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The Panoramic 200CAF scanning laser ophthalmoscope is intended to be used as a wide field and retinal autofluorescence imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases or disorders that manifest in the retina.

The Panoramic 200CAF.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 wavelengths of the lasers residing in the Optos Panoramic 200CAF and the P200 are the same. The generation of the image is performed in the conventional manner using light detectors, the output of which is digitized, and the data collected in a computer for reconstruction, display, and storage. The scanning of 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 Panoramic 200CAF and the P200, 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 Panoramic 200CAF 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. 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 Panoramic 200CAF and P200 capture one image at a time and can present each image as a thumbnail sketch. If more than one image is captured, the Panoramic 200CAF and Panoramic 200 display a series of thumbnail sketches in the order in which they were scanned. The Panoramic 200CAF, like the P200, allows the user to view one or more images of the eve.

The provided text describes a 510(k) submission for the Optos Panoramic 200CAF Ophthalmoscope. It primarily focuses on the device's technical characteristics and its substantial equivalence to a predicate device (Optos Panoramic 200).

However, the document does not contain detailed information about specific acceptance criteria or an explicit study proving the device meets these criteria in the way you've outlined. The "Performance Testing" section is very brief and general.

Here's a breakdown of what can be extracted and what is missing, based on the provided text:

1. Table of acceptance criteria and the reported device performance

Note: The document states that "performance testing was conducted to demonstrate that the P200CAF accurately and reproducibly produces images the eye in both standard and autofluorescence imaging modes." However, it does not specify how "accuracy" and "reproducibility" were quantitatively defined as acceptance criteria (e.g., specific metrics like resolution, signal-to-noise ratio, or specific error rates) nor does it provide a detailed report of the numerical outcomes of this performance testing.

Missing Information (Not Available in the Provided Text):

The document focuses on demonstrating substantial equivalence to a predicate device (Optos Panoramic 200) based on similar intended use, principles of operation, and technological characteristics. The "performance testing" described is for basic functionality and safety, not for diagnostic efficacy as might be proven in a clinical study with image interpretation and ground truth.

Specifically, the following information is not provided in the given text:

• 2. Sample size used for the test set and the data provenance: No information on a specific test set, its size, or origin (country, retrospective/prospective).
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No mention of expert review or ground truth establishment.
• 4. Adjudication method for the test set: Not applicable as there's no described test set with expert review.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size: No mention of such a study.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is an imaging tool; its performance is described in terms of image production, not as an algorithm interpreting images. Therefore, a "standalone algorithm" performance isn't applicable in the context of this submission focused on the imaging device itself.
• 7. The type of ground truth used: No ground truth data is described for performance evaluation beyond general functional checks.
• 8. The sample size for the training set: Not applicable as this is an imaging device, not an AI/ML algorithm requiring a training set in the conventional sense.
• 9. How the ground truth for the training set was established: Not applicable.

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