(182 days)
The PLEX™ Elite 9000 Swept-Source OCT [SS-OCT] is a non-contact, high resolution, wide field of view tomographic and biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional and three-dimensional imaging of posterior ocular structures. The device is indicated for visualizing posterior ocular structures including, but not limited to, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, optic nerve head, vitreous and choroid.
The PLEX™ Elite SS-OCT angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid.
The PLEX™ Elite 9000 SS-OCT is a computerized instrument that acquires cross-sectional tomograms of the posterior ocular structures (including cornea, retinal nerve fiber layer, macula, and optic disc). It employs non-invasive, non-contact, low-coherence interferometry to obtain these high-resolution images. Using this non-invasive optical technique, the PLEX Elite SS-OCT produces high-resolution cross-sectional tomograms of the eye without contacting the eye. It also produces images of the retina and layers of the retina from an en face perspective (i.e., as if looking directly in the eye) and non-contrast angiographic imaging of the retinal microvasculature.
The PLEX Elite 9000 SS-OCT is offered in one model, the Elite 9000 in a new compact desktop system. The PLEX Elite SS-OCT contains a swept source, Class 1 Laser system operating at 1060 nm and includes a new system computer and archive with up to 24 TB storage capacity. The PLEX Elite also contains an iris viewer, fixation system and the fundus camera is a similar line-scanning ophthalmoscope (LSO) as used on the CIRRUS HD-OCT system, model 4000.
The provided text describes the Carl Zeiss Meditec, Inc. K161194 submission for the PLEX Elite 9000 SS-OCT device. However, it does not explicitly detail a standalone study with acceptance criteria and reported device performance in the format requested. Instead, it focuses on demonstrating substantial equivalence to predicate devices through technological comparisons, bench testing, non-clinical tests, and a clinical case series.
Here's an attempt to extract and synthesize the information based on the provided document, acknowledging the limitations regarding the specific details of a formal "acceptance criteria and study" as might be found in a performance study report:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria with specific quantitative targets and corresponding reported performance for a standalone clinical study. Instead, it describes general claims of improved performance compared to the predicate device.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance (PLEX Elite 9000 SS-OCT) |
|---|---|---|
| Image Quality | Images of posterior ocular structures should be "high quality" and visualize structures as well as or better than the predicate device. | "produce high quality images of the retina and choroid." |
| Signal-to-Noise Ratio | Improved signal-to-noise ratio compared to the predicate device (CIRRUS HD-OCT). | "higher signal-to-noise ratio and an increased depth of penetration as compared to the CIRRUS OCT angiography with intensity only processing." |
| Depth Penetration | Increased depth penetration compared to the predicate device (CIRRUS HD-OCT). | "higher signal-to-noise ratio and an increased depth of penetration as compared to the CIRRUS OCT angiography with intensity only processing." Also, axial scan depth is 3.0 mm (in tissue) for PLEX Elite 9000 vs. 2.0 mm for predicate. |
| Field of View | Wider field of view for imaging posterior ocular structures compared to the predicate device. | "wider field of view, increased depth penetration and with a higher signal-to-noise ratio as compared to the CIRRUS HD-OCT system." Also, transverse scan range up to 42°x42° (Cube) and 56°x0° (Max line scan) for PLEX Elite 9000, compared to 31°x31° (Max) for predicate. |
| Visualization of Vascular Structures | Ability to image vascular structures of the retina and choroid as well as the predicate device. | "The PLEX Elite 9000 angiography scans were shown to image the structures of the retina and choroid as well as the predicate CIRRUS HD- OCT device." |
| Scan Speed (OCT) | Higher scan speed than the predicate device. | 100,000 A-scan points per second for all scan types, compared to 27,000-68,000 A-scans/sec for the predicate. |
| Axial Resolution | Similar axial resolution to the predicate. | 5.5 µm (in tissue) for PLEX Elite 9000, compared to 5 µm (in tissue) for predicate. Described as "Similar resolution, change due to wavelength of imaging beam." |
| Transverse Resolution | Similar transverse resolution to the predicate. | ≤ 20 µm (in tissue) for PLEX Elite 9000, compared to ≤ 15 µm (in tissue) for predicate. Described as "Similar resolution, change in technology." |
| Safety | Compliance with relevant international standards and risk mitigation. | "Risk management is ensured via a risk analysis... These potential hazards are controlled by software means, user instructions, verification of requirements and validation of the clinical workflow... To minimize electrical, mechanical and radiation hazards, ZEISS adheres to recognized and established industry practice and relevant international standards." Laser is Class 1. Controlled optical power |
§ 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.