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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

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not explicitly stated for the non-clinical performance tests mentioned. The clinical study section mentions testing "across multiple oculomotor tests," but doesn't quantify the number of patients or cases.
• Data Provenance: Not explicitly stated for the non-clinical performance tests. For the clinical study, it's mentioned that NeuroEars-Anna™ was "tested side by side with its predicate device," but the location or whether the data was retrospective or prospective is not provided.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• This information is not provided in the given document. The non-clinical performance tests likely relied on instrument calibration and established measurement standards (like ANSI 3S.45). For the clinical study, it states the data is for "interpretation by qualified medical personnel trained in vestibular diagnostic testing," implying expert review, but the number and qualifications are not detailed.

4. Adjudication Method for the Test Set

• This information is not provided in the given document. For the non-clinical performance tests, adjudication would likely involve comparing device outputs against known or standard measurements. For the clinical study, the method for comparing NeuroEars-Anna™'s measurements to the predicate's and determining agreement or clinical reliability is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• A MRMC comparative effectiveness study that explicitly measures how human readers improve with AI vs. without AI assistance is not explicitly described.
  • The document states: "The NeuroEars-Anna™ was tested side by side with its predicate device across multiple oculomotor tests. The results of these tests confirm that the NeuroEars-Anna™ provides clinically reliable and equivalent measurements compared to the predicate..." This suggests a comparison of the device's output to a predicate, not necessarily a human reader performance improvement study. The "assist" nature of the device (providing information for trained medical professionals) implies human-in-the-loop, but the format of the study doesn't detail an explicit MRMC study measuring reader improvement.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• Yes, the performance testing described in the "Performance Testing Results" table appears to be a standalone (algorithm only) evaluation against technical acceptance criteria. The "Eye Tracking Camera Frame Rate," "Eye Tracking Accuracy," and "Visual Fixation Point Requirements" are objective measurements of the device's technical capabilities, independent of human interpretation.
• Additionally, the device is described as "standalone software device that analyzes eye movements," reinforcing its independent algorithmic function.

7. The Type of Ground Truth Used

• For the non-clinical performance tests (Eye Tracking Camera Frame Rate, Eye Tracking Accuracy, Visual Fixation Point Requirements), the ground truth appears to be based on:
  • Hardware specifications/standards: For frame rate and accuracy, referring to "Hardware specification standard" (e.g., 120 Hz, 1.15° median accuracy).
  • Internal validation results: Comparing measurements against expected or reference values derived during internal testing, aligning with the ANSI 3S.45 standard.
• For the clinical study, the ground truth is implicitly established by comparison to a "predicate device" which is "clinically reliable." This suggests the predicate device's measurements serve as the reference standard for "equivalent measurements."

8. The Sample Size for the Training Set

• The document does not provide information on the sample size used for the training set. It focuses on the clearance process based on comparisons and specific performance tests.

9. How the Ground Truth for the Training Set Was Established

• The document does not provide information on how the ground truth for the training set was established, as the training set details are not included.

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