(28 days)
The MGP 15 Dicom Theater device is intended to be used in displaying and viewing digital images for review by trained medical practitioners.
The MGP 15 Dicom Theater is intended to be used as a tool in displaying and viewing digital images for review and analysis by trained medical practitioners.
The MGP 15 Dicom Theater device is a digital image display system
The MGP 15 Dicom Theater consists of components to provide high resolution visualization of digital images.
This 510(k) premarket notification (K042942) for the Barco MGP 15 Dicom Theater is for a digital image display system. As such, it is not an AI/ML device and the concept of "acceptance criteria" and a "study proving the device meets the acceptance criteria" in the context of diagnostic performance metrics like sensitivity, specificity, or reader agreement is not applicable here.
This submission focuses on demonstrating substantial equivalence to a predicate device (Dicom Theater, K033153) for its function of displaying and viewing digital images for review by trained medical practitioners. The "acceptance criteria" for such a device would relate to technical specifications, image quality, and compliance with standards, rather than clinical performance metrics.
The provided documents do not contain information about:
- A table of acceptance criteria and reported device performance: This type of table is relevant for medical devices with diagnostic or AI/ML components where performance metrics like sensitivity, specificity, accuracy, etc., are measured against predefined targets. For a display system, performance would be characterized by technical specifications like resolution, brightness, contrast, color depth, viewing angles, and compliance with DICOM standards, none of which are detailed here.
- Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone study, type of ground truth, training set size, or how ground truth was established: These details are typically found in studies evaluating the diagnostic performance of a device, especially AI/ML systems. Since the MGP 15 Dicom Theater is a display system, these types of studies are not relevant to its regulatory clearance.
In summary, based on the provided text, the MGP 15 Dicom Theater is a display system, not an AI/ML diagnostic tool. Therefore, the questions posed regarding acceptance criteria validated by clinical performance studies are not applicable to this device and no such information is present in the 510(k) summary.
§ 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).