(30 days)
The Insight Infrared Video Goggles are intended for viewing and recording eye movements in support of identifying vestibular disorders in patients. The device is intended for use only by a trained healthcare professional in an appropriate healthcare setting. This device provides no diagnoses nor does it provide diagnostic recommendations. The target population is 12+ years of age.
The Insight Infrared Video Goggles system displays and records eye movements on a computer from cameras mounted to goggles worn by a patient The eye movements called nystagmus are part of the body's balance system and can be analyzed by a trained clinician to provide objective information during a vestibular exam. The goggles are designed to block all external light from the patient's eyes so they are unable to fixate on anything in their visual field. This is an important performance characteristic of the googles since the eyes can suppress abnormal nystagmus when not occluded. The goggles have a durable plastic shell that houses two (2) cameras, infrared LED lights, two (2) switch-driven visible lights, and a face cushion. The goggles connect to the computer with a 4 m USB cable and are designed to be worn by the patient for 10 to 15 minutes on average in various body positions as directed by the clinician.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the Insight Infrared Video Goggles (K203082):
Device: Insight Infrared Video Goggles
Intended Use: Viewing and recording eye movements in support of identifying vestibular disorders in patients. For use by trained healthcare professionals, target population 12+ years of age. Provides no diagnoses or diagnostic recommendations.
1. Table of Acceptance Criteria and Reported Device Performance
The core performance claims for this device revolve around its ability to clearly view and record eye movements for vestibular assessment, mirroring the capabilities of the predicate device. The study design reflects this by focusing on the subjective assessment of eye movement visibility by trained clinicians.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Ability to view eye movements clearly enough for assessment during relevant Vestibular Function Tests (spontaneous nystagmus, gaze-evoked nystagmus, positional/positional nystagmus). | "YES" for all criteria for all subjects tested by both clinicians. |
| Performance present (i.e., eye movements visible and clear for assessment). | 100% PASS |
| Demonstrated equivalent performance to the VisualEyes Video Eye Monitor (K964325) for shared vestibular tests. | Results "demonstrate equivalent performance." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 5 subjects.
- Data Provenance: Not explicitly stated regarding country of origin, but implied to be a prospective study conducted specifically for this submission. The testing was comparative against a predicate device.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Two trained clinicians.
- Qualifications of Experts: Described as "trained clinicians." No specific years of experience or board certifications (e.g., radiologist) are provided in this document, but their role is to assess the visibility and clarity of eye movements, not to make diagnostic calls. The indication for use specifies "trained healthcare professional," and the predicate comparisons mention a similar level of training for the intended operator (audiologists, ENT doctors, physicians, vestibular rehabilitation specialists, or licensed healthcare personnel).
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly described as a formal adjudication process. The document states that "two trained clinicians viewed the eye movements." Since the Insight Infrared Video Goggles were rated "YES" for all criteria by both clinicians for all subjects tested, perfect concordance was achieved, negating the need for a specific adjudication rule like 2+1 or 3+1.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a formal MRMC comparative effectiveness study in the sense of human readers improving with AI vs. without AI assistance was not performed.
- This device is not an AI-assisted diagnostic tool; it's a hardware device for viewing and recording eye movements.
- The comparative performance testing focused on whether the device itself could provide clear visibility of eye movements, equivalent to a predicate device, as assessed by human clinicians. It does not measure the improvement of human readers' diagnostic accuracy with or without the device, but rather the device's functional equivalence.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
- Standalone Performance: Not applicable in the context of an algorithm's (AI) performance. This device is a hardware component (goggles with cameras) that provides visual data for human interpretation. The "performance" being evaluated is the clarity of the video output as perceived by human clinicians, not an automated algorithm's output. The device "provides no diagnoses nor does it provide diagnostic recommendations."
7. Type of Ground Truth Used
- Type of Ground Truth: Expert consensus on the visibility and clarity of eye movements offered by the device. The "ground truth" here is the subjective assessment by the trained clinicians that the eye movements were adequately visible for performing the vestibular function tests. It is not based on pathology, outcomes data, or a definitive clinical diagnosis.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a hardware system for capturing video, not an AI/ML algorithm that requires a training set. The "testing" described is performance validation against basic functionality, not machine learning model training.
9. How Ground Truth for Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.
§ 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).