(368 days)
Oculogica EveBOX (DEN170091)
Yes
The device description mentions "Eye tracker assessment analysis using visual synchronization metrics" and "Analysis report generation with visualizations". The performance studies section describes a "classifying algorithm" with sensitivity, specificity, PPV, and NPV metrics, which are characteristic of machine learning model evaluation. While the terms AI/ML are not explicitly used, the description of an algorithm performing classification based on eye movement analysis strongly suggests the use of ML.
No.
The device is intended for recording, viewing, and analyzing eye movements as an aid in diagnosis, not for providing therapy or treatment.
Yes
The device is explicitly stated to be "an aid in the diagnosis of concussion." It provides classifications (positive/negative) corresponding to the presence or absence of eye movements consistent with concussion.
No
The device description explicitly states it is a "portable, fully enclosed eye tracking environment with three primary components" including an "Eye Tracker (head-mounted device) with eye tracking sensor," an "Eye tracking display," and an "Android Tablet." These are all hardware components. While software is used on these components, the device is not software-only.
Based on the provided information, the EYE-SYNC® device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens derived from the human body. The EYE-SYNC® device analyzes eye movements, which are physiological responses, not biological specimens like blood, urine, or tissue.
- The device's function is based on tracking and analyzing physical movements. It uses infrared cameras to capture eye movements and software to analyze patterns in these movements. This is distinct from the chemical, immunological, or molecular analysis typically performed by IVDs.
- The intended use describes aiding in diagnosis based on eye movement patterns. While it aids in diagnosis, it does so by assessing a physical function, not by analyzing a biological sample.
Therefore, the EYE-SYNC® device falls under the category of a medical device that assesses physiological function, rather than an In Vitro Diagnostic device.
No
The letter does not state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
QEA
Device Description
The SyncThink EYE-SYNC device is a portable, fully enclosed eye tracking environment with three primary components:
-
- Eye Tracker (head-mounted device) with eye tracking sensor
-
- Eye tracking display
-
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Eyes
Indicated Patient Age Range
17-24 years of age
Intended User / Care Setting
medical professionals qualified to interpret the results of a concussion assessment examination.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Validation data analysis was performed on 1,069 subjects. The validation study population included subjects ages 17-24 years actively engaged in competitive athletics. Of these 1,069 subjects, 107 subjects met the SCAT-5 clinical reference standard definition of concussion, where the evaluations were conducted by a healthcare practitioner blinded to EYE-SYNC device output +3 days from injury.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical performance analysis did not include assessments with poor eye-tracking quality. In these cases, the device does not provide an assessment result.
Clinical performance: Validation data analysis was performed on 1,069 subjects. The validation study population included subjects ages 17-24 years actively engaged in competitive athletics. Of these 1,069 subjects, 107 subjects met the SCAT-5 clinical reference standard definition of concussion, where the evaluations were conducted by a healthcare practitioner blinded to EYE-SYNC device output +3 days from injury. Retrospective analysis determined 82% (74%, 89%) sensitivity and 93% (91%, 94%) specificity of the EYE-SYNC test. Negative predictive value made by the classifying algorithm was 98% (97%, 99%) and positive predicative value was 56% (48%, 64%). For PPV and NPV reference, the study prevalence of clinical classification of concussion (mTBI) was 10% (107/1069). The analysis validates the clinical utility of the eye-tracking assessment as an aid in diagnosis of concussion within three days of sport-related head injury.
Test-retest reliability: The test-retest reliability of the EYE-SYNC metrics were reported through an independent study of 150 athletes from 11 sports with a mean (SD) age of 20 (1.3) years and 55% female population. The Intra-class correlation (ICC) was calculated with its 95%CI for each EYE-SYNC metric:
- SD tangential error: 0.86 (0.82, 0.90) .
- SD radial error: 0.78 (0.71, 0.84) .
- Mean phase error: 0.83 (0.77, 0.87) .
The ICC describes the level of correlation between two or more observations made on the same student athlete; a higher ICC (closer to 1) indicates greater reliability of the measure.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
82% sensitivity (74%, 89%)
93% specificity (91%, 94%)
56% PPV (48%, 64%)
98% NPV (97%, 99%)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Oculogica EveBOX (DEN170091)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
SyncThink EYE-SYNC (K152915), GN Otometric 1068 A/S Type 1085 ICS Impulse (K151504)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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October 2, 2021
SyncThink, Inc. % Allison Kumar Regulatory Consultant Arina Consulting, LLC 27 Hilltop Dr San Carlos, California 94070
Re: K202927
Trade/Device Name: EYE-SYNC Regulation Number: 21 CFR 882.1455 Regulation Name: Traumatic brain injury eye movement assessment aid Regulatory Class: Class II Product Code: QEA Dated: August 18, 2020 Received: September 29, 2020
Dear Allison Kumar:
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
1
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,
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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Indications for Use
510(k) Number (if known) K202927
Device Name EYE-SYNC
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | ✖ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ❍ |
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510(k) Summary
This summary is being submitted in accordance with the requirements of 21 CFR Part 807.92.
510(k) Owner Information:
SyncThink, Inc. 2172 Staunton Court Palo Alto, CA 94306 Tel 508-446-4287 Contact: John Ferreira, VP Engineering jferreira@syncthink.com
Submission Correspondent:
Allison Kumar Arina Consulting, LLC allison@arinaconsulting.com
Device Information:
Trade Name: EYE-SYNC Device: Traumatic Brain Injury Eye Movement Assessment Aid Regulation: 882.1455 Classification Panel: Neurology Device Class: 2 Product Code: QEA
Predicate Device:
Oculogica EveBOX (DEN170091)
Reference Devices:
SyncThink EYE-SYNC (K152915), GN Otometric 1068 A/S Type 1085 ICS Impulse (K151504)
Intended Use/Indications for 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
4
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:
-
- Eye Tracker (head-mounted device) with eye tracking sensor
-
- Eye tracking display
-
- 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
5
- 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.
Comparison of Technological Characteristics with Predicate Device:
The claim of substantial equivalence of EYE-SYNC to the predicate device is based on a detailed comparison of several factors. This compairson is included in the table below:
| | Subject Device
(EYE-SYNC) | Predicate Device
(Eye-BOX) | |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission
Number | K202927 | DEN170091 | Comparison |
| Product Code | QEA | QEA | SAME |
| Intended Use | Measure and
analyze eye
movement as an aid
in the diagnosis of
concussion | Measure and
analyze eye
movement as an aid
in the diagnosis of
concussion | SAME |
| Indications for
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 | The EyeBOX is
intended to measure
and analyze eye
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 | SIMILAR
Differences between the
subject device and predicate
include:
• Age range of population for
subject device is a small
subset of predicate.
• Population of subject device
is specific to sports-related
injury.
• Use of test is a shorter time
period since injury compared
to predicate.
The differences do not raise |
| | aid in the diagnosis
of concussion 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 and aid
in the management
of concussion.
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. | 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. | new questions of safety or
effectiveness. |
| Rx Use Only | Yes | Yes | SAME |
| Hardware
Components | VR Headset
Tablet | Stand with
integrated Computer | DIFFERENT
Subject device uses VR
headset to capture gaze
measurements. Analysis is
done via a software app on the
accompanying tablet. This
method has been validated
with performance and clinical
testing to verify it provides the
same information as the |
| | | | |
| | | | predicate device and therefore
does not raise new questions
of safety and effectiveness. |
| Wireless
Communication | Bluetooth
connection between
VR Headset and
Tablet. Tablet has
4G cellular
connection Cloud. | Single, non-
networked device | DIFFERENT
Subject eye tracking device
communicates over Bluetooth
wireless to an administrative
tablet for control and data
exchange. The predicate
device achieves the same
functionality within a single
computer system.
Cellular connectivity to the
cloud is a convenience feature
and does not contribute to the
IFU. Bluetooth connectivity is a
common systems interface.
This method has been
validated with performance
and clinical testing to verify itprovides the same functionality
as the predicate device and
therefore does not raise new
questions of safety and
effectiveness. |
| | | | |
| Eye Tracking | Gaze | Gaze | SAME |
| Camera Speed | 60 Hz | 500 Hz | DIFFERENT
Eye tracking cameras can be
oversampled with respect to
the signal of interest. The
subject device has elected to
go with a lower sample rate,
but has validated this decision
with performance and clinical
testing to verify it provides the
same functionality as the
predicate device and therefore
does not raise new questions
of safety and effectiveness. |
| | | | therefore does not raise new
questions of safety and
effectiveness. |
| Software | Algorithm provides
analysis and results | Algorithm provides
analysis and results | SAME |
| Patient
Contacting
Materials | Yes - Foam cushion
on face mask. | N/A | Different
Patient contacting material is
biocompatible. Does not raise
new questions of safety or
effectiveness. |
| Sterility | Non-Sterile | Non-Sterile | SAME |
| EMC and
Electrical
Safety | IEC 60601-1:2012
IEC 60601-1-2:2014 | IEC 60601-1:2012
IEC 60601-1-2:2014 | SAME |
| Performance
Testing - Bench | Light Safety | Light Safety | SAME |
| Performance
Testing -
Clinical | 82% sensitivity
(74%, 89%)
93% specificity
(91%, 94%)
56% PPV***
(48%, 64%)
98% NPV***
(97%, 99%) | 80.4% sensitivity
(66.1%, 91.9%)
66.1% specificity
(59.7%, 72.1%)
31.6% % PPV
(23.3%, 40.9%)
94.5% NPV
(89.9%, 97.5%) | Similar
Results from clinical testing*
are substantially equivalent to
predicate device** |
| Special
Controls | Yes | Yes | SAME |
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7
8
*Clinical performance analysis did not include assessments with poor eye-tracking quality. In these cases, the device does not provide an assessment result.
**95% Confidence intervals noted for the subject and predicate device are derived from Clopper-Pearson method. 95% Confidence intervals for the subject device derived using the Wilson Score method for sensitivity are (74%, 88%) and (91%, 94%) for specificity.
*** PPV and NPV was obtained from observed study data without adjustment of the prevalence (10%).
Performance Data
The following performance data were provided in support of the substantial equivalence determination.
9
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing were conducted on the EYE-SYNC device. The system complied with the IEC 60601-1:2012 Ed. 3.0 standard for operator and patient safety and IEC 60601-1-2:2014 Ed 4.0 standard for EMC in the intended use environment. The system complied with IEC 60601-2-57:2011 Ed1.0 Medical electrical equipment – Part 2 for safety of non-laser light source equipment intended for diagnostic use.
Software Verification and Validation Testing and Cybersecurity
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered a "moderate" level of concern, since a failure or latent flaw in the software could directly result in minor injury to the patient or operator, either directly or indirectly through incorrect or delayed information or through the action of a care provider.
Cybersecurity was assessed and documented according to the FDA Guidance, "Off-the-shelf Software - Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software."
Performance Testing - Bench
Testing was performed to demonstrate conformance with the following standards:
- EN62471 Photobiological Safety of Lamps and Lamp Systems
Biocompatibility Testing
The biocompatibility evaluation of the EYE-SYNC device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, "" May 1, 1005, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:
- Cytotoxicity .
- Sensitization ●
- Irritation
Sterility
The device is provided non-sterile. Cleaning instructions are provided in
10
the user manual.
Summary of Clinical Testing:
Clinical performance
Clinical data was submitted to support substantial equivalence and conform to special controls. Validation data analysis was performed on 1,069 subjects. The validation study population included subjects ages 17-24 years actively engaged in competitive athletics. Of these 1,069 subjects, 107 subjects met the SCAT-5 clinical reference standard definition of concussion, where the evaluations were conducted by a healthcare practitioner blinded to EYE-SYNC device output +3 days from injury.
Retrospective analysis determined 82% (74%, 89%) sensitivity and 93% (91%, 94%) specificity of the EYE-SYNC test. Negative predictive value made by the classifying algorithm was 98% (97%, 99%) and positive predicative value was 56% (48%, 64%). For PPV and NPV reference, the study prevalence of clinical classification of concussion (mTBI) was 10% (107/1069). The analysis validates the clinical utility of the eye-tracking assessment as an aid in diagnosis of concussion within three days of sport-related head injury.
Test-retest reliability
The test-retest reliability of the EYE-SYNC metrics were reported through an independent study of 150 athletes from 11 sports with a mean (SD) age of 20 (1.3) years and 55% female population. The Intra-class correlation (ICC) was calculated with its 95%CI for each EYE-SYNC metric:
- SD tangential error: 0.86 (0.82, 0.90) .
- SD radial error: 0.78 (0.71, 0.84) .
- Mean phase error: 0.83 (0.77, 0.87) .
The ICC describes the level of correlation between two or more observations made on the same student athlete; a higher ICC (closer to 1) indicates greater reliability of the measure.
Conclusion:
The non-clinical and clinical data support the safety of the device and the software verification and validation demonstrate that SyncThink's EYE-SYNC device should perform as intended in the specified use conditions, and which are comparable to the predicate device that is currently marketed for the same intended use.