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Canon Non-Mydriatic Retinal Camera CR-DGi is intended to be used for taking pictures of retina of human eye without a mydriatic.

CR-DGi is an improved model of CR5-45NM.

The provided text describes Canon's CR-DGi Non-Mydriatic Retinal Camera. The device is an updated model of the Canon CR 45 NM, and its primary purpose is to capture images of the human retina without the need for pupil dilation. The 510(k) submission (K031629) focuses on demonstrating substantial equivalence to the predicate device.

However, the provided text does not contain information about acceptance criteria, a specific study proving device performance against acceptance criteria, sample sizes used, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, or details about training set size and ground truth establishment for an AI/algorithm-based device.

The document is a 510(k) summary for a medical device that appears to be a hardware product (a camera), not an AI/algorithm. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI performance are not applicable here. The "performance" section in the comparison table refers to physical specifications and features (e.g., angle of view, working distance, focusing mechanism) rather than diagnostic accuracy metrics.

The FDA 510(k) clearance in this case is for a medical device (camera) demonstrating substantial equivalence in its specifications and intended use to a previously cleared predicate device.

Therefore, I cannot fulfill your request for information regarding acceptance criteria, study details, expert involvement, or AI-specific performance metrics as this information is not present in the provided text.

The document primarily states:

• Proposed Device: Canon CR-DGi HKI, Ophthalmic camera
• Predicate Device: Canon CR 45 NM 86HKI, Ophthalmic cameras (K980246)
• Intended Use: Taking pictures of retina of human eye without a mydriatic.
• Performance Comparison: A table comparing specifications between the proposed and predicate devices, showing "Same" for most critical imaging parameters (Angle of view, Min. diameter of pupil required, Working distance, Light source for photography). The primary change noted is the image unit shifting from supporting multiple options (EOS Digital Camera, 35mm film, Polaroid, 3CCD TV Camera) to solely EOS Digital Camera.
• Regulatory Clearance: The FDA found the device substantially equivalent to the predicate device.

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