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 ProtégéAI supports the following indications:

· Creation of contours using machine-learning algorithms for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transfering 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.

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.

AI/ML Overview

The user is asking for information about the acceptance criteria and study proving the device's performance from the provided FDA 510(k) summary. I will extract the relevant information to answer each point.

Here's a breakdown of the requested information and where to find it in the document:

A table of acceptance criteria and the reported device performance: This will primarily come from the "Testing and Performance Data" section, specifically the table comparing MIM Atlas and Contour ProtégéAI Dice coefficients and the equivalence definition.
Sample sizes used for the test set and the data provenance: Found in the "Testing and Performance Data" section.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Found in the "Testing and Performance Data" section.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Found in the "Testing and Performance Data" section regarding ground truth generation.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: The document describes a comparison between the AI (Contour ProtégéAI) and an atlas-based segmentation (MIM Maestro reference device), not a human-in-the-loop study with human readers comparing performance with and without AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The provided data compares the algorithm's performance against a ground truth and an atlas-based reference algorithm. The use of "appropriate image visualization software must be used to review and, if necessary, edit results automatically generated by Contour ProtégéAI" implies it's an AI-assisted tool, but the testing itself appears to be an algorithmic comparison.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Found in the "Testing and Performance Data" section.
The sample size for the training set: Found in the "Device Description" and "Testing and Performance Data" sections.
How the ground truth for the training set was established: Found in the "Testing and Performance Data" section.

Here's the detailed response based on the provided document:

Acceptance Criteria and Study Proving Device Performance

The study evaluated the performance of Contour ProtégéAI, specifically its new 3.0.0 CT neural network models, by comparing its segmentation accuracy (Dice coefficient) against a reference atlas-based segmentation device, MIM Maestro (K071964).

1. Table of Acceptance Criteria and Reported Device Performance:

Item	Acceptance Criteria	Reported Device Performance and Equivalence
Equivalence	Equivalence is defined such that the lower 95th percentile confidence bound of the Contour ProtégéAI segmentation is greater than 0.1 Dice lower than the mean MIM atlas segmentation reference device performance. This means: Contour ProtégéAI_LB95 > MIM_Atlas_Mean - 0.1	"Contour ProtégéAI results were equivalent or had better performance than the MM Maestro atlas segmentation reference device." This was demonstrated at a p=0.05 significance level for all structures. Below is a sample of reported Dice coefficients, where * indicates equivalence demonstrated.*

2. Sample size used for the test set and the data provenance:

Test Set Size: 739 independent images.
Data Provenance: Gathered from 12 institutions. The specific countries for the test set are not explicitly stated, but the training data (from which test subjects were explicitly excluded) was from Australia, France, Hong Kong, and the USA. The data collection was prospective in the sense that the training data explicitly excluded patients from the institutions contributing to the test set, ensuring independence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not explicitly stated as a fixed number.
Qualifications of Experts: Ground truth segmentations were generated by a "trained user (typically, a dosimetrist or radiologist)" and then reviewed and approved by a "supervising physician (typically, a radiation oncologist or a radiologist)."

4. Adjudication method for the test set:

The ground truth generation process involved: initial segmentation by a trained user, followed by review and approval by a supervising physician. If necessary, the data was sent back for re-segmentation and re-review. This constitutes an iterative consensus-building method rather than a strict 2+1 or 3+1 type of adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study involving human readers' improvement with AI vs. without AI assistance was not conducted or reported in this summary. The study focused on the standalone algorithmic performance of the AI tool (Contour ProtégéAI) compared to an existing atlas-based automatic segmentation method (MIM Maestro). The device is intended as a "tool to assist" and mandates review/editing by users, but the performance study itself was not a human-in-the-loop clinical trial.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, the primary study reported is a standalone algorithmic performance comparison. The Dice coefficients were calculated for the algorithm's output directly against the established ground truth, and then compared to the performance of the MIM Maestro atlas segmentation reference device.

7. The type of ground truth used:

The ground truth used was expert consensus segmentation, established by trained users (dosimetrists or radiologists) and approved by supervising physicians (radiation oncologists or radiologists).

8. The sample size for the training set:

Training Set Size: 4061 CT images.

9. How the ground truth for the training set was established:

The ground-truth segmentations used for both training and validation (test set) were established using the same method: generated by a "trained user (typically, a dosimetrist or radiologist)" that were then "reviewed and approved by a supervising physician (typically, a radiation oncologist or a radiologist) and sent back for re-segmentation and re-review as necessary."

Summary

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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: K213976

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: December 30, 2021 Received: January 5, 2022

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

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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.

Julie M. Sullivan, Ph.D. Assistant Director Nuclear Medicine and Radiation Therapy Branch 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

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Indications for Use

510(k) Number (if known) K213976

Device Name

Contour ProtégéAI

Indications for Use (Describe)

· 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 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 letters "TM" are in superscript to the right of the word "SOFTWARE".

510(k) Summary

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

Submitter:

K213976

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

Phone: 216-455-0600 216-455-0601 Fax:

Contact Person:

Lynn Hanigan

Date Summary Prepared: Feb 1, 2022

Device Name

Trade Name: Common Name: Regulation Number / Product Code: Classification Name:

Contour ProtégéAl Medical Imaging Software 21 CFR 892.2050 / Product Code QKB Medical Image management and processing system

Predicate Device

K210632

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 ProtégéAl.

Contour ProtégéAl is not intended to detect or contour lesions.

Indications for Use

. Creation of contours using machine-learning algorithms for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation

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Image /page/4/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 SOFTWARE" in black, with "mim" in a larger font than "SOFTWARE".

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 T2weighted MR images.

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

Device Description

A total of 4061 CT images from 31 clinical sites across multiple continents was gathered for the training of the final neural network models. The following table lists the data used for the training of the final 3.0.0 production models.

Institution	Country	# of images
Institution 1	USA	22
Institution 2	USA	157
Institution 3	USA	105
Institution 4	Australia	420
Institution 5	USA	67
Institution 6	USA	46
Institution 7	USA	83
Institution 8	USA	82
Institution 9	USA	89
Institution 10	USA	63
Institution 11	France	40
Institution 12	USA	116
Institution 13	Hong Kong	394
Institution 14	USA	73
Institution 15	USA	230

CT data used to train the final production of the 3.0.0 CT models

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Image /page/5/Picture/0 description: The image is a logo for MIM Software. The logo consists of a red square with rounded corners and a gray square with rounded corners overlapping each other. The word "mim" is written in black, bold letters to the right of the squares. Below the word "mim" is the word "SOFTWARE" in smaller, black letters.

Institution	Country	# of images
Institution 16	USA	139
Institution 17	USA	15
Institution 18	USA	96
Institution 19	USA	103
Institution 20	USA	29
Institution 21	USA	325
Institution 22	USA	13
Institution 23	USA	54
Institution 24	USA	10
Institution 25	USA	284
Institution 26	USA	622
Institution 27	USA	152
Institution 28	USA	58
Institution 29	USA	66
Institution 30	USA	101
Institution 31	USA	7

Substantial Equivalence

ITEM	Contour ProtégéAl(K213976)	Contour ProtégéAl(K210632)	MIM 4.1 SEASTAR[i.e., MIM Maestro](K071964)
Clearance Dates	TBD	10/20/2021	9/26/2007
Intended Use	Contour ProtégéAl is anaccessory to MIM softwareused for the contouring ofanatomical structures inimaging data using machine-learning-based algorithmsautomatically.	Contour ProtégéAl is anaccessory to MIM softwareused for the contouring ofanatomical structures inimaging data using machine-learning-based algorithmsautomatically.	MIM 4.1 (SEASTAR)software is intendedfor trained medicalprofessionalsincluding, but notlimited to, radiologists,oncologists,physicians, medical
ITEM	Contour ProtégéAl(K213976)	Contour ProtégéAl(K210632)	MIM 4.1 SEASTAR[i.e., MIM Maestro](K071964)
	Appropriate imagevisualization software must beused to review and, ifnecessary, edit resultsautomatically generated byContour ProtégéAl.Contour ProtégéAl is notintended to detect or contourlesions.	Appropriate imagevisualization software must beused to review and, ifnecessary, edit resultsautomatically generated byContour ProtégéAl.Contour ProtégéAl is notintended to detect or contourlesions.	technologists,dosimetrists, andphysicists.MIM 4.1 (SEASTAR)is a medical imageand informationmanagement systemthat is intended toreceive, transmit,store, retrieve, display,print and processdigital medicalimages, as well ascreate, display andprint reports fromthose images. Themedical modalities ofthese medical imagingsystems include, butare not limited to, CT,MRI, CR, DX, MG,US, SPECT, PET andXA as supported byACR/NEMA DICOM3.0.MIM 4.1 (SEASTAR)provides tools toquickly create,transform, and modifycontours forapplications including,but not limited to,quantitative analysis,aiding adaptivetherapy, transferringcontours to radiationtherapy treatmentplanning systems andarchiving contours for
ITEM	Contour ProtégéAl(K213976)	Contour ProtégéAl(K210632)	MIM 4.1 SEASTAR[i.e., MIM Maestro](K071964)
			patient follow-up andmanagement.
Indications forUse	Trained medical professionalsuse Contour ProtégéAl as atool to assist in the automatedprocessing of digital medicalimages of modalities CT andMR, as supported byACR/NEMA DICOM 3.0. Inaddition, Contour ProtégéAlsupports the followingindications:• Creation of contours usingmachine-learningalgorithms for applicationsincluding, but not limitedto, quantitative analysis,aiding adaptive therapy,transferring contours toradiation therapytreatment planningsystems, and archivingcontours for patient follow-up and management.• Segmenting normalstructures across a varietyof CT anatomicallocations.• And segmenting normalstructures of the prostate,seminal vesicles, and	Trained medical professionalsuse Contour ProtégéAl as atool to assist in the automatedprocessing of digital medicalimages of modalities CT andMR, as supported byACR/NEMA DICOM 3.0. Inaddition, Contour ProtégéAlsupports the followingindications:• Creation of contours usingmachine-learningalgorithms for applicationsincluding, but not limitedto, quantitative analysis,aiding adaptive therapy,transferring contours toradiation therapytreatment planningsystems, and archivingcontours for patient follow-up and management.• Segmenting normalstructures across a varietyof CT anatomicallocations.• And segmenting normalstructures of the prostate,seminal vesicles, and	MIM 4.1 (SEASTAR)software is used bytrained medicalprofessionals as a toolto aid in evaluationand informationmanagement of digitalmedical images. Themedical imagemodalities include, butare not limited to, CT,MRI, CR, DX, MG,US, SPECT, PET andXA as supported byACR/NEMA DICOM3.0. MIM 4.1(SEASTAR) assists inthe followingindications:• Receive, transmit,store, retrieve, display,print, and processmedical images andDICOM objects.• Create, display andprint reports frommedical images.• Registration, fusiondisplay, and review ofmedical images for
ITEM	Contour ProtégéAl(K213976)	Contour ProtégéAl(K210632)	MIM 4.1 SEASTAR[i.e., MIM Maestro](K071964)
	urethra within T2-weightedMR images.Appropriate imagevisualization software must beused to review and, ifnecessary, edit resultsautomatically generated byContour ProtégéAl.	urethra within T2-weightedMR images.Appropriate imagevisualization software must beused to review and, ifnecessary, edit resultsautomatically generated byContour ProtégéAl.	diagnosis, treatmentevaluation, andtreatment planning.• Localization anddefinition of objectssuch as tumors andnormal tissues inmedical images.• Creation,transformation, andmodification ofcontours forapplications including,but not limited to,quantitative analysis,aiding adaptivetherapy, transferringcontours to radiationtherapy treatmentplanning systems, andarchiving contours forpatient follow-up andmanagement.
Modalities	CT and MR	CT and MR	CT, MR, CR, DX, MG,US, SPECT, PET andXA
Atlas-BasedSegmentation	No	No	Yes
ITEM	Contour ProtégéAl(K213976)	Contour ProtégéAl(K210632)	MIM 4.1 SEASTAR[i.e., MIM Maestro](K071964)
AutomaticallyContour ImagingData UsingMachine-Learning	Yes	Yes	No
OperatingPlatform	Server-based applicationsupportingLinux-based OS- and -Local deployment on Windowsor Mac	Server-based applicationsupportingLinux-based OS- and -Local deployment on Windowsor Mac	Windows, Mac
Cloud-baseddeployment	Yes	Yes	No
Locally deployed(or installed)	Yes	Yes	No
ITEM	Contour ProtégéAl(K213976)	Contour ProtégéAl(K210632)	MIM 4.1 SEASTAR[i.e., MIM Maestro](K071964)
Neural NetworkModels included	(1.0.0 models)Head and Neck CTProstate CTThorax CTLiver CTProstate MR(1.1.0 model)Prostate MR(2.0.0 models)Head and Neck CTProstate CTThorax CTAbdomen CTLungs and Liver CT(3.0.0 models)Head and Neck CTProstate CTThorax CTAbdomen CTLungs and Liver CTMRT Additional Structures CT(which include:SpleenPelvic Lymph NodesDescending AortaBone)	(1.0.0 models)Head and Neck CTProstate CTThorax CTLiver CTProstate MR(1.1.0 model)Prostate MR(2.0.0 models)Head and Neck CTProstate CTThorax CTAbdomen CTLungs and Liver CT	None

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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 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 letters "TM" are in superscript to the right of the word "SOFTWARE".

25800 Science Park Drive - Suite 180 Cleveland, OH 44122 866-421-2536 www.mimsoftware.com

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Image /page/7/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 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.

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Image /page/8/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 in 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.

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Image /page/9/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 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/10/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 letters in "mim" are all lowercase.

25800 Science Park Drive - Suite 180 Cleveland, OH 44122 866-421-2536 www.mimsoftware.com

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Image /page/11/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 simple color palette.

Discussion

Changes within this submission include new CT 3.0.0 neural network models with additional contours. These changes differ when comparing to Contour ProtégéAl 510(k)210632. 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, the new 3.0.0 CT neural network models were trained on a pool of training data that did not include any patients from the same institution as the test subjects. This training data included 4.061 images gathered from 31 clinical sites, from Australia, France, Hong Kong, and the USA. Models were trained using images of adults at various ages. No ethnicities or genders were excluded from training, with the exception of the training pool for the prostate model, for which only subjects with male anatomy were used. The models were then evaluated on the test subjects from a pool of 739 independent images gathered from 12 institutions.

The ground-truth segmentations used for both training and validation were generated by a trained user (typically, a dosimetrist or radiologist) that are then reviewed and approved by a supervising physician (typically, a radiation oncologist or a radiologist) and sent back for re-segmentation and re-review as necessary. The Dice coefficient was then calculated for each structure, and aggregated over all patients. All patients were imaged on an indexed couch in treatment position ("simulation CT"). Series that were non-axial, had slices thinner than 0.5mm, or had non-Fan Beam or mV acquisitions were excluded.

With the MM 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, the 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 seqmentation reference device for each structure of each neural network model. Contour ProtégéAl results were equivalent or had better performance than the MM 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.

Structure:	MIM Atlas	Contour ProtégéAl
A_Aorta_Desc	0.73 ± 0.15	0.78 ± 0.07 (0.68) *
Bladder	0.80 ± 0.12	0.94 ± 0.02 (0.86) *
Bone	0.80 ± 0.03	0.83 ± 0.05 (0.76) *
Bone_Mandible	0.79 ± 0.16	0.83 ± 0.04 (0.74) *
Structure:	MIM Atlas	Contour ProtégéAl
Bowel †	0.60 ± 0.13	0.75 ± 0.07 (0.68) *
Bowel_Large	0.15 ± 0.12	0.28 ± 0.20 (0.15) *
Bowel_Small	0.29 ± 0.17	0.42 ± 0.19 (0.29) *
BrachialPlex_L	0.32 ± 0.11	0.37 ± 0.13 (0.27) *
BrachialPlex_R	0.38 ± 0.13	0.41 ± 0.10 (0.31) *
Brain	0.97 ± 0.01	0.96 ± 0.01 (0.95) *
Brainstem	0.77 ± 0.12	0.76 ± 0.12 (0.68) *
Breast_L	0.81 ± 0.06	0.81 ± 0.06 (0.76) *
Breast_R	0.83 ± 0.06	0.83 ± 0.06 (0.77) *
Bronchus	0.57 ± 0.12	0.62 ± 0.11 (0.54) *
Carina	0.54 ± 0.18	0.64 ± 0.17 (0.52) *
CaudaEquina	0.74 ± 0.09	0.72 ± 0.06 (0.64) *
Cavity_Oral	0.79 ± 0.10	0.81 ± 0.11 (0.73) *
Cochlea_L	0.39 ± 0.15	0.41 ± 0.17 (0.30) *
Cochlea_R	0.43 ± 0.15	0.46 ± 0.17 (0.34) *
Colon_Sigmoid	0.08 ± 0.09	0.50 ± 0.19 (0.33) *
Esophagus	0.43 ± 0.17	0.56 ± 0.19 (0.47) *
Eye_L	0.83 ± 0.10	0.82 ± 0.06 (0.77) *
Eye_R	0.81 ± 0.13	0.78 ± 0.06 (0.71) *
Femur_Head_L	0.93 ± 0.04	0.90 ± 0.06 (0.86) *
Femur_Head_R	0.93 ± 0.03	0.93 ± 0.03 (0.91) *
Femur_L	0.96 ± 0.01	0.95 ± 0.01 (0.93) *
Femur_R	0.96 ± 0.02	0.94 ± 0.01 (0.91) *
Genitals	0.64 ± 0.11	0.68 ± 0.13 (0.53) *
GInd_Lacrimal_L	0.29 ± 0.15	0.39 ± 0.20 (0.24) *
GInd_Lacrimal_R	0.31 ± 0.15	0.38 ± 0.22 (0.23) *
GInd_Submand_L	0.68 ± 0.10	0.78 ± 0.07 (0.71) *
Structure:	MIM Atlas	Contour ProtégéAl
Glnd_Submand_R	0.67 ± 0.11	0.76 ± 0.06 (0.69) *
Glnd_Thyroid	0.51 ± 0.14	0.57 ± 0.18 (0.44) *
GreatVes	0.75 ± 0.06	0.71 ± 0.08 (0.65) *
Heart	0.85 ± 0.08	0.89 ± 0.04 (0.86) *
Humerus_Head_L †	0.88 ± 0.07	0.91 ± 0.04 (0.87) *
Humerus_Head_R †	0.88 ± 0.09	0.91 ± 0.03 (0.85) *
Kidney_L	0.76 ± 0.14	0.91 ± 0.03 (0.83) *
Kidney_R	0.74 ± 0.18	0.89 ± 0.04 (0.80) *
Larynx	0.52 ± 0.15	0.57 ± 0.18 (0.44) *
Lens_L	0.30 ± 0.17	0.52 ± 0.10 (0.41) *
Lens_R	0.36 ± 0.14	0.65 ± 0.09 (0.56) *
Lips	0.39 ± 0.14	0.57 ± 0.18 (0.43) *
Liver	0.84 ± 0.12	0.93 ± 0.04 (0.87) *
LN_Pelvic	0.76 ± 0.03	0.80 ± 0.04 (0.77) *
Lung_L	0.94 ± 0.03	0.95 ± 0.02 (0.93) *
Lung_R	0.95 ± 0.02	0.95 ± 0.02 (0.94) *
Musc_Constrict	0.44 ± 0.12	0.50 ± 0.17 (0.38) *
OpticChiasm	0.34 ± 0.16	0.37 ± 0.17 (0.25) *
OpticNrv_L	0.46 ± 0.12	0.52 ± 0.10 (0.44) *
OpticNrv_R	0.50 ± 0.10	0.54 ± 0.09 (0.47) *
Parotid_L	0.68 ± 0.13	0.81 ± 0.04 (0.74) *
Parotid_R	0.71 ± 0.10	0.78 ± 0.05 (0.72) *
PenileBulb	0.62 ± 0.12	0.65 ± 0.11 (0.56) *
Pituitary	0.53 ± 0.15	0.56 ± 0.18 (0.43) *
Prostate	0.71 ± 0.12	0.82 ± 0.06 (0.74) *
Rectum	0.67 ± 0.14	0.76 ± 0.08 (0.67) *
SeminalVes	0.58 ± 0.15	0.70 ± 0.08 (0.60) *
Structure:	MIM Atlas	Contour ProtégéAI
Spinal_Cord	0.76 ± 0.10	0.82 ± 0.07 (0.78) *
Spleen	0.78 ± 0.14	0.91 ± 0.07 (0.80) *
Stomach	0.45 ± 0.20	0.79 ± 0.09 (0.69) *
Trachea	0.77 ± 0.09	0.73 ± 0.07 (0.67) *

Results over the validation set compared to the reference device are presented here:

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Image /page/12/Picture/0 description: The image is a logo for MIM Software. The logo consists of a red square with rounded corners and a white circle in the lower left corner, partially covered by a gray square with rounded corners. To the right of the graphic is the text "MIM" in large, bold, black letters, with the word "SOFTWARE" in smaller black letters below.

25800 Science Park Drive - Suite 180 Cleveland, OH 44122 866-421-2536 www.mimsoftware.com

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Image /page/13/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, with the word "SOFTWARE" below it in a smaller font. The logo is simple and modern, and the colors are eye-catching.

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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 large, bold, black letters, with the word "SOFTWARE" in smaller black letters below it. The logo is simple and modern, with a clean design.

Mean ± Std Dice coefficient (lower 95th percentile confidence bound based on normal distribution in parentheses) * Equivalence demonstrated at p=0.05 significance level between Contour ProtégéAI and MIM Atlas † Comparisons for both atlas and Contour ProtégéAI calculated only on axial slices that contained the ground truth.

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 K210632. In addition, the proposed device performs as well as the reference device, MIM 4.1 SEASTAR K071964.

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).