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.

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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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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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.

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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The CureSight™ system is indicated for improvement in visual acuity in amblyopia patients, aged 4 - years, associated with anisometropia and/or with mild strabismus, having received treatment instructions (frequency and duration) as prescribed by a trained eye-care professional. CureSight™ is intended for both previously treated and untreated patients and is intended to be used as an adjunct to full-time refractive correction, such as glasses, which should also be worn under the anaglyph glasses during CureSight™ is intended for prescription use only, in an at-home environment.

The CureSight™ system is an eye-tracking-based system aimed for improving visual acuity and stereo acuity under dichoptic conditions. The technology is based on real-time eye tracking and separation of the visual stimuli presented on a monitor into two separate digital channels, one for each eye. Using this dichoptic method, any streamed video content can be tailored individually per eye and then presented simultaneously to each eye.

During the treatment, dichoptic anaglyph (red-blue) glasses that are part of the CureSight system are to be worn over the habitual spectacle correction.

The CureSight™ system comprises the following components/modules:

• CureSight-CS100 device (console and anaglyph glasses) ●
• CureSight Web-App/Portal

CureSight™ system is aimed for improving visual acuity and stereo acuity under dichoptic conditions, using digital content in pediatric patients (age 4 to

Acceptance Criteria and Device Performance for NovaSight CureSight-CS100

1. Table of Acceptance Criteria and Reported Device Performance

The primary effectiveness endpoint for the study was non-inferiority in the improvement of amblyopic eye distance visual acuity (AEDVA) compared to standard patching treatment.

Secondary Effectiveness Endpoints:

4. Adjudication Method for Test Set

The document does not describe an adjudication method involving multiple experts reviewing cases to establish ground truth for the visual acuity measurements. The visual acuity data was collected prospectively through direct measurement using standardized protocols (Lea symbol per ATS VA protocol and E-ETDRS VA protocol).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described for the device's performance. The study was a clinical trial comparing the CureSight device to a traditional treatment (patching) in human subjects ("evaluator-masked"), not a study comparing human readers with and without AI assistance in interpreting diagnostic images. Thus, no effect size of human readers improving with AI vs. without AI assistance is applicable or reported.

6. Standalone (Algorithm Only) Performance

Based on the provided text, a standalone (algorithm only without human-in-the-loop performance) study was not conducted or reported for the effectiveness of the device in improving visual acuity. The CureSight device is a treatment system that subjects use, and its performance is measured by the change in their visual acuity over time, not by an algorithm's diagnostic output. The software validation mentioned ("Software verification and validation testing") refers to the functional performance and safety of the software within the device, not its standalone diagnostic accuracy.

7. Type of Ground Truth Used for the Test Set

The ground truth for the clinical study (test set) was based on direct clinical measurements of visual acuity (Amblyopic Eye Distance Visual Acuity - AEDVA, Binocular Distance Visual Acuity - DVA) and stereo acuity using standardized, clinically accepted tests (Lea symbol per ATS VA protocol, E-ETDRS VA protocol, and Randot preschool test). This can be categorized as clinical outcome measures or objective clinical assessments.

8. Sample Size for the Training Set

The document does not provide information about a separate training set or its sample size. The description of "Performance Data" focuses exclusively on the pivotal clinical study (test set) and bench testing. The device is a digital therapy device, and while it uses "real-time software algorithm[s]," the text does not detail an AI/ML model that would typically have a distinct training set for diagnostic or predictive purposes related to the primary effectiveness endpoint.

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

As no specific training set for an AI/ML model in the context of diagnostic or predictive performance is described, the method for establishing its ground truth is not provided. The "software algorithm" mentioned dynamically processes visual information based on eye tracking, but there's no indication that this algorithm was "trained" on a dataset with external ground truth labels in the conventional sense of AI validation studies.

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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 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; 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 a Software as a Medical Device (SaMD) intended to improve visual acuity in pediatric patients with amblyopia (also known as lazy eye). The device is indicated for improvement in visual acuity at 12 weeks of use in amblyopia patients aged 4-7. The software is designed to be used with commercially available head-mounted displays (HMDs) and is intended for at-home use. In this submission, the Samsung Gear HMD has been validated to be compatible with Luminopia One. The Patient should wear their refractive correction, such as glasses, under the HMD during treatment. The software allows patients to select videos to watch. Treatment is provided through algorithms that apply modifications to the videos to encourage use of the amblyopic eve. The video presented to the fellow eye (the stronger eye) is different from the video presented to the amblyopic eve (weaker eye). When a video begins in the software application, the patient will see a modified version of the original video through each eye. This is intended to rebalance the visual input to the eyes and encourage weaker eye usage. The treatment regimen is the following: the patient watches the video 1 hour per day, 6 days per week for a total of 12 weeks. Luminopia One also includes a Patient Portal. The Patient/Caregiver will also have access to an online Patient Portal where they can review the Patient's adherence and select their favorite videos to watch in the HMD. The Patient Portal enables the Caregiver to review the patient's progress and treatment plan and curate content for the patient to watch. The Patient Portal is designed to be used by the Caregiver.

Here's a detailed breakdown of the acceptance criteria and the study proving the Luminopia One device meets them, based on the provided document:

1. Acceptance Criteria and Reported Device Performance

Bench/Non-Clinical Performance Testing

Clinical Performance Testing (Effectiveness)

Clinical Performance Testing (Safety)

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