(44 days)
CS 3D Imaging is digital imaging software intended to be used with Carestream's 3D extra-oral X-ray equipment by healthcare professionals to display, make measurement, print, export and store 2D and 3D views of the dento-maxillofacial and ENT (Earn, Nose and Throat) region of the human anatomy as diagnostic support.
It is also a software application used for the management of the implant library and the virtual placement of dental implants.
It can be used as stand-alone software in a standard computer and does not perform any radiographic image acquisition.
CS 3D Imaging is digital imaging software intended to be used with Carestream's 3D extra-oral X-ray equipment by healthcare professionals to display, make measurement, print, export and store 2D and 3D views of the dento-maxillofacial and ENT (Earn, Nose and Throat) region of the human anatomy as diagnostic support.
It is also a software application used for the management of the implant library and the virtual placement of dental implants.
It can be used as stand-alone software in a standard computer and does not perform any radiographic image acquisition.
I apologize, but the provided text from the FDA 510(k) summary for "CS 3D Imaging" is a general notification letter and an "Indications for Use" statement. It does not contain any information regarding acceptance criteria, study details, performance data, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.
To answer your request, I would need a detailed performance study report or a section of the 510(k) submission specifically describing the validation studies and their results.
§ 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).