(15 days)
The Cardio-View system is intended to be used by health care professionals to integrate the video outputs from several commercially-available instruments commonly used in a medical procedure laboratory into a single video display. Control of the video sources is accomplished using a touchpad device.
Cardio-View is a very large screen monitor for integrating the outputs from multiple video sources onto a single display. This unit is ideally suited for training labs where physicians and medical technologists can simultaneously view the disparate systems in use in the procedure rooms for complex procedures such as electrophysiology and heart surgery. The single display can be set up with customized views of many different procedure room activities to emphasize a particular area of interest while still providing the ability to monitor many others. For example, the display might simultaneously show the information being provided by an anesthesiology monitoring system, an EKG monitoring system, a CAT/MRI simulator, and fluoroscope; with each optimally-positioned for the type of procedure underway. While the display is primarily designed as an integrator and repeater of the many individual monitors typically in use in the procedure room; there is really no limit as to where it can actually be used.
The provided document is a 510(k) summary for a medical device called "Cardio-View." This document does not describe acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for algorithms or AI-driven diagnostic devices.
The Cardio-View device is described as a "very large screen monitor for integrating the outputs from multiple video sources onto a single display" intended for use by healthcare professionals in a medical procedure laboratory. It functions as a display and integrator, not a diagnostic or AI-powered analytical tool.
Therefore, the requested information elements related to algorithm performance, sample sizes for test and training sets, ground truth establishment, expert adjudication, or MRMC studies are not applicable to this device and its 510(k) submission.
The "Test Conclusions" section states:
"CuriView IGT, LLC, has conducted extensive testing of the Cardio-View system during development and installation. In addition, all electrical safety testing necessary to meet the IEC 60601-1 and its collateral standard IEC 60601-1-1 was completed by an experienced medical device electrical testing facility."
This indicates that the testing focused on the electrical safety and functional performance of a display and integration system, rather than diagnostic accuracy or algorithmic performance.
In summary, based on the provided text, the device is a medical monitor/integrator, and the 510(k) submission does not contain the type of performance study details requested for AI/algorithm-driven devices.
§ 870.2450 Medical cathode-ray tube display.
(a)
Identification. A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.(b)
Classification. Class II (performance standards).