(62 days)
The Materialise CT-Modeller System is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a Magnetic Resonance imaging scanner or CT scanner. The input data file is processed by the CT-Modeller System and the result is an output data file which may then be used as input data for a CAD or Rapid Prototyping System. The CT-Modeller System which is the subject of this 510(k) premarket notification is confined solely to the software image segmentation system.
The Materialise CT-Modeller System is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a Magnetic Resonance imaging scanner or CT scanner. The input data file is processed by the CT-Modeller System and the result is an output data file which may then be used as input data for a CAD or Rapid Prototyping System.
The provided text is a Summary of Safety and Effectiveness for the Materialise CT-Modeller System, which is a 510(k) premarket notification document from 1997. This document details the device's general information, predicate device, device description, and indications for use, but does not contain the information required to answer the specific questions about acceptance criteria and study details.
Specifically, the document lacks:
- A table of acceptance criteria and reported device performance. The document states the device is substantially equivalent to a predicate device, but actual performance metrics or criteria are not mentioned.
- Details about a study that proves the device meets acceptance criteria. There is no mention of a specific clinical or technical study, sample sizes, data provenance, expert involvement, adjudication methods, or ground truth establishment.
- Information regarding multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- Details about training sets, ground truth types, or how ground truth was established.
The document focuses on demonstrating substantial equivalence to a predicate device (SurgiCAD View System) based on design, material, and function, rather than presenting a performance study against predefined acceptance criteria. Therefore, most of the requested information cannot be extracted from the provided text.
§ 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).