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The Digital Retinal Camera CR-2 Plus AF is intended to be used for taking digital images of the retina of the human eye without a mydriatic. The CR-2 Plus AF has the following photography modes: color, red free, cobalt digital and fundus autofluorescence (FAF).

The Digital Retinal Camera CR-2 Plus AF is used for taking digital images of a human retina without a mydriatic. Canon EOS Digital Camera is mounted to the CR-2 Plus AF. Images can be viewed immediately, and procedures of imaging are more efficient with many different applications such as telemedicine and electronic filing. The CR-2 Plus AF is equipped with autofocus/automatic shooting/automatic switching function from anterior segment image to fundus image.

The provided text describes a 510(k) summary for the "Digital Retinal Camera CR-2 Plus AF." This document outlines the device's technical characteristics, its intended use, and a comparison to a predicate device (K111612 Canon Digital Retinal Camera CR-2 Plus). However, it focuses on the device's safety and effectiveness being substantially equivalent to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics for an AI-powered diagnostic device.

The essential information requested in the prompt, such as detailed acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, and ground truth establishment, is largely absent from this type of regulatory submission for a non-AI medical imaging device.

Here's an analysis based on the provided text, highlighting what is (and isn't) present:

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the document. The document states that "The unit complies with the US Performance Standard for ophthalmic equipment" and "The CR-2 Plus AF met all requirements of the standards," but it does not specify what those standards are or what the acceptance criteria within them entailed. No specific device performance metrics (e.g., sensitivity, specificity, accuracy) are reported for the AF function.

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

This information is not provided. The document mentions "non-clinical tests were performed" to evaluate safety and effectiveness, but it does not specify a test set size or data provenance.

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):

This information is not provided. Since this is an imaging device rather than a diagnostic AI, there is no mention of establishing ground truth by experts in the context of diagnostic performance.

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

This information is not provided.

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:

This is not applicable and not mentioned. The device is a digital retinal camera, and the modifications are related to autofocus, automatic shooting, and automatic switching, not AI assistance for human readers in diagnostic interpretation.

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

This is not applicable and not mentioned. The device is an imaging camera, not an AI algorithm. Its automated features (autofocus, auto-shooting) are inherent to its operation, not a separate standalone algorithm performance.

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

This is not applicable and not mentioned in the context of diagnostic interpretation. For the device itself, the "ground truth" for its performance would be its ability to capture clear images according to technical specifications and safety standards, but these details are not elaborated upon.

8. The sample size for the training set:

This information is not provided. As this is not an AI/machine learning device, there wouldn't typically be a "training set" in the common sense.

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

This information is not provided. (Not applicable for this type of device.)

Summary of Device and Performance Information from the Text:

The document describes the Canon Digital Retinal Camera CR-2 Plus AF, an ophthalmic camera used for taking digital images of the human retina without mydriatic.

Acceptance Criteria and Device Performance (as inferred):

Key Takeaways from the document:

• This is a 510(k) premarket notification for a medical imaging device (digital retinal camera), not an AI diagnostic tool.
• The focus of the submission is to demonstrate substantial equivalence to an existing predicate device (K111612 Canon Digital Retinal Camera CR-2 Plus).
• The "study" referenced involves non-clinical tests (performance, software validation, electrical safety, electromagnetic compatibility) to ensure the modified device (CR-2 Plus AF) remains safe and effective despite added features like autofocus and automatic shooting.
• The document states the device "met all requirements of the standards" and "does not raise any new safety and effectiveness concerns." However, it does not detail specific quantitative performance metrics beyond this general statement of compliance.

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