(17 days)
ExpressEye is used to measure the saccadic movements of the eye and classify a subject's performance in different tasks as normal or abnormal. Subjects are patients above the age of 6 years with suspicion of problems in dynamic vision and/or optomotor control.
ExpressEye can be used in any case of problems in the optomotor domain. The measured horizontal eye movements of a person made in response to generated stimuli are analysed to nontonial cyc inovential or a person's fixation and reflexive and voluntary eye movement control.
ExpressEye measures horizontal eye movements and analyses the fixation quality, direction and reaction time of fast eye movements. The device consists of a head band, which carries light sources for visual stimuli, an amplifier, and infrared light emmitting/receiving elements. A hand held processor controls the stimuli and analyses the eye movement signals. Optional the user can transfer the data to a personal computer.
The device, ExpressEye, is an eye movement recorder that measures horizontal eye movements and analyzes fixation quality, direction, and reaction time of fast eye movements.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Laser power output (Class II classification) | 0.2 milliwatts (5 times less than permitted for a Class 2 device) |
| Infrared light spectral radiance | Inside the Threshold Limit Value recommended by the American Conference of Governmental Industrial Hygienists |
| Electromagnetic compatibility | Below the level allowed for Class A (certified by FCC-approved laboratory) |
| Biocompatibility of materials | Materials of the head band are declared biocompatible and conformant to European and US regulations |
| Safety of additional data analysis | "The additional acquirement of variables from the eye movement traces does not affect the safety because it results in recommendations of training procedures, not in any kind of medication." |
Study Information
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Sample size used for the test set and the data provenance: Not mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
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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: Not mentioned. The device's primary function is described as measurement and analysis of eye movements, not as an AI-assisted diagnostic tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The provided text primarily focuses on the device's technical specifications and safety compliance for regulatory approval (510(k)). It describes the device as measuring and analyzing eye movements, but it does not detail a specific performance study in terms of diagnostic accuracy or comparison to a gold standard. The "Summary and conclusion of technical tests" section indicates physical and electrical safety tests, but not a clinical or standalone performance study in the context of diagnostic accuracy.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
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The sample size for the training set: Not mentioned.
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How the ground truth for the training set was established: Not mentioned.
Overall Conclusion from the Provided Text:
The provided document is a 510(k) summary for regulatory clearance, primarily focusing on demonstrating substantial equivalence to a predicate device and adherence to safety standards (laser safety, infrared light, EMC, biocompatibility). It describes the device's intended use and technical features. However, it does not contain information about a clinical performance study that would typically include details such as sample sizes, ground truth establishment, expert readers, or comparative effectiveness studies regarding its analytical capabilities (e.g., classifying a subject's performance as normal or abnormal). The "Summary and conclusion of technical tests" section addresses safety and compliance, not clinical performance metrics for diagnosis.
§ 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).