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510(k) Data Aggregation
(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 ( |
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(29 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, MRI, 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-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 this 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 mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Images that are printed to film must be printed using a 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 - Additional Tracers is an expansion of the standalone software application MIM -On Linux (K190379). MIM - Additional Tracers Indications for Use have not been modified, and the Intended Use is the same as in MIM - On Linux. With the addition of additional tracers to the standalone MIM software, engineering drawings, schematics, etc. are not applicable to the device.
These Indications for Use include quantitative and statistical analysis of PET/SPECT brain scans by comparing to other registered PET/SPECT brain scans. MIM - Additional Tracers includes the above features and capabilities and adds support for new PET/SPECT new tracers. While MIM - On Linux supported FDG and HMPAO tracers, this special 510k submission includes new tracers support for: Amyvid™ (Florbetapir), Vizamyl™ (Flutemetamol), Neuraceq™ (Florbetaben), and DaTscan™ (Joflupane).
MIM - Additional Tracers operates on Windows, Mac, and Linux computer systems.
The provided text describes the acceptance criteria and a study proving the device meets those criteria, specifically for the "MIM - Additional Tracers" software (K223800). The key information is extracted below.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list numerical acceptance criteria. Instead, it describes a validation process focused on the accuracy of template registration and quantitative analysis for the newly supported PET/SPECT tracers. The "reported device performance" is a qualitative statement of approval by experts.
| Acceptance Criteria (Inferred from testing) | Reported Device Performance |
|---|---|
| Accurate template registration for each tracer (Amyvid™, Vizamyl™, Neuraceq™, DaTscan™) and corresponding clinical use case. | Assessed and approved by a radiologist and MIM technical experts. Risk mitigation for automatic registration error is built-in with adjustment and verification steps. |
| Accurate placement of reference and analysis regions (specifically for DaTscan™). | Verified with built-in affine registration to the template and individual hemisphere verification and adjustment. |
| Creation of accurate normal patient databases for each tracer. | Alignment to template space and accuracy of analysis contours for each tracer were approved by a radiologist and MIM technical experts before inclusion. |
| Quantitative analysis results on representative population scans align with expert reads. | Compared to expert reads and reviewed by physicians and MIM technical experts. Discrepancies only acceptable for misregistered, borderline, or poor-quality scans. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "Normal patient scans were curated to span demographics appropriate for each tracer." The exact number of scans is not specified.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). It is implied that these are existing patient scans curated for the purpose of creating normal databases and performing quantitative analysis.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: A "radiologist" (singular) and "MIM technical experts" (plural) were involved. The exact number of MIM technical experts is not specified.
- Qualifications: "Radiologist" and "MIM technical experts" are provided as qualifications. No specific experience levels (e.g., "10 years of experience") are given for the radiologist.
4. Adjudication Method for the Test Set
The adjudication method appears to be a consensus-based approach with expert review and approval. For template registration accuracy, a radiologist and MIM technical experts assessed and approved. For normal patient database creation, the same group approved. For quantitative analysis, results were compared to expert reads and reviewed by physicians and MIM technical experts. Discrepancies were noted and deemed acceptable only under specific conditions (misregistered, borderline, or poor-quality scans). This suggests a process where expert input directly defines or validates the acceptable outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The study described focuses on the standalone performance of the software with expert review, not on human readers' improvement with AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone performance study was done. The description indicates that the software's template registration accuracy and quantitative analysis results were assessed by experts. The "risk mitigation for automatic registration error" built into the software, which includes "registration adjustment and verification steps" by the user, implies a workflow involving a human in the loop. However, the initial assessment and comparison of quantitative results to expert reads suggest an evaluation of the algorithm's output independently, even if human verification is part of the clinical workflow.
7. Type of Ground Truth Used
The ground truth was established through expert consensus/reads. For template registration and contour accuracy, a radiologist and MIM technical experts approved the alignment and contours. For quantitative analysis, results were compared to "expert reads" and reviewed by physicians and MIM technical experts.
8. Sample Size for the Training Set
The document does not explicitly mention a separate "training set" or its sample size. The description focuses on creating "normal patient scans...curated to span demographics appropriate for each tracer" which were then aligned to template space to create "databases for each tracer." These databases could be considered analogous to a reference/training set for the software's internal operations or for comparison, but it's not explicitly labeled as such for a machine learning model.
9. How the Ground Truth for the Training Set Was Established
If the "normal patient scans" and "databases for each tracer" are considered part of a training or reference set, then their ground truth was established by:
- Expert Approval: "Alignment to template space and accuracy of analysis contours for each tracer were approved by a radiologist and MIM technical experts before each series could be included in the normals database."
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