SyncThink's EYE-SYNC™ consists of two components. These components are provided as a system with preloaded software. The EYE-SYNC is a fullyintegrated, 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 pupilcorneal 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

AI/ML Overview

This document (K152915) is a 510(k) summary for the EYE-SYNC device, a nystagmograph. It states that "No performance data was required or provided." and that "Software validation and verification demonstrate that the EYE-SYNC performs as intended and meets its' specifications."

Therefore, based on the provided document, the following information about acceptance criteria and a study proving device performance cannot be answered:

A table of acceptance criteria and the reported device performance: No performance data was provided, thus no acceptance criteria specific to clinical performance are listed, nor are reported performance metrics.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set was used for performance evaluation as no performance data was required/provided.
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): No ground truth for a test set was established as no performance data was required/provided.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: No test set adjudication occurred as no performance data was required/provided.
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: Not applicable as no clinical performance data or MRMC study was mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as no clinical performance data was mentioned.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth was established for performance evaluation as no performance data was required/provided.
The sample size for the training set: No training set was mentioned as no performance data was required/provided.
How the ground truth for the training set was established: Not applicable as no training set was mentioned or ground truth established for it.

The document focuses on demonstrating substantial equivalence to a predicate device (Fall Prevention Technologies, LLC balanceback Mobile Intuitive VNG System K070729) based on identical intended use, similar principles of operation, and similar technological characteristics. The argument is that since the device is substantially equivalent to a legally marketed device, no new clinical performance data was required.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 29, 2016

SyncThink, Inc. % Ms. Maureen O'Connell President O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864

Re: K152915

Trade/Device Name: EYE-SYNCTM Regulation Number: 21 CFR 882.1460 Regulation Name: Nystagmograph Regulatory Class: Class II Product Code: GWN Dated: December 23, 2015 Received: December 28, 2015

Dear Ms. O'Connell:

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. 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 801); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Y. Alexander -A

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

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.

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

SyncThink, Inc. EYE-SYNC

510(k) Owner

SyncThink, Inc. 54 Canal Street Suite 200 Boston, MA 02114

Submission Correspondent

Maureen O'Connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864 Phone: (978) 207-1245 Email: Maureen@oconnellregulatory.com

Date Prepared: January 25, 2016

Trade Name of Device EYE-SYNC

Common or Usual Name

Nystagmograph

Classification Name

21 C.F.R. 882.1460 Nystagmograph Product Code GWN

Predicate Device

Fall Prevention Technologies, LLC balanceback Mobile Intuitive VNG System (K070729)

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.

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Device Description

Performance Data

No performance data was required or provided. Software validation and verification demonstrate that the EYE-SYNC performs as intended and meets its' specifications.

Substantial Equivalence

EYE-SYNC is substantially equivalent to Fall Prevention Technologies, LLC's balanceback Mobile Intuitive VNG System cleared in K070729. As explained in more detail below, EYE-SYNC has the same intended use, and similar principles of operation and similar technological characteristics as the previously cleared predicate device. Thus, EYE-SYNC is substantially equivalent to its predicate.

The intended use of the EYE-SYNC and the intended use of the balanceback Mobile Inuitive VNG System are the same. Both devices are intended for recording, viewing, and analyzing eye movements in support of identifying specific types of impairment. The EYE-SYNC device performs these activities

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to identify visual tracking impairment while the balanceback device attempts to identify balance disorders. Neither device provides a diagnosis or any diagnostic recommendations. Both devices are used by physicians or clinicians.

Both devices have the same technological characteristics. Both devices consist of a computing device with software and goggles. The EYE-SYNC utilizes a tablet while the balanceback system uses a computer. This difference in the form of the computing device has no impact on the functionality performed by the computing device.

Both devices include goggles with a camera and a light source. In both cases stimuli are displayed to the patient for the purpose of conducting eye movement tests. Both devices contain a head-mounted display system. The balanceback system projects the visual stimulus onto a front-facing surface, while the EYE-SYNC is the projection surface. The intent and functionality are identical.

The tests conducted with EYE-SYNC are a subset of the tests conducted by the balanceback system. This difference in the exact tests offered does not impact the safety or effectiveness as the tests offered by the EYE-SYNC are a subset of the tests offered on the balanceback system and are the tests necessary to allow evaluation of visual tracking impairment.

Both systems have software which records the patient's eye movements while he/she follows the stimulus. For both devices, this is performed to support the recording, viewing and analyzing of horizontal and vertical eye movements.

Therefore, the EYE-SYNC is substantially equivalent to the balanceback Mobile Intuitive VNG System.

Regulation Number and Section

§ 882.1460 Nystagmograph.

(a)
Identification. A nystagmograph is a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.(b)
Classification. Class II (performance standards).