(175 days)
The RADMAX Digital Imaging Software, used together with a digital X-ray image processing system designed for acquiring images and processing acquired images. The main features of the software are controlling and interfacing the detector, acquiring images after X-ray, storing acquired images, managing data, and image processing. The RADMAX Digital Imaging Software, is not intended for the acquisition of mammographic image data.
The X-ray generator is not part of the RADMAX Digital Imaging Software, device.
If the X-ray generator does not allow interfacing with external software the RADMAX Digital Imaging Software device cannot be interfaced with X-ray Generator.
However, when using third-party generator, use the AED function to acquire the image by sensing the X-ray photon. When using the DRGEM Corporation, generator (models GXR, GXR-U), the RADMAX Digital Imaging Software can only select or change values of X-ray exposure parameters (kVP, mAs or kVP, mA or density).
The RADMAX Digital Imaging Software from DRGEM Corporation, is a digital Xray image processing system designed for acquiring images and processing acquired images. The software can be used together with a digital X-ray detector and or an X-Ray generator. The main features of the software are controlling and interfacing the detector, acquiring images after X-ray, storing acquired images, managing data, and image processing.
The X-ray generator or digital detector is not part of the RADMAX Digital lmaging Software, device. The RADMAX Digital Imaging Software does not control exposure or electrical charge and X-ray calibration. If the X-ray generator does not allow interfacing with external software like the RADMAX Digital Imaging Software device, then the software cannot be interfaced with X-ray Generator. The RADMAX Digital Imaging Software can only select or change values of X-ray exposure parameters (KVp. mA second or kVp. mAs) according to the defined value determined by each X-ray company.
The RADMAX Digital Imaging Software, is not intended for the acquisition of mammographic image data.
The RADMAX Digital Imaging Software device is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel only. The Users must be qualified to create and diagnose radiological image data.
The main functions of the RADMAX Imaging Software are as follows:
- . Acquisition and storage of digital X-ray images from a digital X-ray Detector.
- Input Study information (patient information, exam information). .
- . Management of stored (archived) images.
- Image processing for enhancement of archived images. ●
- Review of stored images. ●
- Editing of images. ●
- DICOM conformance (e.g. DICOM Storage, DICOM Work list, DICOM Print, etc.) ●
- For a DR system (X-ray machine and generator and Digital X-rav detector, etc.) or a need to interface with installed X-ray system, the:
- Ability to configure X-ray exposure condition (kVp, mA, Sec etc) for various body parts and positions.
- -Communication between the Generator Console and the RADMAX device.
The X-ray generator control function depends on the X-ray Generator company. The X-ray generator is not part of the RADMAX Digital Imaging Software device since the RADMAX device can only interface and control the Generator by the algorithm provided by the X-ray Company. The RADMAX device can only select or change values of X-ray exposure parameters (kVp, mA second or kVp; mAs) according to the defined value determined by each X-ray company.
The RADMAX Digital Imaging Software, device does not control exposure or electrical charge and or calibration of the X-ray equipment. If the X-ray generator does not allow interfacing with an external software like the RADMAX Imaging Software, then RADMAX, cannot be interfaced with the X-rav Generator.
The provided text describes the RADMAX Digital Imaging Software, focusing on its substantial equivalence to a predicate device (K123650: ARIX RAD ACQUISITION CONSOLE). Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a formal table of quantitative acceptance criteria with reported numerical performance values in the way a diagnostic AI would. Instead, it uses a comparative table to demonstrate "substantial equivalence" to a predicate device (K123650: ARIX RAD ACQUISITION CONSOLE) across various functionalities. The "acceptance criteria" here are essentially that the new device's functionality must be "Same" or, if "different," must have "No impact on safety or efficacy" and "no new potential or increased safety risks."
| Item | Functionality | Subject Device: RADMAX Digital Imaging Software | Predicate K123650 ARIX RAD Acquisition Console | If different, Impact on Safety and or Efficacy | Reported Device Performance (as per document) |
|---|---|---|---|---|---|
| 1 | Computer & Operating System | Microsoft Windows 10 (minimum) | Microsoft Windows XP/Windows 7 (minimum) | Yes, there is a difference. Differences are in the processor speeds, Windows operating system, amount of RAM memory, monitors, and hard drive space requirements. These differences are due to the state of computer technology that was available at the time the predicate device was developed. There is "No impact on safety or efficacy" and there are no new potential or increased safety risks. | Meets modern OS requirements; deemed equivalent in safety/efficacy |
| 2 | Intended use | Acquiring, viewing, editing and storing radiographs and related patient images | Same | No difference | Same as predicate |
| 3 | Intended user | radiologist | radiologist | No difference | Same as predicate |
| 4 | Network | 10/100/100 Ethernet | Same | No difference | Same as predicate |
| 5 | Monitor | Two color display adaptors 1920x1080 | 19-inch monitor using 1280x1024 | Yes, there is a difference. See item 1 above. | Meets modern display requirements; deemed equivalent in safety/efficacy |
| 6 | User interaction/input | Mouse, keyboard, touch monitor | Same | No difference | Same as predicate |
| 7 | Multi-user | Available, but at a time, only one user can use it | Same | No difference | Same as predicate |
| 8 | Import / export images | Yes | Yes | No difference | Same as predicate |
| 9 | Acquisition devices | Digital X-Ray detectors | Digital X-Ray detectors | No difference | Same as predicate |
| 10 | Imaging interfaces | Detector dependent | Detector dependent | Yes, there is a difference. Subject device uses Flat panel detectors cleared by FDA: K171138, & K172951 | Compatible with modern FDA-cleared flat panel detectors; deemed equivalent in safety/efficacy |
| 11 | Image organization | Yes. Patient ID, Name, study instance UID | Same | No difference | Same as predicate |
| 12 | Image search available | Yes | Yes | No difference | Same as predicate |
| 13 | Image storage | Yes | Yes | No difference | Same as predicate |
| 14 | Database software | MySQL | MySQL | No difference | Same as predicate |
| 15 | Image viewing | Yes | Yes | No difference | Same as predicate |
| 16 | Image measurement | Yes | Yes | No difference | Same as predicate |
| 17 | Image annotation | Yes | Yes | No difference | Same as predicate |
| 18 | Image operations | Yes | Yes | No difference | Same as predicate |
| 19 | Security | Yes (Priority by user) | Same | No difference | Same as predicate |
| 20 | DICOM 3.0 compatibility | Yes | Yes | No difference | Same as predicate |
| 21 | Generator Control | Yes | Yes | No difference | Same as predicate |
| 22 | Generator Control Protocol | Generator dependent | Generator dependent | No difference | Same as predicate |
| 23 | RAW Image data processing | Yes | Yes | No difference | Same as predicate |
| 24 | Post image data processing | Yes | Yes | No difference | Same as predicate |
| 25 | RIS code manager | Yes | Yes | No difference | Same as predicate |
| 26 | Worklist | Yes | Yes | No difference | Same as predicate |
| 27 | Patient size/Laterality | Yes | Yes | No difference | Same as predicate |
| 28 | Display radiographic technique, kV, mA, ms, mAs | Yes | Yes | No difference | Same as predicate |
| 29 | Thumbnail viewing | Yes | Yes | No difference | Same as predicate |
| 30 | Login | Yes | Yes | No difference | Same as predicate |
| 31 | New patient manual register | Yes | Yes | No difference | Same as predicate |
| 32 | X-Ray generator window | Yes | Yes | No differences | Same as predicate |
| 33 | Bucky selection | Yes | Yes | No difference | Same as predicate |
| 34 | Body part | Yes | Yes | No difference | Same as predicate |
| 35 | Generator status display | Yes | Yes | No difference | Same as predicate |
| 36 | Image reset | Yes | Yes | No difference | Same as predicate |
| 37 | panning | Yes | Yes | No difference | Same as predicate |
| 38 | Magnify glass | Yes | Yes | No difference | Same as predicate |
| 39 | Fit image | Yes | Yes | No difference | Same as predicate |
| 40 | Image Stitching | Yes | Yes | No difference | Same as predicate |
| 41 | Series/Image list | Yes | Yes | No difference | Same as predicate |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "nonclinical testing results are provided in the 510(k)" and that "The Validation Test Plan was designed to evaluate all input functions, output functions, and actions performed by the RADMAX Digital Imaging Software and followed the process documented in the System Validation Test Plan." However, it does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective) for any testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The device functionality is primarily compared against a predicate device based on technical specifications rather than diagnostic performance against clinical ground truth.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method like 2+1 or 3+1. The testing appears to be focused on system validation and functionality comparison, not on inter-rater agreement for diagnostic interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No MRMC comparative effectiveness study was mentioned in the provided text. The document focuses on demonstrating substantial equivalence in features and functionality, not on how the software improves human reader performance or diagnostic accuracy.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
The document explicitly states: "Diagnosis is not performed by the software but by Radiologists, Clinicians and or referring Physicians." This indicates the device is not a standalone diagnostic algorithm; it's an imaging software for acquisition, processing, and management. Therefore, a standalone performance study as typically understood for an AI diagnostic algorithm was not performed or applicable in this context.
7. The Type of Ground Truth Used:
Given that the device is primarily a software for image acquisition, processing, and management, the "ground truth" for its validation appears to be functional correctness and adherence to technical specifications rather than clinical ground truth (like pathology results or physician consensus on a diagnosis). The "predetermined acceptance criteria" mentioned in the nonclinical testing section would likely relate to whether the software performs its intended functions as designed (e.g., correct image acquisition, storage, processing, display of controls).
8. The Sample Size for the Training Set:
The document does not mention any training set size. This is consistent with the device being a general imaging software rather than a machine learning or AI-driven diagnostic tool that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Since there's no mention of a training set, there's no information on how its ground truth would have been established.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).