(17 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 (K220098) 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 subject of this Special 510(k) submission is a change to the predicate device, including compatibility with the Multi Box and Status Indicator, DIGITAL RADIOGRAPHY CXDI-Elite components that were cleared under K213780. The Status Indicator can be used when the proposed device is used in combination with the Multi Box. In addition, the CXDI Control Software has been updated from V3.10.0.8 to V3.10.2.2 to fix some bugs. Together, these changes make up the CXDI-Pro.
Based on the provided text, the device in question, DIGITAL RADIOGRAPHY CXDI-Pro / D1, is a digital radiography system, and the submission (K221876) is a Special 510(k). This means the submission focuses on modifications to an already cleared predicate device (K220098) rather than a completely new device. Therefore, the clinical testing section is deemed "not necessary" due to "minor differences from the predicate device."
This significantly limits the type of performance study and acceptance criteria information available. Special 510(k) submissions typically rely heavily on non-clinical bench testing and verification/validation activities to demonstrate that changes do not adversely affect safety or effectiveness, rather than large-scale clinical trials measuring diagnostic accuracy.
Here's an analysis based on the constraint that "clinical testing is not necessary" for this specific submission:
1. A table of acceptance criteria and the reported device performance:
Since clinical testing was not performed for this submission, there are no acceptance criteria related to diagnostic accuracy or human-in-the-loop performance. The acceptance criteria and performance reported are focused on demonstrating that the modifications (addition of Multi Box and Status Indicator, software update, and firmware update) do not negatively impact the fundamental scientific technology and existing safety/performance standards of the predicate device.
| Acceptance Criteria Category | Specific Acceptance Criteria (from text) | Reported Device Performance / Evaluation (from text) |
|---|---|---|
| Safety & Electrical Performance | Conformance with U.S. Performance Standard for radiographic equipment. | Evaluation confirmed changes did not impact conformance. |
| Conformance with relevant voluntary safety standards for Electrical safety (IEC 60601-1). | Evaluation confirmed changes did not impact conformance. | |
| Electromagnetic Compatibility (EMC) | Conformance with relevant voluntary safety standards for Electromagnetic Compatibility (IEC 60601-1-2). | Evaluation confirmed changes did not impact conformance. |
| Usability / Software Lifecycle | Conformance with IEC 60601-1-6 (Usability). (Implied by software update context) | Verification/validation activities demonstrated the device continues to meet standards. |
| X-ray Imaging Equipment | Conformance with IEC 60601-2-54 (X-ray equipment for radiography and radioscopy). | Evaluation confirmed changes did not impact conformance. |
| Software Functionality | CXDI Control Software V3.10.2.2 fixes previous bugs (from V3.10.0.8). | Verification/validation activities demonstrated the CXDI-Pro works as intended with the updated software. |
| Bio-compatibility | Conformance with ISO 10993-1 for biological evaluation. | Follows applicable elements of ISO 10993-1. |
| Overall Equivalence | No new questions regarding safety or effectiveness compared to the predicate device. | Verification/validation activities support a determination of substantial equivalence. |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document explicitly states: "Clinical testing is not necessary for the current submission, based on the minor differences from the predicate device. Adequate verification and validation activities should be sufficient to demonstrate that the CXDI-Pro works as intended."
Therefore, there is no human patient "test set" or related sample size or data provenance information. The "test set" here refers to the bench tests and engineering validations performed on the device and its components to ensure compliance with the mentioned technical standards and functionality.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as human clinical evaluation or ground truth adjudication by experts (e.g., radiologists) for diagnostic performance was not part of this "Special 510(k)" submission. The "ground truth" for the non-clinical tests would be established through engineering specifications, calibration standards, and regulatory requirements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as there was no test set requiring human expert adjudication for diagnostic performance.
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 done. This device is a digital radiography system; the submission focuses on hardware and software updates to the imaging system itself, not an AI feature that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No standalone performance evaluation of a diagnostic algorithm was done. This is a review of a general-purpose digital X-ray system, not an AI diagnostic algorithm. The software update mentioned is for the CXDI Control Software, which governs the imaging process and display, not for an AI interpretation algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this submission's evaluation is based on engineering specifications, regulatory standards (e.g., IEC 60601 series, U.S. Performance Standard for radiographic equipment), and the performance characteristics of the predicate device. It's not clinical ground truth (like pathology or patient outcomes) because clinical testing was not required.
8. The sample size for the training set:
Not applicable. This submission is for modifications to a general radiography system, not for an AI algorithm. There is no "training set" 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 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.