(75 days)
CANON X-RAY DIGITAL CAMERA CXDI-22 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 X-ray digital camera model CXDI-22 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 provided 510(k) summary for the Canon CXDI-22 X-ray Digital Camera focuses on establishing substantial equivalence to a predicate device (Canon CXDI-11) rather than presenting a performance study with specific acceptance criteria and detailed results.
Therefore, much of the requested information regarding specific acceptance criteria, a study proving device performance, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not available in the provided text. The document primarily details the hardware specifications and intended use of the device and its predicate.
Here's a breakdown of what can be extracted and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Metric | Acceptance Criteria (Not Explicitly Stated as AC, but implied by predicate comparison) | Reported Device Performance (CXDI-22) | Basis (from comparison table) |
|---|---|---|---|
| Intended Use | Provide diagnostic images for general radiography, replacing film/screen systems. | Provide diagnostic images for general radiography with table system. Intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. | Same as predicate (CXDI-11) for diagnostic imaging purposes |
| Design | Digital acquisition, electronic processing. | Same | Same as predicate |
| Energy Usage | Receives x-radiation generated by external x-ray generator. | Same | Same as predicate |
| X-ray Absorber | Fluorescent screen ($Gd_2O_2S:TB^{3+}$), Visible emission peak: 545nm. | Same | Same as predicate |
| Sensing Means | Amorphous Silicon W/TFT Array, Detection peak: 540-620nm. | Same | Same as predicate |
| Anatomical Sites | General radiography. | Same | Same as predicate |
| Target Population | General population. | Same | Same as predicate |
| Physical Safety | Minimize exposure to x-radiation. | Same | Same as predicate |
| Compliance | Complies with IEC 601-1-2. | Same | Same as predicate |
| Biocompatibility | N/A. | N/A | Same as predicate |
| Performance | After digital processing (optimize the gray-scale). | Same | Same as predicate |
| MTF@2lp/mm | 42% (for CXDI-11). Implied acceptance criterion would be >= 42%. | 42% | Same as predicate |
| Dynamic Range | Approximately 4 digit (linear A/D : 14bit), output data : 12bit. | Same | Same as predicate |
| Key Difference | N/A (CXDI-11 operates with upright stand). | Retrofit kit for installation into an existing radiologic table. | Specific difference between the two models |
Note on Acceptance Criteria: The document implies that the CXDI-22 meets "acceptance criteria" by demonstrating that its technical characteristics are "Same" as the predicate device (CXDI-11) or by detailing the specific physical changes (e.g., sensor unit dimensions, power supply, table integration) without indicating any degradation in core imaging performance metrics like MTF or Dynamic Range. The performance metrics listed for CXDI-11 are implicitly the acceptance criteria for CXDI-22 for substantial equivalence.
2. Sample size used for the test set and the data provenance:
- Not available. The document does not describe a performance study with a specific test set. The submission is based on comparison to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not available. As there is no described test set or performance study, there is no mention of experts establishing ground truth.
4. Adjudication method for the test set:
- Not available.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. The document does not describe an MRMC comparative effectiveness study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The device itself is an image capture system; its performance metrics (MTF, dynamic range) are inherent to the hardware and are evaluated as "standalone" technical specifications rather than in a human-in-the-loop context for this type of 510(k) submission. However, a formal "standalone study" report is not provided. The comparison chart indicates that the CXDI-22 shares the "Same" performance characteristics as the predicate CXDI-11, which would have undergone similar standalone technical evaluations.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not available. For demonstrating substantial equivalence for an X-ray digital camera, the "ground truth" often refers to physical measurements of image quality (e.g., MTF, DQE) rather than clinical diagnostic accuracy against pathology or outcomes. The provided document relies on demonstrating equivalent technical specifications to a previously cleared device.
8. The sample size for the training set:
- Not applicable / Not available. This device is a hardware digital X-ray capture system, not an AI or algorithm-driven diagnostic tool in the sense of requiring a "training set" of data to learn from.
9. How the ground truth for the training set was established:
- Not applicable / Not available. Similar to point 8, this question is not relevant for this type of device and submission.
§ 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.