(51 days)
dicomPACS® is a software system for the administration, archiving, improvement and compression of medical image data for diagnosis. The images are either acquired from imaging modalities via DICOM or imported directly. All images are archived in a database as DICOM compliant files. The data is displayed on a computer monitor for diagnosis. dicomPACS® also provides services for administering the data.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.
Functions to be carried out using dicomPACS® are, for example, but not limited to, adjustment of window leveling, rotation, zoom, and measurements.
dicomPACS® is meant to be used by qualified medical personnel only. All users must be qualified to create and diagnose radiological image data.
dicomPACS® is a Picture Archiving and Communications System (PACS), as are the two Predicate Devices HIPAX and eFilm. All of them have been developed to acquire, store, communicate, display and process medical images, for example X-ray, CR, CT, MRI, and ultrasound images etc. They offer features (e.g. window levelling, zoom, measurements, annotations etc.) routinely used by medical professionals, such as radiologists and orthopaedists, and required of all PACS solutions.
dicomPACS® has a modular system architecture. It consists of the basic application dicomPACS-Viewer for image viewing and processing, the dicomControlCenter as application for image storage and communication and a number of other modules for database management, image acquisition, printing etc.
dicomPACS® conforms to the DICOM (Digital Imaging and Communications in Medicine) standard.
dicomPACS® is an autonomous software and involves no hardware.
The provided text is a 510(k) summary for the dicomPACS® device, a Picture Archiving and Communications System (PACS). While it describes the device's intended use and comparison to predicate devices, it does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or detailed performance metrics like sensitivity, specificity, or AUC.
The document states: "dicomPACS® has been tested according to the specifications documented in this notification (Section 14 g). It conforms to the DICOM standard as laid out in the included DICOM Conformance Statement." However, "Section 14 g" and the DICOM Conformance Statement are not provided in this extract, nor are any performance results from such testing.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, experts, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text.
The information primarily focuses on:
- Device identification: Trade name, common name, applicant details, regulation number, classification.
- Device description: Functionality (acquire, store, communicate, display, process medical images), modular architecture, DICOM conformance.
- Predicate devices: HIPAX (K052411) and eFilm Workstation (K020995) are identified as comparable devices.
- Intended use: Acquisition, storage, communication, and viewing of medical images from various modalities, with tools for viewing (zoom, filters, measurements) and exchange. It also mentions integration with RIS/KIS.
- Technological characteristics: Software-only, runs on specific MS Windows operating systems, does not control life-sustaining devices, and requires interpretation by qualified specialists.
- Conclusion: Stating substantial equivalence to predicate devices.
- FDA Communication: A letter from the FDA stating the device is substantially equivalent to legally marketed predicate devices.
- Indications for Use: Further detailing the device's use for administration, archiving, improvement, and compression of medical image data for diagnosis, emphasizing requirements for mammographic images.
In summary, the provided text does not contain the specific performance study information requested.
§ 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).