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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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Measuring temporal characteristics of saccadic refixation responses when viewing lateral visual stimulus and identifying the individual time delays of moving the eyes toward the stimuli.

The Saccadometer system measures eye movements in horizontal axis with temporal 1kHz and spatial resolution

The provided FDA 510(k) summary for the Saccadometer Plus and Saccadometer Advanced devices describes performance data, but does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner typical for clinical trials or formal validation studies. Instead, it presents results of various tests demonstrating the device's characteristics and performance.

Therefore, the table below will list the reported device performance characteristics based on the provided text, rather than explicitly stated acceptance criteria. For questions where the information is not provided in the document, it will be stated as "Not provided."

Acceptance Criteria and Reported Device Performance

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The VPS is a non-invasive ultrasonic device intended to measure the pattern of eye and head movement when viewing lateral visual stimulus, to use as a guide for prescribing progressive power eyeglass lenses.

The VPS is a non-invasive ultrasonic device intended to measure the pattern of eye and head movement when viewing lateral LED fixation lamps. It consists of a headset and a main body with an ultrasonic transmitter. Two ultrasonic receivers are imbedded in the center nosepiece of the headset. The patient wears the headset and looks at three orange LED fixation lamps in the main body as they light up in succession. As the patient follows the lights from side to side, the device measures the degree of head movement from the center light against a target angle of 40° and a standard deviation. Eye movement is extrapolated to fill the remaining vision angle. The calculated ratio of head/eye movement is used to determine the shape of the peripheral and central fields of the progressive spectacle lenses.

Here's a breakdown of the acceptance criteria and study information for the Varilux® VisionPrint™ System (VPS) based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state pre-defined "acceptance criteria" against which the device performance was measured. Instead, it describes characteristics of the device's performance in a clinical study. The performance described focuses on the reproducibility and correlation of the VPS measurements.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 175 presbyopic patients.
• Data Provenance: The document does not explicitly state the country of origin. It is a "clinical study," implying prospective data collection for the purpose of the submission. The date of the 510(k) summary (December 19, 2003) and the FDA approval date (July 2, 2004) suggest recent data for that period.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The provided summary does not mention the use of experts to establish ground truth for the test set. Instead, it uses a comparator device (Polhemus Fastrak) as a reference for comparison.

4. Adjudication Method for the Test Set

Not applicable. There's no mention of an adjudication process as external experts were not used to establish ground truth.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. The study focused on the device's internal consistency and its correlation with another measurement device, not on how human readers' performance with or without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Yes, the performance data presented is for the standalone device. The VPS is an "Eye Movement Monitor" that measures eye and head movement; the study describes its measurements directly, not its impact on human performance. It is a measurement device, not an interpretative AI.

7. The Type of Ground Truth Used

The "ground truth" for the comparative analysis was the measurements obtained from an "electromagnetic sensor -- the Polhemus Fastrak." This serves as a reference standard to demonstrate the accuracy or agreement of the VPS's measurements.

8. The Sample Size for the Training Set

The document does not mention a "training set" or "training data." The VPS is described as an ultrasonic measurement device, not an AI/machine learning algorithm requiring a distinct training phase. The clinical study described appears to be a validation or performance evaluation study of the device itself.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set or AI algorithm requiring ground truth for training is explicitly described.

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