DEVICE: Alleye (EOMA32120)
Device Identifier (DI) Information
Alleye
3.2.12
In Commercial Distribution
OCULOCARE medical AG
3.2.12
In Commercial Distribution
OCULOCARE medical AG
Alleye® is a vision function test provided on a commercially available mobile phone. Alleye® implements an alignment hyperacuity task which 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 verifying the efficacy of ongoing treatments. Alleye is a digital technology, consisting of two different items: a mobile app for patients and a web interface for eye care professionals. Principle of Operation The test consists of 12 tasks that are performed on the user’s mobile phone. For each task, two dots are placed at each extremity of an invisible axis. A third dot is placed between these two dots, 40 pixels above or 40 pixels below the axis. The test consists in aligning the three dots by moving the dot in the middle. A single click on the up and down buttons moves the dot by 0.3 pixels up or down, respectively. If the patient maintains their finger on the buttons, the dot keeps moving. When it reaches a limit of 50 pixels away from its ideal position on the axis, the dot automatically stops. Once the user is satisfied with the position of the middle dot, they confirm it by tapping the circle button between the two arrow buttons. Overall, the patient must perform three alignments on four different axes (horizontal, vertical, oblique upper left / lower right, and oblique upper right / lower left). The test is performed on one eye only. The eye that is not being tested must be covered before starting the test. The TRAINING mode allows the patient to learn how to use the app, without recording the score results. To start the test, the patient must select TEST, and then select the eye (RIGHT or LEFT) to be tested. The Alleye tasks will proceed until COMMENT ON TEST appears on the screen. The patient can select REPEAT to start the test again, or DONE to save the test and display the results.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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65889 | Vision self-testing software |
A software as a medical device (SaMD) application intended to be used by a patient for self-testing of visual function under consultation of a clinician (e.g., ophthalmologist). It provides on-screen images (e.g., shapes) whereby visual function can be tested over time (e.g., to monitor macular degeneration). It is intended to store and allow communication of the results with healthcare professionals.
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FDA Product Code
[?]Product Code | Product Code Name |
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HOQ | Grid, Amsler |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K180895 | 000 |
Sterilization
Storage and Handling
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Clinically Relevant Size
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No Device Sizes |
Device Record Status
7dbc8846-8fc9-41ba-8eba-13121566b5c6
May 23, 2023
1
May 15, 2023
May 23, 2023
1
May 15, 2023
Alternative and Additional Identifiers Additional Identifiers
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Unit of Use DI
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CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined