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The CenterVue DRSplus is a confocal scanning ophthalmoscope indicated for color and infrared imaging of a human retina without the use of a mydriatic agent.

The CenterVue DRSplus with Software version 2.0 is a modification of the CenterVue DRSplus (K192113). The DRSplus (K192113) is a scanning ophthalmoscope which uses infrared and white light to obtain confocal images of the retina, without pharmacological dilation. With respect to the previous cleared device, DRSplus with software version 2.0 (subject of this submission) provides one additional software feature that enable to acquire, store and review infrared retinal images, in addition to color and red-free photos which were the only imaging modalities of the previously cleared device. This feature does not require any hardware modification, because the infrared illumination is already present in the previously cleared device: in fact, the infrared retinal pictures were automatically taken by the device for alignment and focusing purposes, but they were not presented in the patient's image collection. In the proposed device modification, the user can decide to acquire also infrared pictures that are stored and displayed amongst the other, color and red-free images. The modified device uses the same base technology and maintains the same Intended Use of the previously cleared device; the Indications for Use of the modified device are amended to add the infrared imaging modality. The fundamental scientific technology of the device is unchanged from the previously cleared device and remains confocal, line scanning, LED-based, imaging.

This document describes the CenterVue DRSplus with Software version 2.0, a confocal scanning ophthalmoscope. The key change from the previous version (K192113) is the addition of the ability to acquire, store, and review infrared retinal images.

Here's the breakdown of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a formal table of acceptance criteria with corresponding performance metrics for the infrared imaging capability specifically. Instead, it focuses on demonstrating
that the device, with its new software feature for infrared imaging, continues to meet existing safety and performance standards relevant to ophthalmoscopes.

The reported device performance, in terms of technical specifications, is available:

The core "acceptance criteria" presented are compliance with various international standards, which is a demonstration of meeting safety and fundamental performance requirements, rather than specific diagnostic accuracy metrics for the new infrared imaging feature.

2. Sample Size Used for the Test Set and Data Provenance:

The document explicitly states: "No clinical data required to evaluate the proposed change, only image comparisons are provided." Therefore, there is no clinical test set with a specific sample size of patients. The evaluation relied on technical comparisons and conformance to standards.

The reference to image comparisons between the DRSplus (subject device) and the EIDON (K142047) concerned the infrared imaging modality, as comparing infrared with the predicate's color imaging was not possible. No details are given about the provenance (country of origin, retrospective/prospective) of these comparison images.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Given that no clinical data was required and only image comparisons were provided, it is highly probable that no experts were used to establish ground truth for a clinical test set in the traditional sense of diagnostic accuracy evaluation. The evaluation focused on technical performance and image quality for the new infrared modality, likely reviewed by engineers or product specialists.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set for diagnostic performance was evaluated or adjudicated using expert consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was mentioned or performed, as "no clinical data required to evaluate the proposed change." The document does not describe any study comparing human readers with and without AI assistance, or the effect size of such assistance.

6. Standalone (Algorithm Only) Performance:

The device is a confocal scanning ophthalmoscope for imaging, not an AI/algorithm-only diagnostic device. The new feature is the ability to acquire, store, and review infrared images. Therefore, the concept of "standalone performance" for an algorithm in a diagnostic capacity is not applicable in this context. The document describes the device's technical capabilities in acquiring images, not an algorithm's diagnostic performance.

7. Type of Ground Truth Used:

For the image comparisons, the "ground truth" implicitly would have been the technical quality and characteristics of the infrared images themselves, possibly judged against expected output or established benchmarks for ophthalmoscope image quality, rather than a clinical ground truth like pathology or patient outcomes. Fundamentally, for standard compliance, the ground truth is adherence to the specifications and requirements outlined in the respective standards (ANSI Z80-26, ISO 15004-1, IEC 62304, ISO 10940).

8. Sample Size for the Training Set:

This information is not provided and is likely not relevant, as the device is not described as involving machine learning or AI that would require a "training set" for diagnostic algorithmic development. The modification is a software feature enabling existing hardware to utilize an already present infrared illumination for image acquisition and storage.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as no training set for machine learning/AI is described.

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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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