(130 days)
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.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| myVisionTrack® Model 0005 performance not significantly different from myVisionTrack® Model 0003 performance. | Cross-sectional study concluded that the performance of Model 0005 (4AFC) is not significantly different from Model 0003 (3AFC). |
| Test variability across different device platforms (iPod Touch, iPad Air, iPhone 6+) should be comparable to or smaller than the inherent mVT™ test variability over time (0.10 logRM). | Test variability across different devices was comparable to or smaller than 0.10 logRM. Mean results for iPod Touch, iPad Air, and iPhone 6+ were -2.11 logRM, -2.07 logRM, and -2.07 logRM, respectively (F=0.047, p>0.95), indicating no significant difference. |
| Self-test usability: users should effectively self-test and find the device user-friendly. | 100% of participants completed the self-test with a training demo. 90% met the criteria for completing without issues. 90% understood accessing "More" screen. 80% completed self-test in |
§ 886.1330 Amsler grid.
(a)
Identification. An Amsler grid is a device that is a series of charts with grids of different sizes that are held at 30 centimeters distance from the patient and intended to rapidly detect central and paracentral irregularities in the visual field.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.