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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 4-7, associated with anisometropia and/or with mild strabismus. having received treatment instructions (frequency and duration) as prescribed by a trained eye-care professional. Luminopia is intended for both previously treated and untreated patients; however, patients with more than 12 months of prior treatment (other than refractive correction) have not been studied. 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) that is intended to improve vision in pediatric patients with amblyopia. The Luminopia SaMD consists of four software-only components: the Mobile Application, the Prescription Manager Portal, the Patient Portal, and the Backend Service Layer. The first 3 components are user-facing, while the Backend Service Layer is designed to only communicate with the other 3 components. The Luminopia SaMD is intended for prescription use only, in an at-home environment.

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 proposed modification is the addition of the DPVR P1 Pro HMD to the list of compatible HMDs in the Directions For Use for the Luminopia SaMD.

Here's a summary of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the added Head-Mounted Display (HMD) are defined by a set of minimum hardware requirements. The reported device performance indicates that the subject device (DPVR P1 Pro 4K HMD) met all these requirements.

2. Sample size used for the test set and the data provenance

The document describes hardware bench testing and optical testing for the DPVR P1 Pro 4K HMD and software testing to validate the Mobile Application on this HMD. It does not provide specific sample sizes for these tests in terms of number of devices or data points, nor does it explicitly mention the country of origin for the data or whether it was retrospective or prospective. Given the nature of hardware and software testing for device compatibility, it would typically be prospective testing performed in a lab setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not mention the use of external experts to establish ground truth for the hardware and software compatibility testing. The "ground truth" here is the adherence to the defined technical specifications and proper functioning of the software on the new HMD, which would typically be assessed by internal engineering and quality assurance teams.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

No adjudication method for the test set is mentioned, as the described testing is for technical compatibility against defined specifications, not for interpretation of medical data by experts.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was performed or mentioned. This submission is for the addition of a compatible HMD to an already cleared therapeutic device (Luminopia SaMD), not for the initial clearance or evaluation of the therapeutic effectiveness of the AI component itself. The "AI" here refers to the "Therapeutic Algorithms" within the SaMD, but their effectiveness was likely established in the predicate device's clearance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This submission focuses on hardware compatibility. The "Luminopia" device is a Software as a Medical Device (SaMD) that operates standalone (algorithm only) in that it applies therapeutic algorithms to video content without continuous human input during the viewing session. However, its use is prescribed by an eye-care professional, and the prescription dictates frequency and duration. The performance data presented here is for the compatibility of the HMD with the SaMD, not a re-evaluation of the SaMD's standalone therapeutic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the hardware and software compatibility testing, the ground truth was the pre-defined minimum technical specifications and expected software functionality. The tests confirmed whether the DPVR P1 Pro 4K HMD met these engineering and functional requirements.

8. The sample size for the training set

This document does not pertain to the development of the core therapeutic algorithm itself, but rather the compatibility of an additional HMD. Therefore, no information about the training set size for the Luminopia's "Therapeutic Algorithms" is provided in this submission.

9. How the ground truth for the training set was established

As in point 8, the document does not provide information on how the ground truth for the training set of the Luminopia's "Therapeutic Algorithms" was established, as this is a submission for an HMD compatibility update, not a new device or a re-evaluation of the core therapeutic AI.

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