(209 days)
The Nidek Optical Coherence Tomography RS-3000 Advance, including scanning laser ophthalmoscope function with Image Filing Software NAVIS-EX is a noncontact system for imaging the fundus and for axial cross sectional imaging of ocular structures. It is indicated for in vivo imaging and measurement of:
- the retina, retinal nerve fiber layer, and optic disc, and .
- the anterior chamber and cornea (when used with the optional auxiliary . anterior chamber adapter),
as an aid in the diagnosis and management of adults having or suspected of having ocular disease.
The NIDEK Optical Coherence Tomography RS-3000 Advance is an ophthalmic camera that allows non-invasive and non-contact observation of the fundus and its ocular structures. The device captures an image of the fundus using both a Scanning Laser Ophthalmoscope and Optical Coherence Tomography.
The Nidek RS-3000 Advance is a non-contact ophthalmic imaging system for the viewing and axial cross sectional imaging of ocular structures. It is used for in vivo imaging and measurement of the retina, retinal nerve fiber layer, and optic disc as an aid in the diagnosis and management of the retinal disease. In addition, the anterior segment adapter (special lens unit) attached over the objective lens of the main body enables non-invasive and non-contact observation of the shape of the anterior segment of the eye such as the cornea or anterior chamber angle.
Fundus images (hereafter referred to as SLO image) are captured with the confocal laser scanning using a near-infrared light source with a wavelength of 785 nm. Cross-sectional images of the fundus (hereafter referred to as OCT image) are captured with the optical interferometer using an infrared light source with a wavelength of 880 nm. With the images captured using the RS-3000 Advance, the shape, structure, and evidence of pathology of the fundus and retina can be observed.
The RS-3000 Advance is comprised of a main body for capturing images, a computer (hereafter called PC) for storing and analyzing captured images, and an isolation transformer. The RS-3000 Advance offers the following features:
- . High-speed OCT imaging for image capture that is resistant to the effect of subtle eye movements during eye fixation
- . High-quality OCT imaging by creating an averaged image from multiple images captured using high-speed OCT imaging
- . Simultaneous capture of SLO and OCT images for accurate and easy alignment to the fundus
- . Fundus auto focusing, OCT image position detection function, and auto polarization function
- . Automatic alignment to and capture of previously captured parts of the fundus
- . Easy operation and image capture using the control panel of the main body or the PC mouse
- . The tracing HD feature provides the averaged OCT image which uses the greater number of the images than the normal HD scan. This function is available in Macula Line scan only.
- . OCT sensitivity setting (Regular/Fine/Ultra-fine) enables users to use different exposure time of the line CCD camera for OCT imaging.
The Nidek RS-3000 Advance is an ophthalmic camera for observing the fundus and its ocular structures. The device captures images of the fundus using both a Scanning Laser Ophthalmoscope and Optical Coherence Tomography. The device passed non-clinical performance evaluations.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Retinal thickness measurement accuracy | Within the repeatability limits of the predicate device (RS-3000) for full retinal thickness, inner retinal thickness, outer retinal thickness, and RNFL thickness. | The clinical performance summary states: "Results show that the measurements of full retinal thickness, inner retinal thickness, outer retinal thickness, and RNFL thickness with the different OCT sensitivity settings in RS-3000 Advance are similar to the thickness measurements of RS-3000. All mean differences are within the repeatability limits of RS-3000 (K121622). This indicates that the 3 sensitivities of RS-3000Advance are equivalent to RS-3000." |
| Measurement errors accuracy | ±5% accuracy of thickness measurements. | The non-clinical performance summary states: "Analysis of measurement errors in each result maintains sufficient accuracy with the device requirement specification of ± 5% accuracy of thickness measurements. As a result of this testing, the RS-3000 Advance was found to maintain sufficient accuracy and to meet requirement specifications." |
| Compliance with standards | Meet requirements of applicable FDA recognized consensus standards. | The non-clinical performance summary states: "The Nidek Optical Coherence Tomography RS-3000 Advance...was evaluated according to the requirements of FDA recognized consensus standards (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 62304, IEC 62366, ISO 15004-1, and ISO15004-2) and was found to meet the requirements of the applicable parts." |
2. Sample Size and Data Provenance (Test Set)
The provided document does not explicitly state the sample size used for the clinical test set or the country of origin of the data. It merely describes the results of the clinical performance summary against the predicate device. The clinical study was a comparative study between the RS-3000 Advance and its predicate device, the RS-3000, to demonstrate equivalence, focusing on thickness measurements. The data is implicitly prospective if it refers to newly acquired measurements from the RS-3000 Advance, compared to established measurements from the RS-3000.
3. Number of Experts and Qualifications (Test Set Ground Truth)
The document does not provide information on the number or qualifications of experts used to establish ground truth for the test set. Given it's a comparison study to a predicate device, the "ground truth" for the new device's measurements is its similarity to the predicate device's measurements, which themselves would have been validated.
4. Adjudication Method (Test Set)
The document does not specify any adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was mentioned or described. The study focused on the performance of the device itself (specifically, its measurement capabilities) compared to a predicate device.
6. Standalone (Algorithm Only) Performance Study
The clinical study described is a standalone performance study in the sense that it evaluates the device's ability to measure various retinal thicknesses with its different sensitivity settings. It compares these measurements directly to those from an existing, legally marketed predicate device (RS-3000) to establish equivalence for the algorithm's output. The performance is evaluated based on the consistency of the measurements.
7. Type of Ground Truth Used (Clinical Test Set)
The ground truth used for the clinical evaluation was implicitly the measurements obtained by the legally marketed predicate device, Nidek RS-3000. The study aimed to show that the RS-3000 Advance's measurements for retinal thickness (full, inner, outer, and RNFL) were "similar" and "within the repeatability limits" of the RS-3000. For the non-clinical performance, the ground truth was "the device requirement specification of ± 5% accuracy of thickness measurements".
8. Sample Size for the Training Set
The document does not provide information regarding a training set size. This device is an Optical Coherence Tomography (OCT) system that captures images and performs direct measurements, not an AI/ML algorithm that requires a "training set" in the conventional sense of machine learning. The term "training set" is not applicable here as it's a hardware device with inherent measurement capabilities.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, the concept of a "training set" and its associated ground truth establishment is not relevant for this device. The device's measurement accuracy is likely established through calibration and comparison to known physical standards or previously validated instruments during its development and testing phases, rather than through a machine learning training process.
§ 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.