(26 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 submission (K221876) consists of the CXDI-703C Wireless and CXDI-403C Wireless detectors, also called the AR-D3543W and AR-D4343W detectors respectively. The detectors intercept 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-Pro are not a part of this submission. The proposed changes to the predicate device, CXDI-Pro, includes the addition of the new detector, CXDI-803C Wireless (also called the AR-D2735W) to the CXDI-Pro series; a firmware update from 01.01.03.00 to 01.02.00.01; and a CXDI Control Software version update from 3.10.2.2 to 3.10.2.6. The new detector, CXDI-803C Wireless, which differs in pixel count, imaging area, external dimensions, and weight, has the same image performance as the predicate detectors. None of the CXDI-Pro detectors have any dynamic functions (such as fluoroscopy).
Here's a breakdown of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical "acceptance criteria" in the format of a table with thresholds and corresponding performance values. Instead, it focuses on demonstrating substantial equivalence to a predicate device by comparing technological characteristics and ensuring continued conformance with safety and performance standards.
The closest to "reported device performance" are the shared technical specifications and the statement that the new detector has the "same image performance as the predicate detectors."
| Characteristic / Standard | Acceptance/Conformance Statement (Implied Criteria) | Reported Device Performance |
|---|---|---|
| Intended Use | Identical to predicate device: Digital image capture for conventional film/screen radiographic examinations, displaying radiographic images of human anatomy, replacing film/screen systems in all general diagnostic procedures (excluding mammography). | The proposed device's Indications for Use are identical to the predicate device. |
| Functional Design | Substantially equivalent to predicate device. | The flat panel detector units are functionally the same, using the same components. The fundamental scientific technology has not been modified. |
| Device Components | Primarily identical, with specific modifications in detector model additions and firmware/software updates not impacting safety or effectiveness. | Proposed Device: CXDI-703C, CXDI-803C (NEW), CXDI-403C Wireless detectors. CXDI Control Software V3.10.2.6. Detector Firmware V01.02.00.01. |
| Predicate Device: CXDI-703C, CXDI-403C Wireless detectors. CXDI Control Software V3.10.2.2. Detector Firmware V01.01.03.00. (The table lists the predicate as also having CXDI-803C, implying it was part of the earlier submission, but the text states the addition of 803C.) | ||
| Image Performance | Same as predicate detectors. | The new detector, CXDI-803C Wireless, has the same image performance as the predicate detectors. |
| Safety Standards | Conformance with U.S. Performance Standard for radiographic equipment and relevant voluntary safety standards for Electrical safety and Electromagnetic Compatibility testing (specifically IEC 60601-1, 60601-1-2, 60601-1-6, and 60601-2-54). Changes did not impact conformance and raised no new questions regarding safety or effectiveness. | Evaluation and verification/validation activities successfully demonstrated that the device continues to meet the standards for areas impacted by modifications. |
| Cybersecurity | Conformance with "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" guidance. | Not explicitly detailed, but stated as followed for applicable guidance documents. |
| Wireless Technology | Conformance with "Radio Frequency Wireless Technology in Medical Devices" guidance. | Not explicitly detailed, but stated as followed for applicable guidance documents. |
| Mechanical/Electrical | Conformance with "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices" guidance. | Not explicitly detailed, but stated as followed for applicable guidance documents. |
2. Sample size used for the test set and the data provenance
The document states: "Adequate detector bench testing should be sufficient to demonstrate that the subject detector. CXDI-Pro, works as intended."
It also mentions "verification/validation activities" which included "detector bench testing."
- Sample Size for Test Set: Not explicitly stated in terms of number of images or cases. The testing appears to be primarily at the component level (detector, firmware, software) through bench testing and conformance to standards, rather than a clinical study with a specific number of patient cases.
- Data Provenance: Not specified, but given the nature of "bench testing" and "conformance with U.S. Performance Standard," it would likely involve laboratory test data and manufactured test images, rather than patient data from specific countries. This is a "Special 510(k) Submission" for modifications, so extensive new clinical data is often not required if substantial equivalence can be demonstrated through non-clinical means.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was a non-clinical submission focused on technical equivalency, safety, and performance standards. There was no clinical ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This was a non-clinical submission; no adjudication method for a clinical test set was required or mentioned.
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 detector system, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study regarding human reader improvement with AI assistance is not relevant or reported.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is a hardware component (detector) and associated software/firmware for image acquisition and display, not an algorithm providing a standalone diagnostic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For this specific submission, the "ground truth" was established against technical specifications, engineering performance metrics (e.g., MTF, DQE), and conformance to internationally recognized safety and performance standards (e.g., IEC 60601 series). There was no clinical ground truth (expert consensus, pathology, outcomes data) as this was a non-clinical submission for device modifications.
8. The sample size for the training set
Not applicable. This device is a diagnostic imaging system component, not a machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. There was no training set for 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.