(14 days)
The Fuji CR Console is a CR modality workstation intended to associate FCR images (except mammography images) with patient and exam information, apply image processing to facilitate diagnosis, display the image, and output the resulting image and exam data for further display, distribution, or archiving.
The CR Console (Flash IIP) is used by a radiographer to view CR images for final quality assurance (QA) checking and image processing/optimization prior to transfer of those images to external (&A) oncelling and intage problem. Furthermore, when connected to Fuji Image Readers via a network, the CR Console is used to enter patient ID information, exposure information and register Inage Plate (IP) barcode numbers. The CR Console application software runs on an "off-the-shell" personnel computer under the Windows 2000 or Windows XP operating system with a choice of a high resolution monitor (Plus configuration) or standard resolution monitor (Lite configuration) for image display.
The provided text is a 510(k) summary for the Fuji Medical CR Console, Model Flash IIP, which is a medical image processing workstation. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device.
However, there is explicitly no mention of acceptance criteria, study design, or performance metrics related to diagnostic accuracy or clinical effectiveness for the device. This document focuses on the technological characteristics and safety information to demonstrate substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a clinical study.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size, data provenance, number of experts, adjudication method for a test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone algorithms.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document does not contain any of this information. It is a regulatory submission focused on demonstrating equivalence based on technological features and safety, not on clinical performance metrics from a study.
§ 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).