(189 days)
No
The summary describes standard image processing and quantitative analysis techniques, with no mention of AI, ML, or deep learning. The performance evaluation focuses on statistical comparisons and agreement with expert reads, not on the training or validation of an AI/ML model.
No
Explanation: The device is a software tool used to aid in evaluation and information management of digital medical images for diagnosis, treatment evaluation, and treatment planning. It does not exert a therapeutic effect on the patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that the software assists in "Registration, fusion display, and review of medical images for diagnosis, treatment evaluation, and treatment planning." It also mentions "Localization and definition of objects such as tumors and normal tissues in medical images," which aids in diagnosis. Furthermore, the device is used to evaluate "cardiac left ventricular function and perfusion," and helps in "Quantitative and statistical analysis of PET/SPECT brain scans by comparing to other registered PET/SPECT brain scans," all of which contribute to diagnostic processes.
Yes
The device description explicitly states that MIM - Centiloid Scaling is a "standalone software application" and extends the functionality of a predicate software device. The summary focuses entirely on software features, algorithms, and performance testing related to image processing and calculation, with no mention of accompanying hardware components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that this software is used to process and analyze medical images obtained from various imaging modalities (CT, MR, PET, etc.). These are images of the body, not specimens taken from the body (like blood, urine, tissue samples, etc.).
- The device description focuses on image processing and analysis. The core functions involve receiving, transmitting, storing, displaying, processing, and analyzing medical images. While it performs calculations (like SUVr and Centiloid scaling), these calculations are based on the image data, not on the results of tests performed on biological specimens.
- The performance studies evaluate the accuracy of image-based calculations and comparisons. The studies described involve comparing SUVr values and Centiloid calculations to published values and expert visual reads of images. This is consistent with the evaluation of an image analysis tool, not an IVD.
Therefore, while this device is a medical device used in the diagnostic process, it falls under the category of medical image analysis software, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
LLZ
Device Description
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™)
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, CR, DX, MG, US, SPECT, PET and XA
Anatomical Site
Brain, Cardiac (Left Ventricle), General (tumors and normal tissues)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical professionals including, but not limited to, radiologists, oncologists, physicians, medical technologists, dosimetrists and physicists.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
- GAAIN database: used tracer data cohorts and GAAIN-published Centiloid values for each scan to evaluate accuracy of Centiloid calculation.
- ADNI2 study: 100 Amyvid scans. Visual reads by consensus expert.
- Multi-center Phase II clinical trial: 109 Neuraceq scans. Visual reads by consensus expert.
- Multi-center Phase II clinical trial: 79 Vizamyl scans. Visual reads by consensus expert.
Summary of Performance Studies
Software verification and validation testing was performed for the three FDA-cleared amyloid tracers: Florbetapir (Amyvid®), Florbetaben (Neuraceg®), and Flutemetamol (Vizamyl™); Testing was performed for the qualification of the MIM pipeline to the Centiloid scale and to evaluate the accuracy of Centiloid quantification using consensus expert visual reads as the standard of truth.
SUVr calculation within MIM - Centiloid Scaling was validated by following the processes described in The Centiloid Project' for calibrating a non-PiB tracer to the Centiloid scale. This process involves computing and comparing MIM SUVr values to the GAAIN-published SUVr values for each subject with tracer-specific patient cohorts available from the GAAIN database.
SUVr values were first computed using the published GAAIN Regions in MIM's PET registration pipeline and then recomputed using the Florbetapir Clark Regions. To assess the accuracy of SUVr calculation in MIM - Centiloid Scaling in comparison to the GAAIN-published values, these results were compared to a previously published study using Clark Regions for Centiloid calculation. SUVr calculation in MIM - Centiloid Scaling yielded linear regressions with R2 values greater than 0.97 for GAAIN Regions and greater than 0.96 for Clark regions across all three tracers. These results are comparable to those in Navitsky et al.2, where SUVr results with GAAIN regions yielded an R² of 0.89 and an R² of 0.90 using Clark Regions.
To create Centiloid conversion equations for each tracer, the next test described in The Centiloid Project' was to see if a linear regression of MIM-calculated SUVr with Clark regions for each tracer and GAAIN-published SUVr for PiB scans for the same subjects yielded an R2 > 0.70. Regression plots for each tracer yielded R2 > 0.91, therefore the regression equations (Tracer SUVr = PiB SUVr *slope - intercept) were validated for use in the Centiloid conversion equation.
Using the tracer data cohorts from the GAAIN database and the GAAIN-published Centiloid values for each scan, the accuracy of Centillod calculation in MIM - Centiloid Scaling was evaluated. Linear regression yielded R2 values of 0.97, 0.98, and 0.96 for Amyvid, Neuraceg, and Vizamyl, respectively. Bland-Altman plots showed minimal bias (all
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency name in a lighter blue. The text reads "FDA U.S. FOOD & DRUG ADMINISTRATION".
May 20, 2024
MIM Software Inc. Sydney Lindner Senior Clinical Engineer 25800 Science Park Drive Suite 180 Cleveland, Ohio 44122
Re: K233620
Trade/Device Name: MIM - Centiloid Scaling Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: April 19, 2024 Received: April 19, 2024
Dear Sydney Lindner:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
2
Indications for Use
Submission Number (if known)
Device Name
MIM - Centiloid Scaling
Indications for Use (Describe)
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 FDAapproved 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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
3
Image /page/3/Picture/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" underneath in a smaller font.
25800 Science Park Drive - Suite 180 Cleveland, OH 44122 866-421-2536 www.mimsoftware.com
510(k) Summary (The following information is in conformance with 21 CFR 807.92)
Submitter
MIM Software Inc. 25800 Science Park Drive - Suite 180 Cleveland, OH 44122
| Phone: | 216-455-0600 |
|---|---|
| Fax: | 216-455-0601 |
| Contact Person: | Sydney Lindner |
| Date Summary Prepared: | April 19, 2024 |
Device Name
Trade Name:
Common Name:
Requlation Number / Product Code:
Classification Name:
MIM - Centiloid Scaling
Medical Imaging Software
21 CFR 892.2050 Product Code LLZ
System, Imaging Processing, Radiological
Predicate Devices
K223800 MIM - Additional Tracers Primary: Secondary: K060816 MIM 4.0 (NEURO)
MIM Software Inc. MIM Software Inc.
Intended Use
MIM software is intended for trained medical professionals including, but not limited to, radiologists, oncologists, physicians, medical technologists, dosimetrists and physicists.
4
Image /page/4/Picture/0 description: The image is a logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" in a smaller font below it. The logo is clean and modern, with a focus on simplicity and readability.
MIM is a medical image and information management system that is intended to receive, transmit, store, retrieve, display, print, and process digital medical images, as well as create, display, and print reports from those images. The medical modalities of these medical imaging systems 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 provides the user with the means to display, register, and fuse medical images from multiple modalities. Additionally, it evaluates cardiac left ventricular function and perfusion, including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction.
The Region of Interest (ROI) feature reduces the time necessary for the user to define objects in medical image volumes by providing an initial definition of object contours. The objects include, but are not limited to, tumors and normal tissues.
MIM provides tools to quickly create, transform, and modify 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.
MIM aids in the assessment of PET/SPECT brain scans. It provides automated quantitative and statistical analysis by automatically registering PET/SPECT brain scans to a standard template and comparing intensity values to a reference database or to other PET/SPECT scans on a voxel-by-voxel basis, within stereotactic surface projections or standardized regions of interest.
MIM allows the dose distribution of an implant to be individually shaped for each patient and is a general-purpose brachytherapy planning system used for prospective and confirmation dose calculations for patients undergoing a course of brachytherapy using permanent implants of various radioisotopes (not including radioactive microspheres).
MIM allows voxel-based dose calculations for patients who have been administered radioisotopes or radioactive microspheres.
Indications for Use
MIM software is used by trained medical professionals as a tool to aid in the 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:
5
Image /page/5/Picture/0 description: The image is a logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" in a smaller font below it.
- 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 imaqes.
- · 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 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 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.
6
Image /page/6/Picture/0 description: The image is a logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the text "mim" in a sans-serif font, with the word "SOFTWARE" below it in a smaller font.
| Subject Device: | Primary Predicate Device: | Secondary Predicate Device: | |
|---|---|---|---|
| ITEM | MIM - Centiloid Scaling | ||
| (K233620) | MIM - Additional Tracers | ||
| (K223800) | MIM 4.0 (NEURO) | ||
| (K060816) | |||
| Clearance Date | TBD | January 17, 2023 | May 16, 2006 |
| Intended Use | MIM software is intended for | ||
| trained medical professionals | |||
| including, but not limited to, | |||
| radiologists, oncologists, | |||
| physicians, medical | |||
| technologists, dosimetrists, | |||
| and physicists. |
MIM is a medical image and
information management
system that is intended to
receive, transmit, store,
retrieve, display, print and
process digital medical
images, as well as create,
display, and print reports from
those images. The medical
modalities of these medical
imaging systems 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 software is intended for
trained medical professionals
including, but not limited to,
radiologists, oncologists,
physicians, medical
technologists, dosimetrists,
and physicists.
MIM is a medical image and
information management
system that is intended to
receive, transmit, store,
retrieve, display, print and
process digital medical
images, as well as create,
display, and print reports from
those images. The medical
modalities of these medical
imaging systems 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 4.0 (NEURO) is a
software package that
provides the physician with the
means to display, register and
fuse medical images from
multiple modalities. |
| | MIM provides the user with
the means to display, register
and fuse medical images from
multiple modalities.
Additionally, it evaluates
cardiac left ventricular
function and perfusion,
including left ventricular
end-diastolic volume,
end-systolic volume, and
ejection fraction. | MIM provides the user with
the means to display, register
and fuse medical images from
multiple modalities.
Additionally, it evaluates
cardiac left ventricular
function and perfusion,
including left ventricular
end-diastolic volume,
end-systolic volume, and
ejection fraction. | Additionally, it evaluates
cardiac left ventricular function
and perfusion including left
ventricular end-diastolic
volume, end-systolic volume,
and ejection fraction. |
| | The Region of Interest (ROI)
feature reduces the time
necessary for the user to
define objects in medical
image volumes by providing
an initial definition of object
contours. The objects include,
but are not limited to, tumors
and normal tissues.
MIM provides tools to quickly
create, transform, and modify | The Region of Interest (ROI)
feature reduces the time
necessary for the user to
define objects in medical
image volumes by providing
an initial definition of object
contours. The objects include,
but are not limited to, tumors
and normal tissues.
MIM provides tools to quickly
create, transform, and modify | The Region of Interest (ROI)
feature reduces the time
necessary for the physician to
define objects in medical
image volumes by providing
an initial definition of object
contours. The objects include
but are not limited to tumors
and organs. |
| | 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. | 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. | MIM 4.0 (NEURO) also aids
the physician in the
assessment of PET/SPECT
brain scans. It provides
automated quantitative and
statistical analysis by
automatically registering
PET/SPECT brain scans to a
standard template and
comparing intensity values to a
reference database or to other
PET/SPECT scans on a voxel
by voxel basis, within
stereotactic surface
projections, or within
standardized
regions of interest. |
| | MIM aids in the assessment
of PET/SPECT brain scans. It
provides automated
quantitative and statistical
analysis by automatically
registering PET/SPECT brain
scans to a standard template
and comparing intensity
values to a reference
database or to other
PET/SPECT scans on a
voxel-by-voxel basis, within
stereotactic surface
projections or standardized
regions of interest. | MIM aids in the assessment
of PET/SPECT brain scans. It
provides automated
quantitative and statistical
analysis by automatically
registering PET/SPECT brain
scans to a standard template
and comparing intensity
values to a reference
database or to other
PET/SPECT scans on a
voxel-by- voxel basis, within
stereotactic surface
projections or standardized
regions of interest. | |
| | MIM allows the dose
distribution of an implant to be
individually shaped for each
patient and is a
general-purpose
brachytherapy planning
system used for prospective
and confirmation dose
calculations for patients
undergoing a course of
brachytherapy using
permanent implants of various
radioisotopes (not including
radioactive microspheres). | MIM allows the dose
distribution of an implant to be
individually shaped for each
patient and is a
general-purpose
brachytherapy planning
system used for prospective
and confirmation dose
calculations for patients
undergoing a course of
brachytherapy using
permanent implants of various
radioisotopes (not including
radioactive microspheres). | |
| | MIM allows voxel-based dose
calculations for patients who
have been administered
radioisotopes or radioactive
microspheres. | MIM allows voxel-based dose
calculations for patients who
have been administered
radioisotopes or radioactive
microspheres. | |
| Indications for
Use | 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, | 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, | 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. |
| CT, MR, CR, DX, MG, US,
SPECT, PET and XA as
supported by ACR/NEMA
DICOM 3.0. MIM assists in
the following indications: | 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. | • Receive, transmit, store,
retrieve, display, print, and
process medical images and
DICOM objects. | | |
| • Create, display, and print
reports from medical images. | • Create, display and print
reports from medical images. | | |
| • Registration, fusion display,
and review of medical images
for diagnosis, treatment
evaluation, and treatment
planning. | • 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. | • 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. | • Localization and definition of
objects such as tumors and
normal tissues in medical
images. | MIM assists in definition of
structures in medical images
including tumors, organs, and
cardiac left ventricular cavity. | |
| • 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. | • 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. | • Quantitative and statistical
analysis of PET/SPECT brain
scans by comparing to other
registered PET/SPECT brain
scans. | MIM aids in the assessment of
PET/SPECT brain scans by
providing quantitative and
statistical comparisons to other
registered PET/SPECT brain
scans. | |
| • Planning and evaluation of
permanent implant
brachytherapy procedures
(not including radioactive
microspheres). | • Planning and evaluation of
permanent implant
brachytherapy procedures
(not including radioactive
microspheres). | | |
| | • Calculating absorbed
radiation dose as a result of
administering a radionuclide. | • Calculating absorbed
radiation dose as a result of
administering a radionuclide. | • 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. | 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. | 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. | 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. | 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. |
| Operating
Platform | Microsoft Windows, Apple®
OS X, Linux-based OS | Microsoft Windows, Apple®
OS X, Linux-based OS | Microsoft Windows |
| Supported
Imaging
Modalities | CT, MR, CR, DX, MG, US,
NM, PET, XA, and other
DICOM modalities | CT, MR, CR, DX, MG, US,
NM, PET, XA, and other
DICOM modalities | CT, MR, NM, PET, OT, and
other DICOM modalities |
| Receive,
transmit,
display, general
manipulation
(window/level,
pan, zoom,
cross-hairs,
slice
navigation),
and
co-registration
of medical
images | Yes | Yes | Yes |
| Radiopharmac
eutical-specific
template | Yes, unchanged from MIM –
Additional Tracers (K223800) | Yes | Yes |
| registration | | | |
| Amyloid PET
Quantification | Voxel-based z-scores,
regional z-scores, regional
SUVr, global SUVr,
Centiloid scaling | Voxel-based z-scores,
regional z-scores, regional
SUVr, global SUVr | Voxel-based z-scores, regional
z-scores, regional SUVr, global
SUVr |
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Image /page/7/Picture/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" underneath in a smaller font. The logo is simple and modern, with a focus on the company's name.
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Image /page/8/Picture/0 description: The image is a logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle in the intersection. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" in a smaller font below it.
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Image /page/9/Picture/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" in a smaller font below it. The logo is simple and modern, with a focus on the company's name.
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Device Description
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™)
Substantial Equivalence
MIM - Centiloid Scaling is substantially equivalent to the predicate devices, MIM -Additional Tracers (K223800) and MIM 4.0 (NEURO) (K060816).
Testing and Performance Data
Software verification and validation testing was performed for the three FDA-cleared amyloid tracers: Florbetapir (Amyvid®), Florbetaben (Neuraceg®), and Flutemetamol (Vizamyl™); Testing was performed for the qualification of the MIM pipeline to the Centiloid scale and to evaluate the accuracy of Centiloid quantification using consensus expert visual reads as the standard of truth.
SUVr calculation within MIM - Centiloid Scaling was validated by following the processes described in The Centiloid Project' for calibrating a non-PiB tracer to the Centiloid scale. This process involves computing and comparing MIM SUVr values to the GAAIN-published SUVr values for each subject with tracer-specific patient cohorts
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Image /page/11/Picture/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" in a smaller font below it. The logo is clean and modern, with a simple color scheme.
available from the GAAIN database. SUVr values were first computed using the published GAAIN Regions in MIM's PET registration pipeline and then recomputed using the Florbetapir Clark Regions. To assess the accuracy of SUVr calculation in MIM - Centiloid Scaling in comparison to the GAAIN-published values, these results were compared to a previously published study using Clark Regions for Centiloid calculation. SUVr calculation in MIM - Centiloid Scaling yielded linear regressions with R2 values greater than 0.97 for GAAIN Regions and greater than 0.96 for Clark regions across all three tracers. These results are comparable to those in Navitsky et al.2, where SUVr results with GAAIN regions yielded an R² of 0.89 and an R² of 0.90 using Clark Regions.
To create Centiloid conversion equations for each tracer, the next test described in The Centiloid Project' was to see if a linear regression of MIM-calculated SUVr with Clark regions for each tracer and GAAIN-published SUVr for PiB scans for the same subjects yielded an R2 > 0.70. Regression plots for each tracer yielded R2 > 0.91, therefore the regression equations (Tracer SUVr = PiB SUVr *slope - intercept) were validated for use in the Centiloid conversion equation.
The Centiloid equation for a non-PiB tracer is defined as,
$$^{\text{Tracer}}\text{Centiloid} = \frac{^{pIB-Calc}{SUbr}{\text{Tracer}} - ^{\text{PIB}}\text{SUbr}{\text{Yc}-0}}{^{pIB}{SUbr} - ^{\text{PIB}}\text{SUbr}{\text{Yc}-0}} ^{\ast}\mathbf{100}$$
where $SUVr_{Tracer}^{PIB-Calc}$ is computed using the previously validated regression equations from tracer SUVr to PiB SUVr. The healthy control cohort (YC-0) and AD patient cohort (AD-100) values are the Centiloid scale anchor points, defined as the mean PiB SUVr values for a standard cohort of young (