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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.

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.

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The device is intended to measure, record and display the movements of the eyeballs during their involuntary movements (nystagmus) and while testing the patient's vestibular function.

The device is for prescription use only and it is intended for use by qualified medical personnel trained in the use of nystagmographs. This device provides no diagnoses nor does it provide diagnostic recommendations.

The device is a PC-based system for measuring, recording and displaying the eve movements. Its components include video goggles or surface electrodes to record the eve movements, a PC interface to acquire the data, a series of software modules to display and analyze the data and various stimulation devices.

This 510(k) summary does not contain information related to specific acceptance criteria, a study proving device performance against those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement as requested.

The document primarily focuses on establishing substantial equivalence to previously cleared devices based on intended use and technological characteristics (like safety compliance, type of system, construction, power source, and computer interface).

Therefore, I cannot populate the requested table or answer the specific questions about the study from the provided text. The document doesn't include a performance study with detailed acceptance criteria and reported results.

Here's an overview of what is available in the document:

1. A table of acceptance criteria and the reported device performance:

• Not Available. The document does not specify performance acceptance criteria (e.g., accuracy, precision, sensitivity, specificity) for measuring eye movements, nor does it present results from a study demonstrating the device meets such criteria. The table in the document compares technological specifications (safety compliance, type, construction, power source, computer interface) of the device against predicate devices, not performance against acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not Available. No performance study is described, so no sample size for a test set or data provenance is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not Available. No ground truth establishment is described as part of a performance study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Available. No adjudication method is described.

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:

• Not Applicable. The device is a Nystagmographer (EyeTracker, IDEAS), which measures and displays eye movements. It is not an AI-assisted diagnostic device, and thus, a MRMC study on human reader improvement with AI assistance is not relevant to this type of device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not Available. While the device works as a standalone measurement system, the document does not describe a formal "standalone performance study" in the context of typical AI/diagnostic device evaluations, with specific metrics and acceptance criteria. It mainly focuses on functional equivalence to predicates.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not Available. No performance study or ground truth definition is provided.

8. The sample size for the training set:

• Not Applicable/Not Available. The device is a measurement system, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established:

• Not Applicable/Not Available. As above, no training set is relevant to this device's description.

In summary, the provided 510(k) documentation focuses on substantial equivalence based on design and intended use, rather than presenting a detailed performance study with specific acceptance criteria and clinical results. For devices like nystagmographs, regulatory clearance often relies more on demonstrating that the device reliably performs its intended measurement function and is safe, similar to existing predicate devices, rather than a clinical efficacy trial with diagnostic accuracy metrics.

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