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

The DRSplus is a scanning ophthalmoscope which uses infrared and white light to obtain confocal images of the retina, without pharmacological dilation. The DRSplus operates as a standalone unit, running a dedicated software application, is intended for prescription use only, and includes: 1. an optical head; 2. a patient forehead rest; 3. a display; 4. a base; 5. a stand. The CenterVue DRSplus operates based on the following principles: a) An illumination system consisting of infrared (IR) LEDs, white LEDs and a green LED illuminates the patient eye with the following functions: · the IR LED allows the capture of IR photos, which are used for alignment and focusing purposes. The patient's retina is uniformly illuminated by a line in the horizontal direction. Along the optical path there is an oscillating mirror which scans the line in order to illuminate the retina. · Two IR LEDs 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 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. · 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. 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 the cameras allow a stereoscopic reconstruction of the pupil's position to be obtained with respect to the instrument's frontlens. The DRSplus interacts with the patient by directing infrared, white (for imaging) and green (for fixation) illumination into the patient's eye. The only part of the only part of the device that contacts the patient.

The provided text describes a 510(k) premarket notification for the CenterVue DRSplus, a confocal scanning ophthalmoscope. The majority of the document focuses on regulatory information, device description, technical specifications, and comparison to predicate devices, demonstrating substantial equivalence based on engineering and safety standards.

However, the provided text does not contain the details required to directly answer all parts of your request regarding acceptance criteria and a specific study proving device performance against those criteria as would typically be found in an AI/ML medical device submission.

The document mentions "Performance data - Clinical" but this section is very brief and describes a qualitative comparison ("similar to those of the mentioned predicate device") rather than a quantitative study with defined acceptance criteria and performance metrics. It also does not describe an AI/ML algorithm within the device that would necessitate ground truth establishment, expert adjudication, or MRMC studies.

Given the information, here's what can be extracted and what is missing:

Acceptance Criteria and Device Performance (Based on provided text)

The document implicitly defines acceptance criteria through compliance with various industry standards and demonstrating substantial equivalence to predicate devices, particularly in terms of image quality for a fundus camera. No specific quantitative performance metrics for a disease detection algorithm are provided.

Table of Acceptance Criteria and Reported Device Performance:

Regarding the study proving the device meets acceptance criteria (Clinical Performance Data):

The document describes a very limited qualitative clinical performance assessment, not a robust AI/ML algorithm validation study. Therefore, most of the requested information regarding AI/ML-specific study design is not present in the provided text.

1. Sample size used for the test set and the data provenance:

   • Test Set Size: "Images from randomly selected normal subjects and subjects with retinal pathologies were acquired." No specific number of subjects or images is provided.
   • Data Provenance: "acquired at two different sites" and "patients were imaged without pharmacological pupil dilation." No country of origin is explicitly stated, but the manufacturer is Italian. The study appears to be "prospective" in the sense that images were acquired specifically for this comparison using both devices.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable / Not Mentioned. The "clinical performance data" section describes a qualitative comparison of images between two devices, not a study evaluating an AI/ML algorithm's diagnostic performance against a clinical ground truth. Hence, there's no mention of experts establishing a ground truth for diagnostic purposes.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not Applicable / Not Mentioned. As no ground truth for diagnostic performance was established, no adjudication method is described.

4. 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. The provided text does not describe an AI-assisted reading study or an MRMC study. The device is described as an imaging device, not an AI diagnostic algorithm.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not Applicable. The device, as described, is an ophthalmoscope that captures images. It's not presented as a standalone diagnostic algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not applicable for diagnostic ground truth. The "ground truth" implicitly used for the clinical comparison was that the DRSplus should produce images similar to the predicate device (EIDON) for both normal and pathological retinas. There's no mention of a ground truth for disease diagnosis itself in this section.

7. The sample size for the training set:

   • Not applicable. This device is an imaging instrument, not an AI/ML algorithm that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable. As above.

Summary of what's missing and why:

The provided document (K192113) is a 510(k) clearance letter and summary for an ophthalmoscope. This type of device is an imaging hardware device. It is not an Artificial Intelligence/Machine Learning (AI/ML) diagnostic or assistive device. Therefore, the detailed criteria typically required for AI/ML performance validation (e.g., expert reads, ground truth establishment for disease, MRMC studies, training/testing sets for algorithms) are not present and not relevant to this specific submission as described. The performance data presented focuses on demonstrating imaging quality and electrical/software safety compliance in comparison to a predicate device, which is typical for hardware clearances.

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