(88 days)
The EyeSeeCam vHIT is designed to provide information on the performance of the vestibular ocular reflex (VOR) by providing objective measures of eye-velocity response to head-velocity stimulus, showing the VOR gain in the plane of rotation of the head.
The EyeSeeCam vHIT system consists of a head mounted goggle/mask, a camera unit with calibration laser and a software application running on a standard PC. The vHIT goggle generally has one camera (monocular) fixed at the top side(s) of the mask. The camera is held in place mechanically with a spherical ball-and-socket joint. The vHIT goggle has support for camera position-for the left and for the right eye. Therefore the camera is interchangeable between the left and right eyes. The vHIT goggle supports the camera that is used to record the eye images. This constitutes the major component of the vHIT system. The USB camera uses infrared light (IR), which is not visible to the naked eye. The IR illumination enables sessions to be performed in complete darkness. The vHIT goggle has dichroic mirrors that allow visible light to pass through and infra red light to be reflected towards the cameras. A calibration laser is placed in the center of the goggle. This is used for camera / pupil calibration before testing. The complete system is operated from a standard PC/Laptop via a standard USB connection. The PC application software controls the camera recordings and shows the results of the tests. EyeSeeCam utilizes an inertial measurement unit (IMU) which is an accelerometer and gyroscope combined. The IMU is contained inside the camera unit. The camera housing is attached to a light weight goggle. The camera records eye movements and the IMU records an electronic waveform that is proportional to head angular velocity (deg/sec).
The EyeSeeCam vHIT is a device intended to objectively measure the vestibular ocular reflex (VOR) in response to head movements specifically for patients experiencing dizziness or balance problems. The submission states that clinical testing compared results between the EyeSeeCam vHIT and a predicate device (VORTEQ/VISUALEYES) and found substantial equivalence.
Here's a breakdown of the requested information based on the provided document:
Acceptance Criteria and Device Performance
The document does not explicitly state numerical acceptance criteria in terms of sensitivity, specificity, or similar metrics. Instead, "substantial equivalence" to the predicate device, VORTEQ/VISUALEYES, is used as the primary acceptance criterion. The device's performance is demonstrated through this comparison.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (VORTEQ/VISUALEYES) | "Clinical testing compared test results between the EyeSeeCam vHIT and the Predicate Device. The results showed compliance and substantial equivalence between the two instruments." and "We have performed a comparison validation between EyeSeeCam and VORTEQ. All similarities and differences have been discussed. We trust that the results of these comparisons demonstrate that the EyeSeeCam vHIT is substantially equivalent to the marketed predicate device." |
| Functionality (Technical Characteristics) | EyeSeeCam vHIT has similar technology and functionality to the predicate device, with minor differences (e.g., USB vs. Firewire, monocular vs. optional binocular cameras) that are appraised as not having adverse effects on safety and effectiveness. |
| Compliance with Standards | "Design verification and validation were performed according to current standards for medical device safety and EMC. The device was found in compliance with current standards." This includes IEC 60601-1, ANSI/AAMI ES60601-1, CAN/CSA-C22.2 No. 60601.1:08 for Safety; IEC 60601-1-2 for EMC; and IEC 62471-1, IEC 60825-1 for Laser. |
Additional Information:
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Sample size used for the test set and the data provenance:
- The document states "Clinical testing compared test results between the EyeSeeCam vHIT and the Predicate Device," and "We have performed a comparison validation between EyeSeeCam and VORTEQ." However, the specific sample size (number of patients or cases) for this clinical comparison is not provided.
- Data provenance is not specified (e.g., country of origin, retrospective or prospective nature of the clinical study).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number of experts or their qualifications used to establish ground truth for any test set. The study primarily relies on a comparison between the EyeSeeCam vHIT and a predicate device.
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Adjudication method for the test set:
- The document does not describe any adjudication method for a test set. The comparison is between two devices, not an evaluation against a manually established ground truth using multiple experts.
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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:
- No, an MRMC comparative effectiveness study was not done. This device is a diagnostic tool for measuring the VOR, not typically categorized as an "AI assistance" tool for human readers in the context of image interpretation. The study focused on device-to-device equivalence.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The EyeSeeCam vHIT operates as a standalone diagnostic device. The clinical comparison study evaluates the performance of the device itself (algorithm only, without human-in-the-loop performance influencing the measurement of VOR, though human interpretation of the results is implied) against another device. So, yes, a standalone performance assessment (in the context of device function) was done by comparing its output to the predicate device.
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The type of ground truth used:
- The "ground truth" for the comparison study appears to be the measurements and results obtained from the predicate device (VORTEQ/VISUALEYES), as the study aimed to demonstrate substantial equivalence to this legally marketed device rather than an independent gold standard like pathology or long-term outcomes.
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The sample size for the training set:
- The document does not provide information regarding a specific "training set" or its sample size. This submission focuses on the premarket notification for a medical device demonstrating equivalence, which typically does not detail machine learning model training data.
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How the ground truth for the training set was established:
- As no information on a training set is provided, how its ground truth would have been established is also not detailed.
§ 882.1460 Nystagmograph.
(a)
Identification. A nystagmograph is a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.(b)
Classification. Class II (performance standards).