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510(k) Data Aggregation
K Number
K242116Device Name
EyeBOX EBX-4.1
Manufacturer
Oculogica, Inc.
Date Cleared
2025-04-04
(259 days)
Product Code
QEA
Regulation Number
882.1455Why did this record match?
Product Code :
QEA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
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. 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.
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K Number
K212310Device Name
EyeBOX (Model EBX-4)
Manufacturer
Oculogica, Inc.
Date Cleared
2021-12-22
(152 days)
Product Code
QEA
Regulation Number
882.1455Why did this record match?
Product Code :
QEA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
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.
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K Number
K202927Device Name
EYE-SYNC
Manufacturer
SyncThink, Inc.
Date Cleared
2021-10-02
(368 days)
Product Code
QEA
Regulation Number
882.1455Why did this record match?
Product Code :
QEA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
The SyncThink EYE-SYNC device is a portable, fully enclosed eye tracking environment with three primary components:
- 1. Eye Tracker (head-mounted device) with eye tracking sensor
- 2. Eye tracking display
- 3. Android Tablet
The eye tracker is a modified Samsung GearVR provided by SensoMotoric Instruments (SMI). It is mounted to the subject's face and held either by hands placed on the side or using a strap. The eye tracking sensor includes two high-speed infrared cameras (for each eye) connected to a visual display for battery, computation, and display. Camera lighting is provided by 12 high-quality Light-emitting Diodes (LEDs) centered at 850 nanometers. Eye gaze tracking is performed using a proprietary implementation of the pupil- corneal reaction method. The eye tracker display is a nonnetworked mobile device that fits within the eye tracking sensor and connects over USB. The display receives eye tracking sensor information for post-processing, manages sensor calibration, provides binocular visual display to the subject, and interfaces with the Android tablet over Bluetooth. Eye gaze tracking and visual display is combined to provide several assessment paradigms to characterize subject eye tracking performance:
- Smooth Pursuit
- · Saccades
- · Vestibular-Ocular Reflex (VOR)
- · VOR Cancellation (VORx)
An EYE-SYNC software app on the display device manages these functions.
The Android tablet is a standard off-the-shelf 9.7" mobile tablet from Samsung with Verizon 4G cellular connectivity. A second EYE-SYNC software app designed to provides an integrative platform for data collected on the HMD eye tracker:
- · Patient, administrator, and records management
- · Eye tracker assessment Bluetooth control
- · Assessment Vestibular/Ocular-Motor Screening (VOMS) self-report tools
- · Eye tracker assessment real-time Bluetooth monitoring
- Eye tracker data log Bluetooth transfer
- Eye tracker assessment analysis using visual synchronization metrics
- · Analysis report generation with visualizations
- · Background diagnostics to verify device health
- · Cloud connectivity for data synchronization
Internal batteries from the eye tracking display and Android tablet provide power for remote use, away from power source. Each device has an EYE-SYNC software app installed to provide the described functionality. EYE-SYNC is provided as a complete system and both apps are managed a single software project with identical version numbers. EYE-SYNC is provided in a standalone carry-case with user manual, strap, cleaning, and charging accessories.
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K Number
K201841Device Name
EyeBOX
Manufacturer
Oculogica, Inc.
Date Cleared
2020-09-06
(66 days)
Product Code
QEA
Regulation Number
882.1455Why did this record match?
Product Code :
QEA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
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.
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K Number
K191183Device Name
EyeBOX
Manufacturer
Oculogica, Inc.
Date Cleared
2019-07-31
(90 days)
Product Code
QEA
Regulation Number
882.1455Why did this record match?
Product Code :
QEA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
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.
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K Number
DEN170091Device Name
EyeBOX
Manufacturer
Oculogica, Inc.
Date Cleared
2018-12-28
(371 days)
Product Code
QEA
Regulation Number
882.1455Why did this record match?
Product Code :
QEA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EveBOX is intended to measure and analyze eve movements as an aid in the diagnosis of concussion 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
The Oculogica EyeBOX system consists of an integrated stand, eye-tracking camera, video stimulus display screen, and computer programmed for analysis of eye movements. It is intended to detect abnormal eye movement that may be related to a concussion. The device measures gaze, calculates a score on a 0-20 scale based on these measurements, and displays an EyeBOX classification based upon whether the scale value is above 10 or not. Scale values of 10 or more yield a positive EyeBOX classification, while scale values under 10 yield a negative EyeBOX classification.
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