Search Results

The my VisionTrack® Model 0005 is intended for the detection of central 3 degrees metamorphopsia (visual distortion) in patients with maculopathy, including age-related macular degeneration and diabetic retinopathy, and as an aid in monitoring progression of disease factors causing metamorphopsia. It is intended to be used by patients who have the capability to regularly perform a simple self-test at home. The myVisionTrack® Model 0005 is not intended to diagnose; diagnosis is the responsibility of the prescribing eye-care professional.

The myVisionTrack® Model 0005 is a vision function test provided as a downloadable app on to the user's supplied cell phone or tablet. The myVisionTrack® Model 0005 implements a shape discrimination hyperacuity (SDH) vision test which allows patients to perform their own vision test at home. If a significant worsening of vision function is detected the physician will be notified and provided access to the vision self-test results so that they can decide whether the patient needs to be seen sooner than their next already scheduled appointment.

Here's a breakdown of the acceptance criteria and study information for the myVisionTrack® Model 0005, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily focuses on demonstrating substantial equivalence to a predicate device (myVisionTrack® Model 0003) rather than defining explicit, quantitative acceptance criteria for the new device. However, based on the comparative study, we can infer the performance expectation.

Ask a specific question about this device

The my Vision TrackTM is intended for the detection of central 3 degrees metamorphopsia (visual distortion) in patients with maculopathy, including agerelated macular degeneration and diabetic retinopathy, and as an aid in monitoring progression of disease factors causing metamorphopsia. It is intended to be used by patients who have the capability to regularly perform a simple self-test at home. The myVisionTrackTM is not intended to diagnose; diagnosis is the responsibility of the prescribing eye-care professional.

The myVisionTrack™ is a vision function test provided on a commercially available cell phone. The myVisionTrack™ implements a shape discrimination hyperacuity (SDH) vision test which allows patients to perform their own vision test at home. This enables regular monitoring of disease progression, and for timely detection of significant changes in vision function. If a significant worsening of vision function is detected the physician will be notified and provided access to the vision self-test results so that they can decide whether the patient needs to be seen sooner than their next already scheduled appointment.

The provided document describes the myVisionTrack™ Model 0003, a device intended for the detection and characterization of central 3 degrees metamorphopsia in patients with maculopathy, including age-related macular degeneration and diabetic retinopathy, and as an aid in monitoring progression of disease factors causing metamorphopsia.

However, the document does not explicitly state specific acceptance criteria (e.g., sensitivity, specificity thresholds) for the device's performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices and verifying that patients can effectively use the device for self-monitoring.

Here's an analysis based on the information provided, highlighting what is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, no explicit acceptance criteria thresholds (like specific sensitivity or specificity values) are provided in the document. The study's conclusion is that the device is "as safe, as effective and performs at least as safely and effectively as the predicate devices."

The document mentions that the study "did show a significant difference between those patients with mild-to-moderate non-proliferative DR (NPDR) and those with very severe NPDR or proliferative DR (PDR), whereas traditional clinic-based visual acuity and contrast sensitivity tests were not able to detect a significant difference." This implies a performance benefit in detecting disease severity, but no specific metrics or acceptance criteria are given for this.

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

• Sample Size for Test Set: 36 individuals.
• Data Provenance: The study was a "6-month Clinical Study" and "6-month longitudinal study" performed by VAS (Vital Art and Science Incorporated). The document does not explicitly state the country of origin but implies it was conducted by the submitter (Vital Art and Science Incorporated, Richardson, TX, USA). It was a prospective longitudinal study.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated. The ground truth was based on "clinical judgment" and "traditional clinic-based visual acuity and contrast sensitivity tests" for assessing disease condition (NPDR vs. PDR). It is reasonable to assume these judgments were made by qualified ophthalmologists or eye care professionals, but specific numbers and qualifications are not detailed.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. The document mentions "clinical judgment" for assessing the disease condition, but how multiple experts (if any) arrived at a consensus is not described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described or conducted in the context of human readers improving with or without AI assistance. The study focused on the device's ability to monitor changes and patient compliance.

6. Standalone Performance (Algorithm Only without Human-in-the-loop Performance)

• Standalone Performance: Yes, the described study appears to be a standalone performance study. The myVisionTrack™ device "implements a shape discrimination hyperacuity (SDH) vision test which allows patients to perform their own vision test at home." The results are then analyzed by the device's algorithm, and "If a significant worsening of vision function is detected the physician will be notified." The study tested "effective self-monitoring... using myVisionTrack™" and demonstrated its ability to detect differences in disease states and generate notifications based on a "0.2 logMAR notification rule." This rule is an algorithmic threshold applied to the device's output.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for defining "significant change of disease condition" was based on clinical judgment by medical professionals and comparisons to traditional clinic-based visual acuity and contrast sensitivity tests.

8. Sample Size for the Training Set

• Sample Size for Training Set: The document does not specify a separate training set or its sample size. The description of the clinical study appears to relate to the validation of the device's performance, not necessarily the training of its algorithm (which is a "shape discrimination hyperacuity test"). The algorithms are described as using an "adaptive staircase algorithm," which is a testing methodology, not typically a machine learning training process that requires a training set in the conventional sense.

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

• Establishment of Ground Truth for Training Set: Not applicable, as a distinct training set for a machine learning algorithm is not described. The "shape discrimination hyperacuity test" is a known psychophysical testing method. The "adaptive staircase algorithm" is a method for efficiently finding thresholds. The document states "Numerous published studies have shown that patients with AMD and other forms of maculopathy have significantly poorer results as compared to normal subjects on the shape discrimination test," indicating that the underlying principle is well-established in scientific literature.

Ask a specific question about this device