(84 days)
MediSurf is intended to facilitate access to clinical images and information in distributed locations. Along with image processing capabilities, MediSurf can be used by radiologists for on-call teleradiology over "intranets", Internet, direct or dial-up lines, and for providing second opinion services. It can also be used by physicians for enhanced interpretation of cases through the inclusion of images in imaging related reports and in patient records in general. Similarly it can be used by healthcare organization staff for facilitated access to clinical images throughout the healthcare organization.
The MediSurf server is an access engine to healthcare information. MediSurf provides its end-users with easy access to DICOM devices and networks for the retrieval of images in full diagnostic quality using adaptive progressive compression for efficient transfer over different communication links. The server also provides the user with the software applets needed to display, process, store, and send the retrieved clinical data.
The MediSurf server is based on off-the-shelf UNIX based computer that complies with the accepted international standards for computer systems. The system also comprises software developed and validated by Algotec Systems Ltd..
The provided text is a 510(k) summary for the MediSurf device, which is a teleradiology system. It explicitly states that the device is substantially equivalent to a predicate device (ProVision Diagnostic Workstation) and does not introduce new features affecting safety or effectiveness. As such, the document does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way a medical AI/CADe device would.
The submission focuses on the substantial equivalence argument based on the device's technological characteristics and intended use being similar to the predicate device. It highlights that the core functionalities (image viewing, processing, archiving, communication) are largely shared, with the primary difference being the user interface (web browser vs. dedicated workstation interface).
Therefore, I cannot populate the requested table and answer the specific questions about performance studies, sample sizes, expert ground truth, adjudication, or MRMC studies, as this information is not present in the provided 510(k) summary. These types of studies and details are typically required for different classes of medical devices or for AI/CADe devices demonstrating clinical performance, which MediSurf, as described here, is not.
§ 892.2020 Medical image communications device.
(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.