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NeuroSwift Pro is intended for Viewing and recording eye movements in support of identifying vestibular disorders.The system is to be used by trained healthcare personnel in an appropriate healthcare setting. This system provides no diagnosis and does not provide diagnostic recommendations. The target population is 12+ years of age.

The NeuroSwift Pro is intended for viewing and recording eye movements in support of identifying vestibular disorders. The system is to be used by trained healthcare personnel in an appropriate healthcare setting. This system provides no diagnosis and does not provide diagnostic recommendations. NeuroSwift Pro. model NS01-2 contains goggles and software. The NeuroSwift Pro is a combination of hardware and software, designed to provide information for clinicians as a supplement in clinical decision-making by eye movements. The NeuroSwift Pro goggle is a see-through binocular video goggle with a pair of light reflectors and 3 metered, nylon braided USB cable connecting to the computer interface. Accompanying components include a stable and sturdy head strap, face cushion, and a lightweight eye cover. The hardware provides high-definition video recording capability. The NeuroSwift Pro software is a computer interface designed to record eye movement videos and simultaneously display the visual target(s) on the computer screen. The software provides vestibular test modes and calibration functions. Initially, the software instructs the users to follow calibration functions. Then, the examiner can observe spontaneous nystagmus using the eye cover. The examiner can perform oculomotor tests with the goggles, while the patient follows visual targets on the screen. During gaze tests, the patient will fixate on stationary white spots that are positioned at center, right, left, up and down. In saccade tests the patient is asked to stare at the target moving in horizontal, vertical, or mixed pattern. In pursuit tests the patient's ability to track a target that moves in a sinusoidal or triangular pattern across the screen. The optokinetic function provides a large moving checkerboard pattern on the screen. Patients can change in various body positions as directed by the clinician. The software measures the eye movement via slow phase velocity and measures the eye position shift and trace. The recorded video and test protocols are processed in the NeuroSwift Pro software. The NeuroSwift Pro generates the traces of eye movements, eye velocities, and analytical data, which allows the clinician to determine the response of the patient according to the test functions.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The provided document details a performance comparison test to demonstrate substantial equivalence to a predicate device. The acceptance criteria are implicit in the conclusion that the device "meets the pre-specified acceptance criteria" and that all criteria generated a "Pass" status.

Table of Acceptance Criteria and Reported Device Performance

Study Details

1. Sample Size and Data Provenance:

• Test Set Sample Size: 10 subjects.
• Data Provenance: The document does not explicitly state the country of origin. It appears to be a prospective study as subjects underwent testing with both devices specifically for this evaluation.

2. Number and Qualifications of Experts for Ground Truth:

• Number of Experts: Two (2) healthcare professionals (referred to as "Evaluators").
• Qualifications of Experts: They are described as "experienced healthcare professionals." More specific qualifications (e.g., audiologist, neurologist, years of experience) are not provided.

3. Adjudication Method for the Test Set:

• The evaluation involved "two experienced healthcare professionals (Evaluators)" who were responsible for "observing the eye movements, generating test reports for each vestibular function test, and comparing the results between the two devices."
• A "data analyzer utilized the Deming regression method (95% CI) to analyze and plot the data for comparison."
• Finally, "The evaluators then assessed and rated the 'Pass/Fail' status for all criteria of all tested subjects, including the calibration ability, eye movement direction, and Deming regression results."
• This suggests a consensus-based adjudication method where both evaluators assessed and rated the results, likely agreeing on the "Pass/Fail" status after reviewing the data and Deming regression analysis. It's not a specified 2+1 or 3+1 method; rather, it appears to be a joint assessment and rating by the two evaluators, supported by quantitative analysis.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Was it done?: No, a traditional MRMC study comparing human readers with and without AI assistance was not conducted. This study's purpose was to demonstrate the equivalence of the new NeuroSwift Pro device to a predicate device, not the improvement of human reader performance with AI. The device itself (NeuroSwift Pro) is for "viewing and recording eye movements in support of identifying vestibular disorders" and "provides no diagnosis and does not provide diagnostic recommendations." Therefore, it's not an AI-assisted diagnostic tool in the typical sense that would necessitate an MRMC "human + AI vs human only" study.
• Effect Size: N/A, as an MRMC study comparing human readers with AI assistance was not performed.

5. Standalone Performance (Algorithm Only):

• Was it done?: Yes, to an extent. While not explicitly framed as "algorithm only performance," the study conducted a performance comparison test where the device's output (eye movements, test reports, and quantitative data like slow phase velocity, eye position shift, and trace) was compared to that of the predicate device. The Deming regression analysis specifically evaluated the agreement of quantitative measurements between the two devices. This could be considered a form of standalone performance evaluation in the context of device function and measurement accuracy, rather than diagnostic accuracy.

6. Type of Ground Truth Used:

• The ground truth in this comparative study was the performance of the legally marketed predicate device (VisualEyes 505/515/525) and the expert assessment of the evaluators. The study aimed to demonstrate that the NeuroSwift Pro's measurements and qualitative assessments ("Pass/Fail" for calibration, eye movement direction) were equivalent to those obtained from the predicate device, as interpreted by experienced healthcare professionals. It's a comparative ground truth rather than an independent gold standard like pathology or long-term clinical outcomes.

7. Sample Size for Training Set:

• The document does not provide information on a training set for any machine learning components. This is likely because the device primarily functions as an eye movement recording and analysis system (nystagmograph), not explicitly an AI/ML diagnostic algorithm that would require a separate training dataset for model development. The focus is on the accuracy and equivalence of its measurements and recording capabilities.

8. How Ground Truth for Training Set was Established:

• N/A, as information on a training set is not provided.

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