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The device is intended to be used for taking digital images of retina of human eye without a mydriatic.

The DIGITAL RETINAL CAMERA CR-1 Mark II is used for taking digital images of a human retina without a mydriatic. Canon EOS Digital Camera is mounted to the CR-1 Mark II. Images can be viewed immediately, making procedures more efficient with many different applications, such as telemedicine and electronic filing.

The provided text is a 510(k) summary for the DIGITAL RETINAL CAMERA CR-1 Mark II. This document focuses on establishing substantial equivalence to a predicate device (Canon CR-1) and does not contain detailed information about a study proving device acceptance criteria in the way a clinical trial report would.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a study proving the device meets acceptance criteria from the provided text.

The document primarily describes:

• Device Identification: Manufacturer, trade name, model name, classification, and 510(k) number of the proposed device (CR-1 Mark II) and its predicate (CR-1).
• Description of Device: The CR-1 Mark II is an ophthalmic camera used for taking digital images of the human retina without mydriatics. It uses a Canon EOS Digital Camera.
• Differences from Predicate: The primary difference highlighted is the flash intensity settings, with the CR-1 Mark II offering an additional "Low flash intensity mode (LOW2)" at 1/8 flash intensity compared to the CR-1.
• Intended Use/Indications for Use: To take digital images of the retina of the human eye without a mydriatic.
• FDA Determination: The FDA found the device substantially equivalent to the predicate device.

Key Missing Information for your Request:

The 510(k) summary is a regulatory document to demonstrate substantial equivalence, not a detailed scientific study report. It does not typically include:

• Specific, quantified acceptance criteria for performance (e.g., minimum resolution, image quality metrics).
• Results from a formal study that tests against these acceptance criteria.
• Clinical data with sample sizes, expert ground truth, or MRMC analyses.

Without a detailed clinical or performance study report, which is not part of this 510(k) summary, I cannot fulfill your request for specific study details.

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