(15 days)
CANON DIGITAL RADIOGRAPHY CXDI-40C provides digital image capture for conventional film/screen radiographic examinations. The device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
The Canon digital radiography CXDI-40C is used to directly capture and convert conventional projection X-ray images to digital images. A sub-sampled image can be displayed on a preview monitor for viewing. The diagnostic image can be transmitted through a DICOM compatible digital network for printing. The device provides digital image capture for conventional film/screen radiographic examinations. The CXDI-40C uses CsI (Cesium Iodide) as the fluorescent screen deposited on the amorphous silicon array, while the predicate CXDI-40G uses GOS (Gadolium Oxy-Sulfide). The CXDI-40C delivers diagnostic images with approximately half the xray dosage required by CXDI-40G and CXDI-40C's DQE approximately doubles compared to CXDI-40G. The CXDI-40C's imaging size, number of pixels and pixel pitch are the same as those of CXDI-40G. CXDI-40C operates in conjunction with an upright stand, table, and universal stand. CXDI-40C's housing size and shape are almost as same as those of CXDI-40G. A Control PC is required to operate the CXDI-40C.
The provided text is a 510(k) summary for a medical device (Canon CXDI-40C digital radiography system) seeking clearance from the FDA. It declares substantial equivalence to a predicate device (Canon CXDI-40G).
Here's an analysis of the acceptance criteria and study information, based on the provided text:
Key Takeaway: The provided 510(k) summary does not contain information about acceptance criteria or specific studies that prove the device meets those criteria in the way typically required for AI/CAD-based devices. This document is from 2003 and for a digital radiography system replacing film/screen, not a system with advanced analytics or AI. The FDA clearance is based on substantial equivalence to an existing device, primarily focusing on hardware differences (fluorescent screen material) and the impact on image quality (DQE, dosage).
Therefore, many of the requested fields below will be marked as "Not Applicable" or "Not Provided" because the nature of this submission is different from one for an AI/CAD device.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Goal: Substantial Equivalence to predicate device (Canon CXDI-40G) | The submission states, "Based on the information in this submission, similarity to the predicate devices (the Canon digital radiography the CXDI-40G), and the results of our design control activities, it is our opinion that the Canon digital radiography CXDI-40C described in this submission is substantially equivalent to the predicate devices." The FDA concurred with this determination. |
| Image Quality: | CXDI-40C delivers diagnostic images with approximately half the x-ray dosage required by CXDI-40G. |
| Image Quality: | CXDI-40C's DQE approximately doubles compared to CXDI-40G. |
| Imaging System Equivalence: | Same amorphous silicon array, imaging size, number of pixels, and pixel pitch as CXDI-40G. Operates in conjunction with the same accessory equipment (upright stand, table, universal stand). Housing size and shape are almost the same. |
| Intended Use Equivalence: | Provides digital image capture for conventional film/screen radiographic examinations, intended to replace radiographic film/screen systems in all general purpose diagnostic procedures – same as predicate. |
Study Details
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Sample sized used for the test set and the data provenance:
- Not Provided. The document relies on similarity to a predicate device and improved technical specifications (like DQE and reduced dosage), rather than a clinical test set with patient data for performance evaluation in the context of an AI/CAD system.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable / Not Provided. This type of evaluation (expert-established ground truth) is typical for AI/CAD devices, not for a fundamental digital X-ray capture system like this, where the primary evaluation is technical equivalence and imaging characteristics.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable / Not Provided.
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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 Applicable / Not Done. This is not an AI-assisted device. The primary comparison is between the proposed device and a predicate digital radiography device, focusing on hardware and image acquisition characteristics.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable / Not Done. This device is a digital X-ray capture system, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable / Not Provided. The "ground truth" in this context would be the successful capture of diagnostic-quality X-ray images, as demonstrated by technical metrics (DQE, dosage) and clinical history/usage of the predicate device. It's not about disease detection performance.
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The sample size for the training set:
- Not Applicable / Not Provided. This is a hardware device submission, not an AI model submission. There is no concept of a "training set" for the device itself in this context.
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How the ground truth for the training set was established:
- Not Applicable / Not Provided.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.