The Alleye is a mobile medical software application indicated for the detection and characterization of metamorphopsia, a visual distortion, in patients with age-related macular degeneration (AMD) and as an aid in the monitoring of the progression of this condition in respect of metamorphopsia. It is intended to be used by patients who have the capability to regularly perform a simple self-test at home.

Device Description

Alleye is a digital technology visual function test, consisting of two different items: a mobile app for patients and a web interface for eye care professionals. Alleye implements an alignment hyperacuity task that helps patients with age-related macular degeneration (AMD) to assess their vision at home. This allows the timely detection of significant changes in vision function, enabling the regular monitoring of the disease progression and/or monitoring the visual function associated with ongoing treatments. Two elements provide feedback about the Alleye test: a score and a colored circle. The score value reflects the visual performance in the dots alignment, whereas the color indicates whether the performance has worsened considerably (red) or remained stable or improved (green) compared to the previous test.

AI/ML Overview

The provided text describes the Alleye device, a mobile medical software application indicated for the detection and characterization of metamorphopsia in patients with age-related macular degeneration (AMD) and as an aid in monitoring the progression of this condition.

Here's an analysis of the acceptance criteria and the studies conducted:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for Alleye are not explicitly stated as quantitative targets in the provided document. Instead, the document focuses on demonstrating substantial equivalence to a predicate device (myVisionTrack Model 0005) through various clinical and non-clinical studies. The device performance is described in terms of its ability to detect worsening visual function and its reliability.

Acceptance Criteria (Implied)	Reported Device Performance
Preamble: Substantially equivalent to predicate device.	Preamble: Alleye is deemed substantially equivalent to K143211 (myVisionTrack) based on similar intended use and technological characteristics (mobile app for hyperacuity self-testing).
Functional: Reliability in metamorphopsia testing.	Test-Retest Study: Evaluated the reliability of metamorphopsia testing with Alleye.
Clinical Efficacy: Aid in monitoring disease progression/need for injection.	Longitudinal Study: Demonstrated that patient self-testing with Alleye allows the detection of worsening visual function prior to follow-up visits, aiding in monitoring for the need of an injection.
Usability: User-friendliness for elderly AMD patients.	Usability Study: Oral feedback and System Usability Scale (SUS) results confirmed user-friendliness for elderly subjects with AMD.
Software Quality: Compliance with medical device software standards.	Software Verification: Complied with IEC 62304 Medical Device Software - Software Life Cycle Processes.
Safety and Effectiveness: Does not raise new issues.	Conclusion: Based on validation and clinical evaluation, the device does not raise new issues of safety or effectiveness compared to the predicate. It is considered safe and effective for its intended use.

2. Sample Size Used for the Test Set and Data Provenance

Test-Retest Study:
- Sample Size: 26 healthy subjects and 60 subjects with age-related macular degeneration (AMD).
- Data Provenance: Not explicitly stated, but the study was conducted to evaluate reliability. It implies clinical, prospective data.
Clinical Evaluation – Longitudinal Study:
- Sample Size: 60 patients diagnosed with wet AMD who were undergoing pro re nata intravitreal injection (IVI) of anti-VEGF for treatment. They completed at least a 3-month follow-up, providing 1506 Alleye measurements over 150 follow-up periods.
- Data Provenance: Not explicitly stated, but implies prospective clinical data from patients undergoing treatment.
Usability Study:
- Sample Size: Elderly subjects with AMD (specific number not provided, but at least two clinical studies were conducted).
- Data Provenance: Implies prospective data collection through user interaction and feedback.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not explicitly state the number or qualifications of experts used to establish ground truth for the test sets.

In the Longitudinal Study, the "need of an injection at the next follow-up visit" served as a clinical outcome, which would typically be determined by an ophthalmologist or retina specialist based on their clinical assessment (e.g., OCT scans, visual acuity changes, signs of active disease). However, the specific methodology for establishing this "ground truth" (i.e., whether an injection was truly needed) and the role of experts in that determination is not detailed.
For the Test-Retest Study, the "reliability of the metamorphopsia testing" itself is the outcome, suggesting a measure of internal consistency within the device's readings rather than comparison against an external expert-determined ground truth for metamorphopsia.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth within the described studies. Clinical decisions in the longitudinal study would likely follow standard medical practice by the treating ophthalmologists.

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 involving human readers with and without AI assistance is described in the provided text. The Alleye device is positioned as a patient self-testing tool for monitoring, not as an AI-assisted diagnostic tool for human readers.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the studies described investigate the standalone performance of the Alleye application (algorithm only) as a patient self-testing tool.

The Test-Retest Study evaluated the reliability of the Alleye's metamorphopsia testing.
The Longitudinal Study evaluated the Alleye's ability to detect worsening visual function.
The Usability Study evaluated the app's user-friendliness.

In all these cases, the "performance" refers to the Alleye device's capabilities without direct human interpretive input during the testing process itself. The interpretation of the Alleye results by eye care professionals is an intended use, but the studies focus on the patient-facing component.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Test-Retest Study: The ground truth for this study was the internal consistency/reproducibility of the Alleye's own measurements over time in the same individuals. It's about how reliably the device detects metamorphopsia, not necessarily how accurately it matches an external ground truth for metamorphopsia presence.
Clinical Evaluation – Longitudinal Study: The ground truth appears to be clinical outcomes data related to the "need for an injection at the next follow-up visit," which would be a physician's clinical decision based on a comprehensive assessment (e.g., visual acuity, OCT, physical exam). The study shows Alleye's ability to predict or indicate this need, implying these clinical decisions serve as the reference.
Usability Study: The ground truth for usability was user feedback (oral feedback and System Usability Scale scores) from the target patient population.

8. The Sample Size for the Training Set

The document does not provide information about the sample size used for the training set of the Alleye algorithm. As a Predicate device (myVisionTrack) is mentioned and the focus is on substantial equivalence, it's possible that the "algorithm" for hyperacuity testing is based on established principles rather than requiring extensive de novo machine learning training data in the context of this submission. However, if machine learning was used, the training data details are not disclosed here.

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

Since information about a specific training set and its sample size is not provided, the method for establishing its ground truth is also not detailed in this document.

Summary

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June 27, 2018

Oculocare Medical AG % Allison Komiyama Consultant AcKnowledge Regulatory Strategies, LLC 2834 Hawthorn St. San Diego, CA 92104

Re: K180895 Trade/Device Name: Alleye Regulation Number: 21 CFR 886.1330 Regulation Name: Amsler Grid Regulatory Class: Class I Product Code: HOQ Dated: March 30, 2018 Received: April 5, 2018

Dear Allison Komiyama:

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. 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

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(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Bradley S. Cunningham -A

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180895

Device Name Alleye

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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eyelash extensions

510(k) Summary K180895

DATE PREPARED

June 20, 2018

MANUFACTURER AND 510(k) OWNER

Oculocare Medical AG Verena Conzett Strasse 9, Zurich, ZH 8004, Switzerland Telephone: +41 44 700 42 28 Official Contact: Prof. Dr. Lucas Bachmann, CEO

REPRESENTATIVE/CONSULTANT

Allison C. Komiyama, Ph.D., R.A.C. Lucie Dalet, Ph.D. AcKnowledge Regulatory Strategies, LLC Telephone: +1 (619) 208-7888 Email: akomiyama@acknowledge-rs.com

PROPRIETARY NAME OF SUBJECT DEVICE

Alleye

COMMON NAME

Grid, Amsler

DEVICE CLASSIFICATION

21 CFR 886.1330 Amsler Grid Product Code HOQ, Class I

PREMARKET REVIEW

ODE/DOED/DSDB Ophthalmic

INDICATIONS FOR USE

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Image /page/4/Picture/1 description: The image shows a stylized eye with the words "eyelashcare products" arranged in an arc above the eye. The eye is closed, with a thick, curved line representing the upper eyelid and long, separated lines representing the eyelashes. The text is in a small, sans-serif font and follows the curve of the eyelid.

DEVICE DESCRIPTION

PREDICATE DEVICE IDENTIFICATION

Alleye is substantially equivalent to the following predicate:

510(k) Number	Predicate Device Name / Manufacturer	Primary Predicate
K143211	myVisionTrack Model 0005 / Vital Art and Science, LLC	✓

SUMMARY OF NON-CLINICAL TESTING

No FDA performance standards have been established for Alleye. The following tests were performed to demonstrate safety based on current industry standards:

Software Verification: The software development and testing was executed in compliance to IEC 62304 Medical Device Software - Software Life Cycle Processes
The results of these tests indicate that Alleye is substantially equivalent to the predicate device.

SUMMARY OF CLINICAL TESTING

The clinical performance of Alleye was evaluated in accordance with ISO 14155 Clinical Investigation of Medical Devices for Human Subjects - Good Clinical Practice.

. Test-Retest Study: the reliability of the metamorphopsia testing with Alleye was evaluated in a test-retest study performed on 26 healthy subjects and 60 subjects with age-related macular degeneration (AMD).
Clinical Evaluation – Longitudinal Study: This study evaluated the extent to which regular patient self-measurement with Alleye performed between two clinical visits provides an aid in the monitoring for the need of an injection at the next follow-up visit. The 60 patients evaluated in this study had been diagnosed with wet AMD and were undergoing a pro re nata intravitreal injection (IVI) of anti-VEGF for treatment. They had completed at least a follow-up of 3 months, providing 1506 Alleye measurements in 150 follow-up periods. This clinical study demonstrates that patient self-testing with Alleye allows the detection of worsening visual function prior to follow-up visits.
Usability Study: The usability of the Alleye app was evaluated on elderly subjects with AMD, in two clinical studies. The subjects provided oral feedback on the mobile app's user-friendliness and filled out the System Usability Scale.

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The results of these studies demonstrate that Alleye is substantially equivalent to the predicate device.

EQUIVALENCE TO PREDICATE DEVICES

Oculocare believes that Alleye is substantially equivalent to the predicate device based on the information summarized here:

The subject device has a similar intended use, and similar technological characteristics (mobile app for hyperacuity self-testing) as the device cleared in K143211. The principle of the hyperacuity testing is similar to the predicate as it involves global visual integration, and no fixation is required to perform the test. The main difference between the subject device and the predicate device is the task being used to assess the patient. The subject device incorporates the use of an alignment hyperacuity task whereas the predicate device is based on a shape discrimination hyperacuity task. The subject device has undergone clinical testing to ensure the device is as safe and effective as the predicate.

CONCLUSION

Based on the software validation and clinical evaluation, it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate device. The similar indications for use and technological characteristics for Alleye are assessed to be substantially equivalent to the predicate device. The device is considered safe and effective for its intended use.

Regulation Number and Section

§ 886.1330 Amsler grid.

(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.