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The Orion rotary chair is an optional accessory for VisualEyes 515 eye movement recording systems.

The VisualEyes™ system provides information to assist in the nystagmographic evaluation, diagnosis and documentation of vestibular disorders. VNG testing evaluates nystagmus using goggles mounted with cameras. These images are measured, recorded, displayed and stored in the software. This information can then be used by a trained medical professional to assist in diagnosing vestibular disorders. The target population for videonystagmography is five years of age and above.

The Orion is a rotary chair designed to assess the Vestibular Ocula Reflex (VOR).

Orion rotary chair includes these three variants

• Orion Reclining
• Orion Auto Traverse
• Orion Comprehensive .

The Orion is considered an accessory to vestibular examination system software designated VisualEyes 525 and VisualEyes 515 manufactured by Interacoustics (FDA 510(k) K200534).

The Orion is an update of the System 2000 by Micromedical ((FDA 510(k) ID K922037).

The provided text is a 510(k) summary for a medical device (Orion Rotary Chair). It does not contain details about acceptance criteria or a study proving the device meets those criteria in a quantitative sense.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (System 2000 by Micromedical). The "performance tests" mentioned are primarily comparative, asserting that the new device performs "as specified" and is "safe and effective" based on these comparisons, rather than against predefined, quantitative acceptance criteria. There are no clinical tests performed.

Therefore, many of the requested items cannot be extracted from the provided text.

Here is a summary of what can be extracted and what cannot:

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

The document does not explicitly state quantitative acceptance criteria or a formal table comparing them against reported performance. Instead, it offers a "Comparison table" between the Orion device and its predicate (System 2000) for various descriptive and technical characteristics, aiming to show equivalence rather than adherence to specific numeric performance thresholds.

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

Not applicable. No formal test set or clinical study is described. The "performance tests" involved comparisons of the physical device features and operational parameters against the predicate device.

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 applicable. No ground truth was established by experts for a test set, as no clinical study or diagnostic performance assessment involving human interpretation is described.

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

Not applicable. No test set requiring adjudication 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. This is a rotary chair for vestibular testing, not an AI-assisted diagnostic imaging device that would typically undergo an MRMC study. No AI component is mentioned.

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

Not applicable. This is a physical medical device (rotary chair) that requires operation by a trained medical professional; it is not a standalone algorithm.

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

Not applicable. The basis for safety and effectiveness is substantial equivalence to a predicate device, demonstrated through comparative technical specifications and internal performance testing, not against a clinical ground truth.

8. The sample size for the training set

Not applicable. This document describes a physical medical device, not a machine learning model; therefore, there is no "training set."

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

Not applicable, as there is no training set.

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