(90 days)
This device is used to observe, record and measure eye movements in patients during testing of vestibular function.
The CHARTR® ENG/VNG Diagnostic System is a computer based medical device consisting of a Computer utilizing the Pentium III processor, Windows 98 Operating System. Computer Monitor, two Display Monitors for viewing eve movements and utilizes the following accessories: Light Bar, Video Goggles, External Isolation Transformer. Video Distribution Amplifier. Caloric Stimulator. Color Printer, Patient Electrodes, and Interconnection Cables.
The provided text is a 510(k) summary for the ICS Medical CHARTR® ENG/VNG Diagnostic System, and a letter from the FDA determining substantial equivalence to predicate devices. This type of document is generally focused on regulatory approval based on equivalence to existing devices, rather than detailed studies proving performance against acceptance criteria for a novel device. Therefore, much of the requested information regarding specific study details (like sample sizes, expert qualifications, adjudication methods, or MRMC studies) is not present in the provided text.
Based on the information available:
Acceptance Criteria and Device Performance
The document does not explicitly state acceptance criteria in terms of quantitative performance metrics for the CHARTR® ENG/VNG Diagnostic System itself. Instead, the basis for approval is "substantial equivalence" to predicate devices. The "performance" reported implicitly is that the device "observes, records, and measures eye movements in patients during testing of vestibular function," which aligns with the intended use statement.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices for observing, recording, and measuring eye movements during vestibular function testing. | The CHARTR® ENG/VNG Diagnostic System is substantially equivalent to the 2D VOG-VIDEO-OCULOGRAPHY device marketed by SensoMotric Instruments, GmbH ("SMI") and the CHARTR®ENG SYSTEM marketed by ICS Medical Corporation. It observes, records, and measures eye movements in patients during testing of vestibular function. |
Study Details (Based on available information)
1. Sample sizes used for the test set and the data provenance:
- Not provided. The document describes a regulatory submission based on substantial equivalence to predicate devices, not a de novo study with a specific test set.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not provided. Ground truth establishment, if any, is not detailed.
3. Adjudication method for the test set:
- Not provided.
4. 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 study was not described. The device is for recording and measuring eye movements, not an AI-assisted diagnostic tool for human readers in the context typically associated with MRMC studies in imaging.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not explicitly described as a standalone performance study. The device is a "computer based medical device" that utilizes accessories to "observe, record, and measure eye movements." Its performance is inherent in its function as a diagnostic system for vestibular function, rather than an "algorithm only" in the sense of an AI model being evaluated. The approval is based on its functional equivalence to existing devices.
6. The type of ground truth used:
- Not explicitly stated as a separate ground truth study. The basis for approval is substantial equivalence to established devices, implying that the "ground truth" is effectively the established performance and clinical utility of those predicate devices for their intended use.
7. The sample size for the training set:
- Not applicable/Not provided. This document does not describe the development or training of an AI model with a training set. It refers to a computer-based system, but not an AI/ML system in the modern sense.
8. How the ground truth for the training set was established:
- Not applicable/Not provided. As there is no mention of a training set, the establishment of its ground truth is not discussed.
§ 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).