific parameters measured by each device differ slightly, the fundamental principles and technological characteristics are similar, i.e., both use infrared-based eye-tracking at a high frequency and corneal reflection to measure pupil position. These differences in eye-tracking metrics are supported by performance testing based on acceptable methods that demonstrate the proposed device is as safe and effective as the predicate.
The following table presents a comparison of the device of this submission to the predicate devices.
| Primary Predicate Device K212310 (EyeBOX EBX4) | Secondary Predicate Device K202927 (EYE-SYNC) | Subject Device K242116 (EyeBOX EBX 4.1) | |
|---|---|---|---|
| Trade Name | EyeBOX EBX4 | EYE-SYNC | EyeBOX EBX 4.1 |
| Manufacturer | Oculogica, Inc. | SyncThink (now NeuroSync) | Oculogica, Inc. |
| Model | EBX-4 (Oculogica P/N: DMR-0004) | EYE-SYNC | EBX-4.1 |
| Product Code and Regulation | QEA 21 CFR 882.1455 Traumatic brain injury eye movement assessment aid | QEA 21 CFR 882.1455 Traumatic brain injury eye movement assessment aid | QEA 21 CFR 882.1455 Traumatic brain injury eye movement assessment aid |
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| Primary Predicate Device K212310 (EyeBOX EBX4) | Secondary Predicate Device K202927 (EYE-SYNC) | Subject Device K242116 (EyeBOX EBX 4.1) | |
|---|---|---|---|
| Indications for Use | 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. | The EYE-SYNC® is intended for recording, viewing, and analyzing eye movements in support of identifying visual tracking impairment in human subjects.The EYE-SYNC® is intended to record, measure, and analyze eye movements as an aid in the diagnosis of concussion, also known as mild traumatic brain injury (mTBI), within three days of sport-related head injury in patients 17-24 years of age in conjunction with a standard neurological assessment, for use by medical professionals qualified to interpret the results of a concussion assessment examination.A negative EYE-SYNC® classification corresponds to eye movements that are consistent with a lack of concussion.A positive EYE-SYNC® classification corresponds to eye movements that may be present in patients with concussion.The EYE-SYNC output report shows results in comparison to a normative database. | 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), in patients 5 through 67 years of age in conjunction with a standard neurological assessment of concussion.A negative BOX Score classification may correspond to eye movement that is consistent with a lack of concussion within one week of injury.A positive BOX Score classification corresponds to eye movement that may be present in patients with concussion within one week of injury.The EyeBOX provides a set of eye-tracking metrics in relation to a reference database of uninjured individuals. |
| User Population | Patients 5 through 67 years of age | No age range specified for visual tracking impairment.Ages 17 – 24 years for concussion | Patients 5 through 67 years of age |
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| Primary Predicate Device K212310 (EyeBOX EBX4) | Secondary Predicate Device K202927 (EYE-SYNC) | Subject Device K242116 (EyeBOX EBX 4.1) | |
|---|---|---|---|
| Indications for Use | 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. | The EYE-SYNC® is intended for recording, viewing, and analyzing eye movements in support of identifying visual tracking impairment in human subjects.The EYE-SYNC® is intended to record, measure, and analyze eye movements as an aid in the diagnosis of concussion, also known as mild traumatic brain injury (mTBI), within three days of sport-related head injury in patients 17-24 years of age in conjunction with a standard neurological assessment, for use by medical professionals qualified to interpret the results of a concussion assessment examination.A negative EYE-SYNC® classification corresponds to eye movements that are consistent with a lack of concussion.A positive EYE-SYNC® classification corresponds to eye movements that may be present in patients with concussion.The EYE-SYNC output report shows results in comparison to a normative database. | 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), in patients 5 through 67 years of age in conjunction with a standard neurological assessment of concussion.A negative BOX Score classification may correspond to eye movement that is consistent with a lack of concussion within one week of injury.A positive BOX Score classification corresponds to eye movement that may be present in patients with concussion within one week of injury.The EyeBOX provides a set of eye-tracking metrics in relation to a reference database of uninjured individuals. |
| User Population | Patients 5 through 67 years of age | No age range specified for visual tracking impairment.Patients 5 through 67 years of age |
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| Primary Predicate Device K212310 (EyeBOX EBX4) | Secondary Predicate Device K202927 (EYE-SYNC) | Subject Device K242116 (EyeBOX EBX 4.1) | |
|---|---|---|---|
| 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 and patient stimulus, eye tracking camera, and separate head-stabilizing 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 infrared (IR) camera records gaze positions 500 times per second. The post-processed data are analyzed automatically to produce one or more outcome measures. | SyncThink's EYE-SYNCTM consists of two components. These components are provided as a system with preloaded software. The EYE-SYNC is a fully-integrated, head-mounted eye-tracking system with two primary system components: 1) the head mounted display, containing the eye-tracking hardware and software system; and, 2) an integrated handheld peripheral used to administer the test and store testing results. The eye tracking unit includes two high-speed infrared cameras connected to a dedicated image analysis computing system. Camera lighting is provided by 12 high quality Light-emitting Diodes (LEDs) centered at 850 nanometers. EYE-SYNC is a less than one minute, non-invasive eye-tracking test that provides a quantitative representation of attention using precise measurements of eye gaze position relative to a target stimulus. Eye gaze tracking is performed using a proprietary implementation of the pupil-corneal reaction method. Display and eye tracking are controlled using the attached Windows-based handheld. Batteries provide power for remote use (away from power source). As a subject tracks a predictable moving target that follows a circular trajectory on a screen within the head mounted system, eye gaze position and time stamp are recorded by the use of cameras in the head mounted system. Multiple eye gaze positions relative to the target stimulus are measured and analyzed for position error variability using installed software, and the results are displayed and stored on the handheld peripheral | 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 and patient stimulus, eye tracking camera, and separate head-stabilizing 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 infrared (IR) camera records gaze positions 500 times per second. The post-processed data are analyzed automatically to produce one or more outcome measures. |
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| Primary Predicate Device K212310 (EyeBOX EBX4) | Secondary Predicate Device K202927 (EYE-SYNC) | Subject Device K242116 (EyeBOX EBX 4.1) | |
|---|---|---|---|
| Accessories | External power supply with power cord | External power supply with power cord | External power supply with power cord |
| Dimensions (l x w x h) | 18.7in (H) x 11.6in (W) x 7.8in (D) | Headset | 18.7in (H) x 11.6in (W) x 7.8in (D) |
| Weight | 12 lb. | None specified | 12 lb. |
| Power Source | 18V DC, 65W, internal rechargeable battery | Internal battery | 18V DC, 65W, internal rechargeable battery |
| Biocompatibility | None claimed | None specified | None claimed |
| Software | EyeBOX 4.0 | None specified | EyeBOX 4.13.16 |
| Sterilization | Not required | Non-sterile | Not required |
| Standards with which the Device Complies | Provided in the K212310 and K242116 Submissions | EN62471 Photobiological Safety of Lamps and Lamp Systems | Provided in the K212310 and K242116 Submissions |
| WiFi Functionality | Provided | None specified | Provided |
| Enclosure | Table-top | Goggles | Table-top |
| Patient position | Seated only | None specified | Seated only |
| Normative database reporting | Special controls provide for a reference database in K212310 | None specified | Reference database provided for in the special controls for K212310 EyeBOX Model EBX-4Metrics are measured using the same technology and process as K202927 |
| Tissue Contact | None. Patient is not intended to touch the device. | Goggles | None. Patient is not intended to touch the device. |
| Head stabilization | External chin rest | None needed | External chin rest |
| Length of test | 220 seconds | Less than 1 minute | 220 seconds |
| Eye-tracking region of interest | Dynamic region of interest moves during test | Virtually presented region of interest | Dynamic region of interest moves during test |
| Eye-tracking Speed | 500 fps | 60 Hz | 500 fps |
| IR Illuminator Size | 5x5 grid of LED's | 12 LEDs | 5x5 grid of LED's |
| IR Illumination wavelength | 850 nm | 850 nm | 850 nm |
| IR Illumination and Camera Placement | Below stimulus screen | Around edges of stimulus screen | Below stimulus screen |
| IR light filter | IR-passing acrylic | None specified | IR-passing acrylic |
| Blink Removal | 400ms before and after detected blinks | None specified | 400ms before and after detected blinks |
| Gaze Normalization | Automatic | None specified | Automatic |
| Diagnostic Algorithm | BOX score | Negative or Positive classification | BOX score |
| Eye-tracking precision / Spatial Resolution | 0.016 +/- 0.001 degrees RMS | None specified | 0.016 +/- 0.001 degrees RMS |
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| Primary Predicate Device K212310 (EyeBOX EBX4) | Secondary Predicate Device K202927 (EYE-SYNC) | Subject Device K242116 (EyeBOX EBX 4.1) | |
|---|---|---|---|
| Eye-tracking Step Response | 3 frames at 500fps | 60 Hz | 3 frames at 500fps |
| Eye-tracking pre-processing | For BOX Score: Blink removal, normalization using variance, noise filteringNormative Database: Blink removal, normalization using variance, noise filtering | None specified | For BOX Score: K212310 EyeBOX Model EBX-4Normative Database: Blink removal, normalization using segment medians, noise filtering, pupil size conversion |
| Scan Quality Criteria | >30% usable data | None specified | >40% usable data and <=5% data removed due to gaze failures, and no missing segments |
| Operator Interface | Touchscreen | None specified | Touchscreen |
| Patient Stimulus | Combined with operator interface screen | Within V/R Goggle headset | Combined with operator interface screen |
| Stimulus Size | 174mm ± 2mm (H) x 218mm ± 2mm (W) | None specified | 174mm ± 2mm (H) x 218mm ± 2mm (W) |
| Computer | Internal Windows-based computer | Android tablet | Internal Windows-based computer |
| Distance from screen to patient's eyes | 38-42 cm | None specified | 38-42 cm |
| Distance from camera to patient's eyes | 45-50 cm | None specified | 45-50 cm |
| Camera angle to patients face | 20 ± 2 degrees | None specified | 20 ± 2 degrees |
| Eye-tracking Metrics | N/A | • Smooth Pursuit• Saccades• VOR• VOR cancellation | • Horizontal/Vertical Disconjugacy• Path Departure from Stimulus• Average Gaze Displacement ("Travel")• Saccades• Pupil size and dynamics• Blinks |
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Performance Data
The following verification / validation activities were performed. Results of this testing demonstrates these changes do not adversely impact device performance.
- Software verification
- User acceptance testing
- Normative database testing
- Output Report Metric Selection for Concussion
Additional Eye-tracking Metrics Performance Testing
The following eye-tracking metrics are included in the EyeBOX report:
- Pupil Size (Pupil Size, Pupil Size Dynamics, Dilation Speed, Dilation Speed Variance, Constriction Speed Variance)
- Blinks (Blink Rate, Blink Duration)
- Horizontal/Vertical Disconjugacy
- Path Departure from Stimulus
- Average Gaze Displacement ("Travel")
- Saccades (Saccade Rate, Saccade Peak Velocity Variance)
These metrics are provided for contextual clinical information and are not intended to aid in diagnosis.
To support the inclusion of these additional eye metrics, accuracy and precision testing was completed for eye-tracking measurements including timestamp, gaze position, pupil size (diameter), and blink duration. Accuracy testing was also conducted for blink count and saccade detection.
Reliability of EyeBOX eye-tracking metrics was evaluated through test-retest performance testing using a study of 30 healthy individuals from the EyeBOX normative database. Each participant completed two EyeBOX assessments using identical stimulus videos, with the second test conducted shortly after the first test.
The expected variation between repeated tests was expressed using Bland-Altman 95% limits of agreement (LoA). The expected variation range for each metric is incorporated in the device output. In all instances, the EyeBOX Model EBX-4.1 functioned as intended.
Conclusion
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The EyeBOX Model EBX-4.1 has the same intended use and principle of operation as the previously cleared EyeBOX Model EBX-4. In addition, the EyeBOX Model EBX-4.1 device has similar technological characteristics as its predicates. 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-4.1 device is substantially equivalent to its predicate devices.
§ 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.