(231 days)
Yes
The device description explicitly states that it "automatically creates contours on medical images through the use of machine-learning algorithms." Additionally, the training and test set descriptions mention the use of "neural network models," which are a type of machine learning.
No.
The device is a tool to assist in the automated processing of medical images and does not directly provide therapy.
No
This device is described as a tool to assist in the automated processing of digital medical images and to create contours for applications like quantitative analysis and aiding adaptive therapy. It is an image processing and segmentation tool, not a device that makes a diagnosis.
Yes
The device is described as software that operates on standard computer systems (Windows, Mac, Linux) and is deployed either remotely or locally on a workstation. It functions as an accessory to existing software and processes digital medical images. There is no mention of proprietary hardware components being part of the device itself.
Based on the provided information, it is highly likely that this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "tool to assist in the automated processing of digital medical images of modalities CT and MR". While it doesn't directly analyze biological samples, the processing of medical images for diagnostic purposes falls under the broader scope of devices used in healthcare for diagnosis and treatment planning.
- Creation of Contours for Applications: The intended use lists applications like "quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management." These are all activities that contribute to the diagnostic process, treatment planning, and patient management, which are key aspects of healthcare where IVDs play a role.
- Segmenting Normal Structures: The segmentation of normal structures is a step in analyzing medical images to identify abnormalities or for treatment planning. This analysis contributes to the overall diagnostic picture.
- Input Imaging Modality: The use of CT and MR images, which are standard diagnostic imaging modalities, further supports its role in the diagnostic process.
- Intended User: The intended users are "Trained medical professionals," indicating its use in a clinical setting for medical purposes.
- Device Description: While described as an "accessory to MIM software," its function of automatically creating contours on medical images using machine learning is a specific processing step that contributes to the interpretation of those images for medical purposes.
Why it's not a definitive "Yes" without further context:
The definition of an IVD can be nuanced and depends on the specific regulatory framework (e.g., FDA in the US, CE marking in Europe). While the intended use strongly suggests a diagnostic purpose, a device is typically classified as an IVD if it is intended to be used in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
In this case, the device processes images derived from the human body, not biological specimens. However, regulatory bodies often classify software that processes medical images for diagnostic purposes as medical devices, and sometimes specifically as IVDs or devices with similar regulatory requirements due to their impact on diagnosis and treatment.
In summary:
While the device doesn't directly analyze biological samples, its intended use in processing medical images for diagnostic and treatment planning purposes, used by medical professionals, strongly aligns with the function of devices that contribute to the diagnostic process. Therefore, it is highly probable that this device is regulated as an IVD or a medical device with similar regulatory oversight.
To be absolutely certain, one would need to consult the specific regulatory classification assigned to this device by the relevant regulatory body (e.g., the FDA's classification database for K193252). However, based on the provided description, it fits the functional profile of a device used in the diagnostic workflow.
No
The provided text does not contain any explicit statements indicating that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
Trained medical professionals use Contour ProtegeAI as a tool to assist in the automated processing of digital medical images of modalities CT and MR, as supported by ACR/NEMA DICOM 3.0. In addition, Contour ProtégéAI supports the following indications:
· Creation of contours using maching algorithms 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.
· Segmenting normal structures across a variety of CT anatomical locations.
· And segmenting normal structures of the prostate, seminal vesicles, and urethra within T2-weighted MR images.
Appropriate image visualization software must be used to review and, if necessary, edit results automatically generated by Contour ProtégéAI.
Product codes
QKB
Device Description
Contour ProtégéAl is an accessory to MIM software that automatically creates contours on medical images through the use of machine-learning algorithms. It is designed for use in the processing of medical images and operates on Windows, Mac, and Linux computer systems. Contour ProtégéAl is deployed on a remote server using the MIMcloud service for data management and transfer; or locally on the workstation or server running MIM software.
Mentions image processing
Trained medical professionals use Contour ProtegeAI as a tool to assist in the automated processing of digital medical images of modalities CT and MR, as supported by ACR/NEMA DICOM 3.0.
Mentions AI, DNN, or ML
Creation of contours using maching algorithms 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.
Contour ProtégéAl is an accessory to MIM software that automatically creates contours on medical images through the use of machine-learning algorithms.
Input Imaging Modality
CT and MR
Anatomical Site
Segmenting normal structures across a variety of CT anatomical locations. And segmenting normal structures of the prostate, seminal vesicles, and urethra within T2-weighted MR images.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained medical professionals
Description of the training set, sample size, data source, and annotation protocol
For the proposed Contour ProtégéAl device, neural network models were trained for each modality (CT and MR) on a pool of training data that did not include any patients from the same institution as the test subjects.
Description of the test set, sample size, data source, and annotation protocol
The models were then evaluated on the test subjects, and a Dice coefficient was calculated for each structure. These Dice coefficients were then aggregated, overall patients.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-inferiority testing was used to compare the proposed Contour ProtégéAl device to atlases created from the MIM Maestro reference device.
The mean and standard deviation Dice coefficients, along with the lower 95th percentile confidence bound, were calculated for both the proposed Contour ProtégéAl device and the MIM Maestro atlas segmentation reference device for each structure of each neural network model. Contour ProtégéAI results were equivalent or had better performance than the MIM atlas seqmentation reference device. Equivalence is defined such that the lower 95th percentile confidence bound of the Contour ProtégéAl segmentation is greater than 0.1 Dice lower than the mean MIM Maestro atlas segmentation reference device performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Dice coefficients
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
MIM Software Inc. % Lynn Hanigan Quality Assurance Director 25800 Science Park Drive - Suite 180 CLEVELAND OH 44122
Re: K210632
Trade/Device Name: Contour ProtégéAI Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QKB Dated: September 17, 2021 Received: September 20, 2021
Dear Lynn Hanigan:
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 (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 located 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.
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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,
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210632
Device Name
Contour ProtégéAI
Indications for Use (Describe)
Trained medical professionals use Contour ProtegeAI as a tool to assist in the automated processing of digital medical images of modalities CT and MR, as supported by ACR/NEMA DICOM 3.0. In addition, Contour ProtégéAI supports the following indications:
· Creation of contours using maching algorithms 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.
· Segmenting normal structures across a variety of CT anatomical locations.
· And segmenting normal structures of the prostate, seminal vesicles, and urethra within T2-weighted MR images.
Appropriate image visualization software must be used to review and, if necessary, edit results automatically generated by Contour ProtégéAI.
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) |
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Image /page/3/Picture/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping rounded squares, one red and one gray, 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 palette.
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:
Lynn Hanigan
Date Summary Prepared:
October 12, 2021
Device Name
| Trade Name: | Contour ProtégéAl |
|---|---|
| Common Name: | Medical Imaging Software |
| Regulation Number / Product Code: | 21 CFR 892.2050 / Product Code QKB |
| Classification Name: | Medical image management and processing system |
Predicate Device
| K193252 | Contour ProtégéAl | MIM Software Inc. |
|---|---|---|
| Reference Device | ||
| K071964 | MIM 4.1 SEASTAR (tradename MIM Maestro) | MIMvista Corp. |
Intended Use
Contour ProtégéAl is an accessory to MIM software. It includes processing components to allow the contouring of anatomical structures using machine-learning-based algorithms automatically.
Appropriate image visualization software must be used to review and, if necessary, edit results automatically generated by Contour ProtégéAI.
Contour ProtégéAl is not intended to detect or contour lesions.
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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, and the colors are eye-catching.
Indications for Use
Trained medical professionals use Contour ProtégéAl as a tool to assist in the automated processing of digital medical images of modalities CT and MR, as supported by ACR/NEMA DICOM 3.0. In addition, Contour ProtégéAl supports the following indications:
- Creation of contours using machine-learning algorithms 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.
- Segmenting anatomical structures across a variety of CT anatomical locations.
- . And segmenting normal structures of the prostate, seminal vesicles, and urethra within T2-weighted MR images.
Appropriate image visualization software must be used to review and, if necessary, edit results automatically generated by Contour ProtégéAI.
Device Description
Contour ProtégéAl is an accessory to MIM software that automatically creates contours on medical images through the use of machine-learning algorithms. It is designed for use in the processing of medical images and operates on Windows, Mac, and Linux computer systems. Contour ProtégéAl is deployed on a remote server using the MIMcloud service for data management and transfer; or locally on the workstation or server running MIM software.
Substantial Equivalence
| ITEM | Contour ProtégéAl | Contour ProtégéAl
(K193252) | MIM 4.1 SEASTAR
[i.e., MIM Maestro]
(K071964) |
|--------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clearance Dates | TBD | 7/2/2020 | 9/26/2007 |
| Intended Use | Contour ProtégéAl is an
accessory to MIM software
used for the contouring of
anatomical structures in
imaging data using
machine-learning-based
algorithms automatically.
Appropriate image
visualization software must
be used to review and, if | Contour ProtégéAl is an
accessory to MIM software
used for the contouring of
anatomical structures in
imaging data using
machine-learning-based
algorithms automatically.
Contour ProtégéAl must
be used in conjunction
with MIM software to | MIM 4.1 (SEASTAR)
software is intended for
trained medical
professionals including,
but not limited to,
radiologists, oncologists,
physicians, medical
technologists,
dosimetrists, and
physicists. |
| ITEM | Contour ProtégéAl | Contour ProtégéAl
(K193252) | MIM 4.1 SEASTAR
[i.e., MIM Maestro]
(K071964) |
| | necessary, edit results
automatically generated by
Contour ProtégéAl.
Contour ProtégéAl is not
intended to detect or
contour lesions. | review and, if necessary,
edit results automatically
generated by Contour
ProtégéAl.
Contour ProtégéAl is not
intended to detect or
contour lesions
automatically. | MIM 4.1 (SEASTAR) 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 4.1 (SEASTAR)
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. |
| ITEM | Contour ProtégéAl | Contour ProtégéAl
(K193252) | MIM 4.1 SEASTAR
[i.e., MIM Maestro]
(K071964) |
| Indications for
Use | Trained medical
professionals use Contour
ProtégéAl as a tool to assist
in the automated
processing of digital
medical images of
modalities CT and MR, as
supported by ACR/NEMA
DICOM 3.0. In addition,
Contour ProtégéAl supports
the following indications:
Creation of contours
using machine-learning
algorithms 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. Segmenting normal
structures across a
variety of CT
anatomical locations. And segmenting normal
structures of the
prostate, seminal
vesicles, and urethra
within T2-weighted MR
images. Appropriate image
visualization software must
be used to review and, if
necessary, edit results | Contour ProtégéAl is used
by trained medical
professionals as a tool to
aid in the automated
processing of digital
medical images of
modalities CT and MR, as
supported by ACR/NEMA
DICOM 3.0. Contour
ProtégéAl assists in the
following indications:
The creation of
contours using
machine-learning
algorithms 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. Segmenting normal
structures across a
variety of CT
anatomical locations. And segmenting
normal structures of
the prostate, seminal
vesicles, and urethra
within T2-weighted MR
images. Contour ProtégéAl must
be used in conjunction
with MIM software to
review and, if necessary,
edit contours that were | MIM 4.1 (SEASTAR)
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 4.1 (SEASTAR)
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. Localization and
definition of objects
such as tumors and
normal tissues in
medical images. Creation,
transformation, and
modification of contours
for applications |
| ITEM | Contour ProtégéAl | Contour ProtégéAl
(K193252) | MIM 4.1 SEASTAR
[i.e., MIM Maestro]
(K071964) |
| | automatically generated by
Contour ProtégéAl. | automatically generated
by Contour ProtégéAl. | 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. |
| Modalities | CT and MR | CT and MR | CT, MRI, CR, DX, MG,
US, SPECT, PET and
XA |
| Atlas-Based
Segmentation | No | No | Yes |
| Automatically
Contour Imaging
Data Using
Machine-Learning | Yes | Yes | No |
| ITEM | Contour ProtégéAl | Contour ProtégéAl
(K193252) | MIM 4.1 SEASTAR
[i.e., MIM Maestro]
(K071964) |
| Neural Network
Models included | (1.0.0 models)
Head and Neck CT
Prostate CT
Thorax CT
Liver CT
Prostate MR
(1.1.0 model)
Prostate MR
(2.0.0 models)
Head and Neck CT
Prostate CT
Thorax CT
Abdomen CT
Lungs and Liver CT | (1.0.0 models)
Head and Neck CT
Prostate CT
Thorax CT
Liver CT
Prostate MR | None |
| Operating
Platform | Server-based application
supporting
Linux-based OS
- and -
Local deployment on
Windows or Mac | Server-based application
supporting
Linux-based OS | Windows, Mac |
| Cloud-based
deployment | Yes | Yes | No |
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Image /page/5/Picture/0 description: The image is a logo for MIM Software. The logo consists of two overlapping squares, one red and one gray, with a white circle cut out of the red square. To the right of the squares is the text "mim" in black, bold letters. Below the text "mim" is the text "SOFTWARE" in smaller, black letters.
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Image /page/6/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 in the red square. To the right of the squares is the text "mim" in a bold, sans-serif font. Below the text "mim" is the text "SOFTWARE" in a smaller, sans-serif font.
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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 cut out of the red square. 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, and the colors are eye-catching.
8
Image /page/8/Picture/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red. 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.
9
Image /page/9/Picture/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping rounded squares, one red and one gray, with a white circle cut out of the red square. 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, and the colors are eye-catching.
| ITEM | Contour ProtégéAl | Contour ProtégéAl
(K193252) | MIM 4.1 SEASTAR
[i.e., MIM Maestro]
(K071964) |
|------------------------------------|-------------------|--------------------------------|-----------------------------------------------------|
| Locally deployed
(or installed) | Yes | No | Yes |
Discussion
Changes within this submission include a slightly modified Intended Use and Indications for Use, new and modified CT neural network models with additional contours, a modified Prostate MR neural network model, and added functionality to install locally on a MIM workstation or server. These changes differ when comparing to Contour ProtégéAl 510(k)193252. Non-inferiority testing was used to compare the proposed Contour ProtégéAl device to atlases created from the MIM Maestro reference device.
Testing and Performance Data
For the proposed Contour ProtégéAl device, neural network models were trained for each modality (CT and MR) on a pool of training data that did not include any patients from the same institution as the test subjects. The models were then evaluated on the test subjects, and a Dice coefficient was calculated for each structure. These Dice coefficients were then aggregated, overall patients.
With the MIM Maestro atlas segmentation reference device, multiple atlases were created over the test subjects. Each Atlas contained images of the same anatomical field of view from the same institution. Each structure appeared in one Atlas. For each patient in an Atlas was used to segment the structures in that patient. The test patient itself was excluded from this Atlas (leave-one-out analysis).
The mean and standard deviation Dice coefficients, along with the lower 95th percentile confidence bound, were calculated for both the proposed Contour ProtégéAl device and the MIM Maestro atlas segmentation reference device for each structure of each neural network model. Contour ProtégéAI results were equivalent or had better performance than the MIM atlas seqmentation reference device. Equivalence is defined such that the lower 95th percentile confidence bound of the Contour ProtégéAl segmentation is greater than 0.1 Dice lower than the mean MIM Maestro atlas segmentation reference device performance.
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Image /page/10/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 cut out of the red square. To the right of the squares is the text "mim" in a bold, sans-serif font. Below the text "mim" is the text "SOFTWARE" in a smaller, sans-serif font.
Conclusion
Based on the Discussion and Testing and Performance Data above, the proposed device is determined to be as safe and effective as its predicate device, Contour ProtégéAl 510(k)193252. In addition, the proposed device performs as well as the reference device, MIM 4.1 SEASTAR (k)071964 [MIM Maestro].