(119 days)
Mimics inPrint is intended for use as a software interface and image segmentation system for the transfer of DICOM imaging information from a medical scanner to an output file. It is also used as pre-operative software for treatment planning. For this purpose, the Mimics inPrint output file can be used for the fabrication of the output file using traditional or additive manufacturing methods.
The physical replica can be used for diagnostic purposes in the field of orthopedic, maxillofacial and cardiovascular applications. Mimics inPrint should be used in conjunction with other diagnostic tools and expert clinical judgement.
Mimics inPrint is an image processing and segmentation software that was built on top of the Mimics application framework, an image processing and segmentation framework for the transfer of imaging information to an output file.
The provided text describes a 510(k) submission for the device "Mimics inPrint." However, it does not contain any information about acceptance criteria, device performance, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth, or training set details. The "Performance Data" section briefly mentions "Non-clinical tests" and "measurement accuracy and calculate 3D study" but provides no specific results or methodologies for these tests.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. The text focuses on establishing substantial equivalence to a predicate device, as is common in 510(k) submissions, rather than providing detailed performance study results against specific acceptance criteria.
The 510(k) summary only states:
- "Measurement accuracy and calculate 3D study were performed and confirmed to be within specification." (No specific "specification" or acceptance criteria are provided, nor are the results of these studies.)
- "Validation of printing of physical replicas was performed and demonstrated that anatomical models for cardiovascular, orthopedic and maxillofacial cases can be printed accurately when using any of the compatible 3D printers." (Again, no specific "accuracy" metric or acceptance criteria are provided.)
To answer your questions, the provided text would need to contain a detailed performance study section with quantitative results against predefined acceptance criteria.
§ 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).