(118 days)
Luminopia is a software-only digital therapeutic designed to be used with commercially available Head-Mounted Displays (HMDs) which are compatible with the software application. Luminopia is indicated for improvement in visual acuity in amblyopia patients, aged 4 to
Luminopia is Software as a Medical Device (SaMD) Mobile Application that is intended to improve vision in pediatric patients with amblyopia. The Mobile Application ("Mobile App") consists of two software units: the Video Content Platform and the Therapeutic Algorithms. The Video Content Platform allows the Patient to browse from a library of popular TV shows and movies and select videos to watch. The Video Content Platform, without the Therapeutic Algorithms, is analogous to consumer video applications (e.g., YouTube, Netflix). The Therapeutic Algorithms provide the actual treatment, by applying modifications to the videos shown by the Video Content Platform.
It is hypothesized that the Therapeutic Algorithms improve vision by breaking interocular suppression and encouraging amblyopic eye usage. The Therapeutic Algorithms are applied to patient-selected video content in the same manner for every video. The algorithms reduce contrast to the stronger eye's input to break interocular suppression and encourage amblyopic eye usage. Additionally, parts of each eye's input are occluded by dichoptic masks superimposed over the video content to promote binocular combination. The masks rotate through predefined pairs over the course of treatment.
The Mobile App is designed to be used with commercially available, off-the-shelf head-mounted displays ("HMDs") and does not require any hardware modifications or customization. These HMDs can either consist of a headset combined with a display unit or consist of an all-in-one unit. The HMD serves two functions. Firstly, the HMD serves as the computing platform for the Mobile App, analogous to a smartphone for a mobile medical application. The HMD requires a Wi-Fi connection to run the Mobile App. Secondly, the HMD serves as a viewing device for dichoptic presentation of the content in the app, similar to a stereoscope device (FDA Product Code: HJR). During usage, the Mobile App displays a separate image to each of the Patient's eyes within the HMD, and the images appear as one when viewed together.
The FDA 510(k) clearance letter for Luminopia (K243819) describes a clinical performance evaluation study to support the expanded indication for use. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria (Implied) and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" in a table format with specific thresholds before the study results. However, the study aims to demonstrate improvement in visual acuity in amblyopia patients within certain age groups. The reported device performance demonstrates this improvement.
| Performance Metric | Implied Acceptance Criteria (Demonstrated Improvement) | Reported Device Performance |
|---|---|---|
| Amblyopic Eye BCVA Improvement (Age 4-12) | Improvement in mean amblyopic eye best-corrected visual acuity (BCVA) | 1.1 lines (95% CI: 0.92-1.3 lines, N=290) |
| Amblyopic Eye BCVA Improvement (Age 4-7 Subgroup) | Improvement in mean amblyopic eye best-corrected visual acuity (BCVA) | 1.2 lines (95% CI: 1.0-1.4 lines, N=186) |
| Amblyopic Eye BCVA Improvement (Age 8-12 Subgroup) | Improvement in mean amblyopic eye best-corrected visual acuity (BCVA) | 0.95 lines (95% CI: 0.66-1.3 lines, N=104) |
| Safety Profile | Low incidence of reported adverse events, consistent with established risks | 9 non-serious adverse events (3%, N=290) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 334 patients were included in the registry study. Of these, 290 patients aged 4 to
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