(108 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 with Software version 4.0 and Ultra Widefield Lens is a modification of the CenterVue EIDON FA (K180526). 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. CenterVue EIDON FA (K180526) is a scanning ophthalmoscope white light to obtain color images of the retina, infrared light to obtain infrared-reflectance images of the retina, and blue light to obtain autofluorescence and fluorescence images. 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. 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. With respect to the CenterVue EIDON FA, EIDON FA with software version 4.0 provides additional features to acquire retinal images with the Ultra Widefield Lens. The optional Ultra Widefield Lens increases the field of view of the devices from 60° to 80°. All the features related to the acquisition without the Ultra Widefield Lens are unchanged. The modified devices use the same base technology and maintains the same Intended Use and Indications for Use of the predicate device. The fundamental scientific technology of the subject device is unchanged from the predicate and remains confocal, line scanning, LED-based, imaging. The functional differences between EIDON FA and EIDON FA with software version 4.0 are as follows: EIDON FA with software version 4.0 allows to capture retinal picture with an increased field of view, from 60° to 80° to allow the user to view a greater proportion of the posterior eye in one view. EIDON FA with software version 4.0 allows to capture Ultra Widefield images with the same modalities of the unmodified device, namely: color images, infrared-reflectance images, autofluorescence images and fluorescence images. No technological differences between EIDON FA and EIDON FA with SW version 4.0 exist. The modified device can be used with or without the Ultra Widefield Lens. The technological principle of retinal acquisitions remains the same in the modified device. The device software has been modified to implement the acquisition and management of images taken with the Ultra Widefield Lens. The EIDON UWFL – Ultra Widefield Lens accessory is composed of a lens doublet, assembled in a custom lens holder, which can be mounted on the standard objective of the parent device by means of an incorporated threaded ring to increase the field of view of the parent device from 60° (standard objective) to 80° (with UWFL). The CenterVue EIDON UWFL – Ultra Widefield Lens is an optional accessory to extend the field of view of the CenterVue EIDON, EIDON AF and EIDON FA from 60° to 80°. It is indicated for color, infrared and autofluorescence imaging and fluorescein angiography of a human retina with or without the use of a mydriatic agent. The principle of operation of the EIDON UWFL is an increase of the standard objective to achieve a greater field of view. The mechanism of action and the conditions for use are the same of the predicate device. Other than the above, no differences exist between the EIDON FA with Ultra Widefield Lens, in particular the principle of operation, mechanism of action and interaction with the patient are unchanged.
The provided text describes a 510(k) submission for the CenterVue EIDON FA, EIDON, EIDON AF, and EIDON UWFL devices, specifically focusing on the modifications to the EIDON FA with software version 4.0 and an Ultra Widefield Lens (UWFL).
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a structured table. Instead, it focuses on demonstrating substantial equivalence to a predicate device (EIDON FA K180526) by showing that the modified device (EIDON FA with SW 4.0 and UWFL) performs similarly and has no significant effect on safety or effectiveness. The core "acceptance criteria" here are implied to be image quality similarity within the common field of view and conformance to relevant standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (EIDON FA K180526) | The modified device maintains the same intended use, indications for use, and fundamental scientific technology (confocal, line scanning, LED-based, ophthalmoscopy). The principle of operation, mechanism of action, and interaction with the patient are unchanged. The modification primarily increases the field of view from 60° to 80°. |
| Image Quality Similarity within 60° Field of View | "The comparison shows that EIDON FA with software version 4.0 and UWFL provides images that are similar in the central 60° to those of the cleared device, for all imaging modalities." This was assessed for Color, Infrared, Autofluorescence, and Fluorescein Angiography. |
| Conformance to Applicable Standards | - ANSI Z80-36 (Light Hazard Protection): Fulfilled requirements for a group 2 determination. |
- ISO 15004-1: Complies with the standard for ophthalmic instruments.
- IEC 62304: Software complies with this standard.
- ISO 10940 (Fundus Cameras): Fully complies without the optional lens, and partially complies with the optional lens mounted. |
| Safety and Effectiveness | "None of these differences have any significant effect on safety or effectiveness of the Subject Device." Reviewed for optical radiation safety per ANSI Z80-36:2016. |
2. Sample Size Used for the Test Set and Data Provenance
The clinical summary provides a breakdown of the sample size for different imaging modalities:
- Infrared images: 10 eyes without pathology and 8 eyes with pathology. (Total 18 eyes)
- Color images: 11 eyes without pathology and 10 eyes with pathology. (Total 21 eyes)
- Autofluorescence images: 10 eyes with diagnosed pathology. (Total 10 eyes)
- Fluorescein Angiography images: 10 eyes with diagnosed pathology. (Total 10 eyes)
Note: There is overlap in the eyes used across different modalities, as the same patients were likely imaged with various techniques. The total number of unique patients/eyes is not explicitly stated but is at least 21 (from the color images, which has the highest unique count for non-pathology eyes, plus pathology eyes).
Data Provenance:
- Country of Origin: Italy ("The data were collected at four different sites located in Italy.")
- Retrospective or Prospective: The study was conducted prospectively, as patients were "tested according to booked appointments for the day."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). It mentions "diagnosed pathology" and "clinician's decision," implying that clinical diagnosis was used, but the process of establishing the ground truth for comparison images is not detailed.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method (e.g., 2+1, 3+1). It states a "comparison shows that EIDON FA with software version 4.0 and UWFL provides images that are similar in the central 60° to those of the cleared device." This suggests a comparative assessment, but the methodology for agreement or resolution of discrepancies among observers (if more than one was involved) is not provided.
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, an MRMC comparative effectiveness study was not done. This study is not evaluating the performance of an AI-assisted diagnostic tool or how human readers improve with AI. Instead, it's a submission for a hardware/software modification to an ophthalmoscope, demonstrating that the modified device's image quality for a specific Field of View (FOV) remains substantially equivalent to the predicate device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device (EIDON FA with UWFL) is an imaging device, not an algorithm for automated diagnosis or a device requiring standalone performance evaluation of an AI algorithm. It functions to acquire images for clinical interpretation by a human. The "standalone performance" here refers to the device's ability to capture images with certain technical specifications (resolution, FOV, etc.), which are outlined in the technical specifications section.
7. The Type of Ground Truth Used
The ground truth for the comparison appears to be based on:
- Clinical Diagnosis: Indicated by phrases like "eyes which presented without pathology" and "eyes which presented with diagnosed pathology."
- Predicate Device Images: For image quality comparison, the images captured by the predicate EIDON FA device served as a reference for "similarity."
8. The Sample Size for the Training Set
Not applicable. This document describes a 510(k) submission for a medical imaging device and its accessory/software update. It is not an AI/Machine Learning device that requires a separate training set for algorithm development. The "training" for the device would involve engineering and quality assurance tests, not a data-driven model training set in the context of AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention or indication of a training set in the context of an AI/ML algorithm.
§ 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.