(112 days)
DIGITAL RADIOGRAPHY CXDI-401G, CXDI-401C, CXDI-401G COMPACT and CXDI-401C COMPACT provide digital image capture for conventional film/screen radiographic examinations. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. These devices are not intended for mammography applications.
The DIGITAL RADIOGRAPHY CXD1-401G CXD1-401C, CXD1-401G COMPACT and CXDI-401C COMPACT are solid state x-ray imagers which have 41.5 x 42.6cm imaging area. The device intercents x-ray photons and the scintillator emits visible spectrum photons that illuminate an array of photo-detectors that create an electrical signals. After the electrical signals are generated, it is converted to digital value, and the images will be displayed on monitors. The CXDI-401G and CXDI-401G COMPACT use GOS (Gadolium Oxy-Sulfide) as the material for fluorescent screen, while CXDI-401C and CXDI-401C COMPACT use Csl (Cesium Iodide) which provides high x-ray absorption as fluorescent screen. The CXDI-401G COMPACT and CXDI-401C COMPACT employ housing for easy installation in stand unit and table unit.
The provided text describes a 510(k) Summary for the Canon DIGITAL RADIOGRAPHY CXDI-401G/C and COMPACT models. It outlines the device description, intended use, comparison to predicate devices, and performance testing. However, it does not contain specific information regarding device acceptance criteria, reported performance metrics, sample sizes for test sets, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, type of ground truth used, or training set details.
The document focuses on demonstrating substantial equivalence to predicate devices through electrical safety, electromagnetic compatibility, and other performance tests, but it does not provide the detailed study information requested.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is what can be inferred:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy). The implicit acceptance criteria are that the device is "safe and effective" and "equivalent to the predicate devices" based on general performance testing.
- Reported Device Performance:
- "The Electrical safety, Electromagnetic compatibility and other performance testings were performed on these devices which demonstrated that these devices are safe and effective, and are equivalent to the predicate devices."
- No specific quantitative performance metrics (e.g., image quality scores, diagnostic accuracy) are reported for the new devices or compared against predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not specified. The document only mentions "other performance testings" without detailing the nature of these tests or the data used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/not specified. The testing described appears to be technical performance testing (electrical safety, EMC) rather than diagnostic efficacy testing involving expert readers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/not specified, as diagnostic efficacy testing is not 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
- No. The device described is a digital radiography imager, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. The device is hardware (an imager), not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not specified, as diagnostic efficacy testing is not described. For electrical safety and EMC, ground truth would be established by relevant engineering standards.
8. The sample size for the training set
- Not applicable. This is a hardware device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is a hardware device, not a machine learning algorithm.
§ 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.