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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 <13, associated with anisometropia and/or with mild strabismus, having received treatment instructions (frequency and duration) as prescribed by a trained eye-care professional. Luminopia One is intended for both previously treated and untreated patients. Luminopia is intended to be used as an adjunct to full-time refractive correction, such as glasses, which should also be worn under the HMD during Luminopia therapy. Luminopia is intended for prescription use only, in an at-home environment.

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.

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 <13 with a diagnosis of amblyopia associated with anisometropia and/or strabismus were specifically analyzed for the extended indication.
  • Subgroup Age 4-7: N=186
  • Subgroup Age 8-12: N=104
• Data Provenance:
  • Country of Origin: Not explicitly stated in the provided text.
  • Retrospective or Prospective: The study was "designed prospectively, which collected retrospective data from medical health records of patients treated with Luminopia under usual care." This indicates a retrospective registry study based on prospectively defined data collection protocols.

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

This information is not provided in the document. The study collected data from "medical health records of patients treated with Luminopia under usual care." This implies that the visual acuity measurements and amblyopia diagnoses were established by the treating eye-care professionals as part of routine clinical practice, rather than by a specific panel of experts for the purpose of the study's ground truth.

4. Adjudication Method for the Test Set:

This information is not provided in the document. Given that the data was collected from "medical health records" and not explicitly stated otherwise, there's no indication of a formal adjudication process for the visual acuity measurements.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not explicitly done in this context. The study evaluates the effectiveness of Luminopia therapy on patient visual acuity, not the improvement in human reader performance (e.g., ophthalmologists interpreting images) with AI assistance. The device is the therapeutic intervention.

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

Yes, in a sense. The "performance data" presented is the algorithm's effect on patients' visual acuity when used as prescribed. Luminopia is a "software-only digital therapeutic" where the "Therapeutic Algorithms provide the actual treatment." While a human (patient) interacts with the software, and an eye-care professional prescribes it, the performance metrics directly measure the outcome of the algorithm's application to the visual stimuli, rather than the algorithm assisting a human in a diagnostic task. Therefore, the reported "Improvement in BCVA" is a measure of the standalone therapeutic effect.

7. The Type of Ground Truth Used:

The ground truth used for performance evaluation was:

• Clinical Measurements of Visual Acuity (BCVA): Best-corrected visual acuity (BCVA) measurements recorded in patient medical records are the primary ground truth for efficacy.
• Medical Diagnosis of Amblyopia: The inclusion criteria required a diagnosis of amblyopia associated with anisometropia and/or mild strabismus, as established by eye-care professionals.
• Adverse Event Reporting: Patient or clinician-reported adverse events constitute the ground truth for safety.

8. The Sample Size for the Training Set:

This information is not provided in the document. The document describes a "Real-World Registry study" for performance evaluation (test set), and references a prior clinical trial (DEN210005) for safety and initial efficacy in a narrower age range. It does not disclose details about the training data used to develop the Luminopia algorithms themselves.

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

This information is not provided in the document, as the training set details are not discussed.

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