Search Results

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.

Study Details:

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: 21 human subjects (ages 21-55 for the intended use validation, ages 19-53 for retinal vs. pupil comparison).
     • For the intended use validation: The study used 10-second human eye movement videos, with >200 videos for fixation stability and >300 videos for horizontal saccade tracking.
   • 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.

Ask a specific question about this device

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 < 5 arc min. The system incorporates a built in visual target presentation using miniature laser projectors mounted on the sensor forehead plate. Saccadometer Plus is equipped with three red laser projectors with 10° separation. Saccadometer Advanced has additional extra green laser and it allows to perform more complex saccadic task. Information about eye movement is acquired by analyzing the infrared light reflected from eye orbit. The left and right eve orbit are illuminated by two infrared LEDs, providing eve surface irradiance below 1mW/cm-(operating condition). Due to the conjugacy and synchronicity of the saccadic eye movements, the rotation of left and right eyes, can be added and averaged. The inner canthi of the left and right eyes are illuminated with the low intensity IR. The difference between the amounts of IR reflected back from the eye surfaces toward the photodetecting circuitry, carries the information about the eye position changes. The eye landmarks are taking part in generation of the eye movement signal. The corneal bulge and the limbus (the border between darker iris and white sclera). Main contributor to the eye movement signal is the corneal bulge. Being the relative eye position measurement system, it requires to define the initial eye position. It means that at the beginning of every measurement, a steady eye fixation point needs to be provided. In Saccadometer the central fixation target serves this purpose. The Saccadometer Plus and Saccadometer Advanced systems are composed of: - proprietary hardware and firmware, enclosed in - examination control unit with 2 x 1.5V AA batteries, and the - eye movement sensor with integrated miniature laser spot projectors - proprietary software application LatencyMeter. - optical fiber to USB data transmitter

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

Study Details

1. Sample size used for the test set and the data provenance:

   • Saccade Detection Algorithm Accuracy: Test environment allowing simulation of saccade response with given parameters on a photoelectric converter. This implies a simulated, rather than human, test set. No human subject sample size is provided for this specific test.
   • Measurement Linearity Testing: "12 subjects aged 22-69."
   • Spatial Resolution of eye movement measurement: "12 subjects (aged 22-69)."
   • Reliability study: "17 subjects aged 22-69."
   • Data Provenance: For human subject studies (linearity, spatial resolution, reliability), it's explicitly stated: "Studies were performed only outside United States." This indicates the data is retrospective or prospective, but no further detail is given. For the algorithm accuracy, it was a simulated environment.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Saccade Detection Algorithm Accuracy: The ground truth was established by the simulated "pseudosaccade" parameters in a controlled test environment. No human experts were involved in establishing ground truth for this test.
   • Measurement Linearity, Spatial Resolution, Reliability: The document does not describe the establishment of ground truth by human experts for these performance tests. The tests appear to measure the device's agreement with expected physical properties or its own consistency, rather than comparing it against a human interpretation of data.

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

   • No adjudication method is described for any of the performance tests. The tests focus on device-centric performance metrics rather than interpretative output requiring human adjudication.

4. 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:

   • No MRMC comparative effectiveness study was done. The device (Saccadometer) is an "Eye Movement Monitor" that objectively measures characteristics; it is not described as an AI-assisted diagnostic tool that human readers would use to improve their performance in interpreting images or data.

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

   • Yes, the "Experimental verification of the saccade detection algorithm" was a standalone test of the device's algorithm performance using a simulated environment. Other tests like measurement linearity, spatial resolution, and temporal resolution also assess the device's standalone performance, though they involved human subjects whose eye movements were measured by the algorithm.

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

   • Saccade Detection Algorithm Accuracy: Simulated "pseudosaccade" parameters provided as input to the photoelectric converter.
   • Measurement Linearity, Spatial Resolution, Reliability: Ground truth for these characteristics appears to be implicitly defined by the physical or physiological processes being measured (e.g., actual target displacement for linearity, intrinsic eye movement characteristics for resolution and reliability), which the device then attempts to quantify. It's not based on expert consensus, pathology, or outcomes data.

7. The sample size for the training set:

   • The document does not mention machine learning or AI models with distinct "training sets." The device's "saccade detection algorithm" seems to be based on established algorithms for eye movement analysis rather than requiring a specifically labeled training dataset in the modern sense of deep learning.

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

   • As no training set is described for a machine learning model, this information is not applicable.

Ask a specific question about this device

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.

Ask a specific question about this device