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Canon non-mydriatic retinal camera CR series (CR-2 plus AF and CR-2 AF) is intended to be used for taking digital images of the retina of the human eye without mydriatic. The CR-2 plus AF has the following photography modes: color, red-free, cobalt digital and fundus autofluorescence (FAF). The CR-2 AF has the following photography modes: color, red-free, cobalt digital and additional infrared photography for anterior segment.

The Canon non-mydriatic retinal camera CR series is composed of two retinal cameras and its control software and is used for taking digital images of a human retina without mydriatic.
Two retinal cameras: The CR-2 Plus AF and CR-2 AF

• Both models take digital photographic retinal images of patient's eyes across an angle of view of 45 degrees, and have autofocus and automatic shooting of retinal image, and automatic switching from anterior segment image to retinal image.
• The CR-2 Plus AF camera is identical to the camera cleared under K123208. The photography mode includes color, red-free, cobalt and fundus autofluorescence (FAF).
• The CR-2 AF camera is modified version of the predicate CR-2 Plus AF (K123208). Most of the specifications are identical to the predicate; however, the photography mode does not include fundus autofluorescence (FAF) photography.
• Both the CR-2 AF and the CR-2 Plus AF uses infrared light to observe the anterior segment, but CR-2 AF can save such an image.
  Two Software: Retinal image control software (RICS) and Non-myd RC Capture Utility software (CU) programs
• RICS software program supports browsing, processing, and storage function of the images. It also supports the output of the images to the DICOM storage server, export in DICOM or JPEG format and output to a printer.
• CU software program is a simplified version of RICS, without most of the graphic user interface and the database. It allows user to capture and transfer the retinal images from the retinal camera to the PC.
  Both RICS and CU software programs are compatible with both CR-2 AF and CR-2 Plus AF cameras.

The provided document, a 510(k) Premarket Notification for the Canon non-mydriatic retinal camera CR series, primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria for an AI/algorithm-driven diagnostic device.

Therefore, the document does not contain the specific information required to answer many of the questions, particularly those related to acceptance criteria, sample sizes for test sets in an AI context, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

The document discusses the technical specifications and modifications of the CR-2 AF camera compared to its predicate (CR-2 Plus AF) and confirms compliance with various electrical safety, EMC, performance, and software validation standards. It emphasizes that the changes do not introduce new risks or affect the basic design principle, usage, effectiveness, and safety.

Given the information in the provided document, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative clinical acceptance criteria or performance metrics (e.g., sensitivity, specificity, AUC) for a diagnostic output. Its performance evaluation focuses on technical compliance and equivalence.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document mentions "Performance testing" and "Software Verification and Validation" but does not detail a specific test set with sample sizes, data provenance, or whether it was retrospective or prospective in a clinical performance context. The testing appears to be primarily for engineering performance and software functionality.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable, as no clinical test set for diagnostic accuracy requiring expert ground truth is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable.

5. 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 in the context of this device. The device is a retinal camera, not an AI-powered diagnostic algorithm.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for the device's performance appears to be its ability to capture images to a certain standard and its compliance with safety regulations, not diagnostic accuracy against a clinical ground truth. A "qualitative assessment of the function of the anterior segment infrared image" was performed, but details are absent.

8. The sample size for the training set

Not applicable, as this is a hardware device with control software, not a machine learning model that requires a training set of images for diagnostic prediction.

9. How the ground truth for the training set was established

Not applicable.

Summary of Device and Performance Information from the Document:

The document describes the Canon non-mydriatic retinal camera CR series (Model CR-2 AF and CR-2 Plus AF).

• Intended Use: To be used for taking digital images of the retina of the human eye without mydriatic.
• Key Differences (CR-2 AF vs. Predicate CR-2 Plus AF):
  • Photography Modes: CR-2 AF includes color, red-free, cobalt, and infrared for anterior segment. It does not have fundus autofluorescence (FAF) photography, which the predicate and CR-2 Plus AF model do.
  • Light Source: CR-2 AF uses White LED (lower output) instead of Xenon tube (required for FAF).
  • Software: Introduction of "Non-myd RC Capture Utility software (CU)" as a simplified version of RICS, without GUI and database, for capturing and transferring images.
  • Physical: CR-2 AF is slightly lighter and smaller due to the light source change.
• Performance Data:
  • Non-clinical tests: Electrical safety, Electromagnetic Compatibility, Performance testing, and Software Verification and Validation.
  • Compliance:
    • ANSI/AAMI ES 60601-1
    • IEC 60601-1-2
    • IEC 60601-1-6
    • ISO 15004-1
    • ISO 10940
    • ANSI Z80.36 (eye safety limits of Group 1 instrument for light hazard)
    • ISO10993 series (biocompatibility of patient contact parts, concluded no new concerns)
  • Software Validation: Validated according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005).
  • Qualitative Assessment: A qualitative assessment of the function of the anterior segment infrared image for CR-2 AF camera was performed.

The conclusion is that the proposed CR-2 AF is substantially equivalent to the predicate CR-2 Plus AF (K123208) because the differences do not affect the basic design principle, usage, effectiveness, and safety, and therefore do not raise any new questions regarding safety and effectiveness.

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