(12 days)
DIGITAL RADIOGRAPHY CXDI-60G 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. This device is not intended for mammography applications.
The Canon digital radiography CXDI-60G is a solid state xrray imagers. The CXDI-60G intercepts x-ray photons and the scintillator of the CXDI-60G emits visible spectrum photons that illuminate an array of photodetectors that create an electrical signals. After the electrical signals are generated, it is converted to digital value. The resultant output signal can be transmitted to remote viewing site. The Canon digital radiography CXDI-60C is different from CXDI-50G in the following respect - The imaging area of CXDI.60G is changed from 35x43cm to 23x28cm. The principle of the CXDI-60G is the same as the CXDI-50G, with some modifications of its housing in size and shape. The sensor of the CXDI-60G has the same characteristics as the CXDI-50G. The CXDI-60G itself is a component without a control PC. Using a general purpose computer with appropriate specifications and the designated system software installed in it, as a control PC, the CXDI-60G achieves performance stated herein(such as image capturing, DICOM transfer and etc.).
The provided text describes Canon's CXDI-60G digital radiography device, which is a solid-state X-ray imager. The 510(k) summary focuses on demonstrating substantial equivalence to its predicate device, the CXDI-50G (K031447).
Based on the provided text, the 510(k) submission primarily focuses on the technical specification changes and equivalence to an existing product, rather than a clinical study with detailed acceptance criteria and performance metrics for a new clinical application. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics is not explicitly available in the provided document.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the substantial equivalence hinges on the CXDI-60G having the "same characteristics as the CXDI-50G" for its sensor, and its "imaging principle and intended use are the same." The key change is the imaging area size.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Imaging Principle | Same as CXDI-50G |
| Sensor Characteristics | Same as CXDI-50G |
| Intended Use | Same as CXDI-50G |
| Image Capturing Performance | Achieved when paired with a general-purpose computer and designated system software (no specific metrics provided) |
| DICOM Transfer Performance | Achieved when paired with a general-purpose computer and designated system software (no specific metrics provided) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a clinical test set for performance evaluation. The submission relies on technical comparisons to its predicate device. Therefore, information on sample size, country of origin, or retrospective/prospective nature of data is not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Since no clinical test set is described, there is no information about experts or ground truth establishment.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study is not mentioned or described. The submission focuses on device equivalence, not clinical effectiveness studies with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The device described is a digital X-ray imager, a hardware component. Its performance relies on the image capture and processing capabilities that are inherent in the device and the associated software. While it operates "standalone" in the sense of capturing an image without human intervention at the moment of capture, the document doesn't provide performance metrics as a standalone algorithm for diagnostic interpretation. The focus is on the hardware's ability to produce images comparable to the predicate.
7. The Type of Ground Truth Used:
No clinical ground truth (e.g., expert consensus, pathology, outcomes data) is mentioned as being used for comparison or validation in the provided text. The "ground truth" for this 510(k) is essentially the performance and characteristics of the legally marketed predicate device, the CXDI-50G.
8. The Sample Size for the Training Set:
This information is not provided and is not applicable to this type of 510(k) submission which focuses on hardware equivalence rather than an AI/algorithmic model requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set is mentioned in the context of this device.
§ 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.