(163 days)
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.
| Description | Orion Model (Reclining) Performance (Reported as 'Same' or 'Equivalent') | System 2000 Model (Reclining) Performance (Predicate) | Equivalence Justification |
|---|---|---|---|
| Intended use | The Orion rotary chair is an optional accessory for VisualEyes 525/VisualEyes 515 eye movement recording systems | The System 2000 rotary chair is an optional accessory for eye movement recording systems | Same |
| Software to support | VisualEyes 515/525 | VisualEyes 515/525 and Spectrum | Same (Spectrum is the replaced software). Evaluated in K163149. |
| Chair and Controller | yes | yes | Same |
| Video Goggle connector | yes USB | yes Firewire | Equivalent - USB and Firewire are communication protocols |
| Patient Weight Maximum | 350 lbs (158kilo) | 350 lbs (158kilo) | Same |
| VOR, VVOR, VFX | yes .01-.64 Hz | yes .01-.64 Hz | Same |
| Step tests | max 200 | max 200 | Same |
| VOR Analysis | yes | yes | Same |
| Equipment cart | yes | yes | Same |
| Ocularmotor Tests | yes | yes | Same |
| VORTEQ/VHIT/DVA | Option | Option | Same |
| EOG | Option | Option | Same |
| Mechanical Foot Brake | Electric Lock | yes (manual foot brake) | Equivalent - both provide an immobile state for patient safety; electronic lock allows chair to be immobile before test and prevents rotation during test. |
| Sinusoidal Frequency | 0.01 to 0.64 Hz | 0.01 to 0.64 Hz | Same |
| Step Velocity (max) | 200 deg/sec | 200 deg/sec | Same |
| Acceleration (max) | 100 deg/sec² | 100 deg/sec² | Same |
| Auto Traverse / Comprehensive Models Differences | |||
| Chair and Controller | Orion: Controller is inside the Chair base | System 2000: Controller is a separate unit | Equivalent - merely a design difference. |
| Patient Weight Maximum | 400 lbs | 400 lbs | Same |
| Step Velocity (max) | 350 deg/sec | 300 deg/sec | Equivalent - typical Step Velocity test parameters do not exceed 180 d/s; SVV test uses 300 d/s. Higher max velocity is not critical. |
| Lateral movement speed | 0.8 cm/sec | 1 cm/sec | Equivalent - speed to go offset is not a critical parameter; lateral offset controls stimulation of Otolith organs, not the speed to attain it. |
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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