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.

Device Description

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.

AI/ML Overview

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.

Parameter	Acceptance Criteria (Predicate HMD: Pico G2 4K)	Reported Device Performance (Subject Device HMD: DPVR P1 Pro 4K)
Luminance and luminance uniformity	≥ 48 cd/m²	≥ 48 cd/m²
Michelson contrast (low spatial frequency)	≥ 90% across field of view	≥ 90% across field of view
Michelson contrast (high spatial frequency grille pattern)	Baseline requirement	Equivalent or higher than Samsung Gear HMD across the field of view, at both nominal IPD and 52mm IPD
Resolution (vertical)	≥ 14.0 pixels/degree	≥ 14.0 pixels/degree
Resolution (horizontal)	≥ 14.4 pixels/degree	≥ 14.4 pixels/degree
IPD range support	Meets requirements ≥ 52mm IPD	Meets requirements ≥ 52mm IPD
Internet capability	Yes	Yes
Battery capacity	> 90 min	> 90 min
Weight	< 500 g (± 5%)	< 500 g (± 5%)
RF compliance	Yes	Yes
Audio support	Yes	Yes
Power button	Yes	Yes
Eye glasses compatibility	Yes	Yes
Processing capacity	> Snapdragon 821	> Snapdragon 821
Refresh rate	≥ 60 Hz	≥ 60 Hz
Field of view (horizontal)	≥ 51.9 degrees	≥ 51.9 degrees
Field of view (vertical)	≥ 30.6 degrees	≥ 30.6 degrees

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.

Summary

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August 8, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Luminopia, Inc. Endri Angjeli VP of Clinical Development 955 Massachusetts Ave #335 Cambridge, Massachusetts 02139

Re: K233720

Trade/Device Name: Luminopia Regulation Number: 21 CFR 886.5500 Regulation Name: Digital therapy device for amblyopia Regulatory Class: Class II Product Code: QQU Dated: July 1, 2024 Received: July 1, 2024

Dear Endri Angjeli:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Elvin Y.

Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Enclosure

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Indications for Use

Submission Number (if known)

K233720 Device Name

Luminopia

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

ver-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

510(k) Owner: Luminopia, Inc. Address: 955 Massachusetts Ave #335, Cambridge, MA 02139 Phone: 857-365-6636 Fax: 857-336-6605 Contact Person: Endri Angjeli Date: August 8, 2024

Trade Name: "Luminopia One" and "Luminopia" Common Name: N/A Classification Name: Digital Therapy Device for Amblyopia (21 CFR 886.5500, Product Code: OOU)

Predicate Device: Luminopia One (Submission Number: K221659)

Indications for Use: 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 eve-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.

Device Description:

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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 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. All compatible HMDs meet the following set of minimum requirements:

Parameter	Pico G2 4K HMD	Subject Device HMD(DPVR P1 Pro 4K)
Luminance and luminanceuniformity	≥ 48 cd/m²	≥ 48 cd/m²
Michelson contrast (low spatialfrequency)	≥ 90% across field of view	≥ 90% across field of view
Michelson contrast (high spatialfrequency grille pattern)	Baseline requirement	Equivalent or higher thanSamsung Gear HMDacross¹
Resolution	≥ 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
Internet capability	Yes	Yes
Battery capacity	> 90 min	> 90 min
Weight	< 500 g (± 5%)	< 500 g (± 5%)
RF compliance	Yes	Yes

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Audio support	Yes	Yes
Power button	Yes	Yes
Eye glasses compatibility	Yes	Yes
Processing capacity	> Snapdragon 821	> Snapdragon 821
Refresh rate	≥ 60 Hz	≥ 60 Hz
Field of view	≥ 51.9 degrees (horizontal)≥ 30.6 degrees (vertical)	≥ 51.9 degrees (horizontal)≥ 30.6 degrees (vertical)

1. The Michelson contrast is lower than 90% when tested with image analysis of a high spatial frequency grille pattern for the Pico G2 4K HMD and the Samsung Gear HMD, the current compatible HMD cleared in K221659. The DPVR P1 Pro 4K has equivalent or higher contrast than that of the Samsung Gear HMD across the field of view, at both the nominal IPD and a 52mm IPD, and therefore meets the minimum requirement.

Feature	Subject Device	Cleared Device(K221659)	Impact
Class	II	II	No change
Classification	886.5500	886.5500	No change
Product code	QQU	QQU	No change
Labeling
Indications forUse	Luminopia is a software-onlydigital therapeutic designed tobe used with commerciallyavailable Head-MountedDisplays (HMDs) which arecompatible with the softwareapplication. Luminopia isindicated for improvement invisual acuity in amblyopiapatients, aged 4-7, associatedwith anisometropia and/or withmild strabismus, havingreceived treatment instructions(frequency and duration) asprescribed by a trained eye-care professional. Luminopiais intended for both previouslytreated and untreated patients;	Luminopia One is a software-only digital therapeuticdesigned to be used withcommercially available Head-Mounted Displays (HMDs)which are compatible with thesoftware application.Luminopia One is indicated forimprovement in visual acuityin amblyopia patients, aged 4-7, associated withanisometropia and/or with mildstrabismus, having receivedtreatment instructions(frequency and duration) asprescribed by a trained eye-care professional. LuminopiaOne is intended for both	No change
	however, patients with morethan 12 months of priortreatment (other than refractivecorrection) have not beenstudied. Luminopia is intendedto be used as an adjunct to full-time refractive correction, suchas glasses, which should alsobe worn under the HMDduring Luminopia therapy.Luminopia is intended forprescription use only, in an at-home environment.	previously treated anduntreated patients; however,patients with more than 12months of prior treatment(other than refractivecorrection) have not beenstudied. Luminopia One isintended to be used as anadjunct to full-time refractivecorrection, such as glasses,which should also be wornunder the HMD duringLuminopia One therapy.Luminopia One is intended forprescription use only, in an at-home environment.
Prescription/over-the-counter use	Prescription-use only	Prescription-use only	No change
Useenvironment	Home use	Home use	No change
CompatibleHMDs listedin labeling	- DPVR P1 Pro 4K- Pico G2 4K	- Samsung Gear HMD- Pico G2 4K	Does notintroduce newtechnologicalcharacteristics orquestions ofsafety andeffectiveness
Technological Characteristics
Device type	Software as a Medical Device(SaMD)	Software as a Medical Device(SaMD)	No change
Device design	4 software-only components:- Mobile Application- Prescription Manager Portal- Patient Portal- Backend Service Layer	4 software-only components:- Mobile Application- Prescription Manager Portal- Patient Portal- Backend Service Layer	No change
Devicematerials	N/A (device is SaMD)	N/A (device is SaMD)	No change
Energy source	N/A (device is SaMD)	N/A (device is SaMD)	No change
Devicefeature:	Modification of visual stimuliusing:	Modification of visual stimuliusing:	No change
Therapeuticmechanism	contrast reduction + dichopticmasks	contrast reduction + dichopticmasks
Devicefeature:Visual stimuli	Video content	Video content	No change
Hardwareplatform	Off-the-shelf Head-MountedDisplay (HMD)	Off-the-shelf Head-MountedDisplay (HMD)	No change

Substantial Equivalence:

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The proposed modification is the addition of one additional head-mounted display (HMD) model to the list of compatible HMDs in the Directions For Use for the Luminopia SaMD. The intended use and Indications for Use remain the same.

No design changes for the SaMD were needed to produce compatibility for this modification, and therefore, there are no changes to the technological characteristics. Any similarities or differences in the technical specifications of the off-the-shelf HMDs are relevant only insofar as they impact one of the HMD parameters for which there are minimum requirements relevant to safety and effectiveness. Since the additional HMD meets all minimum requirements for compatibility, the proposed modification does not impact the safety and effectiveness of the SaMD.

Performance Data:

Hardware bench testing and optical testing were used to establish the compatibility of the additional HMD. The hardware testing confirmed that the additional HMD met the minimum hardware requirements for resolution, luminance, luminance uniformity, contrast, cross-talk, IPD, and non-optical parameters. Software testing validated that the Mobile Application runs as intended on the additional HMD model, and that there is proper integration between the software and the HMD. The software testing methods used were unit and integration testing, functional testing, system regression testing, negative testing, and thermal testing. All of the testing passed without deviations.

Conclusion:

The proposed modification to add one additional HMD for use with the Luminopia SaMD does not change the intended use or the technological characteristics of the predicate device. Performance testing supported this assessment, and therefore the subject and the predicate device are Substantially Equivalent.

Regulation Number and Section

N/A