(30 days)
The P200MAAF scanning laser ophthalmoscope is intended to be used as a wide field and retinal fluorescence and autofluorescence imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases or disorders that manifest in the retina.
The P200MAAF is a conventional scanning laser ophthalmoscope (SLO), which uses a low power laser beam to scan in two dimensions over the retina. The reflected (or returned) light is detected and used to generate a digital image with a computer or electronic imaging device. The blue, red and green lasers and their corresponding wavelengths are the same in the The blac, Tou and groom as The other predicate, the P200CAF does not have the Opted i zoom it does not have an angiographic mode but it does have the exact same red and green lasers in terms of type and wavelength. The generation of the image is performed in the conventional manner using light detectors, the generation of the mitized, and the data collected in a computer for reconstruction, the balput of which is ages on the beams on the two axes is done using a conventional rotating polygon for the fast vertical scan and a motor driven mirror for the slower horizontal scan. An alignment pattern helps ensure that the patient's eye is correctly positioned. The reflected energy from the retinal surface is passed back through the device to an array of two discrete detectors (effectively a red and a green channel). For the P200MAAF, P200MA, and the P200CAF, in standard imaging mode, the images produced can be viewed either as a composite image (red and green images combined) or separate as a green channel and a red channel image. The P200MAAF and P200CAF can also generate an alternate red channel image that shows the natural fluorescence (autofluorescence) of the eye. In this imaging mode, the retina is illuminated using the green laser, while the red laser optical path is blocked by a shutter. In this imaging mode, the red channel image now displays the naturally occurring fluorescent material of the retina, such as lipofuscin. The signal strength varies as the laser beam is scanned across the eye, allowing an image to be created and recorded, revealing the variation in its constituent material and structures. The Panoramic P200MAAF and the P200MA also have an angiographic mode where the red and green lasers are blocked and only the blue laser illuminates the retina. The blue laser causes the fluorescence of an injected contrast media (or dye), fluorescein. Fluorescein absorbs in the blue and emits in the green part of the visible spectrum. In this imaging mode, the green channel now displays the flow (and possible leakage) of the dye through the blood vessels of the eye. This scanning function is housed in the 'scanhead,' which is seated on a table that can move up and down and this affords a height adjustment to achieve correct patient positioning. The P200MAAF, P200MA, and P200CAF capture one image at a time and can present each image as a thumbnail sketch. If more than one image is captured, all three devices display a series of thumbnail sketches in the order in which they were scanned. The P200MAAF, like the P200MA and P200CAF, allows the user to view one or more images of the eye.
The provided text, K102492, is a Special 510(k) Summary for the Optos P200MAAF Ophthalmoscope and the FDA's clearance letter. It describes the technological characteristics and substantial equivalence to predicate devices but does not contain information about acceptance criteria or specific studies proving device performance against such criteria. It explicitly states: "Performance Testing: Compliance to electrical safety (including EMC), light emitting products, programmable devices and biocompatibility standards are met. Each device is tested for electrical safety, laser power output and correct functioning of the laser radiation management system against set criteria and limits." This indicates regulatory compliance testing, not a clinical performance study with acceptance criteria as typically understood for diagnostic accuracy.
Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert adjudication, or comparative effectiveness studies.
The document focuses on demonstrating substantial equivalence to pre-existing, legally marketed devices (P200MA and P200CAF) based on:
- No new intended use: The P200MAAF shares the same "Indications for Use" as its predecessors: "to aid in the diagnosis and monitoring of diseases or disorders that manifest in the retina."
- Similar principles of operation: All devices use lasers scanned across the retina, detected light converted to electrical signals, and digital image reconstruction.
- Similar technological characteristics: The laser types, wavelengths, and image generation methods are largely consistent with the predicate devices, with some minor differences (e.g., P200CAF lacks angiographic mode but shares red/green lasers; P200MAAF and P200MA have an angiographic mode). The document asserts these differences do not raise new questions of safety and effectiveness.
In summary, the provided text does not contain the detailed clinical performance study information requested. It's a regulatory document focusing on substantial equivalence for market clearance, not a report on a clinical trial demonstrating diagnostic accuracy against specific performance metrics.
§ 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.