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The device is intended to measure, record and display the movements of the eyeballs during their involuntary movements (nystagmus) and while testing the patient's vestibular function.

The device is for prescription use only and it is intended for use by qualified medical personnel trained in the use of nystagmographs. This device provides no diagnoses nor does it provide diagnostic recommendations.

The device is a PC-based system for measuring, recording and displaying the eve movements. Its components include video goggles or surface electrodes to record the eve movements, a PC interface to acquire the data, a series of software modules to display and analyze the data and various stimulation devices.

This 510(k) summary does not contain information related to specific acceptance criteria, a study proving device performance against those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement as requested.

The document primarily focuses on establishing substantial equivalence to previously cleared devices based on intended use and technological characteristics (like safety compliance, type of system, construction, power source, and computer interface).

Therefore, I cannot populate the requested table or answer the specific questions about the study from the provided text. The document doesn't include a performance study with detailed acceptance criteria and reported results.

Here's an overview of what is available in the document:

1. A table of acceptance criteria and the reported device performance:

• Not Available. The document does not specify performance acceptance criteria (e.g., accuracy, precision, sensitivity, specificity) for measuring eye movements, nor does it present results from a study demonstrating the device meets such criteria. The table in the document compares technological specifications (safety compliance, type, construction, power source, computer interface) of the device against predicate devices, not performance against acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not Available. No performance study is described, so no sample size for a test set or data provenance is mentioned.

3. 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):

• Not Available. No ground truth establishment is described as part of a performance study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Available. No adjudication method is described.

5. 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. The device is a Nystagmographer (EyeTracker, IDEAS), which measures and displays eye movements. It is not an AI-assisted diagnostic device, and thus, a MRMC study on human reader improvement with AI assistance is not relevant to this type of device.

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

• Not Available. While the device works as a standalone measurement system, the document does not describe a formal "standalone performance study" in the context of typical AI/diagnostic device evaluations, with specific metrics and acceptance criteria. It mainly focuses on functional equivalence to predicates.

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

• Not Available. No performance study or ground truth definition is provided.

8. The sample size for the training set:

• Not Applicable/Not Available. The device is a measurement system, not a machine learning model that requires a training set.

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

• Not Applicable/Not Available. As above, no training set is relevant to this device's description.

In summary, the provided 510(k) documentation focuses on substantial equivalence based on design and intended use, rather than presenting a detailed performance study with specific acceptance criteria and clinical results. For devices like nystagmographs, regulatory clearance often relies more on demonstrating that the device reliably performs its intended measurement function and is safe, similar to existing predicate devices, rather than a clinical efficacy trial with diagnostic accuracy metrics.

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