Predicate Devices

K231765 Contour ProtégéAl

Reference Devices

K071964 MIM 4.1 (SEASTAR) [i.e., MIM Maestro]

AI/ML (Artificial Intelligence / Machine Learning)

Yes
The device description explicitly states that it "automatically creates contours on medical images through the use of machine-learning algorithms." The intended use also mentions "Creation of contours using machine-learning algorithms".

Therapeutic

No.
The device is a tool to assist in the automated processing of medical images for quantitative analysis, aiding adaptive therapy, and transferring contours to radiation therapy treatment planning systems. It does not directly provide therapy or treatment.

Diagnostic

No

Explanation: The device is described as a tool to assist in the automated processing of digital medical images for tasks such as creating contours, segmenting anatomical structures, and aiding adaptive therapy. It does not provide a diagnosis or make clinical decisions.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states that Contour ProtégéAl+ is an accessory to MIM software and operates on standard computer systems (Windows, Mac, Linux). It is deployed either remotely or locally on a workstation/server, indicating it is a software application. While it processes medical images, it does not include or require dedicated hardware beyond the standard computing platforms.

IVD (In Vitro Diagnostic)

Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that trained medical professionals use the device to assist in the automated processing of digital medical images (CT and MR). This processing involves creating contours using machine-learning algorithms for applications like quantitative analysis, aiding adaptive therapy, and transferring contours to radiation therapy treatment planning systems. These are all activities performed in vitro (outside the living body) on biological samples (medical images derived from the patient).
Device Description: The device is described as an accessory to MIM software that automatically creates contours on medical images. This further reinforces its role in processing medical images in vitro.
Input Imaging Modality: The input is medical images (CT and MR), which are representations of the patient's internal structures obtained through imaging techniques. The device operates on these images, not directly on the patient.
Processing of Biological Samples: While the input is images, these images are derived from the patient and represent biological structures. The device processes these images to extract information (contours) about these biological structures.
Assisting in Medical Decisions: The contours created by the device are intended to assist medical professionals in various applications, including quantitative analysis and aiding adaptive therapy. This information derived from the in vitro processing of images is used to inform medical decisions regarding patient care.

While the device doesn't directly analyze biological fluids or tissues in the traditional sense of a lab test, the processing of medical images derived from a patient for the purpose of assisting in medical diagnosis, treatment planning, or monitoring falls under the scope of in vitro diagnostics as defined by regulatory bodies like the FDA. The device is performing an analysis on data derived from the patient's body to provide information relevant to their medical condition and treatment.

PCCP (Predetermined Change Control Plan) Authorized

No
The provided text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The 'Control Plan Authorized (PCCP) and relevant text' section explicitly states 'Not Found'.

Overview

Intended Use / Indications for Use

Trained medical professionals use Contour ProtégéAI 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 the prostate, the seminal vesicles, and the 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 (comma separated list FDA assigned to the subject device)

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

Yes

Mentions AI, DNN, or ML

Yes

Input Imaging Modality

CT and MR

Anatomical Site

Head and Neck, Prostate, Thorax, Liver, Abdomen, Lungs, Breast, Bronchus, Carina, Cricoid, Esophagus, Glnd_Thyroid, GreatVes, Heart, Humerus Head, Kidney, Larynx, Lung, Musc_Constrict, Pancreas, SpinalCord, Stomach, Trachea, A LAD, A Aorta Asc, Rib, Chestwall, LN Ax, LN IMN, LN Sclav, Bladder, Bowel, BowelBag, Cauda Equina, Female Pelvis, Colon Sigmoid, Femur Head, UteroCervix, LN Pelvics, Rectum, SacralPlex, Sacrum, Bone, Glnd_Lacrimal, Glnd_Subman, Parotid, Spleen.

Indicated Patient Age Range

The age breakdown of the training data, where patient age was available, was predominantly in the 40-60 and 60+ ranges. While this is appropriate to the intended patient populations, only a small proportion of testing and training data was for patients under 40, so more intensive review may be warranted for younger patients.

Intended User / Care Setting

Trained medical professionals

Description of the training set, sample size, data source, and annotation protocol

The CT images for this training set were obtained from clinical treatment plans for patients prescribed external beam or molecular radiotherapy, but the original segmentations were not used. Instead, the images were re-segmented by consultants (physicians and dosimetrists) specifically for this purpose, outside of clinical practice. Detailed instructions derived from relevant published contouring guidelines were prepared for the dosimetrists. The initial seqmentations were then reviewed and corrected by radiation oncologists against the same standards and guidelines. Qualified staff at MIM Software (MD or licensed dosimetrists) then performed a final review and correction. All segmenters and reviewers were instructed to spend additional time to ensure the highest quality training data. In particular, the consultants were asked to contour all specified OAR structures on all images according to referenced standards, whether or not they were proximal to the treatment field. All patients were imaged on an indexed couch in the treatment position ("simulation CT"). Series that were no-axial, had slices thinner than 0.5mm, or had non-Fan Beam or MV acquisitions were excluded.

Description of the test set, sample size, data source, and annotation protocol

The Contour ProtégéAl+ subject device was evaluated on the test subjects from a pool of 770 images gathered from 32 institutions.
The verification data used for testing is from a set of institutions that are totally disjoint from the datasets used to train each model in the Contour ProtégéAl+ device. The MIM Maestro (K071964) reference device was configured with Atlases built from the same training data used to train the models. We tested Contour ProtégéAl+ against the reference device, and the goal of this testing is to show that the subject device is equivalent or superior to the reference device. The performance of both segmentation devices was measured by calculating both the Dice score and MDA of the novel segmentations with the original ground-truth contours. User beta testing was also used to evaluate the performance of Contour ProtégéAl+ in the context of time savings compared to contouring from scratch. This user evaluation was made on a three-point scale for each contour, with one indicating negligible time savings, two indicating moderate, and three indicating significant time savings.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-inferiority testing was used to compare the Contour ProtégéAl+ subject device to Atlases created from the MIM Maestro (K071964) reference device.
The Contour ProtégéAl+ subject device was evaluated on the test subjects from a pool of 770 images gathered from 32 institutions.
The mean and standard deviation Dice coefficients and MDA scores, 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 ProtégéAl+ results were equivalent or had better performance than the MIM Maestro atlas segmentation 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 atlas segmentation reference device performance.
Each model was required to have statistically non-inferior cumulative APL compared to the reference predicate.
Each individual feature met the acceptance criteria defined for the verification and validation tests, and the entire software product was determined to be safe and effective for clinical use.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Dice score, MDA score, Added Path (APL), User evaluation (3-point scale).

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K231765 Contour ProtégéAl

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K071964 MIM 4.1 (SEASTAR) [i.e., MIM Maestro]

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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).

Summary

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February 3, 2025

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal of the Department of Health & Human Services - USA, which features an abstract image of an eagle. To the right of the seal, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue color. The word "FDA" is in a square box.

MIM Software Inc. Sydney Lindner Regulatory Affairs Engineer 25800 Science Park Drive, Suite 180 Cleveland, Ohio 44122

Re: K250035

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: January 7, 2025 Received: January 7, 2025

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"

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(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).

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 (OS) 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 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-regulatory

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assistance/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,

Locon Weidner

Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team 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

Enclosure

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Indications for Use

Submission Number (if known)

K250035

Device Name

Contour ProtégéAl+

Indications for Use (Describe)

Trained medical professionals use Contour ProtégéAI 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 the prostate, the seminal vesicles, and the 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/4/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 clean and modern, with a simple color palette.

510(k) Summary (The following information is in conformance with 21 CFR 807.92)

Submitter

K250035

MIM Software Inc. 25800 Science Park Drive - Suite 180 Cleveland, OH 44122

| Phone:
Fax: | 216-455-0600
216-455-0601 |
|------------------------|------------------------------|
| Contact Person: | Sydney Lindner |
| Date Summary Prepared: | January 7, 2025 |

Device Name

Trade Name:

Common Name:

Regulation Number / Product Code:

Classification Name:

Contour ProtégéAl+

Medical Imaging Software

21 CFR 892.2050 Product Code QKB

System, Imaging Processing, Radiological

Predicate and Reference Devices

Predicate:	K231765	Contour ProtégéAl	MIM Software Inc.
Reference:	K071964	MIM 4.1 (SEASTAR)
[i.e., MIM Maestro]	MIMvista Corp.

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Image /page/5/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 left of the text "mim SOFTWARE." The text is in a sans-serif font, with "mim" in a larger size than "SOFTWARE."

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 necessary, edit results automatically generated by Contour ProtégéAI.

Contour ProtégéAl is not intended to detect or contour lesions.

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 the prostate, the seminal vesicles, and the urethra within ● T2-weighted MR images.

Appropriate image visualization software must be used to review and, if necessary, edit results automatically generated by Contour ProtégéAl.

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.

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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 cut out of the red square 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.

Indications for use have not been modified. The intended use is the same as the last 510(k) clearance for Contour ProtégéAl (K231765).

In the upcoming 1.4.0 release, one new neural network model is being added and three existing neural network models are being updated by retraining with additional or updated contours which prompted this premarket submission of the subject device.

| ITEM | Subject Device:
Contour ProtégéAl+
(K250035) | Predicate Device:
Contour ProtégéAl
(K231765) | Substantial Equivalence
Discussion |
|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clearance
Date | TBD | November 8, 2023 | N/A |
| Operating
Platform | Server-based application
supporting:
• Linux-based OS
• Local deployment on
Windows or Mac | Server-based application
supporting:
• Linux-based OS
• Local deployment on
Windows or Mac | No change |
| Modalities | CT and MR | CT and MR | No change |
| Atlas-based
Segmentation | No | No | No change |
| Automatically
contour
imaging data
using
machine-
learning | Yes | Yes | No change |
| Cloud-based
Deployment | Yes | Yes | No change |
| Local
Deployment
or Installation | Yes | Yes | No change |
| Neural | (1.0.0 models) | (1.0.0 models) | The subject device contains |
| | Subject Device: | Predicate Device: | |
| ITEM | Contour ProtégéAl+
(K250035) | Contour ProtégéAl
(K231765) | Substantial Equivalence
Discussion |
| Network
Models
Included | • 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
(3.1.0 models)*
• Head and Neck CT
• Prostate CT
• Thorax CT
• Abdomen CT
• Lungs and Liver CT
• MRT Additional Structures
CT
(4.0.0 models)
• Head and Neck CT | • 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
(3.1.0 models)*
• Head and Neck CT
• Prostate CT
• Thorax CT
• Abdomen CT
• Lungs and Liver CT
• MRT Additional Structures
CT
(4.0.0 models)
• Head and Neck CT | one new neural network
model and three updated
neural network models
compared to the predicate.
These 4 models were all
trained on the same
architecture as the
predicate without any
changes. These 4 models
cover all the existing
structures for contouring
and additional, new
structures, which are
denoted in bold font.
These 4 models were all
tested according to the
same procedures and
acceptance criteria as the
predicate. No unexpected
results were observed. The
changes do not raise new
questions for safety and
effectiveness. |
| | • Thorax CT
• Abdomen CT
• Pelvis CT
• SurePlan MRT CT | • Thorax CT
• Abdomen CT
• Pelvis CT
• SurePlan MRT CT | |
| | (4.1.0 models)
• Head and Neck CT
• Thorax CT
• Whole Body -
Physiological
• Uptake Organs CT | (4.1.0 models)
• Head and Neck CT
• Thorax CT
• Whole Body -
Physiological
• Uptake Organs CT | |
| | (4.2.0 models) | | |
| | Subject Device: | Predicate Device: | |
| ITEM | Contour ProtégéAl+
(K250035) | Contour ProtégéAl
(K231765) | Substantial Equivalence
Discussion |
| | • Thorax CT

LN_IMN_L
LN_IMN_R
LN_Sclav_L
LN_Sclav_R
LN_Ax_L1_L
LN_Ax_L1_R
LN_Ax_L2_L
LN_Ax_L2_R
LN_Ax_L3_L
LN_Ax_L3_R
BrachialPlex_L***
BrachialPlex_R***
Breast_L***
Breast_R***
Breast_L_RTOG**
Breast_R_RTOG**
Bronchus
Carina
Cricoid
Esophagus
Glnd_Thyroid
GreatVes***
Heart***
Humerus_Head_L
Humerus_Head_R
Kidney_L
Kidney_R
Larynx***
Liver
Lung_L
Lung_R
Musc_Constrict
Pancreas
SpinalCord
Stomach***
Trachea
Ribs**
Chestwall_L**
Chestwall_R**
A_Asc_Aorta**
A_LAD**
• Abdomen CT
Bladder
Bowel*** | | |
| | Subject Device: | Predicate Device: | Substantial Equivalence |
| ITEM | Contour ProtégéAl+
(K250035) | Contour ProtégéAl
(K231765) | Discussion |
| | - Bowel Bag***
Cauda Equina
Left Kidney
Right Kidney
Liver
Spinal Cord
Stomach***
Female Pelvis CT**
Bowel Bag**
Bowel**
LN Pelvics**
Bladder**
Uterocervix**
Colon Sigmoid**
Cauda Equina**
Sacral Plexus**
Sacrum**
Rectum**
Femur Head L**
Femur Head R**
SurePlan MRT CT
Bone***
Glnd_Lacrimal_L
Glnd_Lacrimal_R
Glnd_Submand_L
Glnd_Submand_R
Glnd_Thyroid
Kidney_L (Kidney_L w/o
Renal Pelvis)
Kidney_R (Kidney_R
w/o Renal Pelvis)
Liver
Lung_L
Lung_R
Parotid_L
Parotid_R
Spleen | | |

Table 1 - Comparison to Predicate Device.

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Image /page/7/Picture/0 description: The image is a 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. Below the text "mim" is the word "SOFTWARE" in a smaller, sans-serif font.

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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 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.

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Image /page/9/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 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.

The 3.1.0 models share the same training images and architecture as the 3.0.0 models. Some errors and style inconsistencies in the training segmentations were corrected before re-training, resulting in the 3.1.0 models. ** Indicates new contour/model.

*** Indicates updated contour.

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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 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 clarity.

Testing and Performance Data

Changes within this submission compared to the predicate device, Contour ProtégéAl (K231765), include one new 4.2.0 neural network model and three updated 4.2.0 neural network models with additional or updated contours. Non-inferiority testing was used to compare the Contour ProtégéAl+ subject device to Atlases created from the MIM Maestro (K071964) reference device.

Verification and validation tests were performed for each of the core features of Contour ProtégéAl+:

Contour creation time savings ●
Clinical quality contour generation ●

The testing methods include both internal verification by MIM Software's own qualified testers and external validation by trained medical professionals.

The Contour ProtégéAl+ subject device was evaluated on the test subjects from a pool of 770 images gathered from 32 institutions.

The CT images for this training set were obtained from clinical treatment plans for patients prescribed external beam or molecular radiotherapy, but the original segmentations were not used. Instead, the images were re-segmented by consultants (physicians and dosimetrists) specifically for this purpose, outside of clinical practice. Detailed instructions derived from relevant published contouring guidelines were prepared for the dosimetrists. The initial seqmentations were then reviewed and corrected by radiation oncologists against the same standards and guidelines. Qualified staff at MIM Software (MD or licensed dosimetrists) then performed a final review and correction. All segmenters and reviewers were instructed to spend additional time to ensure the highest quality training data. In particular, the consultants were asked to contour all specified OAR structures on all images according to referenced standards, whether or not they were proximal to the treatment field. All patients were imaged on an indexed couch in the treatment position ("simulation CT"). Series that were no-axial, had slices thinner than 0.5mm, or had non-Fan Beam or MV acquisitions were excluded.

The verification data used for testing is from a set of institutions that are totally disjoint from the datasets used to train each model in the Contour ProtégéAl+ device. The MIM Maestro (K071964) reference device was configured with Atlases built from the same training data used to train the models. We tested Contour ProtégéAl+ against the reference device, and the goal of this testing is to show that the subject device is equivalent or superior to the reference device. The performance of both segmentation devices was measured by calculating both the Dice score and MDA of the novel segmentations with the original ground-truth contours. User beta testing was also used to evaluate the performance of Contour ProtégéAl+ in the context of time savings

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Image /page/11/Picture/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, on the left side. To the right of the squares is the text "mim" in a stylized, lowercase font, with the word "SOFTWARE" underneath in a smaller font.

compared to contouring from scratch. This user evaluation was made on a three-point scale for each contour, with one indicating negligible time savings, two indicating moderate, and three indicating significant time savings. Our acceptance criteria combine the statistical tests and the user evaluation - only structures that pass two or more of the following three tests could be included in the final models:

Statistical non-inferiority of the Dice score compared with the reference predicate.
Statistical non-inferiority of the MDA score compared with the reference predicate.
Average user evaluation of 2 or higher, when measured on a three-point scale. ●

Further clinical validation was also conducted in-house to qualitatively evaluate contours compared to detailed criteria based on established clinical guidelines.

In addition, each model as a whole was also evaluated. In order to be included in the released product, the cumulative Added Path (APL) of the contours in the model was evaluated relative to the ground-truth. Cumulative APL has been found to correlate well with the total time spent in editing and correcting auto-segmented contours (Vaassen et al, 2020)1. Each model was required to have statistically non-inferior cumulative APL compared to the reference predicate.

Finally, the localization accuracy of each structure in all models was measured. We did not impose a passing criterion on localization accuracy; the results however are included in this summary document as well as in our User Guide and White Paper to allow the user to better understand the performance of the device.

Across the testing data images, 53.4% were female, 31.3% were male, and 15.3% were unknown for sex. The manufacturer was GE for 43.2%, Siemens for 21.7%, Phillips for 15.5%, Toshiba for 0.4%, and unknown or other scanner vendors for 19.2%. 0.3% were between the ages of 0-20, 4.7% were between the aqes of 20-40, 20.9% were between 40-60, and 50.0% were over the age of 60. 24.1% were unknown for age.

The mean and standard deviation Dice coefficients and MDA scores, 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 ProtégéAl+ results were equivalent or had better performance than the MIM Maestro atlas segmentation 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 atlas seqmentation reference device performance.

Results over the validation set compared to the reference device are presented below.

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Image /page/12/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 lowercase, sans-serif font, with the word "SOFTWARE" in a smaller font below it. The logo is simple and modern, with a clean design.

| 4.2.0 CT
Model | Structure | Dice MIM
Atlas | Dice
Contour
ProtégéAl | MDA
MIM
Atlas | MDA
Contour
ProtégéAl | External
Evaluation
Score |
|-------------------|---------------------|-------------------|------------------------------|---------------------|-----------------------------|---------------------------------|
| Thorax | BrachialPlex_L | 0.30 ± 0.14 | 0.41 ± 0.15
(0.28) * | 3.01 ±
1.19 | 2.89 ± 1.07
(3.94) * | 2.43 |
| | BrachialPlex_R | 0.31 ± 0.12 | 0.39 ± 0.15
(0.26) * | 3.08 ±
1.54 | 3.11 ± 1.38
(4.55) * | 2.43 |
| | Breast_L | 0.74 ± 0.11 | 0.79 ± 0.07
(0.73) * | 5.73 ±
3.10 | 5.00 ± 2.53
(6.98) * | 2.38 |
| | Breast_R | 0.76 ± 0.12 | 0.80 ± 0.11
(0.71) * | 5.03 ±
2.72 | 4.49 ± 2.02
(6.24) * | 2.57 |
| | Breast_L_RTO_G | 0.74 ± 0.11 | 0.77 ± 0.11
(0.69) * | 5.73 ±
3.10 | 5.47 ± 3.72
(7.87) | 2.5 |
| | Breast_R_RTO_G | 0.76 ± 0.12 | 0.77 ± 0.15
(0.67) * | 5.03 ±
2.72 | 5.10 ± 3.17
(7.24) | 2.5 |
| | Bronchus | 0.57 ± 0.19 | 0.62 ± 0.14
(0.50) ** | 2.69 ±
2.22 | 1.86 ± 0.90
(3.19) * | 2.63 |
| | Carina | 0.37 ± 0.18 | 0.50 ± 0.12
(0.41) * | 2.67 ±
2.65 | 1.93 ± 0.83
(3.07) * | 2.43 |
| | Cricoid | 0.02 ± 0.04 | 0.06 ± 0.05
(0.02) * | 4.77 ±
1.53 | 5.01 ± 1.40
(6.27) * | 2.86 |
| | Esophagus | 0.47 ± 0.17 | 0.69 ± 0.16
(0.63) * | 2.73 ±
2.19 | 1.08 ± 1.53
(1.71) * | 2.5 |
| | Glnd_Thyroid | 0.46 ± 0.18 | 0.66 ± 0.18
(0.53) * | 2.84 ±
1.90 | 1.68 ± 1.44
(2.86) * | 2.86 |
| | GreatVes | 0.64 ± 0.17 | 0.70 ± 0.16
(0.53) ** | 4.59 ±
1.99 | 3.44 ± 1.99
(5.46) * | 2.63 |
| | Heart | 0.88 ± 0.08 | 0.90 ± 0.07
(0.87) * | 3.05 ±
2.03 | 2.49 ± 1.84
(3.08) * | 2.63 |
| | Humerus_Head_L | 0.60 ± 0.24 | 0.62 ± 0.24
(0.42) ** | 0.38 ±
0.23 | 0.33 ± 0.22
(0.52) * | 3 |
| | Humerus_Head_R | 0.57 ± 0.22 | 0.60 ± 0.22
(0.41) ** | 0.78 ±
2.00 | 0.33 ± 0.35
(1.60) * | 3 |
| 4.2.0 CT
Model | Structure | Dice MIM
Atlas | Dice
Contour
ProtégéAl | MDA
MIM
Atlas | MDA
Contour
ProtégéAl | External
Evaluation
Score |
| | Kidney_L | 0.73 ± 0.19 | 0.90 ± 0.09
(0.83) * | 3.75 ±
2.66 | 1.32 ± 1.13
(2.27) * | 2.75 |
| | Kidney_R | 0.73 ± 0.19 | 0.89 ± 0.09
(0.83) * | 3.97 ±
2.60 | 1.41 ± 1.06
(2.34) * | 2.75 |
| | Larynx | 0.47 ± 0.19 | 0.59 ± 0.14
(0.51) * | 3.42 ±
1.32 | 2.87 ± 1.34
(3.51) * | 2.63 |
| | Liver | 0.84 ± 0.12 | 0.90 ± 0.13
(0.85) * | 5.06 ±
4.18 | 3.56 ± 9.12
(6.39) * | 2.71 |
| | Lung_L | 0.95 ± 0.02 | 0.96 ± 0.02
(0.96) * | 1.12 ±
0.46 | 0.79 ± 0.40
(0.94) * | 2.75 |
| | Lung_R | 0.95 ± 0.03 | 0.97 ± 0.03
(0.96) * | 1.36 ±
0.67 | 0.85 ± 0.48
(1.04) * | 2.75 |
| | Musc_Constrict | 0.40 ± 0.17 | 0.50 ± 0.17
(0.39) * | 2.00 ±
1.79 | 1.67 ± 1.55
(2.71) * | 3 |
| | Pancreas | 0.17 ± 0.17 | 0.47 ± 0.21
(0.36) * | 16.43 ±
16.42 | 6.80 ± 8.89
(14.66) ** | 2.17 |
| | SpinalCord | 0.66 ± 0.16 | 0.64 ± 0.17
(0.59) * | 1.29 ±
0.91 | 1.28 ± 0.72
(1.50) * | 2.5 |
| | Stomach | 0.46 ± 0.22 | 0.73 ± 0.21
(0.64) * | 12.56 ±
13.48 | 6.89 ± 20.57
(14.36) ** | 2.13 |
| | Trachea | 0.68 ± 0.15 | 0.74 ± 0.17
(0.66) * | 1.43 ±
0.65 | 1.12 ± 0.64
(1.46) * | 2.63 |
| | A LAD | 0.07 ± 0.09 | 0.32 ± 0.12
(0.22) * | 8.77 ±
10.69 | 3.43 ± 4.46
(11.41) ** | 2.67 |
| | A_Aorta_Asc | 0.72 ± 0.16 | 0.83 ± 0.17
(0.68) ** | 2.90 ±
2.16 | 1.11 ± 0.60
(2.64) * | 2.14 |
| | Rib | 0.25 ± 0.09 | 0.28 ± 0.11
(0.21) * | 35.64 ±
12.65 | 39.04 ± 14.62
(49.68) ** | 2.63 |
| | Chestwall_L | 0.40 ± 0.16 | 0.39 ± 0.17
(0.19) ** | 4.35 ±
1.12 | 4.44 ± 1.24
(5.87) * | 2.43 |
| | Chestwall_R | 0.45 ± 0.18 | 0.42 ± 0.18
(0.22) ** | 4.66 ±
1.65 | 4.69 ± 1.56
(6.51) * | 2.43 |
| | LN_Ax_L1_L | 0.59 ± 0.09 | 0.63 ± 0.10
(0.75) * | 2.76 ±
0.89 | 2.25 ± 0.80
(3.32) * | 2.67 |
| 4.2.0 CT
Model | Structure | Dice MIM
Atlas | Dice
Contour
ProtégéAl | MDA
MIM
Atlas | MDA
Contour
ProtégéAl | External
Evaluation
Score |
| | LN_Ax_L1_R | 0.52 ± 0.12 | 0.58 ± 0.13
(0.69) * | 3.46 ±
1.04 | 2.90 ± 1.52
(4.09) * | 2.67 |
| | LN_Ax_L2_L | 0.57 ± 0.16 | 0.64 ± 0.13
(0.77) ** | 2.57 ±
1.25 | 1.93 ± 0.88
(2.88) * | 2.67 |
| | LN_Ax_L2_R | 0.53 ± 0.20 | 0.60 ± 0.18
(0.73) ** | 2.91 ±
1.29 | 2.44 ± 1.26
(3.31) * | 2.67 |
| | LN_Ax_L3_L | 0.55 ± 0.17 | 0.62 ± 0.19
(0.76) ** | 2.21 ±
1.11 | 1.90 ± 1.26
(2.87) * | 2.67 |
| | LN_Ax_L3_R | 0.46 ± 0.16 | 0.52 ± 0.17
(0.65) * | 3.30 ±
1.95 | 2.74 ± 1.73
(4.24) * | 2.67 |
| | LN_IMN_L | 0.17 ± 0.11 | 0.41 ± 0.17
(0.59) * | 4.75 ±
3.26 | 1.82 ± 0.85
(5.05) ** | 3 |
| | LN_IMN_R | 0.23 ± 0.16 | 0.48 ± 0.20
(0.63) * | 3.36 ±
1.95 | 1.69 ± 1.38
(3.09) * | 3 |
| | LN_Sclav_L | 0.58 ± 0.15 | 0.66 ± 0.13
(0.79) * | 2.84 ±
1.94 | 2.49 ± 1.70
(4.18) * | 2 |
| | LN_Sclav_R | 0.48 ± 0.09 | 0.55 ± 0.09
(0.64) * | 2.97 ±
0.75 | 2.67 ± 0.90
(3.56) * | 2.33 |
| Abdomen | Bladder | 0.72 ± 0.23 | 0.92 ± 0.16
(0.81) * | 3.97 ±
3.00 | 0.78 ± 0.73
(1.93) * | 2.6 |
| | Bowel | 0.34 ± 0.14 | 0.52 ± 0.19
(0.37) * | 9.26 ±
3.49 | 5.05 ± 3.17
(8.13) ** | 2.5 |
| | BowelBag | 0.30 ± 0.09 | 0.36 ± 0.11
(0.29) * | 14.13 ±
3.62 | 10.08 ± 3.36
(12.50) * | 2.89 |
| | CaudaEquina | 0.62 ± 0.15 | 0.69 ± 0.13
(0.59) * | 1.17 ±
0.51 | 0.95 ± 0.53
(1.33) * | 2.6 |
| | Kidney_L | 0.74 ± 0.17 | 0.94 ± 0.03
(0.85) * | 3.86 ±
2.48 | 0.82 ± 0.41
(2.12) * | 2.9 |
| | Kidney_R | 0.75 ± 0.18 | 0.92 ± 0.07
(0.83) * | 3.97 ±
3.35 | 0.96 ± 0.62
(2.74) * | 2.9 |
| | Liver | 0.84 ± 0.12 | 0.93 ± 0.08
(0.86) * | 5.23 ±
3.65 | 2.01 ± 2.14
(3.85) * | 2.8 |
| | SpinalCord | 0.60 ± 0.16 | 0.65 ± 0.14
(0.56) * | 1.13 ±
0.60 | 0.83 ± 0.32
(1.10) * | 2.9 |
| 4.2.0 CT
Model | Structure | Dice MIM
Atlas | Dice
Contour
ProtégéAl | MDA
MIM
Atlas | MDA
Contour
ProtégéAl | External
Evaluation
Score |
| | Stomach | 0.49 ± 0.21 | 0.82 ± 0.11
(0.72) * | 11.56 ±
14.68 | 2.68 ± 2.02
(9.37) ** | 2.5 |
| Female
Pelvis | Bladder | 0.61 ± 0.18 | 0.91 ± 0.06
(0.83) * | 5.53 ±
3.76 | 1.04 ± 0.94
(2.66) * | 2.75 |
| | Bag_Bowel | 0.45 ± 0.17 | 0.52 ± 0.20
(0.36) ** | 8.89 ±
2.79 | 6.89 ± 2.25
(9.06) * | 2.63 |
| | Bowel | 0.34 ± 0.10 | 0.55 ± 0.19
(0.42) * | 8.81 ±
3.05 | 4.84 ± 3.03
(7.44) * | 2.75 |
| | Colon_Sigmoid | 0.05 ± 0.05 | 0.47 ± 0.24
(0.36) * | 20.55 ±
12.23 | 14.72 ± 15.14
(23.56) ** | 2.5 |
| | Femur_Head_
L | 0.86 ± 0.07 | 0.91 ± 0.08
(0.84) * | 1.43 ±
0.78 | 0.95 ± 1.03
(1.75) * | 2.75 |
| | Femur_Head_
R | 0.87 ± 0.05 | 0.92 ± 0.02
(0.89) * | 1.22 ±
0.59 | 0.69 ± 0.28
(1.09) * | 2.75 |
| | UteroCervix | 0.16 ± 0.16 | 0.65 ± 0.27
(0.47) * | 10.65 ±
5.73 | 4.39 ± 13.21
(13.49) ** | 2 |
| | LN_Pelvics | 0.64 ± 0.05 | 0.74 ± 0.06
(0.69) * | 4.37 ±
1.11 | 4.12 ± 1.52
(5.28) * | 2.75 |
| | Rectum | 0.38 ± 0.16 | 0.75 ± 0.12
(0.67) * | 6.30 ±
3.30 | 1.52 ± 1.66
(3.04) * | 2.63 |
| | SacralPlex | 0.02 ± 0.01 | 0.03 ± 0.01
(0.02) * | 13.03 ±
1.73 | 12.81 ± 1.86
(14.38) * | 2.5 |
| | Sacrum | 0.84 ± 0.02 | 0.89 ± 0.01
(0.87) * | 1.58 ±
0.32 | 1.09 ± 0.17
(1.31) * | 3 |
| | CaudaEquina | 0.65 ± 0.11 | 0.66 ± 0.11
(0.58) * | 1.19 ±
0.58 | 0.94 ± 0.59
(1.39) * | 2.57 |
| SurePlan
MRT | Bone | 0.76 ± 0.08 | 0.83 ± 0.05
(0.71) * | 4.77 ±
1.97 | 4.57 ± 3.35
(9.50) ** | 3 |
| | Glnd_Lacrimal
_L | 0.23 ± 0.17 | 0.30 ± 0.21
(0.16) * | 1.99 ±
0.86 | 1.26 ± 0.57
(1.96) * | 2.67 |
| | Glnd_Lacrimal
_R | 0.23 ± 0.16 | 0.36 ± 0.23
(0.22) * | 1.53 ±
0.80 | 1.18 ± 0.87
(1.97) * | 2.67 |
| | Glnd_Subman | 0.58 ± 0.12 | 0.67 ± 0.29 | 2.19 ± | 1.00 ± 0.35 | 3 |
| 4.2.0 CT
Model | Structure | Dice MIM
Atlas | Dice
Contour
ProtégéAl | MDA
MIM
Atlas | MDA
Contour
ProtégéAl | External
Evaluation
Score |
| | d_L | | (0.52) * | 0.76 | (1.45) * | |
| | GInd_Subman
d_R | 0.56 ± 0.16 | 0.66 ± 0.31
(0.48) * | 2.41 ±
1.14 | 0.97 ± 0.33
(1.68) * | 3 |
| | Glnd_Thyroid | 0.47 ± 0.19 | 0.75 ± 0.12
(0.63) ** | 2.98 ±
1.95 | 1.29 ± 1.20
(2.46) * | 2.67 |
| | Kidney_L | 0.72 ± 0.18 | 0.91 ± 0.04
(0.82) * | 4.08 ±
2.52 | 1.56 ± 0.61
(2.89) * | 3 |
| | Kidney_R | 0.76 ± 0.17 | 0.91 ± 0.03
(0.82) * | 3.87 ±
3.14 | 1.45 ± 0.63
(3.12) * | 3 |
| | Liver | 0.85 ± 0.12 | 0.93 ± 0.07
(0.88) * | 4.82 ±
3.51 | 1.79 ± 1.50
(3.25) * | 2.67 |
| | Lung_L | 0.94 ± 0.03 | 0.96 ± 0.04
(0.93) * | 1.42 ±
0.51 | 0.90 ± 0.49
(1.32) * | 3 |
| | Lung_R | 0.94 ± 0.04 | 0.96 ± 0.05
(0.92) * | 1.66 ±
0.75 | 1.07 ± 0.86
(1.75) * | 3 |
| | Parotid L | 0.71 ± 0.09 | 0.81 ± 0.05
(0.78) * | 2.17 ±
0.77 | 1.42 ± 0.40
(1.73) * | 3 |
| | Parotid_R | 0.71 ± 0.09 | 0.82 ± 0.05
(0.78) * | 2.17 ±
0.73 | 1.34 ± 0.48
(1.67) * | 3 |
| | Spleen | 0.72 ± 0.10 | 0.95 ± 0.02
(0.87) * | 4.38 ±
1.87 | 0.62 ± 0.45
(2.08) * | 2.67 |

Table 2 – Dice, MDA, and external evaluation results.

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Image /page/13/Picture/0 description: The image shows the MIM Software logo. 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 stylized font, with the word "SOFTWARE" below it.

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Image /page/14/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 stylized font, with the word "SOFTWARE" underneath in smaller letters. The logo is simple and modern, with a focus on the company's name.

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Image /page/15/Picture/0 description: The image shows the logo for MIM Software. The logo consists of a gray square overlapping a red square with a white circle in the middle. 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.

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Image /page/16/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 lowercase, sans-serif font, with the word "SOFTWARE" in a smaller font below it. The logo is simple and modern, with a clean design.

Mean ± Std MDA mm (upper 95th percentile confidence bound based on normal distribution in parentheses) * Equivalence demonstrated at p=0.05 significance level between Contour ProtégéAI and MIM Atlas (green) ** Equivalence was NOT demonstrated because the minimum sample size was not met for this contour (yellow) Cells highlighted in orange indicate that equivalence was NOT demonstrated.

Additionally, preliminary user evaluation conducted as part of testing demonstrated that Contour ProtégéAl+ yields comparable time-saving functionality when creating contours as other commercially available automatic segmentation products.

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Image /page/17/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 intersection. To the right of the squares is the text "mim" in a 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.

Table 3 – 4.2.0 CT Models cumulative APL.

4.2.0 CT Models	MIM Atlas	Contour ProtégéAl
Thorax	220.33 ± 232.42	181.44 ± 219.43 (200.79) *
Abdomen	354.53 ± 386.05	238.05 ± 309.40 (312.07) *
Female Pelvis	433.24 ± 392.19	314.13 ± 349.77 (383.86) *
SurePlan MRT	216.52 ± 207.87	133.01 ± 160.23 (167.60) *

Mean ± Std APL mm (upper 95th percentile confidence bound based on normal distribution in parentheses). * Equivalence demonstrated at p=0.05 significance level between Contour ProtégéAl and MIM Atlas.

4.2.0 CT Models	Structure	Relevant FOV	Whole Body CT
Thorax	BrachialPlex_L	100	100
	BrachialPlex_R	100	100
	Breast_L	100	100
	Breast_R	100	100
	Breast_L_RTOG	100	100
	Breast_R_RTOG	100	100
	Bronchus	100	100
	Carina	99	100
	Cricoid	91	100
	Esophagus	99	100
	Glnd_Thyroid	100	77
	GreatVes	100	91
	Heart	100	100
	Humerus_Head_L	100	100
	Humerus_Head_R	100	100
4.2.0 CT Models	Structure	Relevant FOV	Whole Body CT
	Kidney_L	100	95
	Kidney_R	100	100
	Larynx	100	100
	Liver	99	95
	Lung_L	100	100
	Lung_R	100	100
	Musc_Constrict	100	91
	Pancreas	96	95
	SpinalCord	100	100
	Stomach	97	100
	Trachea	99	100
	A_LAD	100	86
	A_Aorta_Asc	96	100
	Rib	100	86
	Chestwall_L	100	100
	Chestwall_R	100	100
	LN_Ax_L1_L	100	100
	LN_Ax_L1_R	100	100
	LN_Ax_L2_L	100	100
	LN_Ax_L2_R	100	100
	LN_Ax_L3_L	100	100
	LN_Ax_L3_R	100	100
	LN_IMN_L	100	100
	LN_IMN_R	100	100
	LN_Sclav_L	100	100
4.2.0 CT Models	Structure	Relevant FOV	Whole Body CT
Abdomen	LN_Sclav_R	100	100
	Bladder	98	95
	Bowel	100	100
	BowelBag	100	100
	CaudaEquina	100	100
	Kidney_L	100	91
	Kidney_R	100	100
	Liver	100	100
	SpinalCord	100	100
	Stomach	100	100
Female Pelvis	Bladder	100	100
	Bag_Bowel	100	100
	Bowel	100	100
	Colon_Sigmoid	93	86
	Femur_Head_L	100	100
	Femur_Head_R	100	95
	UteroCervix	97	100
	LN_Pelvics	100	100
	Rectum	100	100
	SacralPlex	100	100
	Sacrum	100	100
	CaudaEquina	100	100
SurePlan MRT	Bone	*	100
	Glnd_Lacrimal_L	*	100
	Glnd_Lacrimal_R	*	95
4.2.0 CT Models	Structure	Relevant FOV	Whole Body CT
	Glnd_Submand_L	*	95
	Glnd_Submand_R	*	100
	Glnd_Thyroid	*	82
	Kidney_L	*	91
	Kidney_R	*	95
	Liver	*	100
	Lung_L	*	100
	Lung_R	*	100
	Parotid_L	*	100
	Parotid_R	*	100
	Spleen	*	100

Table 4 – 4.2.0 CT Models localization accuracy.

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19

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20

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Percentage of images that were successfully localized by Contour ProtégéAl.

The relevant FOV for the "SurePlan MRT" model is the Whole Body, so a separate "Relevant FOV" test was not performed.

Each individual feature met the acceptance criteria defined for the verification and validation tests, and the entire software product was determined to be safe and effective for clinical use.

Known Limitations and Biases

Contour ProtégéAl+ can produce incorrect or implausible segmentations when the underlying anatomy is in the field of view of the scan but not clearly discernable due to image quality, noise, or the generally low contrast of some structures. This can occur in any situation where the organ at risk is not clearly discernable in the image.

While both images with and without IV contrast are represented in the training set for Contour ProtégéAl+, the effect of iodinated contrast can vary due to patient weight, contrast dosage, and time since injection. In cases where this is unusually intense brain or kidney enhancement, the posterior boundary can be incorrectly segmented. The age breakdown of the training data, where patient age was available, was predominantly in the 40-60 and 60+ ranges. While this is appropriate to the intended patient populations,

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only a small proportion of testing and training data was for patients under 40, so more intensive review may be warranted for younger patients.

Where patient sex was available, the ratio of male to female patients in the training set was roughly 2:1. The testing data was chosen with a more even ratio (about 0.82:1) to establish applicability of the model to both.

Conclusion

Contour ProtégéAl+ has been developed according to MIM Software Inc.'s established design control process and software development life cycle. This includes risk management alongside verification and validation testing that includes testing of risk mitigations. Therefore, from all evidence gathered, it is MIM Software Inc.'s belief that Contour ProtégéAl+ (K250035) provides a device substantially equivalent to the predicate device.