(150 days)
The SICAT Implant V 1.2 is a software application for the visualization of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or DVT scanners. The SICAT Implant V 1.2 is intended for use as planning and simulation software to aid qualified dental professionals in the placement of dental implants and the planning of surgical treatments. The dental professionals' planning data may be exported from SICAT Implant V 1.2 and used as input data for CAD or Rapid Prototyping Systems.
SICAT Implant V1.2 is a pure software device. SICAT Implant V1.2 is a software application for the visualization of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or DVT scanners. SICAT Implant V1.2 is intended for use as planning and simulation software to aid qualified dental professionals in the placement of dental implants and the planning of surgical treatments.
SICAT Implant V1.2 allows to name, position, move, rotate, resize and visualize dental implants and other planning objects (i.e. nerve canals) within the visualized 3D volume. Thus, dental professionals like implantologists are enabled to precisely plan the positions, orientations, types and sizes of implants to be placed in the patient's mandible/maxilla together with the related surgical procedures.
The dental professionals' planning data may be exported from SICAT Implant V1.2 and used as input data for CAD or Rapid Prototyping Systems.
The provided text describes the SICAT Implant V 1.2 device and its 510(k) submission, but it does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria, as typically found in a clinical study report.
The text focuses on establishing substantial equivalence to predicate devices based on intended use, features, and technical characteristics. It mentions "Performance testing to validate the safety and effectiveness of the SICAT Implant V 1.2 system included validation testing and bench tests of the software functions," but provides no details on these tests, their results, or the methodology.
Therefore, I cannot fulfill your request for a table of acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, or training set information. This information is not present in the provided 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).