(47 days)
The Materialise SimPlant System is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical image boginemation bytten or a Magnetic Resonance scanner. It is also used as a scannel such as a O P Sounterial implant placement and surgical treatment options.
The modified SimPiant System is used to transfer images from a medical scanner and to perform a segmentation of the images. It is also used to provide a means for pre-operative planning. Surgical templates may be fabricated based on the output of the pre-operative planning.
The provided text does not contain information about acceptance criteria, device performance, or any studies conducted. The document is a 510(k) premarket notification summary and an FDA clearance letter for a modified SimPlant System. It primarily discusses the device's intended use, functions, and a comparison with a predicate device to establish substantial equivalence. There is no data regarding sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details on how ground truth was established for training or testing sets.
Therefore, I cannot provide the requested table or answer the specific questions about studies and acceptance criteria based on the given information.
§ 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).