(156 days)
Vascular image archiving, processing, analysis, management and communication.
The VIEW Archiving Station represents the first generation of Electromed International's vascular image archiving and communication stations. The VIEW Archiving Station is intended for vascular image archiving, processing, analysis, management, and communication as the Cinenet Cardiac Image Network with the exception of analysis which is available as an option with the Cardiac Image Management System (CIMS). Some of the features offered in the VIEW Archiving Station are: vascular image processing (zoom, panning, edge enhancement, contrast), analysis (left and right ventricular functions, quantitative coronary analysis), and communication (printing of reports and sending of exam information in DICOM or Electromed encapsulation over a local area network, including images). Images are acquired in real-time on both products.
The VIEW Archiving Station may be interfaced directly with the majority of image digitizers available in todays angiographic systems. It may be linked to video signals of 1249 lines at 25 images/sec or even 1049 lines at 30 images/sec. The video signal is then re-sampled in real time to yield a signal of 625 lines which then may be recorded on a laser video disc by the CRV.
The View Archiving Station is comprised of two principle assemblies: the Electronic Cabinet; and the User Console which is connected solely to the Electronic Cabinet. Unlike the Cinenet Cardiac Image Network which uses digital videocassettes as the archiving media, the VIEW Archiving Station archives it's images on laser video discs and the exam information on internal hard disks. Each uniquely numbered laser video disc holds approximately 48 minutes (24 per side) of recording time, 35-45 examinations. The internal hard disks encompasses records that contain patient and exam information along with the referenced video laser disk ID number, which in turn, contains the recorded images. Approximately 100,000 records can be maintained on the internal hard disks at the present time. The Cinenet Cardiac Image Network incorporates a Data Storage Library which contains anywhere from 84 to 1008 digital video cassettes for automatic retrieval, whereas the VIEW Archiving Station acts as a stand alone unit whereby the laser video discs are manually inserted when prompted.
The VIEW Archiving Station is to be connected to a 230V (±10%), 50/60Hz, 10A power source.
The configurable and add-on options being offered with the VIEW Archiving Station are: Room Loop Playback (the viewing of inages on a remote monitor in the orocedure room). Table Side Joystick (remote console in the procedure room to control the playback of recorded images); SVHS Copier (the recording of exams onto a SVHS tape); and a High Definition Printing of reports, including reference images at 1200cpi and 256 gray scale levels, via an ethernet local area network).
Since the VIEW Archiving Station can transmit information and images in a Dicom compliant format, via an ethernet local area network, a CD-R Station may be connected to record exams onto a transportable media (CD). The CD-R Station is not part of this 510(k) submission.
Since the options or combination of options, as stated above, are available as an integral part of the VIEW Archiving Station, the device will inevitably be offered in various configurations while maintaining the intended use and technological characteristics presented here within.
The provided text is a 510(k) summary for a medical device called "VIEW Archiving Station." It describes the device's intended use and claims substantial equivalence to previously marketed devices. However, this document does not contain specific acceptance criteria, details of a study proving the device meets acceptance criteria, or information on performance metrics, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.
The document states: "The VIEW Archiving Station does not in any way raise new questions of safety or effectiveness, when used as labeled, in comparison to the predicate device." This is a general statement typical of a 510(k) submission, asserting that the device is substantially equivalent to existing devices and therefore does not require new studies to demonstrate safety and effectiveness.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
- Sample sized used for the test set and the data provenance: This information is not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
- Adjudication method for the test set: This information is not present.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: This information is not present.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not present.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not present.
- The sample size for the training set: This information is not present.
- How the ground truth for the training set was established: This information is not present.
The document focuses on describing the device's features, functionality, and comparison to predicate devices for the purpose of demonstrating substantial equivalence for regulatory approval. It does not include the detailed study results and performance metrics that would be associated with acceptance criteria.
§ 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.