The EyeCTester Model iOS is a mobile software as a medical device (SaMD) app for adults ages 22 and above. It is intended to serve as an aid to eyecare providers to monitor and detect central visual distortions (maculopathies) as well as central 10-degree visual field scotomas.

EyeCTester is not intended to screen or diagnose, but it is intended to alert a healthcare provider of any changes in a patient's central visual status. The device is intended for both at-home and clinical use. The EyeCTester is indicated to be used only with compatible mobile devices.

Device Description

The EyeCTester - Monitoring Application comprises a survey and a series of tests to provide remote monitoring of the patient's visual parameters from the patient's home. The EyeCTester -Monitoring application is available to patients with a prescription from the healthcare provider managing their vision. Prescribed, routine patient testing via the app allows providers to monitor vision health in the interim period between visits to the physician's clinical practice. The tool is not intended to replace the need for an in-person eye exam with a professional eve care provider. EyeCTester is not intended to diagnose the patient; diagnosis and management is the responsibility of the qualified team prescribing and interpreting the app measurements.

Prior to regular, at-home use, patients will receive training in the clinic and will then undergo training within the app and verify their understanding of how to complete testing. Pop-ups will appear throughout the app reminding the patient that the app's purpose is to monitor changes in vision, not to provide a diagnosis.

The app uses an Amsler Grid test to detect changes in visual distortions / scotomas / field cuts within the central 10 degrees of vision. The test prompts patients to outline and define distorted and/or missing areas on a series of grids while staring at a pulsating fixation point. At the end of the test, the grids are combined to display the patient's responses. The results of the assessments are summarized in a report that is provided to the prescribing healthcare provider to be interpreted and evaluated for any changes over time.

AI/ML Overview

The provided text describes the EyeCTester - Monitoring Application, a mobile software as a medical device (SaMD) app intended to aid eyecare providers in monitoring and detecting central visual distortions (maculopathies) and central 10-degree visual field scotomas. The device is not intended for screening or diagnosis but to alert healthcare providers of changes in a patient's central visual status.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly laid out in a table format with specific quantitative thresholds. Instead, the document describes the results of clinical testing as demonstrating repeatability, consistency with the paper analogue, and a low human error rate. The overall conclusion is that the device "is demonstrated to be as safe and effective and perform as well as the identified predicate device."

Thus, the implicit acceptance criteria are:

Repeatability: The device should consistently provide similar results when a test is performed multiple times on the same subject.
Consistency with Standard of Care (Paper Amsler Grid): The device's results should be comparable to those obtained using the traditional paper Amsler Grid.
Low Human Error Rate: Users should be able to complete the test with minimal errors.
Safety and Effectiveness: The device should be safe for its intended users and effective in its stated purpose (aiding in monitoring and detection of visual distortions/scotomas).

Based on the "Clinical Testing" section, here's how the device performed against these implicit criteria:

Acceptance Criterion	Reported Device Performance
Repeatability	"These studies demonstrated that a patient may use the EyeCTester application to gather psychophysiological measurements of central and paracentral vision parameters related to normative functioning of the human visual system, and these measurements are useful for remote monitoring in between clinic visits." "The data from this clinical study provide affirmation that the EyeCTester app-based test is repeatable and consistent with the results of the paper analogue."
Consistency with Standard of Care	"Clinical testing was performed to validate the visual parameter assessments of the EyeCTester compared to the standard of care modality (paper Amsler Grid)..." "The data from this clinical study provide affirmation that the EyeCTester app-based test is repeatable and consistent with the results of the paper analogue. The Amsler Grid testing was consistent and repeatable across the two testing methods."
Low Human Error Rate	"An additional metric assessed during the study was rate of human error in completing the test. It was confirmed that the human error rate was below 1% in the EyeCTester app test."
Safety and Effectiveness (Overall Summary)	"Overall, the clinical evaluations support the use of the EyeCTester for testing patients using the Amsler Grid test." "Clinical and Human Factors testing demonstrate that the device performs as intended." "The EyeCTester - Monitoring Application is demonstrated to be as safe and effective and perform as well as the identified predicate device."

Study Details from the Provided Text:

Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact number of participants (sample size) in the clinical studies. It mentions "participants without visual defects" in the Human Factors study and "healthy volunteers and patients with neuro-ophthalmic, retinal, and other diseases" in the clinical study.
- Data Provenance: The clinical studies were "prospective, randomized, cross-over, 2-site studies." The country of origin is not explicitly stated, but the submission is to the U.S. FDA, and the owner and consultant are based in Houston, Texas, suggesting a U.S. context.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number or qualifications of experts used to establish the ground truth for the test set. It mentions the study compared the device to the "standard of care modality (paper Amsler Grid)" and involved "eyecare providers" for interpretation, but doesn't detail expert involvement in ground truth establishment for the comparative study itself.
Adjudication method for the test set:
- The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set results. The comparison was against the "paper Amsler Grid," implying a direct comparison of results rather than a complex multi-reader adjudication process for ground truth.
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, an MRMC comparative effectiveness study involving human readers and AI assistance is not described. The study focuses on the device's performance compared to the paper Amsler Grid, not on how AI assistance improves human reader performance. The device itself is described as an "aid to eyecare providers" and provides a "report that is provided to the prescribing healthcare provider to be interpreted and evaluated." It acts as a tool for monitoring, not necessarily as an AI assisting in the interpretation process itself, though it gathers data that providers interpret.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "Clinical Testing" section describes a study to "validate the visual parameter assessments of the EyeCTester compared to the standard of care modality (paper Amsler Grid)." This implies evaluating the device's output against a known standard.
- While the device is intended to be an "aid" to providers and not for diagnosis, the clinical testing seems to evaluate the data collected by the device itself and its consistency with the paper Amsler Grid. The "human error rate" mentioned is in completing the test by the patient, not necessarily the algorithm's performance. The "report" is then provided to the provider for interpretation. Therefore, it appears a standalone performance evaluation of the data generation by the algorithm was conducted, assessed by its repeatability and consistency with the paper grid.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the clinical study was established by comparing the EyeCTester results to the "standard of care modality (paper Amsler Grid)." This suggests the paper Amsler Grid's results served as the reference or ground truth for the comparison. It is not explicitly stated whether this ground truth was further validated by expert consensus, pathology, or outcomes data.
The sample size for the training set:
- The document does not mention a training set sample size. It describes "software development and testing" and "human factors validation study" and "clinical testing," but no specifics on a separate training phase or dataset for an AI model. Given the description of the device as primarily an Amsler Grid test, it might not involve complex machine learning models that require distinct training sets, or if it does, the details are not provided. The comparison here is against a traditional method.
How the ground truth for the training set was established:
- Since a training set is not explicitly mentioned, the method for establishing its ground truth is also not provided.

Summary

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September 26, 2022

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Neuro-Eye Diagnostic Systems LLC % Isabella Schmitt Director of Regulatory Affairs Proxima Clinical Research, Inc. 2450 Holcombe Blvd. Houston, Texas 77071

Re: K203594

Trade/Device Name: EyeCTester Regulation Number: 21 CFR 886.1330 Regulation Name: Amsler Grid Regulatory Class: Class I Product Code: OTW

Dear Isabella Schmitt:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated September 7, 2022. Specifically, FDA is updating this SE Letter as an administrative correction for a typographical error in your Trade/Device Name.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Elvin Ng, OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, 240-402-4662, Elvin.Ng@fda.hhs.gov.

Sincerely,

Elvin Y. Ng-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

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September 7, 2022

Image /page/1/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and full name on the right. The Department of Health & Human Services logo features an abstract symbol, while the FDA part includes the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Neuro-Eye Diagnostic Systems LLC % Isabella Schmitt Director of Regulatory Affairs Proxima Clinical Research, Inc. 2450 Holcombe Blvd. Houston, Texas 77071

Re: K203594

Trade/Device Name: EyeQTester Regulation Number: 21 CFR 886.1330 Regulation Name: Amsler grid Regulatory Class: Class I Product Code: QTW Dated: June 4, 2021 Received: June 14, 2021

Dear Isabella Schmitt:

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

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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 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 (OS) 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. Ng -S

Enclosure

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Indications for Use

510(k) Number (if known) K203594

Device Name EyeCTester Monitoring App

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

510(k) Owner:	Neuro-Eye Diagnostic Systems, LLC
	2020 Quenby Street
	Houston, TX 77005

Official Contact:	Jade Schiffman, MD
	Telephone: +1 (281) 701-0577
	E-mail: jschiffman@neuroeye.com

Representative Consultant Contact:	Isabella Schmitt, RAC
	Proxima Clinical Research, Inc.
	2450 Holcombe Blvd, Suite J
	Houston, TX 77021
	Telephone: +1 (404) 205-4653
	E-mail: Isabella@ProximaCRO.com
Date Summary Prepared:	06 September 2022
Trade Name:	EyeCTester - Monitoring application
Common Name:	Digital Amsler Grid
Classification:	Class I
Classification Number(s):	21 CFR 886.1330
Product Code(s):	QTW
Classification Advisory Committee:	Ophthalmology
Predicate Device(s):	Alleye (K180895)

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Device Description:

This medical device product has functions subject to FDA premarket review as well as functions that are not subject to FDA premarket review. For this application, for functions that are not subject to FDA premarket review, FDA assessed those functions only to the extent that they either could adversely impact the safety and effectiveness of the functions subject to FDA premarket review.

Specification	EyeCTester (Subject Device)	Alleye
510(k) Number	K203594	K180895
Product Name	EyeCTester App	Alleye
Sponsor	Neuro-Eye Diagnostic Systems, LLC	Oculocare Medical AG
Product Code(s)	QTW	HOQ
Regulation Number(s)	21 CFR 886.1330	21 CFR 886.1330
Classification	Class I	Class I
Rx / OTC	Rx Only	Rx Only
Indications for Use	The EyeCTester Model iOS is a mobilesoftware as a medical device (SaMD)app for adults ages 22 and above. It isintended to serve as an aid to eyecareproviders to monitor and detect central /paracentral visual distortions(maculopathies) as well as central 10-degree visual field scotomas.	The Alleye is a mobile medicalsoftware application indicated for thedetection and characterizationof metamorphopsia, a visual distortion,in patients with age-related maculardegeneration (AMD) and as an aid inthe monitoring of the progression ofthis condition in respect of

Table 1: Comparison of EyeCTester - Monitoring Application to Identified Predicate

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Specification	EyeCTester (Subject Device)	Alleye
	EyeCTester is not intended to screen ordiagnose, but it is intended to alert ahealthcare provider of any changes in apatient's central visual status. Thedevice is intended for both at-home andclinical use. The EyeCTester isindicated to be used only withcompatible mobile devices.	metamorphopsia. It is intended to beused by patients who have thecapability to regularly perform a simpleself-test at home.
Testing Setting	At home and in clinic	At home
Hardware Platform	Software application to be used athome on a patient's personalsmartphone or in clinic on an officesupplied smartphone	Software application to be used at homeon a patient's personal smartphone
Amsler Grid / VisualField Algorithm	Measures 10-degree visual field fordistortions, including crooked anddoubling, and missingness defects, viapresentation of a series of grids onwhich a user fixes their vision andmanually selects and identifies areas ofvisual defects.	Measures visual field for distortions,including crooked defects, through analignment hyperacuity task
Data Upload andStorage	Vision test data are uploaded from thepatient's smartphone to a HIPAA andHiTech-compliant server. The data arepresented on an online physiciandashboard and within the provider'sapp for review and comparison by theprescribing healthcare professional.	Vision test data are uploaded from thepatient's phone and are stored andtransmitted in encrypted form. TheAlleye platform is HIPAA-compliant,and Alleye data is stored on physicalservers. The data are presented on anonline physician dashboard for reviewand comparison by the prescribinghealthcare professional.

Intended Use / Indications for Use:

The EyeCTester Model iOS is a mobile software as a medical device (SaMD) app for adults ages 22 and above. It is intended to serve as an aid to eyecare providers to monitor and detect central / paracentral visual distortions (maculopathies) as well as central 10-degree visual field scotomas.

Technological Characteristics:

The EyeCTester application provides remote visual monitoring for patients through Amsler Grid testing. Patients complete prescribed testing protocols within the application for one or both eyes

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as assigned by their eyecare provider. Providers are then able to access and interpret the results of these tests through the app or an online server and share them with the patient after interpretation, as appropriate. Providers may also be alerted when changes in visual parameters are reported by patients through the testing, based on prespecified rules set by the provider or clinic.

Software Testing:

The software development and testing was executed in compliance with IEC 62304 Medical Device Software Life Cycle Processes. The results of these tests indicate that EyeCTester Amsler Grid/ Visual Field functionality is substantially equivalent to the predicate device.

Human Factors / Usability Engineering Testing:

NEDS conducted a Human Factors Validation study in which participants without visual defects were enrolled to assess the user performance and test results of the EyeCTester compared to the standard, in-office examination tools. Each participant underwent the tests twice to ensure the validity of the findings. The Human Factors Validation study indicated minimal human error risks, many of which are shared with the non-digital test analogs. Additionally, the digital, at-home, mobile (smartphone) format allow considerable improvements to the test environment and test preparation (e.g., education in a quiet and self-paced environment), compared to non-digital test analogs. Overall, all participants were observed to safely use EyeCTester's features. Based on the results from this study, the risk profile of the application is confirmed to be acceptable. The Human Factors Validation study has shown that the EyeCTester application is safe and effective for the intended users, uses, and use environments.

Clinical Testing:

Clinical testing was performed to validate the visual parameter assessments of the EyeCTester compared to the standard of care modality (paper Amsler Grid) in both healthy volunteers and patients with neuro-ophthalmic, retinal, and other diseases. Both studies were approved by wcgIRB.

These clinical studies were prospective, randomized, cross-over, 2-site studies that involved a test and re-test to evaluate repeatability and agreement between the subject device and the paper format. These studies demonstrated that a patient may use the EyeCTester application to gather psychophysiological measurements of central and paracentral vision parameters related to normative functioning of the human visual system, and these measurements are useful for remote monitoring in between clinic visits.

The data from this clinical study provide affirmation that the EyeCTester app-based test is repeatable and consistent with the results of the paper analogue. The Amsler Grid testing was consistent and repeatable across the two testing methods. An additional metric assessed during the study was rate of human error in completing the test. It was confirmed that the human error rate was below 1% in the EyeCTester app test. Overall, the clinical evaluations support the use of the EyeCTester for testing patients using the Amsler Grid test.

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Conclusion:

In conclusion, the NEDS EyeCTester - Monitoring Application is demonstrated to be as safe and effective and perform as well as the identified predicate device. The Amsler Grid test has the same intended use, indication, technological characteristics, and principles of operation as the predicate. Any differences between the EyeCTester application's functionalities and the predicate device's do not alter the intended use of the device and do not raise new or different questions regarding its safety and effectiveness when use as labelled. Clinical and Human Factors testing demonstrate that the device performs as intended. Thus, the EyeCTester application is substantially equivalent to the identified predicate devices.

Regulation Number and Section

§ 886.1330 Amsler grid.

Link to an amendment published at 90 FR 55990, Dec. 4, 2025. (a)
Identification. An Amsler grid is a device that is a series of charts with grids of different sizes that are held at 30 centimeters distance from the patient and intended to rapidly detect central and paracentral irregularities in the visual field.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.