(29 days)
The device is designed to perform radiographic x-ray examinations on all pediatric and adult patient treatment areas.
The DRX-Revolution Mobile X-ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. The system consists of a self-contained x-ray generator, image receptor(s), imaging display and software for acquiring medical diagnostic images outside of a standard stationary xray room. The DRX-Revolution system incorporates a flat-panel detector that can be used wirelessly for exams such as in-bed chest projections. The system can also be used to expose CR phosphor screens or films.
The Carestream DRX-Revolution Mobile X-ray System (K191025) underwent modifications compared to its predicate device (K120062). The primary changes include a different X-ray tube supplier, additional support for DRX Plus detectors, updated image acquisition software (ImageView), and a replaced high-voltage X-ray generator.
Here's an analysis of the acceptance criteria and the study proving adherence:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Image Quality Equivalency | "Results of this data demonstrated that image quality on the modified DRX-Revolution Mobile X-ray System is equivalent to the device on the market." |
| "Testing demonstrates that the modified device produces diagnostic image quality that is the same or better than the predicate." | |
| "The detectors have been tested and verified to meet the requirements for integration with the DRX-Revolution Mobile X-ray System (modified) device and the DQE/MTF data demonstrates image quality is the same as or better than the predicate." | |
| "The image quality of the modified device is at least as good as or better than that of the predicate device." | |
| Safety and Effectiveness Equivalency | "The modified DRX-Revolution Mobile X-ray System is substantially equivalent to the predicate device currently cleared on the market (K120062)." |
| "The change in X-ray tube does not significantly change the functionality of the redesigned DRX-Revolution system, nor do changes significantly affect the safety or effectiveness of the device." | |
| "The generator was verified and validated and passed all testing and demonstrates there is no significant impact on clinical functionality or performance that could significantly affect safety and effectiveness." | |
| "Risks were assessed in accordance to ISO 14971 and risk control options were implemented with safety by design principles and with a risk methodology that reduces risks as far as possible." | |
| "Results of non-clinical testing demonstrate that the modified device is as safe and as effective as the predicate device." | |
| "The subject device is expected to be safe and effective for the device indications and are substantially equivalent to the predicate." | |
| Maintenance of Intended Use | "In addition, the indications for use of the modified device, as described in labeling does not change as a result of the device modification(s)." |
| "The intended use remains unchanged." | |
| Fundamental Scientific Technology Equivalency | "The modified DRX-Revolution employs the same fundamental scientific technology as the predicate device." |
| "The fundamental scientific technology of the modified device is the same and is substantially equivalent to the predicate." | |
| Hardware Components Functionality (e.g., X-ray tube) | "The change in X-ray tube does not significantly change the functionality of the redesigned DRX-Revolution system, nor do changes significantly affect the safety or effectiveness of the device." |
| Detector Integration and Performance | "The detectors have been tested and verified to meet the requirements for integration with the DRX-Revolution Mobile X-ray System (modified) device and the DQE/MTF data demonstrates image quality is the same as or better than the predicate." |
| Software Functionality (ImageView) | "No changes have been made between the DRX Carestream Evolution with ImageView (K163203) and the subject device with ImageView, other than some minor changes necessary for the software to function on the subject device. The image processing between the two devices is the same. This change has no clinical impact on image diagnosis, bench testing data demonstrates substantial equivalence." |
| Generator Performance | "The High-voltage X-ray generator has been replaced. This generator is considered a 1:1 replacement, there was no change in performance specifications. The generator was verified and validated and passed all testing and demonstrates there is no significant impact on clinical functionality or performance that could significantly affect safety and effectiveness." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of images or cases. The document mentions a "Phantom Imaging study."
- Data Provenance: The study was a "Phantom Imaging study," which implies the use of test phantoms rather than real patient data. This is typically done in a controlled laboratory environment. The country of origin is not specified but given Carestream's location (Rochester, New York), it is likely the US. The study type is retrospective, as it's bench testing to compare a modified device to an already marketed predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. As the study was a non-clinical "phantom imaging study" evaluating technical image quality attributes, it might not have involved human expert readers establishing diagnostic ground truth in the traditional sense. The evaluation likely relied on quantitative measurements of image quality metrics.
4. Adjudication method for the test set:
- This information is not provided as the study was a phantom imaging study focusing on technical image quality. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies with human readers interpreting medical images.
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, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical testing was not required to establish substantial equivalence. Bench testing was sufficient to assess the device safety and effectiveness." This device is a mobile X-ray system, not an AI-powered diagnostic software.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, in a sense, a "standalone" evaluation of the device's image quality was performed through the "Phantom Imaging study" and DQE/MTF data. This tested the device's inherent capability to produce images without direct human interpretation for diagnostic purposes, focusing on technical image quality attributes rather than diagnostic accuracy.
7. The type of ground truth used:
- The ground truth used was based on technical image quality attributes such as detail, sharpness, noise, and appearance of artifacts, as evaluated through a "Phantom Imaging study" and by DQE/MTF data. This is an objective technical assessment against established metrics for image quality, rather than a clinical ground truth like pathology or expert consensus on a diagnosis.
8. The sample size for the training set:
- This information is not applicable/not provided. This device is a hardware X-ray system with standard image processing software, not an AI/Machine Learning algorithm that undergoes a "training" phase with a large dataset. The "ImageView" software is a web-based application to improve usability, and its image processing is stated to be the same as previously cleared versions.
9. How the ground truth for the training set was established:
- This information is not applicable/not provided for the same reasons as point 8.
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.