(139 days)
Mimics Medical is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. Mimics Medical is also intended for measuring and treatment planning. The Mimics Medical output 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 orthopaedic, maxillofacial and cardiovascular applications.
Mimics Medical should be used in conjunction with expert clinical judgement.
Mimics Medical is image processing software that allows the user to import, visualize and segment medical images, check and correct the segmentations, and create digital 3D models can be used in Mimics Medical for measuring, treatment planning and producing an output file to be used for additive manufacturing (3D printing). Mimics Medical also has functionality for linking to third party software packages. Mimics Medical is structured as a modular package. This includes the following functionality:
- Importing medical images in DICOM format and other formats (such as BMP, TIFF, JPG and raw images)
- Viewing images and DICOM data
- Selecting a region of interest using generic segmentation tools
- Segmenting specific anatomy using dedicated semi-automatic tools or fully automatic algorithms
- Verifying and editing a region of interest
- Calculating a digital 3D model and editing the model
- Measuring on images and 3D models
- Exporting images, measurements and 3D models to third-party packages
- Planning treatments (surgical cuts etc.) on the 3D models
- Interfacing with packages for Finite Element Analysis
- Creating Python scripts to automate workflows
Here's an analysis of the provided text to fulfill your request, focusing on the acceptance criteria and study proving device performance:
Unfortunately, the provided text (K183105 510(k) Summary for Mimics Medical) does not contain specific acceptance criteria, detailed study results, or information about expert involvement (number, qualifications, adjudication method), MRMC studies, or standalone performance of the algorithm. The document primarily focuses on demonstrating substantial equivalence to a predicate device based on similar technological characteristics and general performance statements.
The document mentions that "Deviations were within the acceptance criteria" but does not define what those acceptance criteria are. It also states that "all performance testing conducted device performance and substantial equivalence to the predicate device" but doesn't elaborate on the specifics of this testing.
Therefore, many of your specific questions cannot be answered from the provided text. I will, however, extract all relevant information from the document to construct as much of the table and detailed answers as possible, noting where information is missing.
Device Description and Intended Use
Device Name: Mimics Medical
Regulation Number: 21 CFR 892.2050
Regulation Name: Picture archiving and communications system
Regulatory Class: Class II
Product Code: LLZ
Intended Use Statement (from page 2 & 4):
Mimics Medical is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. Mimics Medical is also intended for measuring and treatment planning. The Mimics Medical output can be used for the fabrication of physical replicas 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 Medical should be used in conjunction with expert clinical judgement.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document mentions "acceptance criteria" but does not define them. The "Reported Device Performance" is also very summarized, lacking specific metrics or quantitative results.
| Acceptance Criteria Category | Specific Acceptance Criteria (as stated in document) | Reported Device Performance (as stated in document) |
|---|---|---|
| Geometric Accuracy (Virtual Models) | Not explicitly defined in this document. Stated as "Deviations were within the acceptance criteria." | "Accuracy of the virtual models was compared for the subject and predicate device. Deviations were within the acceptance criteria. This shows that for creating virtual models, Mimics Medical is substantially equivalent to the predicate device." |
| Geometric Accuracy (Physical Replicas) | Not explicitly defined in this document. Stated as "Deviations were within the acceptance criteria." | "Deviations were within the acceptance criteria, showing that virtual models can accurately be printed when using one of the compatible 3D printers." (This was assessed for cardiovascular, orthopedic, and maxillofacial models, comparing physical replicas to virtual models). |
| Overall Performance for Substantial Equivalence | Mimics Medical must be "as safe and effective, and performs as well as the predicate device." | "A comparison of intended use and technological characteristics combined with performance data demonstrates that Mimics Medical is substantially equivalent to the predicate device Mimics (K073468). Minor differences in intended use and technological characteristics exist, but performance data demonstrates that Mimics Medical is as safe and effective, and performs as well as the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not state the sample size used for the test set.
The document does not state the data provenance (e.g., country of origin of the data, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide any information on the number of experts used or their qualifications for establishing ground truth for the test set.
4. Adjudication Method for the Test Set
The document does not provide any information on the adjudication method used for the test set (e.g., 2+1, 3+1, none).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document does not indicate that an MRMC comparative effectiveness study was done. The performance evaluation focuses on "geometric accuracy" of models created by the software compared to a predicate device, not on human reader improvement with AI assistance. The device is a "software interface and image segmentation system," implying it's a tool for a user, rather than a standalone AI for diagnostic interpretation. The text also states, "Mimics Medical should be used in conjunction with expert clinical judgement," further suggesting it's a tool, not a replacement or direct assistant in the AI-for-diagnosis sense that would typically warrant an MRMC study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The study described is not a "standalone" algorithm performance study in the sense of an AI model making diagnostic interpretations. Mimics Medical is described as an "image processing software" and "software interface and image segmentation system" that allows users to segment, view, measure, and export data. While it contains "semi-automatic tools or fully automatic algorithms" for segmentation, the performance evaluation discussed (geometric accuracy of virtual models and physical replicas) assesses the output of the software as used, rather than a standalone diagnostic performance metric like sensitivity/specificity for a disease detection task. The product is a tool for creating models, not an algorithm that outputs a diagnostic decision without human input.
7. The Type of Ground Truth Used
The type of "ground truth" implied by the geometric accuracy testing would likely be:
- For virtual models: Comparison against either a known phantom or a reference standard measurement/model established with high precision (e.g., by the predicate device or a gold-standard metrology method). The document states "Accuracy of the virtual models was compared for the subject and predicate device," suggesting the predicate device's output might have served as a reference, or a common reference was used for both.
- For physical replicas: Comparison against the virtual models created by Mimics Medical. The document states, "The physical replicas were compared to the virtual models."
This is a technical ground truth based on geometric measurements, not a clinical ground truth like pathology or patient outcomes.
8. The Sample Size for the Training Set
The document does not provide any information on the sample size for the training set. The descriptions of "semi-automatic tools or fully automatic algorithms" hint at underlying algorithmic components that might require training, but no details are given.
9. How the Ground Truth for the Training Set Was Established
The document does not provide any information on how the ground truth for the training set was established.
§ 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).