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510(k) Data Aggregation
(23 days)
The flat panel detector CSX-20 is designed to provide fluoroscopic and spot radiographic images of human anatomy during diagnostic, surgical and interventional procedures. Examples of clinical application may include angiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care and emergency room procedures or other-imaging applications at the physician's discretion. The device is intended to replace the spot-film devices. The device is also intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.
The Canon CSX-20 is a digital radiography flat panel detector that can take fluoroscopic and spot radiographic images of any part of the body. It directly converts the X-ray images captured by the sensor into high-resolution digital images. The instrument is a component of an x-ray system and as such cannot be used outside of such a system. This unit converts the X-rays into digital signals. Not intended for mammography applications.
The Canon CSX-20 is a digital radiography flat panel detector for fluoroscopic and spot radiographic images. The acceptance criteria and the study that proves the device meets the acceptance criteria are described below:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Improved spatial resolution via 16-bit A/D conversion | Achieved with 16-bit A/D conversion from 14-bit |
| Enhanced signal-to-noise ratio (S/N) | Achieved with 16-bit A/D conversion from 14-bit |
| Increased tonal precision (grayscale gradations) | Grayscale gradations quadrupled from 4096 (CSX-10) to 16384 (CSX-20) |
| Improved maximum frame rate for fluoroscopy | Maximum frame rate of 240 fps achieved |
| Safety and effectiveness | Device demonstrated to be safe and effective through performance testing, software validation, electrical safety, and electromagnetic compatibility testing. Complies with US Performance Standard for radiographic equipment. |
| Substantial equivalence to predicate device (K111824 Canon CSX-10) | Determined to be substantially equivalent based on similarities in intended use, principles of operation, functional design, and medical use. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific "test set" in terms of clinical images or patient data that would have a sample size. The testing appears to be primarily device performance testing and refers to "non-clinical/test data" and "performance testing and software validation." This suggests the test set would consist of technical measurements and functional evaluations of the device itself rather than patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Given the nature of the testing described (performance testing, software validation, electrical safety, EMC), there is no mention of a "ground truth" derived from human expert evaluation of images. The ground truth for this type of device would generally be established by engineering and technical standards.
4. Adjudication Method for the Test Set
Not applicable, as the testing described focuses on technical and performance metrics of the device rather than clinical interpretation by multiple experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was performed or is mentioned. The submission focuses on demonstrating substantial equivalence to a predicate device through technical improvements and performance testing of the device itself. There is no comparison of human reader performance with or without AI assistance.
6. Standalone Performance
The information provided describes the performance of the device (CSX-20 Flat Panel Detector) itself, rather than an algorithm. The device "directly converts the X-ray images captured by the sensor into high-resolution digital images." Its performance metrics (A/D conversion, grayscale, frame rate) relate to its standalone function as an imaging component.
7. Type of Ground Truth Used
The ground truth used for this submission is based on:
- Engineering specifications and standards: For A/D conversion, S/N, grayscale gradations, and frame rate.
- Regulatory standards: For electrical safety, electromagnetic compatibility, and compliance with the US Performance Standard for radiographic equipment.
- Functional equivalence: Comparison to the predicate device (CSX-10) based on intended use, principles of operation, and functional design.
8. Sample Size for the Training Set
Not applicable. This device is a hardware component (digital X-ray detector). The concept of a "training set" typically applies to machine learning algorithms, which are not described as part of this device. The improvements are described as hardware modifications (A/D conversion).
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" or machine learning algorithm described. The improvements are based on hardware modifications and engineering design.
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