(149 days)
Luminopia One 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 One is indicated for improvement in visual acuity in amblyopia patients, aged 4-7, associated 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; however, patients with more than 12 months of prior treatment (other than refractive correction) have not been studied. Luminopia One 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 One therapy. Luminopia One is intended for prescription use only, in an at-home environment.
Luminopia One is Software as a Medical Device (SaMD) that is intended to improve vision in pediatric patients with amblyopia. The Luminopia One 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 One 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.
This document describes the 510(k) summary for Luminopia One, a digital therapeutic for amblyopia. The core of the document discusses the substantial equivalence of the current device (Luminopia One with Pico G2 4K) to a previously cleared version (Luminopia One with Samsung Gear HMD).
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here refer to the minimum hardware requirements that Head-Mounted Displays (HMDs) must meet to be compatible with the Luminopia One SaMD. The performance data presented shows that both the previously cleared Samsung Gear HMD and the newly added Pico G2 4K HMD meet these criteria.
| Parameter | Acceptance Criteria (Minimum Requirements) | Samsung Gear HMD Performance | Pico G2 4K HMD Performance |
|---|---|---|---|
| Luminance and luminance uniformity | ≥ 48 cd/m² | ≥ 48 cd/m² | ≥ 48 cd/m² |
| Michelson contrast (low spatial frequency) | ≥ 90% across field of view | ≥ 90% across field of view | ≥ 90% across field of view |
| Michelson contrast (high spatial frequency grille pattern) | Baseline requirement | (Met) | Equivalent or higher than Samsung Gear HMD across field of view¹ |
| Resolution | ≥ 14.0 pixels/degree (vertical) | ||
| ≥ 14.4 pixels/degree (horizontal) | ≥ 14.0 pixels/degree (vertical) | ||
| ≥ 14.4 pixels/degree (horizontal) | ≥ 14.0 pixels/degree (vertical) | ||
| ≥ 14.4 pixels/degree (horizontal) | |||
| IPD range support | Meets requirements ≥ 52mm IPD | Meets requirements ≥ 52mm IPD | Meets requirements ≥ 52mm IPD |
| Internet capability | Yes | Yes | Yes |
| Battery capacity | > 90 min | > 90 min | > 90 min |
| Weight | Snapdragon 821 | > Snapdragon 821 | > Snapdragon 821 |
| Refresh rate | ≥ 60 Hz | ≥ 60 Hz | ≥ 60 Hz |
| Field of view | ≥ 51.9 degrees (horizontal) | ||
| ≥ 30.6 degrees (vertical) | ≥ 51.9 degrees (horizontal) | ||
| ≥ 30.6 degrees (vertical) | ≥ 51.9 degrees (horizontal) | ||
| ≥ 30.6 degrees (vertical) |
Note¹: The text clarifies that for high spatial frequency Michelson contrast, both HMDs have lower than 90% in general, but the Pico G2 4K is equivalent or higher than the Samsung Gear HMD, thus meeting the "baseline requirement."
2. Sample Size Used for the Test Set and the Data Provenance
The provided document describes hardware and software compatibility testing for the Pico G2 4K HMD, not a clinical study on patient outcomes with the device. Therefore, a "test set" in the context of amblyopia patients is not applicable here.
- Test Set Description: This document focuses on testing the compatibility of a new HMD (Pico G2 4K) with existing software. The sample size for this type of technical compatibility testing would typically refer to the number of HMD units tested, not patients. The document does not specify the exact number of Pico G2 4K HMD units tested, but it implies comprehensive testing was performed.
- Data Provenance: The testing described is prospective (conducted specifically for this submission) and involves hardware bench testing and software validation. No patient data or clinical trial specifics are mentioned within this part of the document for this specific submission (K221659). The original clinical study for Luminopia One (DEN210005) that established its effectiveness did use patients, but the details of that study's test set are not provided in this excerpt.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable in this document. The "ground truth" here is adherence to technical specifications for HMDs. There is no mention of experts establishing ground truth for a clinical test set in this specific 510(k) summary, as it is a submission for an HMD compatibility update, not a new clinical trial.
4. Adjudication Method for the Test Set
Not applicable. This document describes technical verification and validation, not clinical adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
Not applicable. This document describes hardware and software compatibility testing, not a comparative effectiveness study involving human readers or AI assistance for image interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The Luminopia One device is a "Software as a Medical Device (SaMD)" and its "Therapeutic Algorithms" operate in a standalone manner in terms of applying modifications to video content. However, it's not "standalone" in the sense of an AI diagnostic that outputs a result without human review. It's a therapeutic device that works in conjunction with a patient and a prescribing eye-care professional.
The performance data presented here (hardware bench testing and optical testing) is for the HMD's ability to render the software's output correctly, independent of human interaction beyond operating the device. Software testing validated the mobile application's functionality on the HMD.
7. The Type of Ground Truth Used
For the compatibility testing described in this document, the "ground truth" consists of the pre-defined minimum hardware requirements for the HMDs (e.g., specific thresholds for luminance, resolution, contrast, etc.) and the expected functional behavior of the software. The "ground truth" for the therapeutic effectiveness of Luminopia One itself (as established in the original DEN210005 submission) would likely be an improvement in visual acuity measured clinically, but those details are not in this excerpt.
8. The Sample Size for the Training Set
Not applicable to this document. The document describes testing for HMD compatibility, not for an AI algorithm that requires a training set. The underlying "Therapeutic Algorithms" do not appear to be machine learning based in the sense that they would have a training set. They apply "modifications to the videos shown by the Video Content Platform" based on rules (reducing contrast, dichoptic masks).
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set or machine learning algorithms in this context.
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