(107 days)
The CenterVue EIDON is intended for taking digital images of a human retina without the use of a mydriatic agent.
The CenterVue EIDON scanning ophthalmoscope operates as a standalone unit, running a dedicated software application, intended for prescription use only, and includes:
- Optical head, including a removable lens cap;
- Patient head-rest, including removable front-rest;
- Patient chin rest;
Base, including touch-screen device (tablet with magnetic holder and USB cable), USB joystick 4. and an external power supply.
EIDON uses infrared and visible light to obtain colored confocal digital images of a human retina without a mydriatic agent.
The CenterVue EIDON device operates on the following principles:
a) An illumination system consisting of infrared (IR) LEDs (850nm, 940nm), a white LED, a blue LED and a green LED illuminates the patient eye with the following functionality:
- The IR LED with a centroid wavelength of 850 nm allows the capture of IR photos. The patient retina is uniformly illuminated by a line in a horizontal direction. Along the optical path there is an oscillating mirror which scans the line in order to illuminate the retina with a field of view of 60°.
- Two IR Leds with a centroid wavelength of 940 nm are seen from the eye in a free viewing system. The two LEDs are equally shifted with respect to the machine optical axis. The LEDS are switched on during all exams in order to enable pupil tracking.
- The white and blue LEDs allow the capture of color photos. The retina is uniformly illuminated by a line in a horizontal direction. Along the optical path there is an oscillating mirror which scans the line in order to illuminate the retina with a field of view of 60°.
- The green LED is used as fixation target.
b) An imaging system collects back-reflected light from the retina and creates a high resolution image. A focusing lens is included in the imaging path to achieve optimal retinal focusing on a CMOS camera having a resolution of 14 megapixels.
c) An anterior segment alignment system is included, using two cameras and the two IR LEDs: the LEDs illuminate the anterior segment by diffusion, whereas allow a stereoscopic reconstruction of the pupil's position to be obtained with respect to the instrument front lens.
The EIDON device interacts with the patient by directing infrared, white, blue and green wavelength illumination into the patient's eye. The chin-rest and head-rest are the only parts of the device that contact the patient. The chin-rest includes a patient proximity sensor and is motorized for height adjustment.
The CenterVue EIDON Ophthalmoscope is intended for taking digital images of a human retina without the use of a mydriatic agent. The device was evaluated through bench tests against a set of performance criteria.
Here's a breakdown of the acceptance criteria and performance data:
1. Acceptance Criteria and Reported Device Performance
| Performance item | Requirements | Test results |
|---|---|---|
| Sensor resolution | 14 megapixels (4608 x 3288) | 4608 x 3288 |
| Resolution on retina | 60 pixel / deg | 59.7 pixel / deg |
| Optical resolution | 15 microns at the center | 15.1 microns at the center |
| Field of view | 60° (H) × 55° (V) | 60.0° x 55.1° |
| Pixel pitch | 4.9 microns max | 4.79 microns |
| Range of focus | -12 D to +15D | -12 D to +15D |
| Minimum pupil size | 3 mm | 3 mm |
Based on the "Test results" column, the CenterVue EIDON Ophthalmoscope met all of its stated performance requirements.
2. Sample Size and Data Provenance
The document describes "Bench tests" for the device's technical specifications. This typically implies testing on the manufactured device itself rather than human subjects or a dataset of images. Therefore, questions of sample size for a test set, data provenance (country of origin, retrospective/prospective), and ground truth establishment methods for a test set are not applicable in this context. The evaluation focuses on the engineering and optical performance of the device.
3. Number and Qualifications of Experts for Ground Truth
Not applicable for bench testing of device specifications.
4. Adjudication Method
Not applicable for bench testing of device specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was mentioned in the provided text. The submission focuses on the technical specifications and substantial equivalence to predicate devices, not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
The description indicates the device operates as a "standalone unit, running a dedicated software application", suggesting standalone performance of the image acquisition. However, the provided information focuses on the hardware's technical specifications rather than the performance of any image analysis algorithms that might be embedded within the software. There's no mention of a standalone study specifically evaluating algorithmic performance in areas like disease detection or image quality assessment by AI.
7. Type of Ground Truth Used
For the performance criteria listed (e.g., sensor resolution, optical resolution), the ground truth is based on engineering measurements and specifications of the device's optical and imaging components.
8. Sample Size for the Training Set
Not applicable. This submission describes bench testing of a medical device's physical and optical performance, not the development or training of an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of an AI algorithm training set.
§ 886.1570 Ophthalmoscope.
(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.