(131 days)
The Examion X-AQS™ software, used together with a digital X-ray detector is 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, optimizing window level and width of acquired images, rotating images, measuring images and other features used for imaging processing. The Examion X-AQS™ system is compatible with the DICOM 3.x communications standard. It can transfer images processed in PACS and print images with a film printer compatible with DICOM 3.x by using DICOM and network systems. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a monitor that meets technical specification identified by FDA. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, and medical technicians. Contraindications: Examion X-AQS™ is not intended for creation of fluoroscopic/ radioscopic. or angiographic images. The main functions of the Examion X-AQS™ system are: a) Acquisition and storage of digital X-ray images from a digital X-ray Detector, b) Input Study information (natient information, exam information), c) Management of stored (archived) images, d) Image processing for enhancement of archived images, e) Review of stored images, f) Editing of images, g) DICOM conformance (e.g. DICOM Storage, DICOM Work list, DICOM Print, etc.), h) For a DR system (X-ray machine and generator and Digital X-ray 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 Generator Console and Examion X-AQS™. The X-ray generator control function depends on the X-ray Generator company. The X-ray generator is not part of the Examion X-AQS™ system since the Examion X-AQS™ system can only interface and control the Generator by the algorithm provided by the X-ray Company. The Examion X-AQS™ system 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-rav company. The Examion X-AQS™ system does not control exposure and electrical charge and calibration X-ray. If the X-ray generator does not allow interfacing with external software the Examion X-AQS™ software cannot be interfaced with X-ray Generator.
The EXAMION X-AQS system is an enterprise Picture Archiving and Communications System (PACS) used to handle DICOM digital medical images and other associated data. The system enables the receipt of DICOM images from various imaging devices (modalities) like CT, MRT, US DICOM and enables their storage, retrieval, distribution, image manipulation and examination for diagnostic purposes, annotation and report generation The EXAMION X-AQS software system is customizable and scalable to meet various enterprise functional and size requirements. It is a standard based system Integrating the Health Enterprise (IHE) profiles. Digital Imaging and Communications in Medicine (DICOM). Joint Photographic Expert Group (JPEG) and Health Level Seven (HL-7) protocol standards for managing digital medical images as well as patient data. The EXAMION X-AQS supports all types of diagnostic radiographic images, mammography, endoscopy and multi-frame studies. The EXAMION X-AQS console comprise of two major components: - . EXAMION X-AQS PACS Server: A server receives image data in DICOM format from archives, modalities and workstations via universal connections via the hospital network. EXAMION X-AQS PACS Server provides archiving for short term and long term archive. The system provider has to take own appropriate means like redundancy for safety against data loss. - . EXAMION X-AQS PACS Viewer: Client server system that is used to view, edit, manipulate, annotate, and analyze imaqe that are stored on EXAMION X-AQS PACS server. All acquired image data is preserved in the format in which it is received. Changes may be made to the presentation of the image. These changes are saved as a display definition (Presentation states) only and do not alter the acquired image pixel data. All display definitions can be reversed to the original state at any time System interfaces The EXAMION X-AQS software acts in two different ways based on the application. Firstly, as EXAMION X-AQS PACS system involves the interaction between various input devices like RIS work station, diagnostic station (or monitors) or Twain scanner documentation, US grabber, Digitizer CR and DR or any DICOM device and output device. Secondly as a standalone acquisition station which receives images from 3rd party RIS work station and sends to 3rd party PACS systems. The following block diagrams showing the major components of the larger system and interconnections that may be helpful to understand the Examion X-AQS in detail
This document is a 510(k) Premarket Notification for the Examion X-AQS™ system, a Picture Archiving and Communications System (PACS) software. The purpose of this submission is to demonstrate substantial equivalence to a legally marketed predicate device, not to provide evidence of a new clinical claim or an AI algorithm's performance in diagnostic tasks.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML algorithm's diagnostic performance.
Specifically:
- A table of acceptance criteria and the reported device performance: This document does not present a table of quantitative performance metrics for a diagnostic task or an AI algorithm. Its acceptance criteria are based on functional equivalence to a predicate PACS system and compliance with standards.
- Sample sizes used for the test set and the data provenance: Not applicable, as no diagnostic performance study for an AI/ML algorithm is described. The document mentions "testing" of the complete system configuration at the factory, but this refers to functional testing, not a clinical performance evaluation on a test set of medical images.
- Number of experts used to establish the ground truth... and their qualifications: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done...: Not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
What the document does provide:
- Device Description: The Examion X-AQS™ is a PACS software system used for acquiring, storing, retrieving, processing, manipulating, and displaying digital medical images (DICOM). It interfaces with various imaging devices (like digital X-ray detectors) and other hospital systems (RIS).
- Intended Use: The software, together with a digital X-ray detector, is a digital X-ray image processing system. It enables image acquisition, storage, management, processing (e.g., window/level, rotation, zooming, measurement), and review. It's compatible with DICOM 3.x.
- Users: Trained professionals, e.g., physicians, radiologists, nurses, and medical technicians.
- Predicate Device: ARIX RAD ACQUISITION CONSOLE (K123650).
- Demonstration of Substantial Equivalence: The submission primarily focuses on showing that the Examion X-AQS™ has substantially equivalent technological characteristics and intended use to its predicate device. This is done through a comparison table (pages 5-6) highlighting features and functions. The key difference noted is that the subject device "only uses Digital X-Ray detectors to acquire images" compared to the predicate's use of Computed Radiography and Digital X-ray detectors.
- Testing: The document states, "The complete system configuration has been tested at the factory and the device has passed all in-house pre-determined testing criteria without significant failures." This refers to functional and performance testing of the software system, not a clinical study to prove diagnostic accuracy of an AI component.
- Conclusion: The submission contains "adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device." The "Level of Concern for potential hazards has been classified as 'Moderate'."
In summary, this submission is for a PACS system, not a diagnostic AI algorithm. Therefore, the detailed performance metrics and study designs typically required for AI/ML-driven diagnostic devices are not present in this document.
§ 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).