(175 days)
VN415m, VN415b, VO425m, VO425b systems provide information to assist in the Oculographic evaluation, diagnosis and documentation of vestibular disorders. Nystagmus of the eye is recorded by use of goggle mounted cameras. These images are measured, recorded, displayed and stored in the software. This information then can be used by a trained medical professional to assist in diagnosing vestibular disorders.
This system consists of a PC or Laptop (requirements specified), a 2D-VOG% Goggle and a software platform that by licensing enables different levels of functionality recognized as the VN415m, VN415b, VO425m, VO425b products. The 2D-VOGry Goggles component comprises housing and one or two cameras depending on the license obtained for this system. Cameras number two can be added to the 2D-VOGm Goggles afterwards with the goades by uparading the product license. The 2D-VOGry Goggles may be added to other products within the 2D-VOGw System in the future. The 2D-VOG% Goggle is connected to the PC via a standard Firewire connection. Optionally a rotating chair can be added to the 2D-VOGw System. The chair shall meet our specifications developed for compliance with the 2D-VOGn System. Functionalities of the products may be controlled by a remote control and/or a foot switch. These controls are connected to the PC via a wireless connection by means of a USB wireless receiver/transmitter. Test results and reports are formatted and printed by the 2D-VOGw System software. A database containing test results and other patient information can be located and shared on the PC.
The provided text is a 510(k) summary for the Interacoustics 2D-VOGfw System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device "meets acceptance criteria" in the way a clinical trial for a novel device would. Therefore, the information typically requested in your prompt (e.g., sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not present in this 510(k) summary.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The 510(k) summary does not present specific acceptance criteria in a quantitative table format. Instead, it states that "The performance data indicated that the 2D-VOGfw System meets all specified requirements, and is substantially equivalent to the predicate device."
The "performance" in this context refers to the technological characteristics comparing the new device to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device | The 2D-VOGfw System meets all specified requirements and is substantially equivalent to the predicate device (2D VOG-Videooculography, K972243). |
| Intended Use Match | Provides information to assist in oculographic evaluation, diagnosis, and documentation of vestibular disorders by recording, measuring, displaying, and storing nystagmus images for trained medical professionals. |
| Technological Characteristics | Comparison of technological characteristics demonstrated equivalence to the marketed predicate device. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. The document refers to "performance data" but does not detail how this data was generated (e.g., retrospective or prospective studies, country of origin).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a 510(k) summary focused on substantial equivalence, not a clinical study requiring expert-established ground truth for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. The document does not describe a test set or an adjudication process.
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:
- No MRMC comparative effectiveness study is mentioned. This device is a system for recording and displaying eye movements for diagnosis by a trained medical professional; it is not presented as an AI-driven diagnostic aid that would "improve" human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is explicitly stated to "assist in diagnosing vestibular disorders" by a "trained medical professional," indicating a human-in-the-loop system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The submission focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and intended use, not on validating diagnostic accuracy against a specific ground truth.
8. The sample size for the training set:
- Not applicable. The device described does not appear to be an AI/machine learning model where a "training set" would be relevant in this context.
9. How the ground truth for the training set was established:
- Not applicable for the same reason as above.
§ 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).