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The Fundus Photo Digital Imaging System Model CFD-440 Model is intended to capture, archive, and display digital images of the retina and surrounding areas of the eye.

The Fundus Photo Digital Imaging System Model CFD-440 is an automated imaging device used in conjunction with an ophthalmic fundus camera that requires minimal intervention during the capture of an image. The system is simple to use and requires nominal training for a user to become proficient. Like the predicate device, the Fundus Photo Digital Imaging System Model CFD-440 is an accessory attachment comprised of a digital imaging camera or cameras, computer hardware and software platform intended to capture, store, archive, and display images acquired by the fundus camera.

The provided text describes the Fundus Photo Digital Imaging System Model CFD-440, a device intended to capture, archive, and display digital images of the retina and surrounding areas of the eye. It is an accessory attachment that works with existing ophthalmic fundus cameras. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Zeta Diagnostic Retinal Imaging System, K02216), rather than detailing specific acceptance criteria in terms of clinical performance metrics for the CFD-440 itself.

The document states: "Fundus Photo has performed software verification, validation and performance tests. The results indicate that the Fundus Photo Digital Imaging System Model CFD-440 is substantially equivalent to the software standards exhibited by the predicate device." However, no specific performance metrics, acceptance criteria, or the details of these performance tests are provided beyond this general statement.

Therefore, many of the requested details about acceptance criteria and the study proving the device meets them cannot be extracted from this document, as the submission focuses on demonstrating equivalence in intended use, principles of operation, and technological characteristics rather than quantitative performance against defined acceptance criteria.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Acceptance Criteria: Not explicitly stated in the document in terms of quantitative performance metrics (e.g., resolution, accuracy, sensitivity, specificity). The primary "acceptance criteria" for the 510(k) submission appears to be demonstrating substantial equivalence to the predicate device.
• Reported Device Performance: No specific quantitative performance data is provided. The document states that "software verification, validation and performance tests" were done and "the results indicate that the Fundus Photo Digital Imaging System Model CFD-440 is substantially equivalent to the software standards exhibited by the predicate device."

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

• Not specified in the provided text.

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/Not specified as no such test set or ground truth establishment is detailed in the submission.

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

• Not applicable/Not specified.

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

• Not applicable, as this device is a digital imaging system, not an AI or diagnostic aid that assists human readers.

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

• Not applicable. The device is an imaging system, not a standalone diagnostic algorithm. Its performance is tied to the images it captures, stores, and displays, which are then interpreted by a human user.

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

• Not applicable/Not specified. The submission focuses on substantial equivalence in function and technical characteristics, not diagnostic accuracy against a ground truth.

8. The sample size for the training set

• Not applicable/Not specified. The device is not an AI/ML algorithm that requires a "training set" in the conventional sense. Its development involved software verification and validation, but not machine learning training.

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

• Not applicable/Not specified.

In summary, the provided 510(k) submission for the Fundus Photo Digital Imaging System Model CFD-440 is focused on demonstrating substantial equivalence to a predicate device based on intended use, principles of operation, and technological characteristics (hardware and software functions). It does not present detailed performance studies against specific clinical acceptance criteria, nor does it involve aspects like AI algorithms, human-reader studies, or ground truth establishment in the context of diagnostic accuracy.

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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.

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