(118 days)
The CenterVue RETIA 2 is a confocal scanning ophthalmoscope indicated for infrared and auto-fluorescence imaging of a human retina with or without the use of a mydriatic agent.
The CenterVue RETIA 2 is a modification of the CenterVue EIDON (K142047). RETIA 2 is a scanning ophthalmoscope which uses infrared light to obtain infrared-reflectance images of the retina and blue light to obtain auto-fluorescence images of the retina. RETIA 2 operates as a standalone unit, running a dedicated software application, intended for prescription use only, and includes: 1. Optical head, including a removable lens cap; 2. Patient head-rest, including removable front-rest; 3. Patient chin rest; 4. Base, including touch-screen device (tablet with magnetic holder and USB cable), USB joystick and an external power supply. RETIA 2 operates based on the following principles: a) An illumination system consisting of infrared LEDs (850nm, 940nm), a blue LED (450nm) and a green LED illuminates the patient eye with the following functionality: - The IR LED with a centroid wavelength of 850 nm allows the capture of IR photos. The patient's retina is uniformly illuminated by a line in a horizontal direction. An oscillating mirror scans the line in order to illuminate the retina with a field of view of 60°. - Two IR LEDs with a centroid wavelength of 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 blue LED (450 nm) is used to illuminate the retina and capture fluorescence retinal images. The retina is uniformly illuminated by a line in a horizontal direction. An oscillating mirror scans the line in order to illuminate the retina with a field of view of 60°. - 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 only allows fluorescent light to be detected for imaging. A focusing lens is included in the imaging path to achieve optimal retinal focusing on a CMOS camera having a resolution of 5 megapixels. 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 front lens. RETIA 2 interacts with the patient by directing infrared- and blue-wavelength illumination for imaging purposes and green illumination for fixation purposes into the patient's eye. The chin-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 document describes the CenterVue RETIA 2, a confocal scanning ophthalmoscope, and its comparison to predicate devices, specifically the CenterVue EIDON (K142047) and Heidelberg SPECTRALIS (K172649). The study primarily focuses on demonstrating that the RETIA 2 provides infrared and autofluorescence images that are similar to those of the predicate devices.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria in terms of sensitivity, specificity, or other quantitative metrics for image quality or diagnostic performance. Instead, it relies on a qualitative comparison.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Produce infrared images similar to the predicate device (CenterVue EIDON). | "The comparison showed that RETIA 2 provides infrared... images that are similar to those of the mentioned devices." |
| Produce autofluorescence images similar to the reference device (Heidelberg SPECTRALIS). | "The comparison showed that RETIA 2 provides... autofluorescence images that are similar to those of the mentioned devices." |
| Continued conformance with relevant safety and performance standards. | ISO 15004-2 (Light Hazard Protection): RETIA 2 fulfills requirements for a group 1 determination (no potential light hazard). |
| ISO 15004-1: Complies with the standard for ophthalmic instruments. | |
| IEC 60601-1:2005 and IEC 60601-1-2:2007: Complies for electrical safety and electromagnetic compatibility. | |
| IEC 62304: Software complies with the standard. | |
| ISO 10940: Complies with applicable requirements for Fundus Cameras. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample size for the test set (number of images or patients). It states: "Images of eyes with and without diagnosed pathology were included in the comparison."
The data provenance (country of origin, retrospective/prospective) is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not provide this information. It only states that images "with and without diagnosed pathology were included," implying that some form of diagnosis or ground truth was available, but it doesn't describe how it was established or by whom.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not specify the adjudication method used for the comparison.
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
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor is there any discussion of AI assistance or its impact on human reader improvement. The study described is a device-to-device comparison based on image similarity.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone imaging system. The "performance data - Clinical" section describes a comparison of images generated by the RETIA 2 against images from predicate devices. This represents the standalone performance of the device in generating images, as there's no mention of a human in the loop for interpreting the images for the purpose of this comparison study. However, it's not an "algorithm only" study as the device is a piece of hardware.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document mentions "images of eyes with and without diagnosed pathology." This suggests that the ground truth for image classification (e.g., presence or absence of pathology) was based on pre-existing diagnoses, likely from clinicians or medical records. However, the exact nature of this "diagnosis" (e.g., expert consensus, pathology reports, clinical outcomes) is not further detailed.
8. The sample size for the training set
The document does not mention a training set, as the study described is a device comparison for image similarity, not an AI model requiring training data.
9. How the ground truth for the training set was established
Not applicable, as no training set for an AI model 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.