(51 days)
The Doctors Review System (DRS) is general purpose, standalone software for creating patient reports. It consists of Digisonics word processing software together with off-the-shelf computer equipment (PC, VCR, printer, etc.). Using the system, the physician reviews data (from other sources), notes clinical observations from sets of menus, and creates patient reports. Optional analysis programs are provided for quantitation of echo and cath lab data. No diagnoses are made by the software. It is not used for therapy or patient monitoring.
The Doctors Review System is general purpose, standalone software for creating patient reports. It consists of Digisonics word processing software together with off-the-shelf computer equipment (PC, VCR, printer, etc.). Using the system, the physician reviews data (from other sources), notes clinical observations from sets of menus, and creates patient reports. Optional analysis programs are provided for quantitation of echo and cath lab data. No diagnoses are made by the software. It is not used for therapy or patient monitoring. The Doctors Review System is sold either as software alone or as software together with PC based computer parts. The device is available in a variety of configurations, reflecting specific requirements of different specialities. An optional Search package is also available. This program searches the data base of stored reports and list those studies matching the search criteria specified. Links to a variety of ultrasound systems are available as options. The new digital image management option for capturing and displaying digital data is also available as an add-on to the various configurations.
This document does not contain information about acceptance criteria, study details, or specific performance metrics as requested. It is a 510(k) summary for a "Doctors Review System," primarily describing its function as a general-purpose software for creating patient reports. The "Test Discussion" section broadly mentions software verification and validation but does not provide any quantitative results, acceptance criteria, sample sizes, or details about ground truth establishment.
Therefore, I cannot populate the table or answer the specific questions based on the provided text.
§ 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).