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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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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:

1. A table of acceptance criteria and the reported device performance: No performance metrics or acceptance criteria are mentioned.
2. Sample sized used for the test set and the data provenance: No information on a test set (or any study data) is provided.
3. 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.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: No information on adjudication is 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: No MRMC study or AI assistance is mentioned. The device is a camera, not an AI diagnostic tool.
6. 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.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): No ground truth information is provided.
8. The sample size for the training set: Not applicable as the device is a camera.
9. 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.

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The device is intended to be used for taking digital images of the retina of the human eye without a mydriatic.

The DIGITAL RETINAL CAMERA CR-2 is used for taking digital images of retina of human eye without a mydriatic. Canon EOS Digital Camera is mounted to the CR-2. Images can be viewed immediately, making procedures more efficient with many different applications, such as telemedicine and electronic filing.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Canon DIGITAL RETINAL CAMERA CR-2:

It's important to note that this 510(k) summary is for a medical device, specifically a digital retinal camera, not an AI/ML algorithm. Therefore, many of the typical acceptance criteria and study details associated with AI/ML systems (like those for diagnostic accuracy, sensitivity, specificity, reader studies, ground truth establishment for algorithms, etc.) are not present in this document. The focus here is on safety, effectiveness, and substantial equivalence to a predicate device.

Acceptance Criteria and Reported Device Performance

Study Details (Focusing on the type of device and available information)

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

   • The document does not specify a "test set" in the context of clinical image data for evaluating an algorithm's performance. Instead, the testing described is related to engineering and safety standards.
   • Therefore, there is no information on sample size, data provenance, or retrospective/prospective nature for an image-based test set as this is not an AI/ML diagnostic device.

2. 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. This device is an imaging acquisition device, not an AI/ML diagnostic algorithm that requires expert-established ground truth for performance evaluation of its diagnostic capabilities.

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

   • Not applicable. There is no diagnostic "test set" and thus no adjudication of cases by experts for this type of submission.

4. 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. This device is a fundus camera, not an AI-assisted diagnostic tool. No MRMC study was performed in this context.

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

   • Not applicable. This is not an algorithm. The device's "standalone" performance refers to its ability to acquire images and meet technical standards independently.

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

   • Not applicable. The "ground truth" for this device lies in its adherence to established engineering and safety standards (e.g., electrical safety, EMC, ophthalmic instrument standards) and its functional equivalence to a predicate device in terms of image acquisition. There is no medical "ground truth" (like disease presence/absence via pathology) used in evaluating its performance for this 510(k) submission.

7. The sample size for the training set:

   • Not applicable. This device does not involve an AI/ML algorithm that requires a training set. The "training" for such a device would refer to its manufacturing and design process.

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

   • Not applicable, as there is no training set in the context of an AI/ML algorithm.

Summary of the Study:

The "study" described in this 510(k) pertains to performance testing against recognized industry standards and direct comparison of specifications to a predicate device, the Canon DIGITAL RETINAL CAMERA CR-1 Mark II (K090466).

• Testing Protocol: The CR-2 underwent testing in accordance with:
  • IEC60601-1 (Electrical Safety)
  • IEC60601-1-2 (Electromagnetic Compatibility)
  • ISO15004-1:2006 (Ophthalmic instruments — Fundamental requirements and test methods — Part 1: General requirements applicable to all ophthalmic instruments)
  • ISO15004-2:2007 (Ophthalmic instruments — Fundamental requirements and test methods — Part 2: Light hazard protection)
• Purpose of Study: To demonstrate that the CR-2 meets all safety and performance requirements set by these standards and is substantially equivalent to its predicate device. This ensures it is as safe and effective for its intended use (taking digital images of the retina of the human eye without a mydriatic).
• Methodology: The device itself was subjected to these standard tests. A direct comparison of its imaging principle, intended use, dimensions, weight, optical components, alignment, and other specifications was made against the predicate device.
• Conclusion: The tests confirmed compliance with the standards, and the comparison showed that the CR-2 maintains the same or better performance than the predicate, leading to a determination of substantial equivalence.

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The device is intended to be used for taking digital images of retina of human eye with non-mydriatic and mydriatic.

The DIGITAL RETINAL CAMERA CX-1 is used for taking digital images of retina of human eye with non-mydriatic and mydriatic. is mounted with CX-1, can be viewed immediately, making Digital Camera (Dedicated) procedures more efficient and many different applications, such as telemedicine and electronic filing.

The provided text describes a 510(k) premarket notification for the Canon CX-1 Digital Retinal Camera, seeking substantial equivalence to existing predicate devices (Canon CF-1 and CR-1). The document focuses on demonstrating that the CX-1 is as safe and effective as the predicates through a comparison of device features and performance data.

However, the provided document does not contain any information about acceptance criteria or a study that evaluates the device's performance against such criteria in the context of diagnostic accuracy, clinical outcomes, or human reader improvement with AI assistance.

The "Performance Data" mentioned in the "Conclusion" section likely refers to technical performance data (e.g., image quality, safety tests) related to the device itself and its ability to capture images, rather than a clinical study evaluating diagnostic performance. The context of a 510(k) submission generally involves demonstrating substantial equivalence by comparing technical specifications and intended use, not necessarily by conducting extensive clinical efficacy trials against specific performance criteria for AI-driven diagnostic outputs.

Therefore, I cannot fulfill most of the requested information based on the provided text.

Here's what can be inferred or stated as not available from the document:

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

   • Not available. The document does not specify any quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) nor does it report such metrics for the CX-1. The "Performance Data" is vaguely mentioned as demonstrating safety and effectiveness, likely related to technical device operation.

2. Sample size used for the test set and the data provenance:

   • Not available. There is no mention of a "test set" in the context of evaluating diagnostic performance. The document describes the device, its intended use (taking digital images), and compares its features to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not available. No test set is described, and therefore no ground truth establishment by experts is mentioned.

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

   • Not available. No test set or adjudication process is described.

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 available. The CX-1 is a digital retinal camera, not an AI-powered diagnostic system. The document does not describe any MRMC studies or AI involvement.

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

   • Not available. The CX-1 is a camera, not an algorithm, and the document does not discuss standalone algorithm performance.

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

   • Not available. No ground truth for diagnostic performance is mentioned.

8. The sample size for the training set:

   • Not available. Since the device is a camera and not an AI algorithm requiring training, there is no mention of a training set.

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

   • Not available. As above, no training set is mentioned.

Summary based on the provided text:

The Canon CX-1 Digital Retinal Camera is a device for taking digital images of the human retina. Its 510(k) submission demonstrates substantial equivalence to predicate devices (Canon CF-1 and CR-1) by comparing its features (mydriatic/non-mydriatic capabilities, angle of view, photography modes, bundled digital camera) and stating that "Performance Data" (likely technical and safety data) demonstrates it is as safe and effective as the predicates. The document focuses on the device's ability to capture images, not on image interpretation or diagnostic accuracy performance.

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The device is intended to be used for taking digital images of retina of human eye without a mydriatic.

The DIGITAL RETINAL CAMERA CR-1 Mark II is used for taking digital images of a human retina without a mydriatic. Canon EOS Digital Camera is mounted to the CR-1 Mark II. Images can be viewed immediately, making procedures more efficient with many different applications, such as telemedicine and electronic filing.

The provided text is a 510(k) summary for the DIGITAL RETINAL CAMERA CR-1 Mark II. This document focuses on establishing substantial equivalence to a predicate device (Canon CR-1) and does not contain detailed information about a study proving device acceptance criteria in the way a clinical trial report would.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a study proving the device meets acceptance criteria from the provided text.

The document primarily describes:

• Device Identification: Manufacturer, trade name, model name, classification, and 510(k) number of the proposed device (CR-1 Mark II) and its predicate (CR-1).
• Description of Device: The CR-1 Mark II is an ophthalmic camera used for taking digital images of the human retina without mydriatics. It uses a Canon EOS Digital Camera.
• Differences from Predicate: The primary difference highlighted is the flash intensity settings, with the CR-1 Mark II offering an additional "Low flash intensity mode (LOW2)" at 1/8 flash intensity compared to the CR-1.
• Intended Use/Indications for Use: To take digital images of the retina of the human eye without a mydriatic.
• FDA Determination: The FDA found the device substantially equivalent to the predicate device.

Key Missing Information for your Request:

The 510(k) summary is a regulatory document to demonstrate substantial equivalence, not a detailed scientific study report. It does not typically include:

• Specific, quantified acceptance criteria for performance (e.g., minimum resolution, image quality metrics).
• Results from a formal study that tests against these acceptance criteria.
• Clinical data with sample sizes, expert ground truth, or MRMC analyses.

Without a detailed clinical or performance study report, which is not part of this 510(k) summary, I cannot fulfill your request for specific study details.

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