(114 days)
Mimics 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 CT scanner or a Magnetic Resonance Imaging scanner to an output file. It is also used as pre-operative software for simulating /evaluating surgical treatment options. Mimics is not intended to be used for mammography imaging.
The Materialise Mimics software 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 CT scanner or a Magnetic Resonance Imaging scanner to an output file. It is also intended as pre-operative software for simulating / evaluating surgical treatment options. Mimics is not intended to be used for mammography imaging.
This 510(k) summary for the Mimics software does not provide any specific acceptance criteria or a study demonstrating that the device meets those criteria.
Instead, the submission focuses on establishing substantial equivalence to a previously cleared predicate device (SimPlant product from Materialise Dental, K033849). This means that the FDA determined Mimics is as safe and effective as the predicate device based on its similar design, materials, function, and indications for use.
Therefore, I cannot populate the table or answer the specific questions requested, as the information is not present in the provided document.
Here's why and what can be inferred:
- Acceptance Criteria & Reported Performance: No specific performance metrics (e.g., accuracy, precision, sensitivity, specificity for image segmentation or surgical simulation) are mentioned. The concept of "acceptance criteria" is not explicitly discussed in the context of device performance.
- Study Details: There's no description of a study conducted to prove the device meets performance criteria. The clearance is based on substantial equivalence, not a new clinical performance study.
- Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth: None of these details are provided because a direct performance study, as typically described by these parameters, was not the basis for this 510(k) clearance.
- Training Set: There is no mention of a training set as the clearance is not based on an AI/ML model for diagnostic or predictive purposes that would typically require a training set. The device is described as an "image processing system" and "preoperative software for simulating surgical treatment options," implying functionality rather than a learned algorithm.
Conclusion based on the provided document:
The Mimics software received 510(k) clearance by demonstrating substantial equivalence to a predicate device (SimPlant System, K033849). This type of clearance typically relies on showing that the new device has similar technological characteristics and performance (or provides equivalent performance) to a device already on the market, rather than requiring new, independently established acceptance criteria and a performance study against those criteria. The provided document details the regulatory classification, indications for use, and the basis for substantial equivalence, but not a specific performance study.
§ 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).