(17 days)
STARPACS ™ is a device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians.
STARPACS ™ is a server-based software application that is a distributed image management system that manages the viewing, retrieval, manipulation, and distribution of medical images within a Picture Archiving and Communication System (PACS) environment. The system provides online access to patients' current and historical radiological images and relevant examination data and is designed for facilitating the clinical practice of radiologists and physicians. STARPACS ™ implementation is based on the Digital Imaging and Communication in Medicine (DICOM 3.0) standard. The standard allows communications of images and relevant information such as patient demographics and examination data between the system and other DICOM-compliant imaging devices such as CT scanners, MR imager, CR systems, and image viewing workstations.
The provided document is a 510(k) summary for the STARPACS™ device, which is a Picture Archiving Communications System (PACS). This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (MEDIFACE PACS™) based on:
- Device Description: It describes the STARPACS™ as a server-based software application for managing, viewing, retrieving, manipulating, and distributing medical images within a PACS environment, supporting DICOM 3.0.
- Indications for Use: It states that STARPACS™ receives, stores, communicates, processes, and displays digital images and data from various imaging sources, with typical users being trained professionals.
- Technological Characteristics: It notes that the device does not contact the patient or control life-sustaining devices, and images are interpreted by a physician.
- Conclusion of Substantial Equivalence: It concludes that the device is substantially equivalent to the predicate based on the provided information, hazard analysis results, and compliance with voluntary standards.
Therefore, the requested information regarding acceptance criteria and a study proving their fulfillment cannot be extracted from this document.
This type of 510(k) summary for a PACS system typically does not include performance studies with clinical endpoints or detailed statistical analysis of AI model performance, as the device is primarily for image management and display, not diagnostic interpretation itself, and is subject to human-in-the-loop interpretation. The "acceptance criteria" here implicitly refer to meeting the requirements for being substantially equivalent to a legally marketed predicate device, primarily in terms of intended use, technological characteristics, and safety aspects, rather than specific performance metrics like sensitivity or specificity from a diagnostic aid.
§ 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).