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The Retitrack™ is intended for recording, viewing, and analyzing temporal characteristics of fixation and saccadic responses when viewing a visual stimulus. The Retitrack™ is intended for use by healthcare practitioners in healthcare settings (e.g., physician's office, clinic, laboratory).

The Retitrack™ is a monocular, bench-top saccadometer that incorporates scanning laser ophthalmoscope (SLO) technology and eye tracking software to record, view, measure, and analyze eye motion. The Retitrack™ is comprised of an optical head containing an illumination system and an optical system; a base unit with a computer, electronics, and a power distribution system; connections for external input/output devices (e.g., monitor, keyboard, mouse, and storage media); a patient forehead and chin rest; and operational software.

The Retitrack™ interacts with the patient by directing light from an infrared (840 nm) superluminescent diode (SLD) into the patient's eye. The only parts of the device that contact the patient are the forehead and chin rest with adjustable temple pads and an optional attachable head strap to stabilize the patient's head.

The Retitrack™ uses the SLD light to scan the patient's retina in two dimensions while the patient is viewing a visual stimulus. The optical imaging system detects the reflected (or returned) light from the retina and creates high-resolution, digital retinal video sequences over time. The eye tracking software uses eye motion corrected frames to measure the translational retinal movement over time. The device displays the analysis of the eye motion results and saves the retinal video and a report. The Retitrack™ does not provide a diagnosis or treatment recommendation.

The Retitrack™ has separate tests that measure fixation stability (including microsaccades and drift) and visually guided horizontal saccade tracking. The Retitrack™ can be programmed by the user with specific visual stimuli presentations, including a single fixed stimulus to measure fixation stability or two alternating stimuli in different orientations to measure horizontal saccades. For the fixation stability test, the Retitrack™ analyzes the fixation responses, including microsaccade amplitude, microsaccade frequency, microsaccade velocity, drift velocity, and drift ratio over time. For the saccade tracking tests, the Retitrack™ analyzes the saccadic responses, including duration, amplitude, target accuracy, latency, and velocity.

The provided text describes the Retitrack™ device and its performance testing to demonstrate substantial equivalence to a predicate device. However, it does not explicitly state "acceptance criteria" in the format of a table or provide specific values for the device to meet. Instead, it describes various performance tests and their outcomes, implying that successful completion of these tests serves as the criteria for acceptance.

Therefore, the following information is extracted and presented based on what is available in the text, and where specific acceptance criteria are not provided, the reported performance is described as the outcome of the validation.

Acceptance Criteria and Device Performance

Since explicit quantitative acceptance criteria for all aspects are not provided, the "Acceptance Criteria" column will describe the objective of the test, and the "Reported Device Performance" will detail the findings.

*   **Data Provenance:** The document does not specify the country of origin for the human subject data. It also does not explicitly state whether the study was retrospective or prospective, but the description of "human subjects" and "recorded... while pupil videos were recorded simultaneously" implies a prospective data collection.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
* The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set. The ground truth appears to be based on the device's ability to accurately measure expected responses or on comparative analysis with another tracking method, rather than expert consensus on a diagnosis or interpretation.

3. Adjudication Method for the Test Set:

   • The document does not specify any adjudication method for the test set. The validation seems to rely on quantitative measurement comparisons and correlations rather than subjective interpretations requiring adjudication.

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

   • No, an MRMC comparative effectiveness study was not done in the context of human readers improving with AI vs. without AI assistance. The device is an "Eye Movement Monitor" and the studies reported focus on its measurement accuracy and equivalence to other tracking methods, not on assisting human interpretation of images or data.

5. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

   • Yes, standalone performance was assessed. The device itself is an automated measurement tool. The performance tests described (e.g., "Fixation and saccade measurements were successfully measured for all subjects," "linear relationship... found between the expected response and the measured retinal response," "good agreement between the pupil and retinal tracking methods") refer to the algorithm's direct measurement capabilities without human interpretation as part of the primary output.

6. Type of Ground Truth Used:

   • The ground truth appears to be based on:
     • Expected responses: For saccade amplitude and velocity, the device's measurements were compared against "expected response" (likely defined by the stimulus presented).
     • Comparative method: For retinal vs. pupil tracking, the ground truth for comparison was the "pupil videos... processed with a standalone pupil tracking algorithm."
   • This is not typical "expert consensus" or "pathology" ground truth as might be seen for diagnostic imaging devices. It's an engineering and physiological measurement validation.

7. Sample Size for the Training Set:

   • The document does not provide information on the sample size used for the training set.

8. How the Ground Truth for the Training Set Was Established:

   • The document does not provide information on how the ground truth for an implied training set (if any for the analysis algorithm's development) was established.

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