(71 days)
The RATTAN IMACS™ system 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.
RATTAN IMACS™ system is a software picture archiving and communications system that provides users with capabilities relating to the capture, acceptance, transfer, display, storage, and digital processing of medical images. RATTAN IMACS™ system includes features to access and manage medical imaging studies from a film digitizer (FD), cat-scan (CT), magnetic radiography (MR), ultrasound (US), nuclear medicine (NM), computerized radiography (CR), digital radiography (DR), digital x-ray (DX), x-ray angiography (XA), PET scan (PT), and other imaging modalities.
The device is designed to be deployed over conventional networking infrastructure available in most healthcare organizations, and utilizes commercially available computer platforms (Intel Pentium-based) and operating systems (Microsoft Windows 2000, Windows NT, and Windows 98). The system does not produce any original medical images.
The provided text is a 510(k) Summary and related correspondence for the RATTAN IMACS™ system. This document focuses on establishing substantial equivalence to a predicate device for regulatory clearance. It does not contain information about acceptance criteria or a study proving the device meets said criteria, as would typically be found in a performance study report or clinical validation.
The RATTAN IMACS™ system is described as a Picture Archiving Communications System (PACS) designed for the capture, acceptance, transfer, display, storage, and digital processing of medical images. Its clearance is based on its functional similarity to a previously cleared predicate device (MAROSIS PACS, K012844).
Therefore, I cannot fulfill the request to provide acceptance criteria and a study design based on the input document. The document confirms that:
- The device is a software-only PACS, which means it primarily handles images and data, rather than generating new medical images or directly interacting with patients.
- Its regulatory pathway is a 510(k) premarket notification, which aims to demonstrate substantial equivalence to a legally marketed predicate device. This typically involves comparing technological characteristics, indications for use, and safety/effectiveness profiles, rather than conducting new performance studies against specific acceptance criteria for algorithm performance.
- The document states that the "Level of Concern for potential hazards have been classified as 'minor'" and that "A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed." These statements highlight that the device is intended to be used by trained professionals, and human interpretation is a critical part of the clinical workflow, implying that its standalone algorithmic performance (if any advanced image processing is involved) is not the sole determinant of safety and effectiveness.
In summary, the provided text does not contain the information required to answer your specific questions regarding acceptance criteria and a study proving the device meets those criteria. The 510(k) pathway for this type of device typically relies on demonstrating equivalence through documentation of functionalities and adherence to standards, rather than new, quantitative performance studies against specific clinical endpoints or reader performance.
§ 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).