(50 days)
21.3 inch (54 cm) Color 3M pixel LCD Monitor CCL356i2 (CL21356) is intended to be used in displaying and viewing medical images for diagnosis by trained Medical practitioners. It is not meant to be used in digital mammography.
CCL356i2 (CL21356) is a 21.3-inch (54 cm) Color LCD monitor whose display resolution is 1536 x 2048 (landscape), 2048 x 1536 (portrait) supporting DVI (digital visual interface) and Display Port.
The provided text describes a 510(k) summary for a medical display device, the TOTOKU 21.3 inch (54 cm) Color LCD Monitor CCL356i2 (CL21356). It is not a document describing a study for a new AI/ML-based medical device. Therefore, the information required to answer the prompt regarding acceptance criteria and the study proving the device meets these criteria (such as performance metrics, sample sizes, ground truth establishment, or multi-reader multi-case studies) is not present in the provided text.
The document states: "CCL3562 (CL21356) shares the same characteristics with our predicate device CCL354i2 (K081056) except for the power supply." This indicates that the device's acceptance criteria are primarily based on equivalence to a previously cleared predicate device, rather than explicit performance metrics derived from a clinical or technical study on image interpretation or diagnostic accuracy involving AI.
Therefore, I cannot populate the table or answer the specific questions about performance studies, expert involvement, or adjudication methods based on the provided text. The document is a regulatory submission for a display monitor, not an AI/ML-driven diagnostic tool.
§ 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).