(24 days)
The device is intended to be used for taking digital images of retina of human eye without a mydriatic.
CR-1 is an improved model of CR-DGi. Canon EOS Digital Camera is mounted with CR-1, can be viewed immediately, making procedures more efficient and many different applications, such as telemedicine and electronic filing. CR-1's intended use is the same as that of CR-DGiand the CF-1 is only being used as a predicate device in regard to the chin rest motion. The differences between CR-1 and CR-DGi are as follows; · The Chin Rest of CR-1 is moved automatically the same like CF-1. but for CR-DGi it is moved manually. · CR-1 has digital magnification function to change angular field of view (24° (H) x 36° (W), diagonal angle of view: 43° ), while CR-DGi does not have such function. · The Working distance (WD) of CR-1 is shorter than CR-DGi (CR-1: 35 mm, CR-DGi: 45 mm). · CR-1 is visually more compact and lighter than CR-DGi. CR-1 is equivalent to CR-DGi in the following respect:. · The optical components and alignment and the mechanical structures of the CR-1 are almost same as the CR-DGi .
The provided text describes a 510(k) summary for the Canon CR-1 Digital Retinal Camera. However, it does not contain specific acceptance criteria or the details of a study demonstrating the device meets such criteria.
The document primarily focuses on establishing substantial equivalence to a predicate device (Canon CR-DGi and CF-1) by highlighting an improved model with minor design changes. The key information is about the device's technical specifications and its intended use, not its performance against predefined clinical or analytical benchmarks.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets them from the provided text.
Here's why and what's missing:
- No Acceptance Criteria: The document does not define any quantitative or qualitative performance metrics (e.g., sensitivity, specificity, image resolution, accuracy in detecting specific retinal conditions) that the CR-1 must meet.
- No Performance Study Details: There is no mention of a clinical trial or a validation study conducted to measure the device's performance against any established criteria. The comparison is mainly a technical one, describing how the CR-1 is "equivalent to CR-DGi" in optical and mechanical aspects and "improved" in features like automatic chin rest, digital magnification, and working distance.
- No Ground Truth, Sample Sizes, or Expert Adjudication: Because no performance study is described, there's no information about sample sizes (test or training), data provenance, the number and qualifications of experts, or adjudication methods used to establish ground truth.
- No MRMC or Standalone Performance: The document does not discuss any multi-reader multi-case studies or standalone algorithm performance, as the device is an imaging camera and not an AI-powered diagnostic tool.
In summary, the provided document is a 510(k) summary focused on demonstrating substantial equivalence through technical comparison, not a performance study against acceptance criteria.
§ 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.