(23 days)
The DIGITAL RADIOGRAPHY CXDI-Pro / D1 provides digital image capture for conventional film/screen radiographic examinations. This device is intended to capture, for display, radiographic images of human anatomy, and to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.
The DIGITAL RADIOGRAPHY CXDI-Pro, also called the DIGITAL RADIOGRAPHY D1, (hereinafter referred to as CXDI-Pro) is a solid-state x-ray imager. The CXDI-Pro is a series of detectors, and in the predicate device consists of the CXDI-703C Wireless detector unit, also called the AR-D3543W detector. The detector intercepts x-ray photons, and the scintillator emits visible spectrum photons that illuminate an array of photodetectors that create electrical signals. After the electrical signals are generated, the signals are converted to digital values, and the images will be displayed on monitors. The digital image can be communicated to the operator console via a wired or wireless connection.
The subject of this Special 510(k) submission is a change to the CXDI-Pro add a detector, the CXDI-403C Wireless (also called AR-D4343W) to the CXDI-Pro series of detectors. In addition, a Detector Stand (DS-01) and a new Battery Charger (BC-01) have been added as optional components to be used with the proposed CXDI-Pro detectors (CXDI-703C Wireless and CXDI-403C Wireless), the sleep to ready cycle time for the proposed CXDI-Pro detectors has been decreased, and the CXDI Contro Software has been updated from V3.10.0.3 to V3.10.0.8 to add the Intelligent NR function (cleared under K212269) and apply some bug fixes. Together, these changes make up the CXDI-Pro.
Here's a breakdown of the acceptance criteria and study information for the Canon Inc. Digital Radiography CXDI-Pro / D1, based on the provided FDA 510(k) summary:
This submission (K220098) is a Special 510(k) submission, which indicates that the changes made to the device (new detector, accessories, reduced cycle time, software update) did not fundamentally alter its intended use or fundamental scientific technology. Therefore, the primary focus of the performance evaluation is to ensure that these changes do not negatively impact the device's conformance with relevant standards and do not raise new questions of safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a Special 510(k) for modifications to an already cleared device, the "acceptance criteria" are primarily related to maintaining conformance with existing performance and safety standards, rather than establishing new clinical performance targets. The reported device performance confirms that these standards are still met.
| Acceptance Criteria (related to modified aspects) | Reported Device Performance |
|---|---|
| Maintain conformance with U.S. Performance Standard for radiographic equipment. | Evaluation of the addition of the new detector (CXDI-403C Wireless) and optional accessories (Detector Stand, Battery Charger) confirmed that the changes did not impact CXDI-Pro conformance with this standard. |
| Maintain conformance with relevant voluntary safety standards for Electrical safety and Electromagnetic Compatibility (EMC), specifically IEC 60601-1, 60601-1-2, 60601-2-54, 60601-1-6, and IEC 60529. | Verification/validation activities successfully demonstrated that the device continues to meet these standards. |
| Ensure the reduction in "Sleep to Ready Cycle Time" (from 7 sec to less than 5 sec) does not compromise safety or effectiveness. | Implied: The successful verification/validation activities encompass this change, indicating it does not raise new questions of safety or effectiveness. (Specific performance data for this change beyond the stated time is not detailed, but its successful integration into the system meeting overall standards implies acceptance.) |
| Ensure the software update (V3.10.0.3 to V3.10.0.8, including Intelligent NR function K212269) and firmware update (01.00.00.03 to 01.00.02.00) do not compromise safety or effectiveness. | Implied: The software update to incorporate an already cleared feature (Intelligent NR, K212269) and bug fixes, along with the firmware update, were part of the verification/validation activities that demonstrated the device continues to meet standards and raises no new questions regarding safety or effectiveness. (Specific performance data for the software/firmware changes beyond their successful integration and bug fixes are not detailed in this summary.) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set sample size" in terms of patient images or clinical cases. The performance evaluation is described as "Verification/validation activities" which focused on technical performance and safety standards. This suggests that the testing involved:
- Engineering tests on the physical components (new detector, accessories).
- Software testing for the updated control software and firmware.
- Electromagnetic compatibility (EMC) testing.
- Electrical safety testing.
The data provenance is industrial and engineering testing, rather than clinical data from specific countries or retrospective/prospective studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable in the context of this Special 510(k). Ground truth for clinical diagnostic performance (e.g., presence/absence of disease) is not the focus of this submission. The "ground truth" here is adherence to engineering specifications and safety standards, which would be assessed by engineers and quality control personnel.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring reader adjudication of clinical findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed to demonstrate the clinical performance of a diagnostic aid, which is not the scope of this Special 510(k) submission focused on hardware/software modifications and maintaining safety/performance standards.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The document primarily describes the performance of the overall digital radiography system, which includes the detector and control software. While the software update includes an "Intelligent NR function" (cleared under K212269), this submission's performance evaluation focuses on the integrated system's safety and continued conformance, not a standalone algorithm's diagnostic performance. Its effectiveness would have been established in the K212269 submission.
7. The Type of Ground Truth Used
The ground truth used for these verification and validation activities is based on:
- Engineering specifications (for the new detector, cycle time, accessories).
- International standards (IEC 60601-1, 60601-1-2, 60601-2-54, 60601-1-6, IEC 60529).
- U.S. Performance Standard for radiographic equipment.
- Software testing protocols to verify bug fixes and the integration of the Intelligent NR function without introducing new issues.
8. The Sample Size for the Training Set
Not applicable. This submission does not describe a machine learning model being developed or trained on a dataset. The software update includes an "Intelligent NR function" which would have involved a training set in its original K212269 submission, but that information is not provided here.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set described in this 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.