(91 days)
The DCAS i allows the user to look up, keep, and manage all the medical images used in cardiology with Angio, ECHO, and IVUS images as the basic ones. It allows the user to view, arrange, and manage the needed image by only controlling it in a simple way. Also, as the user can arrange images as he or she wants regardless of the sort of the images, the user can compare and analyze the images of all the equipments of cardiology on this system. The user can record the images of the patient wanted on a CD or DVD. Here, the exclusive viewer allows the user to check the recorded images of the patient in all sorts of environment. In addition, the user can edit and convert the DICOM Cine images into AVI and static images to use them for editing various images and framing a report. Only the user authorized by using the Internet can use this system based on the Web, and in an environment with a wireless network built, the user can look up data through a mobile device. DCAS i images can be used for reference purposes only and cannot be used for precise readings.
The DCAS i is an equipment for providing medical treatment services of a good quality in cardiology and developing into an advanced medical institution through innovative work improvement, in order to keep up with the rapidly changing era of medical information. The DCAS i, which has an improved high-speed image processing engine, processes in the method of multi-threading to display multiple DICOM Cine images in a simultaneous way. It allows the user to look up, keep, and manage all the medical images used in cardiology with XA, ECHO, and IVUS images as the basic ones. The DCAS i sends even high-capacity images within only a few seconds and expresses them on the basis of the GIGABIT network environment of its own. The enhanced convenience of its user interface allows the user to view, arrange, and manage the needed image by only controlling it in a simple way. Also, as the user can arrange images as he or she wants regardless of the sort of the images, the user can compare and analyze the images of all the equipments of cardiology on this system. The user can record the images of the patient wanted on a CD or DVD by only controlling a few times. Here, the exclusive viewer allows the user to check the recorded images of the patient in all sorts of environment. In addition, the user can edit and convert the DICOM Cine images into AVI and static images, and this makes it easier to edit various images and frame a report. Only the user authorized by using the Internet can use this system based on the Web as needed, and in an environment with a wireless network built, the user can look up data through a mobile device.
The provided 510(k) summary for the DCAS i device, a Picture Archiving and Communications System, does not contain information related to acceptance criteria or a study proving the device meets specific performance criteria.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Centricity Cardiology CA1000) based on shared intended use and similar technical characteristics. This type of submission relies on the established safety and effectiveness of the predicate device, rather than requiring new performance studies with acceptance criteria for the new device.
Therefore, I cannot provide the requested information in the format specified. The document explicitly states:
- "DCAS i images can be used for reference purposes only and cannot be used for precise readings." (pages 5 and 9) This indicates that the device is not intended for diagnostic interpretation that would typically require rigorous performance studies and associated acceptance criteria.
- The comparison is primarily focused on features and functionalities (e.g., DICOM-Compliant, Architecture, Server, Security, Storage, Web-Based Access, Image Compression, Multi-frame support, Image Control, Play Control, Zoom, Search Patient, Search Case Date, Search Modality, Sort, Common Measurement XA Analysis, Us Analysis) as well as the new addition of mobile applications, rather than quantitative performance metrics.
In summary, based on the provided text, the 510(k) submission for DCAS i does not include the details requested in the prompt regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement.
§ 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).