Search Results

The Retinal Functional Imager (RFI) is intended to observe, capture, display, and store images of patients' fundus (retina) under mydriatic conditions to aid in diagnosing or monitoring diseases of the eye that may be observed and photographed.

The modified RFI, like the cleared RFI, is a mydriatic fundus imaging camera intended for taking red-free images. The modified RFI, as the cleared device, comprises of the following sub-assemblies:

• An optical system for illuminating and imaging the retina. The optical imaging includes a stroboscopic light source for sequential rapid imaging of the retina.
• A high resolution CCD camera.
• An electronic unit for driving the light source.
• A software package for operating the system, controlling the illumination, grabbing the images, data browsing and data analysis.
  The device is also capable of using 35 mm film or using a digital camera similar to the predicate devices. Visible light is used for observation. Alignment and focusing is manual via the fundus camera controls.
  Under red-free imaging, the modified RFI provides, through a series of multiple flashes, the ability to observe and register the blood flow velocity and path of motion.

The Retinal Functional Imager 3000 (RFI 3000) is intended to observe, capture, display, and store images of patients' fundus (retina) under mydriatic conditions to aid in diagnosing or monitoring diseases of the eye. The device provides information on blood flow (velocity) and path of flow in retinal vessels, but its repeatability and trueness for retinal blood flow velocity measurements have not been clinically established.

Here's an analysis of the provided information regarding acceptance criteria and performance studies:

1. Acceptance Criteria and Reported Device Performance

The device's performance was evaluated through bench testing using a model eye simulation. The key metrics assessed were repeatability (standard deviation of repeated measurements) and accuracy (measured versus calculated results) of retinal blood flow velocity (RBFV) measurements. While specific acceptance criteria are not explicitly stated as numerical thresholds (e.g., "SD must be

Ask a specific question about this device