(26 days)
The DIGITAL RADIOGRAPHY CXDI-CS01 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-CS01 (hereinafter referred to as CXDI-CS01) is a solid-state x-ray imager. The CXDI-CS01 is a series of detectors and, in the predicate device submission (K222661), consists of the CXDI-702C Wireless, CXDI-402C Wireless, CXDI-710C Wireless, CXDI-810C Wireless, CXDI-410C Wireless, DIGITAL RADIOGRAPHY CXDI-Pro (CXDI-703C Wireless and CXDI-403C Wireless), and DIGITAL RADIOGRAPHY CXDI-Elite (CXDI-720C Wireless). The CXDI-CS01 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. The digital values are sent to the PC via a wired or wireless connection, converted to images with the CXDI Control Software, and then displayed on the PC/monitors. The PC/monitors used with the CXDI-CS01 are not a part of this submission. The subject of this Special 510(k) submission is the changes to the predicate CXDI-CS01, which include the addition of the DIGITAL RADIOGRAPHY CXDI-Pro detector (CXDI-803C Wireless) and the DIGITAL RADIOGRAPHY CXDI-Elite detectors (CXDI-820C Wireless and CXDI-420C Wireless) to the CXDI-CS01 series of detectors, a firmware update of the DIGITAL RADIOGRAPHY CXDI-Pro and DIGITAL RADIOGRAPHY CXDI-Elite detectors from 01.01.03.00 to 01.02.00.01 and from F2.00.03.00 to 02.01.04.00 respectively, and a CXDI Control Software version update from V3.10.2.2 to V3.10.2.6 to fix bugs. Together, these changes make up the CXDI-CS01.
Here's a breakdown of the acceptance criteria and study information for the DIGITAL RADIOGRAPHY CXDI-CS01, based on the provided FDA 510(k) summary:
This device (DIGITAL RADIOGRAPHY CXDI-CS01) is a digital X-ray imager, and this 510(k) submission (K230175) is a Special 510(k) for changes to a previously cleared predicate device (K222661). The changes primarily involve adding new detectors and a firmware update, along with a minor software bug fix. Therefore, the information related to clinical studies and ground truth establishment will be limited, as determined by the FDA's decision that clinical testing was "not necessary" due to the minor nature of the changes and the device's substantial equivalence to the predicate. Most of the "performance" described here relates to engineering and regulatory compliance rather than clinical diagnostic accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a Special 510(k) for minor changes and not a novel device requiring extensive clinical performance validation, the "acceptance criteria" are primarily related to maintaining or demonstrating equivalence in technical specifications and adherence to safety and performance standards. The document primarily focuses on demonstrating that the changes do not negatively impact safety or effectiveness.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance | Comments |
|---|---|---|---|
| Technological Equivalence | Similarity in components and software version compared to predicate. | Addition of CXDI-803C Wireless, CXDI-820C Wireless, and CXDI-420C Wireless detectors. Firmware update (01.01.03.00 to 01.02.00.01 for Pro; F2.00.03.00 to 02.01.04.00 for Elite). CXDI Control Software updated from V3.10.2.2 to V3.10.2.6 (bug fix). | The core technology (scintillator, pixel pitch, spatial resolution, DQE, wireless communication, photographing mode) remains identical or equivalent to the predicate for comparable detectors. |
| Safety Standards Adherence | Conformance with U.S. Performance Standard for radiographic equipment and relevant voluntary safety standards. | Confirmed conformance with IEC standards 60601-1, 60601-1-2, 60601-1-3, 60601-1-6, 60601-2-54, 62220-1, 62304, and 62366. | "Evaluation of the addition of the new detectors confirmed that the change did not impact the conformance..." |
| Biocompatibility | Device materials meet biocompatibility requirements. | Biocompatibility evaluation successfully demonstrated no new questions regarding safety or effectiveness. | Assessed based on modifications to the predicate. |
| Intended Use | Maintain the same indications for use as the predicate device. | The proposed indications for use statement is identical to the predicate: "digital image capture for conventional film/screen radiographic examinations... to capture, for display, radiographic images of human anatomy, and to replace radiographic film/screen systems in all general purpose diagnostic procedures. Not intended for mammography applications." | Crucial for establishing substantial equivalence. |
| Performance (Bench Testing) | Device works as intended after modifications. | Adequate detector bench testing conducted to support determination of substantial equivalence. | This is the primary method of validation for this Special 510(k). The document states: "Adequate detector bench testing should be sufficient to demonstrate that the subject detector, CXDI-CS01, works as intended." |
| Guidance Document Compliance | Follow applicable FDA guidance documents. | Followed "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices," "Guidance for the Content of Premarket Submissions for Software contained in Medical Devices," "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices," "Use of International Standard ISO 10993-1," "Radio Frequency Wireless Technology in Medical Devices," and "Pediatric Information for X-ray Imaging Device Premarket Notifications." | Demonstrates thoroughness in regulatory compliance. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Clinical testing is not necessary for the current submission, based on the minor differences from the predicate device." Therefore, there is no explicit clinical "test set" in the traditional sense of human patient data for diagnostic accuracy evaluation.
The "test set" for this submission refers to the detectors and software changes themselves, and the testing performed was primarily "detector bench testing" and evaluations against engineering and regulatory standards.
- Sample Size for Test Set: Not applicable in the context of clinical images or patient data. The "sample" would be the specific new detector models (CXDI-803C Wireless, CXDI-820C Wireless, CXDI-420C Wireless) and the updated firmware/software.
- Data Provenance: Not applicable for a clinical test set. The validation data would come from internal Canon testing (bench testing, engineering tests) to ensure the new components perform as expected and meet regulatory standards. This is typically prospective in nature, as new components are being evaluated for the first time. The manufacturing origin is Japan (Canon Inc., Japan).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. Since no clinical testing with patient images was deemed necessary, no experts (like radiologists) were used for establishing ground truth on a clinical test set. The "ground truth" for this submission relates to the functional and safety performance of the hardware and software, established through engineering validation and adherence to technical standards.
4. Adjudication Method for the Test Set
Not applicable. No clinical case review requiring adjudication by multiple experts was performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. The submission explicitly states "Clinical testing is not necessary." This type of study would be performed to evaluate the human-in-the-loop performance of an AI-assisted device, which is not the nature of this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the device itself is a digital radiography system (which essentially is a standalone imaging algorithm/device), there isn't a separate "AI algorithm" being evaluated independently in this submission. The device's performance is fundamental to its imaging capabilities, not an additional AI feature. The "performance" assessment focuses on the image quality metrics and safety standards of the detector and its processing, which are inherent to its "standalone" operation as an X-ray imager.
7. The Type of Ground Truth Used
The "ground truth" for this submission is:
- Engineering Specifications and Performance Standards: The device's performance (e.g., spatial resolution, DQE, IP level, wireless communication) is measured against predetermined technical specifications and international standards (IEC).
- Predicate Device Equivalence: The primary "ground truth" for this Special 510(k) is the demonstrated safety and effectiveness of the previously cleared predicate device (K222661). The new submission aims to prove that the changes do not alter this established equivalence.
8. The Sample Size for the Training Set
Not applicable. This device is a digital X-ray detector and associated software, not an AI model that requires a "training set" of medical images in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for an AI model 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.