(98 days)
The TCS is a software device intended to acquire, print, archive and communicate catheterization laboratory image studies, and to view these images on a PC in real-time mode. In addition, the TCS is intended to provide image enhancement and filtering tools for the viewing of selected images, to import and generate DICOM CDs, to prepare reports in Microsoft® Word format and to export DICOM images into commercial file formats.
The TCS provides a complete software tool for the convenient and efficient recording, storage, review, and communication of heart catheterization and other angiographic studies In the catheterization lab environment. The TCS also creates DICOM 3.0 CDs from the cath lab procedures. The TCS operates on a WindowsNT® PC. The TCS automatically acquires the x-ray video signal and places each video inside the patient's file. The patient file may also contain single images from a video, and reports (which automatically include the full patient details and selected images from the procedure) in Microsoft® Word format. During the review of videos and single images, image enhancement tools, such as zooming, magnification, full screen view, playback loop and brightness, contrast and gamma controls may be applied. As well as creating DICOM CDs, the TCS can also import data from DICOM CDs into its database, where they are written as patient files. Data may also be introduced to the TCS via telecardiology over an ISDN line, enabling professional consultation and referral of patients from level to level of the cardiac health care system. The patient files sent and received via telecardiology may also have vocal and graphic annotations attached to them. All new patient files, whether acquired from x-ray, imported from a DICOM CD, or received via telecardiology, are logged so that their source and ownership may easily be determined.
The provided text describes a medical device, the TCS - Medcon's Telecardiology System, and its submission for 510(k) clearance. However, the document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
The text is a summary of safety and effectiveness, indicating that the device is substantially equivalent to a predicate device (ComView's WriteStar and ViewStar System K964274). It describes the device's functions, such as acquiring, storing, reviewing, and communicating heart catheterization and angiographic studies, creating DICOM 3.0 CDs, and providing image enhancement tools.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details because it is not present in the provided input.
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.