(27 days)
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:
| Feature | Performance |
|---|---|
| Minimum Pupil Size | 3.2 mm (non-mydriatic use) |
| Field of View | 45° (H) x 40° (V) captured in a single exposure |
| Sensor Size | 3600 x 2910 (10 MP) |
| Light Source | infrared LED (825-870 nm), white LED (420-675 nm) |
| Imaging Modalities | color, red-free, infrared |
| Working Distance | 25 mm |
| Pixel Pitch | 3.7 μm |
| Focus Adjustment | -15 D to +15 D |
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.
| Acceptance Criterion (Standard Compliance) | Reported Device Performance (Compliance Status) |
|---|---|
| ANSI Z80-26 (light Hazard Protection) | Fulfills Group 1 determination according to ANSI Z80-36 |
| ISO 15004-1 (Ophthalmic Instruments) | Complies |
| IEC 62304 (Software Life Cycle Processes) | Complies |
| ISO 10940 (Fundus Cameras) | Fully compliant |
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.
§ 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.