(111 days)
SOLIX™ is an optical coherence tomography system intended for the in vivo imaging, cross-sectional, and the threedimensional imaging and measurement of anterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, corneal epithelium, corneal stroma, pachymetry, and anterior chamber of the eye. With the integrated reference database. SOLIX™ is also a quantitative tool for the comparison of the retinal nerve fiber layer, and optic disc measurements in the human eye to a database of known normal subjects. It is indicated for use as a diagnostic device to aid in the detection and management of ocular diseases.
The SOLIX™ with the AngioVue software feature is indicated as an aid in the visualization of vascular structures of the retina and choroid in normal subjects with glaucoma and retinal diseases. The AngioAnalytics software feature of AngioVue is indicated for the measurement of vascular density, the foveal avascular zone, the thickness of retinal layers, and nerve fiber layer, and measurement of optic disc parameters in normal subjects with glaucoma and retinal diseases.
The non-mydriatic color fundus camera of SOLIX™ is an integrated non-contact. high resolution digital imaging component which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions. The SOLIX™ fundus camera component is indicated for in-vivo viewing of the posterior and external area of the images are intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health.
SOLIX is a computer-controlled, ophthalmic imaging system with combined spectral-domain optical coherence tomography (SD-OCT) and non-mydriatic, digital fundus camera. The SD-OCT employs non-invasive, non-contact, low coherence interferometry to acquire crosssectional tomograms of the anterior and posterior segment of the eye and motion-contrast images of the retinal microvasculature (i.e., OCT "angiography" [OCTA]). The fundus camera produces color internal and external ocular images.
The provided text details the 510(k) premarket notification for the Optovue SOLIX device, stating its substantial equivalence to predicate devices Avanti and iCam. It includes information on performance testing, but the document does not explicitly state defined acceptance criteria for many of the quantitative measurements (e.g., repeatability limits for OCT and OCTA parameters, quality metrics for fundus photography). Instead, it presents the results of these tests.
Therefore, the table below will present the reported device performance, and where an indirect acceptance can be inferred (e.g., for comparative image quality), that will be noted.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The provided document primarily presents performance results without explicitly listing acceptance criteria with numerical targets for many parameters. Where an inference of acceptance can be made (e.g., general clinical utility, improvements over predicate), it is noted.
| Category | Acceptance Criteria (Inferred/Reported) | Reported Device Performance |
|---|---|---|
| OCT Hardware | Achieves similar Signal to Noise Ratio (SNR) as Avanti. Light exposure safety is below all applicable exposure limits. | SOLIX with 1.45mW optical power achieves similar SNR as Avanti (0.75mW) due to higher scanner speed. Light exposure safety is below applicable exposure limits per Dr. David Sliney's report. Longer working distance (35mm vs 22mm for retina imaging, 20mm vs 13mm with CAM) improves usability. |
| OCT Software (Vessel Density) | Improved accuracy for vessel density measurements compared to the predicate device. | Improved accuracy was observed from SOLIX vessel density measurements using a local thresholding method (vs. global thresholding in Avanti). For superficial and deep vascular complexes, SOLIX vessel density values tended to be within a smaller range than Avanti XR. Differences are associated with increased scan density and updated algorithm. |
| OCT Software (PAR) | Further reduction of projection artifacts. | SOLIX's PAR is updated to further reduce projection artifacts, as evidenced by qualitative assessment of clinical study data. |
| OCT Software (Vessel Extraction) | Improved extraction of vessels in relatively low OCTA signal areas. | SOLIX's vessel extraction method is updated to extract vessels in low OCTA signal areas, evidenced by bench (phantom) and clinical studies. |
| Anterior Segment R&R | Repeatability and Reproducibility (R&R) generally comparable or improved to predicate. (No explicit numeric acceptance criteria specified in document, but stability across repeated measurements and between operators is the implicit measure of success). The results are presented in tables for "Normal" and "Cornea" subgroups across various parameters (Epithelia (Epi), Cornea (Pachy), Stroma). | For Normal subgroup, repeatability SD for Epithelia (Epi) ranges 0.6-1.2 µm, reproducibility SD 0.7-1.8 µm. For Cornea (Pachy), repeatability SD ranges 1.3-8.8 µm, reproducibility SD 1.9-13.8 µm. For Stroma, repeatability SD ranges 1.0-9.1 µm, reproducibility SD 1.8-14.1 µm. For Cornea subgroup, similar ranges observed. Scan attrition |
§ 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.