(189 days)
MIM software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical images. The medical image modalities include, but are not limited to, CT, MR, CR, DX, MG, US, SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0. MIM assists in the following indications:
· Receive, transmit, store, retrieve, display, print, and process medical images and DICOM objects.
· Create, display, and print reports from medical images.
· Registration, fusion display, and review of medical images for diagnosis, treatment evaluation, and treatment planning.
· Evaluation of cardiac left ventricular function and perfusion, including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction.
· Localization and definition of objects such as tumors and normal tissues in medical images.
· Creation, transformation, and modification of contours for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management.
· Quantitative and statistical analysis of PET/SPECT brain scans by comparing to other registered PET/SPECT brain scans.
· Planning and evaluation of permanent implant brachytherapy procedures (not including radioactive microspheres).
· Calculating absorbed radiation dose as a result of administering a radionuclide.
When using the device clinically, within the United States, the user should only use FDA approved radiopharmaceuticals. If used with unapproved ones, this device should only be used for research purposes.
Lossy compressed mammoaraphic images and digitized film screen images must not be reviewed for primary image interpretations. Images that are printed to film must be printed using an FDA-approved printer for the diagnosis of digital mammography images. Mammographic images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images. The software is not to be used for mammography CAD.
MIM - Centiloid Scaling extends the features of MIM - Additional Tracers (K223800). It is designed for use in medical imaging and operates on Windows, Mac, and Linux computer systems. The intended use and indications for use in MIM - Centiloid Scaling are unchanged from the predicate device, MIM - Additional Tracers (K223800).
MIM - Centiloid Scaling is a standalone software application that extends the functionality of the predicate device by providing:
- · Conversion of SUVr calculations to a standardized Centiloid scale for PET-based amyloid burden measurement with Florbetapir (Amvvid®), Florbetaben (Neuraceq®), and Flutemetamol (Vizamyl™)
The MIM - Centiloid Scaling device is intended to convert SUVr (Standardized Uptake Value ratio) calculations to a standardized Centiloid scale for PET-based amyloid burden measurement using specific radiopharmaceuticals (Florbetapir (Amyvid®), Florbetaben (Neuraceq®), and Flutemetamol (Vizamyl™)).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the validation methods and desired outcomes of the Centiloid Project and comparisons to expert visual reads.
| Criterion | Reported Device Performance |
|---|---|
| SUVr Calculation Accuracy (against GAAIN-published values) | |
| - Linear regression R² for GAAIN Regions (across all 3 tracers) | > 0.97 |
| - Linear regression R² for Clark Regions (across all 3 tracers) | > 0.96 |
| (Comparable to Navitsky et al.²: GAAIN R²=0.89, Clark R²=0.90) | |
| Centiloid Conversion Equation Validation | |
| - Linear regression R² for MIM-calculated SUVr (Clark regions) vs. GAAIN-published SUVr (PiB scans) (across all 3 tracers) | > 0.91 (Acceptance criterion: R² > 0.70) |
| Centiloid Calculation Accuracy (against GAAIN-published Centiloid values) | |
| - Linear regression R² for Amyvid | 0.97 |
| - Linear regression R² for Neuraceq | 0.98 |
| - Linear regression R² for Vizamyl | 0.96 |
| - Bland-Altman bias | Minimal ( |
§ 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).