(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.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the word "SECTRA" in bold, black letters on the top line. Below the word "SECTRA" is the text "K961983" in a handwritten-style font. The text "K961983" is smaller than the word "SECTRA" and is also in black.
Department of Health and Human Services Center for Devices and Radiological Health Office of Device Evaluation Pre-Market Notification Section
15 May 1996
SECTRA Doc. no: 3-96.534-2.0/da-fri PV
510(k) summary of safety and effectiveness information for the SECTRA Teleradiology System TRS 2000
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
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. Typical users are phycians and nurses at a radiology deparment.
The undersigned certifies that the 510(k) Pre-Market Notification for the above referenced product contains adequate information and data to enable CDRH to determine substantial equivalence to Philips PMS Easy Vision (K920950). This information and data is summarized as follows:
-
- The Teleradiology system TRS is subject to and in compliance with the Federal Performance Standards, defined in 21 CFR, part 1000.
-
- The TRS system has been and will be manufactured in accordance with the voluntary standards listed in the enclosed External Standards survey.
-
- The TRS User's Guide contains comprehensive and extensive information on how to operate the system to ensure a safe and effective use.
-
- Close co-operation with radiologists from the specifications to test phases and substantial independent experience from clinical operation has shown the TRS system to be safe and effective. Past experience with substantially equivalent predicate devices has also shown our device to be safe and effective when used as directed in the/User's Guide.
- The submission contains the results of an hazard analysis.
signature
Torbior Krishar Approbation Officer SECTRA - Imtec AB Linköping, Sweden
A
the
growing
75
§ 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).