(97 days)
The CR-2 Plus is intended to be used for taking digital images of the retina of the human eye without a mydriatic. The CR-2 Plus has the following photography modes: color, red free & cobalt digital filter, and fundus autofluorecence (FAF).
The Digital Retinal Camera CR-2 Plus is used for taking digital images of a human retina without a mydriatic. Canon EOS Digital Camera is mounted to the CR-2 Plus. Images can be viewed immediately, making procedures more efficient with many different applications, such as telemedicine and electronic filing.
The provided text describes a 510(k) premarket notification for the Canon Digital Retinal Camera CR-2 Plus. However, it does not contain any information regarding acceptance criteria, device performance, or details of a study (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance). The document focuses on the device's description, indications for use, comparison to predicate devices, and the FDA's substantial equivalence determination.
Therefore, I cannot provide the requested information based on the given text.
The following information is missing from the provided document:
- A table of acceptance criteria and the reported device performance: No performance metrics or acceptance criteria are mentioned.
- Sample sized used for the test set and the data provenance: No information on a test set (or any study data) is provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No information on ground truth establishment is provided.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: No information on adjudication is provided.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No MRMC study or AI assistance is mentioned. The device is a camera, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as the device is a camera, not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): No ground truth information is provided.
- The sample size for the training set: Not applicable as the device is a camera.
- How the ground truth for the training set was established: Not applicable as the device is a camera.
The document only states that "Performance testing on optical radiation safety and fundus autofluorecence photographing demonstrate the minor technological differences between the CR-2 Plus and the predicate devices do not raise any new questions of safety and effectiveness." This is a high-level statement and does not provide specific details about the tests performed or their results.
§ 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.