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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.

• 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.

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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:

1. an optical head, including a removable lens cap;
2. a patient head-rest, including a removable front-rest;
3. a patient chin rest;
4. 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.

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.

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