(11 days)
WIDE 1MP LCD Monitor System™ by WIDE Corporation is intended to be used in displaying and viewing medical digital images for review and analysis by trained medical practitioners. WIDE 1MP LCD Monitor System™ is not indicated for use with Mammographic images.
The WIDE 1MP LCD Monitor System™ is a flat panel hi-resolution LCD monitor system for displaying digital medical images. The system consists of a state-ofthe-art LCD monitor and a high-resolution graphic control board that connects to a PACS workstation for grayscale image display. The WIDE controller board is installed into the PACS workstation computer or other computer system used to display PACS medical images.
The provided text is a 510(k) summary for the WIDE 1MP LCD Monitor System, which is a medical image display system. This document is a regulatory submission for market clearance and does not contain information about acceptance criteria or studies proving device performance for specific clinical tasks.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and safety standards. It describes the device, its intended use (displaying and viewing digital medical images for review and analysis by trained medical practitioners, with an explicit exclusion for mammographic images), and compliance with various safety and EMC standards (UL2601-1/EN60601-1/IEC601-1, FCC Class B, CE, VCC, UL 950, cUL2601-1, CE Mark EMC/IEC = VCCI, CE, MIC FCC Class B).
Therefore, I cannot provide the requested information from the given text as it does not contain:
- A table of acceptance criteria and reported device performance for a clinical task.
- Sample size used for a test set or data provenance.
- Number of experts or their qualifications.
- Adjudication method for a test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information about a standalone performance study.
- The type of ground truth used for a clinical study.
- Sample size for a training set.
- How ground truth for a training set was established.
This document is primarily concerned with regulatory clearance based on substantial equivalence, not a clinical performance 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).