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The IBM Integrated Digital Medical Record (IDMR) provides integrated access to digital patient folders and manages digital information flow in a networked health care environment. It integrates all sources of multimedia patient data into a single patient folder, combining demographic, clinical, and radiological information.

The IDMR system is UNIX and Windows/NT based, with UNIX (IBM RS/6000 and AIX) servers and clients, and Windows/NT clients. IDMR uses standard IBM hardware and software (RISC System/6000, AIX, IBM/PC, ADSM) components. IDMR uses the industry standard structured query language (SQL) database. The system currently supports IBM DB2/6000 and Oracle databases. IDMR is designed to operate over local and wide area networks. Standard transmission control protocol/Internet protocol (TCP/IP) is used throughout the communication networks. The communication systems supported include (but are not limited to) token ring, Ethernet, fiber distributed data interface (FDDI), asynchronous transfer mode (ATM), and integrated services and digital network (ISDN). IDMR is implemented using the C and C++ programming languages. The system implements state-of-the-art client/server technology and enables seamless addition of hardware modules. The system servers (file management system (FMS), data interface server (DIS), storage management system (SMS) can be installed on larger central UNIX machines or can be distributed to smaller machines in various departments. IDMR supports DICOM 3.0 standard for data model, and interconnectivity protocol.

The provided text is a 510(k) summary for the IBM Integrated Digital Medical Record (IDMR) system. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill your request for this specific input as the necessary information is not present. This document is a regulatory submission focused on substantial equivalence rather than a detailed performance study report.

The IBM IDMR is a digital medical record system designed to integrate various types of patient data. Its 510(k) clearance is based on its substantial equivalence to an existing device (IMAGING WORKBENCH by BRIT SYSTEMS, K943383), and not on a detailed clinical performance study with acceptance criteria as typically found for diagnostic or treatment AI devices.

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