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The Nystagram™ is a video nystagmograph intended to view, record, and measure eye movements in support of identification of balance disorders. The device is intended for use only by qualified, trained medical personnel to aid in diagnostic recommendations. This device does not provide any medical diagnosis and is intended to be part of a larger balance assessment battery.

The Nystagram™ is a device that views, records and measures both vertical and horizontal eye movements for support of identification of balance disorders. The results of the video nystagmograph (VNG) tests are combined with other clinical information to allow qualified medical personnel to determine the health of a patient's vestibular function system. The Nystagram™ system consists of a goggles system with a video camera and accelerometers to record eye movements and head position, computer monitors and other hardware and software to control the operation of the patient stimulus and the test administration functions. The system software is used for nystagmus analysis during oculomotor mobility, positional nystagmus, and caloric examinations. The results are presented in visual diagrams for clinical review.

The provided text describes the Nystagram™ Video Nystagmography System and its substantial equivalence to predicate devices, focusing on the comparative evaluation conducted. Here's a breakdown of the requested information:

Acceptance Criteria and Reported Device Performance

Study Information:

1. Sample size used for the test set and the data provenance:

   • Sample Size: Five (5) subjects.
   • Data Provenance: Prospective. The study involved measuring the response of these subjects to stimuli within a 24-hour period by both the Nystagram™ and a predicate device. The audiologists were in Sugarland, Texas and The Woodlands, Texas, respectively.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: Two (2) independent Audiologists.
   • Qualifications of Experts: They are described as "independent Audiologist" without further specification of experience (e.g., years of experience).

3. Adjudication method for the test set:

   • The adjudication method was a direct comparison of clinical findings between the two devices as interpreted by two independent audiologists. The equivalency was demonstrated when interpretations of the data by each audiologist matched for each test and subject. This indicates a consensus approach where agreement between the two independent clinical evaluations served as the basis for equivalency.

4. 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:

   • This was not a multi-reader, multi-case study in the context of AI assistance. It was a comparative performance study of two medical devices (Nystagram™ vs. a predicate VNG device) where human audiologists served as the evaluators of the device's output. The study aimed to show equivalence between the devices, not how human performance improved with or without AI. Therefore, there is no effect size related to AI assistance.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • The provided text does not describe a standalone algorithm-only performance study. The device "views, records, and measures eye movements," and the "system software is used for nystagmus analysis." However, the "results are presented in visual diagrams for clinical review," and the device is intended for "use only by qualified, trained medical personnel to aid in diagnostic recommendations." The clinical equivalency study explicitly involved human audiologists clinically evaluating the resultant tracings and judging them as "Normal/Abnormal" or "Positive/Negative." This indicates human-in-the-loop performance is integral.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The ground truth was established through expert clinical evaluation/interpretation by the independent Audiologists. They clinically evaluated the tracings and judged the findings as "Normal/Abnormal" or "Positive/Negative." Equivalency was achieved when these expert interpretations from both devices matched.

7. The sample size for the training set:

   • The document does not mention a separate training set or its sample size. The study described is a comparative evaluation for establishing clinical equivalency, involving 5 subjects, which serves as the "test set" for this particular equivalency study.

8. How the ground truth for the training set was established:

   • Since no training set and corresponding ground truth establishment are explicitly described in the provided document, this information is not available. The document focuses on the comparative performance of the device in relation to a predicate device for regulatory clearance.

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