(21 days)
iPACS Prism-5.0™ from Real Time Image Inc. is a device that receives medical images, (including mammographic images), and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. iPACS Prism-5.0TM only supports lossless compression for primary mammography image interpretation. Lossy compressed or digitized screen film mammographic images must not be reviewed for primary image interpretations. Only FFDM manufacturer processed images in DICOM "For Presentation" format can be displayed for primary interpretation. Mammographic images must only be interpreted using a FDA approved monitor that offers at least 5Mpixel resolutions ind other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including physicians, nurses, and technicians.
iPACS Prism-5.0 is a modified version of iPACS Prism (K030751). Both devices are picture, archiving and communications system software applications from RealTimelmage. The main significant difference between the modified device and the predicate device is that the modified device will now allow display of presentation quality digital mammography images, sent via the DICOM standard in order to make viewing of these images more convenient for the user. Both systems are a complete PACS solutions designed to be Internet friendly for easy deployment over local area networks and/or wide area networks. IPACS Prism-5.0 is modular and will be offered under different brand names depending upon customer implementation and which system components of iPACS Prism-5.0 are needed The system is modular and will be offered under different brand names depending upon customer implementation and which system components of iPACS Prism are needed. iPACS™ handles various images and data objects in a Picture Archive and Communication System (PACS) environment. These objects can be images, requests, patients, examination etc. PACS transmits digital electronic images and generates reports over a high-speed network to centralized storage. After transmission, patient information and images are available throughout the facility to many users simultaneously.
This 510(k) submission for iPACS Prism-5.0 (K050298) does NOT contain information regarding acceptance criteria and a study to prove the device meets these criteria.
The provided document describes iPACS Prism-5.0 as a modified version of iPACS Prism (K030751), with the key difference being the ability to display presentation quality digital mammography images. The submission focuses on substantial equivalence to the predicate device and adherence to regulatory requirements for PACS systems.
Specifically, the document DOES NOT include any sections discussing:
- Performance data or evaluation studies.
- Acceptance criteria (e.g., accuracy, reliability metrics).
- Sample sizes for test or training sets.
- Expert involvement for ground truth establishment.
- Adjudication methods.
- Multi-Reader Multi-Case (MRMC) studies or any effect sizes of AI assistance.
- Standalone algorithm performance.
- Types of ground truth used (e.g., pathology, clinical outcomes).
Therefore, I cannot populate the requested table or answer the specific questions about studies and ground truth based on the provided text. The submission is a regulatory notification of intent to market a device, primarily focusing on its description, indications for use, and technological characteristics relative to a predicate device, rather than detailed performance study results.
§ 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).