(30 days)
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.
§ 886.1120 Ophthalmic camera.
(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.