(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 is a series of solid-state x-ray detectors. 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 digital values are sent to the PC via wired or wireless connection, converted to images with the CXDI Control Software (CCS), then displayed on monitors. The digital value can be communicated to the operator console via wired or wireless connection.
The subject of this Special 510(k) submission is a change to the DIGITAL RADIOGRAPHY CXDI-702C Wireless and CXDI-402C Wireless to make a series of detectors including the DIGITAL RADIOGRAPHY CXDI-702C Wireless (K192632), CXDI-402C Wireless (K192632), CXDI-710C Wireless (K170332), CXDI-810C Wireless (K170332), and CXDI-410C Wireless (K171270), under the proposed device the DIGITAL RADIOGRAPHY CXDI-CS01. This change will change the Multi Box to be a Standard Component from an optional component for the detectors. The Multi Box has the functions of connecting to the X-ray generator to synchronize the X-ray exposure and photographing, supplying power to the FPD (front panel detector), communicating between the FPD and the image capture computer, connecting the status indicator to the Multi Box to turn the FPD on and off and switch to a ready state, connecting to the WLAN access point to communicate to the FPD wirelessly, and connecting to the docking station to charge the FPD and communicate between the FPD and image capture computer. These functions of the Multi Box have not changed since its clearance under the predicate device (K192632). The X-ray I/F (Interface) Unit has been removed as an optional component for the DIGITAL RADIOGRAPHY CXDI-702C Wireless and CXDI-402C Wireless as the Multi Box performs the function of the X-ray I/F Unit (connecting to the X-ray generator to synchronize the x-ray exposure and photographing). In addition, the detectors will all use the version software cleared under the DIGITAL RADIOGRAPHY CXDI-702C Wireless and CXDI-402C Wireless (K192632). Together, these changes make up the DIGITAL RADIOGRAPHY CXDI-CS01.
The provided text describes a Special 510(k) submission (K203849) for a device called "DIGITAL RADIOGRAPHY CXDI-CS01". This submission is for modifications to previously cleared devices rather than a new standalone device. Therefore, the document focuses on demonstrating that the changes do not negatively impact the device's compliance with established standards and do not raise new questions of safety or effectiveness compared to the predicate device.
The acceptance criteria are therefore related to maintaining compliance with existing performance standards and regulations rather than establishing new performance metrics. The study described is a verification/validation activity to confirm that the modifications do not affect compliance.
Here's the information extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not detail specific quantitative acceptance criteria or performance metrics for the device's diagnostic capabilities (e.g., sensitivity, specificity for detecting a disease). Instead, it focuses on demonstrating continued compliance with established standards after modifications. The "performance" section primarily shows that key technical characteristics related to image acquisition are identical to the predicate and reference devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Continued compliance with FDA requirements for Solid State X-ray Imaging Devices (Guidance for 510(k) Submissions) | Documentation was provided demonstrating that the changes to DIGITAL RADIOGRAPHY CXDI-702C Wireless and CXDI-402C Wireless do not impact the device's compliance. |
| Continued conformance with U.S. Performance Standard for radiographic equipment | Evaluation confirmed that the changes did not impact DIGITAL RADIOGRAPHY CXDI-CS01 conformance. |
| Continued conformance with relevant voluntary safety standards (IEC 60601-1, 60601-1-2, 60601-1-3, 60601-1-6, 62366, 60601-2-54, 62220-1, and 62304) | Evaluation confirmed that the changes did not impact DIGITAL RADIOGRAPHY CXDI-CS01 conformance with these standards for Electrical safety and Electromagnetic Compatibility testing. |
| No new questions regarding safety or effectiveness compared to the predicate device | Verification/validation activities successfully demonstrated that the device continues to meet the standards for the areas impacted by the device modifications to the predicate device and raises no new questions regarding either safety or effectiveness when compared to the predicate device. |
| Technological Characteristics (e.g., Scintillator, Pixel Pitch, Spatial Resolution) remain equivalent to predicate | Scintillator: CsI(Tl) [Cesium Iodide doped with Thallium] (Identical to predicate and reference devices) |
| Pixel Pitch: 125μm (Identical to predicate and reference devices) | |
| Spatial Resolution: 35% [MTF@2lp/mm] (Identical to predicate and reference devices) | |
| Indication for Use: Identical to predicate device | |
| Application: General Radiography (Identical to predicate device) | |
| Case Material: Magnesium alloy / Carbon Fiber (Identical across various models of proposed and predicate/reference devices) | |
| Software functionality (CXDI Control Software V2.19) | CXDI Control Software V2.19 (Identical to predicate device, updated from V2.16 for some reference devices) |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in terms of imaging data or patient cases. The study described is a design verification and validation process focused on the engineering and regulatory impact of changes (making the Multi Box a standard component, removing the X-ray I/F Interface as an option, and updating software). This typically involves testing the modified device against specified technical requirements and standards, not a clinical study with a patient image dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As described above, this was not a clinical study involving image interpretation with expert ground truth.
4. Adjudication method for the test set
Not applicable.
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 MRMC study was performed or described. The device is a digital radiography detector and associated software, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm for autonomous interpretation. It's an imaging capture device.
7. The type of ground truth used
Not applicable in the context of clinical diagnostic accuracy. The "ground truth" for this submission is adherence to existing regulatory requirements and technical standards.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-based device requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.