(266 days)
The NeuroEars-Anna™ system provides information to assist in the nystagmographic evaluation, diagnosis, and documentation of vestibular disorders. Nystagmus of the eye is recorded using a head-mounted display equipped with eye-tracking cameras. These images are measured, recorded, displayed, and stored in the software. This information can then be used by trained medical professionals to assist in diagnosing vestibular disorders.
The NeuroEars-Anna™ system is intended for use in individuals aged 12 years and older, based on the physical compatibility of the FOVE VR headset (FOVE Inc., Japan). While the ANSI S3.45 standard does not define age-based limitations, the FOVE VR headset is generally suitable for individuals aged 12 and above. For improved fit, soft materials such as sponge pads may be used in cases where the headset does not conform properly to the user's face. This applies to both pediatric and adult patients. Any additional padding should be used only if it does not interfere with eye-tracking performance or measurement accuracy and must follow the manufacturer's instructions for proper use.
NeuroEars-Anna™ is a standalone software device that analyzes eye movements to assist medical professionals in the nystagmographic evaluation, diagnosis, and documentation of vestibular disorders. The NeuroEars-Anna™ software is intended to be used with off the shelf hardware including the HMD, PC, and monitors.
The NeuroEears-Anna™ software is designed to perform the following vestibular tests:
- Spontaneous Nystagmus Test
- Gaze-Evoked Nystagmus Test
- Head Shaking Nystagmus Test
- Fistula Nystagmus Test
- Dix-Hallpike Test
- Positional Test
- Smooth Pursuit Test
- Random Saccade Test
- Saccadometry Test
- Optokinetic Nystagmus Test
- Subjective Visual Vertical/Subjective Visual Horizontal (SVV/SVH)
- Caloric Test
- Video Frenzel
NeuroEars-Anna™ is a software program that analyzes eye movements recorded from an eye-tracking camera mounted on a head-mounted display (HMD) with eye-tracking specifications suggested by ANSI/ASA S3.45-2009 (Reaffirmed by ANSI April 16, 2024 version). The HMD devices used can be commercial products such as the FOVE0 (powerd by FOVE Inc., Japan), which meet these minimum eye-tracking specifications. The software is intended to run on a Microsoft Windows PC platform.
Here's a breakdown of the acceptance criteria and study information for NeuroEars-Anna™, based on the provided FDA 510(k) Clearance Letter:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test | Acceptance Criteria | Reported Device Performance | Pass/Fail |
|---|---|---|---|
| Eye Tracking Camera Frame Rate | • Minimum 60 Hz | • Hardware specification standard 120 Hz | Pass |
| Eye Tracking Accuracy | • Horizontal error: 0.1° to 1.0° | ||
| • Vertical error: 0.4° to 1.0° | • Hardware specification standard: 1.15° median accuracy for uniform distribution across screen ( |
§ 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).