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

The Retinal Functional Imager (RFI) is a mydriatic fundus imaging camera intended for taking red-free images. The RFI is comprised of the following subassys:

• 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 Retinal Functional Imager (RFI) provides, through a series of multiple flashes, the ability to observe and register the blood flow velocity and path of motion.

Here's an analysis of the acceptance criteria and study information for the Retinal Functional Imager (RFI) based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it describes general compliance and validation findings.

2. Sample Size Used for the Test Set and Data Provenance:

The document states "known velocity simulated data images" were used for evaluating blood flow velocity measurements, and "subject data measurements" were taken. However, specific sample sizes for the test set (number of simulated images or human subjects) are not provided. The provenance (country of origin, retrospective/prospective) of the subject data is also not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not provided in the document.

4. Adjudication Method for the Test Set:

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A MRMC comparative effectiveness study was not mentioned or conducted based on the provided text. The document focuses on the device's technical performance and equivalence to predicate devices, not on human-in-the-loop performance improvements.

6. Standalone (Algorithm Only) Performance Study:

Yes, a standalone performance study was done for the algorithm described. The device's ability to "map the blood flow through blood vessels in the eye and determine the velocity of the flow by tracking the motion of the blood cells" is a core function of the algorithm. The document states that blood flow velocity measurements were "repeatable and accurate with reference to known velocity simulated data images." This indicates a standalone evaluation of the algorithm's accuracy against a known truth.

7. Type of Ground Truth Used:

For blood flow velocity measurements, the ground truth used was "known velocity simulated data images." For "subject data measurements," it indicates consistency and reasonableness, implying a comparison against expected physiological norms or perhaps other measurement methods (though not explicitly stated as ground truth establishment).

8. Sample Size for the Training Set:

The document does not specify a separate training set or its sample size. The description of the device's capabilities implies that the software was developed and validated, but details about training data are absent.

9. How the Ground Truth for the Training Set Was Established:

This information is not provided as a separate training set is not explicitly mentioned, nor is the method for establishing ground truth for any potential training data.

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