(139 days)
The CenterVue EIDON FA is a confocal scanning ophthalmoscope indicated for color, infrared and autofluorescence imaging and fluorescein angiography of a human retina with or without the use of a mydriatic agent.
The CenterVue EIDON FA has been derived from the CenterVue EIDON, a retinal imaging device cleared under K142047. EIDON FA is a scanning ophthalmoscope which uses LED light to capture confocal images of the retina. In particular, EIDON FA uses infrared light to obtain infraredreflectance images, white light to obtain color images and blue light to obtain auto-fluorescence and fluorescence images. EIDON FA can be used with or without pharmacological dilation.
The CenterVue EIDON FA is part of a family of devices, which includes three models: EIDON FA, EIDON AF, and EIDON. EIDON is the base model, which features the following imaging modalities: infrared reflectance, color and red-free. EIDON AF adds autofluorescence imaging to the base model. The EIDON FA is the fully featured device, which adds fluorescein angiography to the capabilities of the EIDON AF and encompasses the features and functionality of the other models.
EIDON FA operates as a standalone unit, running a dedicated software application, is intended for prescription use only, and includes:
- an optical head, including a removable lens cap;
- a patient head-rest, including a removable front-rest;
- a patient chin rest;
- a base, including a touch-screen device (tablet with magnetic holder and USB cable), USB joystick and an external power supply.
EIDON FA operates based on the following principles:
a) An illumination system consisting of an infrared (IR) LED (825-875 nm and 940 nm), a white LED (440-650 nm), a blue LED (440-475 nm) and a green LED, illuminates the patient eye with the following functions:
- the IR LED with central wavelength at 850 nm allows the capture of IR photos. The patient's 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 central wavelength at 940 nm are seen from the eye in a free viewing system. The two LEDs are equally shifted with respect to the machine's 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 the horizontal direction. Along the optical path an oscillating mirror scans the line in order to illuminate the retina with a field of view of 60°.
- The blue LED is also used to capture auto-fluorescence and fluorescence retinal images;
- The green LED is used as fixation target.
b) An imaging system including a barrier filter (high-pass with a cutoff at 500 nm) stops back reflected light from the retina and allows fluorescent light to be detected for imaging. A focusing lens is included in the imaging path to achieve optimal focusing on a CMOS camera.
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's front lens.
EIDON FA interacts with the patient by directing infrared, white, blue (for imaging) and green (for fixation) 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 provided text describes the regulatory information and technical specifications of the CenterVue EIDON FA device, focusing on its substantial equivalence to predicate devices for FDA clearance. However, it does not contain specific acceptance criteria, comprehensive study details, or performance data in the structured format requested. The clinical performance data section is very brief and high-level.
Therefore, I cannot fully complete the requested table and answer all points accurately based solely on the provided text. I will extract and present the available information, and explicitly state where information is missing.
Acceptance Criteria and Device Performance Study for CenterVue EIDON FA
The provided documentation describes the CenterVue EIDON FA as a confocal scanning ophthalmoscope indicated for color, infrared, autofluorescence imaging, and fluorescein angiography of the human retina. The substantial equivalence determination relies on comparisons to predicate devices (CenterVue EIDON, Kowa VX-20, and Heidelberg Spectralis HRA²).
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the acceptance criteria are not explicitly stated as numerical thresholds or specific performance metrics. Instead, the focus is on demonstrating "substantial equivalence" to predicate devices, particularly regarding imaging capability and safety. The performance is reported qualitatively.
| Criterion Type | Acceptance Criteria (Not explicitly stated in quantitative terms) | Reported Device Performance (Summary from text) |
|---|---|---|
| Imaging Quality | Implied: Images produced by EIDON FA in all modalities (color, infrared, autofluorescence, fluorescein angiography) must be "similar" to or demonstrate "effectiveness" comparable to the respective predicate devices for their specific imaging functions. The document states "no additional concerns for safety and effectiveness" in comparison to predicates. | "The comparison showed that EIDON FA provides in all modalities images that are similar to those of the mentioned devices." This is a qualitative assessment. |
| Safety | Implied: The device must meet electrical safety, EMC, light hazard, and general safety standards (e.g., IEC 60601-1, IEC 60601-1-2, ISO 15004-1, ISO 15004-2). Any technological differences with predicates (e.g., higher power LEDs for AF/FA) must not introduce new safety concerns. | "The device complies with the IEC 60601-1:2005 and IEC 60601-1-2:2007 standards." "The device complies with the ISO 15004-1:2006 standard for ophthalmic instruments and with the ISO 15004-2:2007 standard for light hazard protection." "No additional concerns for safety and effectiveness." |
| Software | Implied: Software must be verified and validated according to FDA guidance and industry standards, with a focus on safety given its "moderate" level of concern. | "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff... The software for this device was considered as a 'moderate' level of concern... The software also complies with the IEC 62304 standard." |
| Fundus Camera Std. | Implied: The device must comply with relevant fundus camera standards. | "The device complies with the ISO 10940:2009 standard for fundus cameras." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states, "Images of eyes with and without diagnosed pathology were included in the comparison." However, it does not specify the number of images or patients used in the clinical comparison.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study implicitly appears to be retrospective, as it involves comparing EIDON FA images with existing images from predicate devices.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: This information is not provided in the document.
- Qualifications of Experts: This information is not provided in the document. The assessment is described as a "comparison" of images, but who performed this comparison (e.g., a panel of ophthalmologists/radiologists or internal staff) and their qualifications are not detailed.
4. Adjudication Method for the Test Set
- The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical image comparison. The assessment seems to be a general comparison.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC study comparing human readers with and without AI assistance was not mentioned or performed. This submission is for an imaging device, not an AI-powered diagnostic algorithm designed to assist human readers. The clinical performance data section describes a comparison of image quality between the EIDON FA device and predicate devices.
6. Standalone (Algorithm Only) Performance
- This question is not applicable as the EIDON FA is an imaging device, not an AI algorithm. Its "performance" refers to the quality of the images it produces, which are then interpreted by a human clinician.
7. Type of Ground Truth Used
- The "ground truth" for the clinical comparison was implicitly the diagnosed pathology of the eyes. The study included "images of eyes with and without diagnosed pathology." The comparison was about the similarity of images captured by EIDON FA to those from predicate devices, rather than a direct diagnostic accuracy assessment against a gold standard for a specific condition.
8. Sample Size for the Training Set
- This question is not applicable, as the device is an imaging system and not an AI algorithm that requires a training set in the typical machine learning sense. The "training" of the device is its manufacturing and calibration process, not data-driven machine learning.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable for the same reason as point 8.
§ 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.