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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.

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

• Usability Study: 10 subjects (5 normal, 5 with maculopathy).
• Cross-sectional Study: 86 subjects (40 with normal vision, 46 with various types of maculopathy).
• Multi-device Performance Study: 4 patients with maculopathy (tested on iPod Touch, iPad Air, and iPhone 6+).

The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) submission for a new device model, it is highly likely these were prospective studies conducted specifically for this submission.

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

The document does not provide details on experts used to establish ground truth. It focuses on comparing the new device's performance to a predicate and evaluating usability, not on establishing a new ground truth for patient conditions. The studies categorize subjects as "normal vision" and "maculopathy," but the method of confirming these classifications is not detailed.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for establishing ground truth for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No MRMC comparative effectiveness study involving human readers and AI assistance was done or described. The myVisionTrack® device is a patient-facing vision testing app and does not involve human readers interpreting AI results.

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

Yes, the studies described are essentially standalone performance studies of the device's algorithms. The myVisionTrack® Model 0005 is a self-test device, meaning the algorithm processes patient input directly without human interpretation in the loop during the test. The "performance" in this context refers to the device's ability to measure vision function (specifically metamorphopsia) and detect changes, not to assist a human expert.

7. The Type of Ground Truth Used

The ground truth for the studies was based on classifying subjects into two groups: "normal vision" and "various types of maculopathy." The specific methods for establishing these classifications (e.g., expert diagnosis, pathology reports, visual acuity tests) are not detailed in the provided text. The device itself is intended for detection and monitoring of metamorphopsia, not for definitive diagnosis, which remains the responsibility of the eye-care professional.

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for the training set. The studies described are performance evaluations of the final device, not details of its developmental training. It mentions that the "original development work and initial studies were done on these smaller devices" (referring to iPhone Models 1-3 for the Model 0003), but no specific training set size is given.

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

The document does not provide details on how the ground truth for any training set was established. As noted above, the focus is on performance validation, not the development process.

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