EYE-SYNC

K202927

SyncThink, Inc. · cleared 2021-10-02 · product code QEA · Neurology

Premarket evidence — what FDA accepted

Device typesimd
source quote (p.5)
“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”
AlgorithmProprietary implementation of the pupil-corneal reaction method
source quote (p.5)
“Eye gaze tracking is performed using a proprietary implementation of the pupil- corneal reaction method.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.10)
“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.””

Validation studies (3)

Retrospective clinical

n=1,069 patients

endpoints: Sensitivity, Specificity, Negative Predictive Value (NPV), and Positive Predictive Value (PPV) for concussion diagnosis

Standalone

n=150 patients

endpoints: Intra-class correlation (ICC) for EYE-SYNC metrics

Bench

sample size not stated

standards: IEC 60601-1:2012 Ed. 3.0, IEC 60601-1-2:2014 Ed 4.0, IEC 60601-2-57:2011 Ed1.0, EN62471 Photobiological Safety of Lamps and Lamp Systems, ISO-10993, ISO 10993-1

Reported performance (4 observations)

sensitivity0.82CI 74%, 89%
source quote (p.11)
“Retrospective analysis determined 82% (74%, 89%) sensitivity”
specificity0.93CI 91%, 94%
source quote (p.11)
“and 93% (91%, 94%) specificity of the EYE-SYNC test.”
ppvas written: “Positive Predictive Value (PPV)”0.56CI 48%, 64%
source quote (p.11)
“positive predicative value was 56% (48%, 64%).”
npvas written: “Negative Predictive Value (NPV)”0.98CI 97%, 99%
source quote (p.11)
“Negative predictive value made by the classifying algorithm was 98% (97%, 99%)”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Neurology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K202927