(14 days)
CANON DIGITAL RADIOGRAPHY CXDI-40G 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-40G 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 text is a 510(k) Summary for the Canon Digital Radiography CXDI-40G. It describes the device, its intended use, and compares it to predicate devices. However, this document does not contain information about a study proving the device meets acceptance criteria in the way typically expected for a medical device efficacy study (e.g., clinical trials, performance benchmarks against specific metrics).
Instead, the submission focuses on substantial equivalence to previously cleared predicate devices (CXDI-11 and CXDI-22). The "proof" that the CXDI-40G meets acceptance criteria is implicitly based on its technical characteristics being similar to or the same as the predicate devices, which were already deemed safe and effective.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance
The document doesn't explicitly state acceptance criteria in terms of performance thresholds for a new study. Instead, it relies on the technical specifications and performance of the predicate devices as the de facto "acceptance criteria." The new device is presented as having "Same" or comparable performance characteristics to the cleared predicate devices.
Table of Acceptance Criteria and Reported Device Performance
| Item / Acceptance Criteria (from Predicate Devices) | Reported CXDI-40G Performance |
|---|---|
| Intended Use: Provide diagnostic images for general radiography | Same |
| Energy Uses: Receives x-radiation generated by external diagnostic x-ray generator | Same |
| X-ray Absorber: Fluorescent screen (Gd2O2S:TB3+) | Same |
| Materials - Visible emission peak: 545nm | (Not explicitly stated for CXDI-40G, but implied as "Same" if the absorber is the same) |
| Sensing: Amorphous Silicon W/TFT Array, Detection peak: 540-620nm | Same |
| Anatomical Sites: General radiography | Same |
| Target Population: General population | Same |
| Physical Safety: Minimize exposure to x-radiation | Same |
| Compliance with Standard: Complies with IEC 601-1-2 | Same |
| Biocompatibility: N/A (for predicate devices) | N/A |
| Performance (Image processing): After digital processing (optimize the gray-scale) | Same |
| Labeling: Approved 510(K) (for predicate devices) | Proposed Device (seeking 510(K) approval) |
| Pixel: 2688 × 2688 pixels (7,200,000 pixels) | Same |
| Image size: 43cm x 43cm | Same |
| Pixel pitch: 160 μm | Same |
| MTF: MTF@2lp/mm 42% | Same |
| Dynamic Range: Approximately 4 digit (linear A/D: 14bit, output data: 12bit) | Same |
| Grid Type: Moving grid (CXDI-11), Removable moving grid (CXDI-22) | Stationary grid (removable) (Difference noted but considered substantially equivalent) |
| Software Version: (V4.1 for predicate devices) | V5.0 (main changes due to CXDI-40G sensor control and GUI, considered substantially equivalent) |
Study Details (Based on Substantial Equivalence Claim)
The document does not describe an independent study to "prove the device meets acceptance criteria" in a typical clinical performance study sense. Instead, the "study" is implicitly the comparison of the CXDI-40G's specifications against those of its predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable (N/A): No specific test set or clinical study data is presented. The submission relies on a descriptive comparison to predicate devices, not a new performance study with a test set of images or patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A: No test set with ground truth established by experts is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A: No test set or adjudication process is described.
5. 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
- N/A: No MRMC study was conducted or reported. This device is an imaging capture system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A: This submission is for a digital radiography capture device, not a standalone AI algorithm. Its performance is assessed through technical specifications consistent with existing radiography systems.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- N/A: No explicit ground truth data is used in this submission, as it focuses on substantial equivalence based on technical specifications and intended use. The "ground truth" for the predicate devices' performance would have been established during their respective clearance processes.
8. The sample size for the training set
- N/A: This is not an AI/machine learning device submission; therefore, there is no concept of a "training set."
9. How the ground truth for the training set was established
- N/A: No training set is involved.
Conclusion from the Document:
The Canon Digital Radiography CXDI-40G is deemed substantially equivalent to its predicate devices (CXDI-11 and CXDI-22) based on a detailed comparison of their technical characteristics (image size, pixel pitch, number of pixels, imaging principle, materials, intended use, etc.), physical characteristics, and software. The primary differences noted relate to mechanical structure, compatibility with different stands/tables, and the type of grid used, which are presented as not raising new questions of safety or effectiveness. The software update (V5.0) is also discussed, highlighting that main changes are related to controlling the CXDI-40G sensor and GUI updates, and is compared to a previously cleared version (V4.1). The FDA's letter concurs with the substantial equivalence finding based on the information 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.