(112 days)
The CXDI-50RF is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures. It is also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.
The Canon Dynamic/Static DR CXDI-50RF is a portable digital radiography that can take images of any part of the body. It directly converts the X-ray images captured by the LANMIT (Large Area New MIS Sensor and TFT) sensor into a high-resolution digital images. The instrument is suited for use inside a patient environment. This unit converts the X-rays into digital signals. The unit can acquire still and moving images.
The Canon Dynamic/Static DR Fluoroscopic Digital X-Ray Receptor Panel (Model CXDI-50RF) is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic, and interventional procedures, as well as for cardiology, diagnostic, and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology and is not intended for mammography applications.
Here's an analysis of the provided information regarding acceptance criteria and the study:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Technological Characteristics | "Comparison with the predicate shows the technological characteristics of the CXDI-50RF are equal to or better than the predicate device. The units are functionally identical." |
| Safety and Effectiveness | "Tests were performed on the device which demonstrated that the device is safe and effective, performs comparably to and is substantially equivalent to the predicate device. Tests include: Performance testing and Software Validation. Electrical safety and Electromagnetic Compatibility testing has been performed. The unit complies with the US Performance Standard for radiographic equipment." |
Details of the Study:
The provided 510(k) summary (K092439) for the Canon Dynamic/Static DR Model CXDI-50RF Fluoroscopic Digital X-Ray Receptor Panel primarily relies on showing substantial equivalence to predicate devices rather than a detailed clinical performance study with specific metrics like sensitivity, specificity, or AUC based on expert reads.
Here's what can be inferred from the document:
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Sample size used for the test set and the data provenance:
- The document does not specify a sample size for a test set in the context of an accuracy or performance study involving image interpretation.
- The data provenance is not described in terms of country of origin or whether it was retrospective or prospective.
- The "Performance Testing/Data" section mentions "Tests were performed on the device," but these tests appear to be primarily technical and safety assessments (e.g., electrical safety, EMC, software validation) and comparative assessments against predicate devices' technological characteristics, not a clinical study on diagnostic accuracy.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The submission focuses on technical equivalence and safety, not on evaluating human reader performance with the device against a ground truth established by experts.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided, as there is no described clinical test set requiring expert adjudication for diagnostic accuracy.
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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:
- No, an MRMC comparative effectiveness study was not done. This submission predates the widespread regulatory requirement for such studies for AI-powered devices. The device described is a digital X-ray receptor panel, an imaging hardware component, not an AI diagnostic algorithm. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. The device is an image acquisition component, not a diagnostic algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- This information is not provided for a clinical diagnostic performance study. The "ground truth" implied in the submission relates to technical specifications, safety standards, and functional equivalence to predicate devices.
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The sample size for the training set:
- There is no mention of a training set in the context of machine learning or AI models. The device is a hardware component for imaging, not a software algorithm that requires a training set.
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How the ground truth for the training set was established:
- This information is not applicable as there is no training set for an AI/machine learning model described.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.