(210 days)
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:
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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.
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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.
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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.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not available. No test set or adjudication process is described.
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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.
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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.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not available. No ground truth for diagnostic performance is mentioned.
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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.
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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.
§ 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.