(56 days)
The MIMviewer software program is used for the registration, fusion and display of medical images from multi-modalities, such as SPECT, PET, CT, and MRI. MIMviewer provides tools for image review, manipulation, and analysis that assist physicians both inside and outside the medical environment.
MIMviewer is a software package designed for use in diagnostic imaging which operates on Windows 2000/XP, MacOS X 10.4+ and Linux. MIMviewer is designed to be used as a standalone software package, as a remote viewing client for the MIM (K060816) software package, or as CD-ROM DICOM viewer for referring physicians. MIMviewer provides the physician with the means to display, register and fuse medical images from multiple modalities including PET, SPECT, CT and MRI.
The provided text describes a 510(k) summary for the MIMviewer 1.0 software, a medical imaging software for displaying, registering, and fusing medical images. However, it does not contain specific details about acceptance criteria or a dedicated study proving these criteria were met.
The relevant section on "Performance Data" states: "MIMvista has conducted performance and functional testing on the MIMviewer software. In all cases, the software passed its' performance requirements and met specifications." This is a very general statement and lacks the specificity needed to answer your questions in detail.
Therefore, I cannot populate the table or provide specific answers to most of your questions based solely on the provided text.
Here's a breakdown of what can be inferred or what is explicitly missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "Passed its' performance requirements and met specifications." (No specific metrics or thresholds provided) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not specified. The document only mentions the software "aids the physician" but doesn't detail how testing was performed involving experts or ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not specified. The document describes MIMviewer as a tool for displaying, registering, and fusing images, not explicitly as an AI-assisted diagnostic tool in the sense of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not specified. The document states MIMviewer can be used as a standalone software package, but this refers to its operational mode, not a standalone performance study in the context of an algorithm's diagnostic accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified.
8. The sample size for the training set
- Not applicable/Not specified. The document describes MIMviewer as a software package for display, registration, and fusion of medical images. It does not indicate that it is an AI/ML device that requires a training set in the typical sense of a diagnostic algorithm.
9. How the ground truth for the training set was established
- Not applicable/Not specified. (See point 8).
Summary of what's provided:
- Device Name: MIMviewer 1.0
- Intended Use: Aids physicians in diagnosing patients by displaying, registering, and fusing medical images from multiple modalities (PET, SPECT, CT, MRI).
- Predicate Device: MIM™ 4.0 (NEURO) software (K060816).
- Performance Data Statement: "MIMvista has conducted performance and functional testing on the MIMviewer software. In all cases, the software passed its' performance requirements and met specifications."
In conclusion, the provided text offers a high-level overview of the device and its intended use but lacks the detailed performance study information, acceptance criteria, and methodology that your questions require. The statement regarding performance data is a general assertion rather than a detailed report of a 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).