(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 | < 500 g (± 5%) | < 500 g (± 5%) | < 500 g (± 5%) |
| RF compliance | Yes | Yes | Yes |
| Audio support | Yes | Yes | Yes |
| Power button | Yes | Yes | Yes |
| Eye glasses compatibility | Yes | Yes | Yes |
| Processing capacity | > 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.
{0}------------------------------------------------
November 4, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below.
Luminopia, Inc. Scott Xiao CEO 955 Massachusetts Ave #335 Cambridge, Massachusetts 02139
Re: K221659
Trade/Device Name: Luminopia One Regulation Number: 21 CFR 886.5500 Regulation Name: Digital Therapy Device For Amblyopia Regulatory Class: Class II Product Code: QQU Dated: September 27, 2022 Received: September 27, 2022
Dear Scott Xiao:
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 (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 located 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.
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 803) for
{1}------------------------------------------------
devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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. Na -S
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
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K221659
Device Name Luminopia One
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for Luminopia. The logo features two overlapping eye-shaped figures in different shades of blue. The word "luminopia" is written in a sans-serif font below the eye figures, also in blue. The logo is simple and modern, with a focus on the company name and a visual representation of vision or sight.
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: Scott Xiao Date Prepared: November 3, 2022
Trade Name: Luminopia One Common Name: Digital Therapy Device for Amblyopia Classification: Class II Classification Name: Digital Therapy Device for Amblyopia Regulation Number: 886.5500 Product Code: QQU
Predicate Device: Luminopia One (Submission Number: DEN210005)
Indications for Use: 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.
Device Description:
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.
{4}------------------------------------------------
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 predicate device was evaluated in a clinical study using the Samsung Gear HMD. The proposed modification is the addition of the Pico G2 4K HMD to the list of compatible HMDs in the Directions For Use for the Luminopia One SaMD. Both HMDs meet the following set of minimum requirements:
| Parameter | Samsung Gear HMD | Pico G2 4K HMD |
|---|---|---|
| Luminance and luminanceuniformity | ≥ 48 cd/m² | ≥ 48 cd/m² |
| Michelson contrast (lowspatial frequency) | ≥ 90% across field of view | ≥ 90% across field of view |
| Michelson contrast (highspatial frequency grillepattern) | Baseline requirement | Equivalent or higher thanSamsung Gear HMD across |
{5}------------------------------------------------
| field of view¹ | ||
|---|---|---|
| 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 ≥ 52mmIPD | Meets requirements ≥ 52mmIPD |
| 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 | ≥ 51.9 degrees (horizontal)≥ 30.6 degrees (vertical) | ≥ 51.9 degrees (horizontal)≥ 30.6 degrees (vertical) |
Substantial Equivalence:
| Feature | Subject Device | Cleared Device(DEN210005) | Impact |
|---|---|---|---|
| Class | II | II | No change |
| Classification | 886.5500 | 886.5500 | No change |
| Product code | QQU | QQU | No change |
| Labeling | |||
| Indications for | Luminopia One is a | Luminopia One is a | No change |
| Use | software-only digitaltherapeutic designed to beused with commerciallyavailable Head-MountedDisplays (HMDs) whichare compatible with thesoftware application.Luminopia One isindicated for improvementin visual acuity inamblyopia patients, aged4-7, associated withanisometropia and/or withmild strabismus, havingreceived treatmentinstructions (frequencyand duration) asprescribed by a trainedeye-care professional.Luminopia One isintended for bothpreviously treated anduntreated patients;however, patients withmore than 12 months ofprior treatment (other thanrefractive correction) havenot been studied.Luminopia One isintended to be used as anadjunct to full-timerefractive correction, suchas glasses, which shouldalso be worn under theHMD during LuminopiaOne therapy. LuminopiaOne is intended forprescription use only, inan at-home environment. | software-only digitaltherapeutic designed to beused with commerciallyavailable Head-MountedDisplays (HMDs) whichare compatible with thesoftware application.Luminopia One isindicated for improvementin visual acuity inamblyopia patients, aged4-7, associated withanisometropia and/or withmild strabismus, havingreceived treatmentinstructions (frequencyand duration) asprescribed by a trainedeye-care professional.Luminopia One isintended for bothpreviously treated anduntreated patients;however, patients withmore than 12 months ofprior treatment (other thanrefractive correction) havenot been studied.Luminopia One isintended to be used as anadjunct to full-timerefractive correction, suchas glasses, which shouldalso be worn under theHMD during LuminopiaOne therapy. LuminopiaOne is intended forprescription use only, inan at-home environment. | |
| Prescription/over-the-counteruse | Prescription-use only | Prescription-use only | No change |
| Use environment | Home use | Home use | No change |
| CompatibleHMDs listed inlabeling | - Samsung Gear HMD- Pico G2 4K | - Samsung Gear HMD | Does notintroduce newtechnologicalcharacteristicsor questions ofsafety andeffectiveness |
| Technological Characteristics | |||
| Device type | Software as a MedicalDevice (SaMD) | Software as a MedicalDevice (SaMD) | No change |
| Device design | 4 software-onlycomponents:- Mobile Application- Prescription ManagerPortal- Patient Portal- Backend Service Layer | 4 software-onlycomponents:- Mobile Application- Prescription ManagerPortal- Patient Portal- Backend Service Layer | No change |
| Device materials | 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 |
| Device feature:Therapeuticmechanism | Modification of visualstimuli using:contrast reduction +dichoptic masks | Modification of visualstimuli using:contrast reduction +dichoptic masks | No change |
| Device feature:Visual stimuli | Video content | Video content | No change |
| Hardwareplatform | Off-the-shelf Head-Mounted Display (HMD) | Off-the-shelf Head-Mounted Display (HMD) | No change |
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 Pico G2 4K HMD 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.
{6}------------------------------------------------
{7}------------------------------------------------
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 One 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
{8}------------------------------------------------
they impact one of the HMD parameters for which there are minimum requirements relevant to safety and effectiveness. Since both the Samsung Gear HMD and the Pico G2 4K HMD met all minimum requirements, 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 One 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.
N/A