(209 days)
ZIRKONZAHN.Implant-Planner is an implant planning software. The software imports and reads DICOM files from CT/CBCT scanners. The patient data is then transformed into 3D volume and different multi-planar 2D images for diagnosis and further implant and surgery guide planning with precise step by step instructions. The software is a stand-alone product that is not connected to any other medical device. Neither automatic diagnosis nor automatic disease detection is performed. The software is intended for use by dental professionals only and requires appropriate training for its use and knowledge in the practice of implantology.
ZIRKONZAHN.Implant-Planner is a fully-featured 3D imaging standalone application for implant planning and surgical guide design. ZIRKONZAHN.Implant-Planner supports all the common 3D medical imaging functionalities used by professionals to support their diagnosis. It includes various volume and surface rendering, masking and sculpting, MPR, 2D and 3D measurement and analysis tools. The software is provided in 2 versions and 2 modules: the first version is a full version (called "ZIRKONZAHN.Implant-Planner") that covers all applications for use, the second version is a basic/limited version (called "ZIRKONZAHN.Implant-Planner Practice") only for implant planning. The first module is a CAD/CAM STL Converter that converts DICOM data into STL files for further processing. The second one is the CAD/CAM Z-Tray for designing individual impression trays.
The provided text describes the ZIRKONZAHN.Implant-Planner, an implant planning software. However, it does not contain information about specific acceptance criteria or a detailed study proving the device meets these criteria in the format requested.
The document states that "Software verification and validation is performed in accordance with the procedures described in this submission and in accordance with the applicable FDA guidelines. Code review, unit, integration and system testing were conducted to establish the functionality characteristics of the subject device. Software validation confirms that the particular requiremented through software are consistently fulfilled. Implemented controls such as collision detection related to device hazards identified in the risk management procedures are validated to establish the safety of the device. Bench tests demonstrate the accuracy of critical items in the whole workflow of the device. The tests performed on the single items report satisfying results that back up the accurate performance of the new device for its achieved outputs when used as intended. The accuracy of data elaboration with its relative outcomes will ensure a safety placement of the clinical use and a positive impact on the overall healthcare situation."
It also explicitly states, "Clinical testing is not a requirement and has not been performed."
Therefore, I cannot provide the requested information in the specified format because the input text does not contain it.
§ 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).