(50 days)
The MIM software program should be used for the registration, fusion and display of medical images from multi-modalities, such as SPECT, PET, CT, and MRI. MIM assists in definition of structures in medical images including tumors, organs, and cardiac left ventricular cavity. MIM aids in the assessment of PET/SPECT brain scans by providing quantitative and statistical comparisons to other registered PET/SPECT brain scans.
MIM 4.0 (NEURO) is a software package designed for use in diagnostic imaging. It is a standalone software package which operates on Windows 2000/XP. Its intended function and use is to provide the physician with the means to display, register and fuse medical images from multiple modalities including DICOM FET, ECAT PET, SPECT, CT and MRI. Additionally it evaluates cardiac left ventricular function and perfusion including left ventricular end-diastolic volume, end-systolic volume, ejection fraction, volumetric curve, Region of Interest (ROI) contouring and quantitative/statistical analysis of PET/SPECT brain scans through nonlinear registration to template space.
The provided text, Koyo814, is a 510(k) Summary of Safety and Effectiveness for the MIM 4.0 (NEURO) device. It includes general information about the device, its intended use, and its equivalence to predicate devices. However, the document does not contain the detailed performance study information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9.
The "Performance Data" section merely states: "MIMvista has conducted performance and functional testing on the MIM 4.0 (NEURO) software. In all cases, the software passed its' performance requirements and met specifications." This is a general statement and does not provide any specific criteria, results, or details about the studies conducted.
Therefore, I cannot provide the requested information from the given text.
To answer your specific points:
- A table of acceptance criteria and the reported device performance: Not found in the document.
- Sample sized used for the test set and the data provenance: Not found in the document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not found in the document.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not found in the document.
- 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 found in the document.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document states MIM 4.0 (NEURO) is a "standalone software package," which implies standalone performance, but no details of such a study are provided.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not found in the document.
- The sample size for the training set: Not found in the document.
- How the ground truth for the training set was established: Not found in the document.
The document focuses on substantial equivalence to predicate devices rather than providing detailed performance study data for the new device's specific claims.
§ 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).