(244 days)
I-Portal® 4D Video Oculography (VOG) System is used to monitor and record eye movements from various stimuli used in vestibular diagnostic testing. The system measures and records horizontal, vertical, and torsional eye movements, as well as pupil area. It is used in conjunction with various stimuli (rotary chair, manual (done by clinician) positional maneuvers, caloric tests, external stimulus) to detect and record nystagmus and eye tracings for interpretation by qualified medical personnel trained in vestibular diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.
Not Found
The provided document is limited to a "Substantial Equivalence Determination" from the FDA and does not contain the detailed study information required to answer your request. This type of FDA letter typically confirms that a device is substantially equivalent to a predicate device already on the market, meaning it has a similar intended use and technology, and any differences do not raise new questions of safety or effectiveness. It does not generally include a detailed description of the studies, acceptance criteria, or performance data that would be found in a 510(k) summary or full submission.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and the reported device performance: This information is not present in the provided document.
- Sample size used for the test set and the data provenance: Not available.
- Number of experts used to establish the ground truth for the test set and the qualifications: Not available.
- Adjudication method: Not available.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned. The device is a "Video Oculography Eye Tracking System," which is a measurement device for eye movements, not typically an AI diagnostic algorithm that would be assessed with MRMC studies in the context of human reader improvement.
- Standalone performance (algorithm only): Not mentioned, and likely not applicable for this type of device which seems to be a hardware/software system for capturing and presenting data.
- Type of ground truth used: Not available.
- Sample size for the training set: Not available.
- How the ground truth for the training set was established: Not available.
The document focuses on the regulatory approval and outlines the device's intended use: "I-Portal® 4D Video Oculography (VOG) System is used to monitor and record eye movements from various stimuli used in vestibular diagnostic testing. The system measures and records horizontal, vertical, and torsional eye movements, as well as pupil area. It is used in conjunction with various stimuli (rotary chair, manual (done by clinician) positional maneuvers, caloric tests, external stimulus) to detect and record nystagmus and eye tracings for interpretation by qualified medical personnel trained in vestibular diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations."
To obtain the detailed study information, one would typically need to review the full 510(k) summary or the complete 510(k) submission, which is not provided in this excerpt.
§ 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).