(85 days)
The TRS 2000 system is a teleradiology system/transmission and advance reviewing station X-ray images. TRS 2000 is used for advanced reviewing and transmission over private or public telecommunications networks of radiological images.
The TRS 2000 system is a teleradiology system/transmission and advance reviewing station X-ray images.
This document is a 510(k) summary for the SECTRA Teleradiology System TRS 2000, dated May 15, 1996. It asserts the system's substantial equivalence to the Philips PMS Easy Vision (K920950) and discusses its safety and effectiveness.
However, the provided text does not contain the specific information needed to answer the request about acceptance criteria and a study proving those criteria are met.
Here's why and what information is missing:
- No specific acceptance criteria: The document states the system is "safe and effective" and complies with federal performance standards and voluntary standards, but it doesn't list quantifiable performance metrics as acceptance criteria (e.g., sensitivity, specificity, accuracy, image resolution targets, transmission speed guarantees).
- No detailed study description: While it mentions "substantial independent experience from clinical operation" and "close co-operation with radiologists from the specifications to test phases," it does not describe a formal study with the elements requested (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details).
Therefore, based only on the provided text, I cannot complete the table or answer the specific questions about the study. The document is a regulatory summary, not a detailed scientific study report.
§ 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).