MIM software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical images. The medical image modalities include, but are not limited to, CT, MR, CR, DX, MG, US, SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0. MIM assists in the following indications:

Receive, transmit, store, retrieve, display, print, and process medical images and DICOM objects.
Create, display, and print reports from medical images.
Registration, fusion display, and review of medical images for diagnosis, treatment evaluation, and treatment planning.
Evaluation of cardiac left ventricular function and perfusion, including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction.
Localization and definition of objects such as tumors and normal tissues in medical images.
Creation, transformation, and modification of contours for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management.
Quantitative and statistical analysis of PET/SPECT brain scans by comparing to other registered PET/SPECT brain scans.
Planning and evaluation of permanent implant brachytherapy procedures (not including radioactive microspheres).
Calculating absorbed radiation dose as a result of administering a radionuclide.
Assist with the planning and evaluation of ablation procedures by providing visualization and analysis, including energy zone visualization through the placement of virtual ablation devices validated for inclusion in MIM-Ablation. The software is not intended to predict specific ablation zone volumes or predict ablation success.

When using the device clinically, within the United States, the user should only use FDA approved radiopharmaceuticals. If used with unapproved ones, this device should only be used for research purposes.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Images that are printed to film must be printed using an FDA-approved printer for the diagnosis of digital mammography images. Mammographic images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images. The software is not to be used for mammography CAD.

Device Description

MIM - Monte Carlo Dosimetry (K232862) extends the features of MIM - Ablation (K220256). It is designed for use in medical imaging and operates on Windows, Mac, and Linux computer systems. The intended use and indications for use in MIM - Monte Carlo Dosimetry are unchanged from the predicate device, MIM - Ablation (K220256).

MIM - Monte Carlo Dosimetry (K232862) is a standalone software application that extends the functionality of the predicate device by providing:

Dose calculation of radionuclides performed using a Monte Carlo method

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: MIM - Monte Carlo Dosimetry (K232862)

Acceptance Criteria and Reported Device Performance:

Criteria / Comparison Type	Acceptance Criteria (Implicit)	Reported Device Performance
Comparison to Model-Based Dosimetry (OLINDA/EXM - K033960)	Agreement with predicate device (OLINDA/EXM) for mean absorbed doses across various structures and isotopes, with differences within expected ranges.	For Lu-177, I-131, and Y-90 activity maps, the average, absolute percent difference between MIM - Monte Carlo Dosimetry and OLINDA/EXM was 4.3% across all structures and isotopes. Excluding lung doses (due to known limitations of OLINDA's model), the average difference dropped to 2.5%. This is within the expected range, citing a similar study with 177Lu-DOTATATE data that showed a 5% average difference. Lung dose differences were higher (18.1%, 10.8% for Lu-177, I-131, and Y-90 respectively) but attributed to OLINDA's underestimation due to cross-dose from nearby tumors and differences in patient-specific lung geometry.
Comparison to Voxel S-value (VSV) Dosimetry (MIM – Ablation - K220256)	Agreement with predicate VSV method, accounting for known differences due to tissue inhomogeneities.	The average, absolute percent difference was 6.0% across all structures and isotopes. This is consistent with previously published results for other commercial VSV software (~10%). Excluding the I-131 lung dose (61% difference, attributed to VSV overestimation in low-density tissue like lungs), the average difference dropped to 4.0%. This large lung difference was expected and within reported discrepancies (30-60%) for VSV methods when compared to Monte Carlo in inhomogeneous tissues.
Comparison to a Well-Established Monte Carlo Algorithm (GATE)	High agreement with a benchmark Monte Carlo algorithm.	The two methods (MIM - Monte Carlo Dosimetry and GATE) were in high agreement, with an average, absolute difference of 1.4% across all structures and isotopes. Monte Carlo calculations differed by 2-3% for Lu-177, I-131, and Y-90.
Characterization of User Inputs (Particle Histories)	Default settings should provide accurate dose calculations with acceptable uncertainty.	The default setting for 1 x 10^9 particle histories is found to be appropriate, resulting in less than 1% uncertainty in regions of interest and less than 1% difference between results when running multiple simulations with random simulation seeds.

Study Details:

Sample size used for the test set and the data provenance:
- The test set used "an existing CT scan of the patient that was of height (1.7m) and weight (77kg) similar to the default Adult Male model in OLINDA (1.7m, 70kg)."
- The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin. However, the use of "an existing CT scan" suggests it was retrospective. The patient data was used for all three main comparison studies.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document describes comparisons against established dosimetry methods (OLINDA/EXM, MIM-Ablation's VSV, and GATE), which serve as the reference for "ground truth" in this context. It does not mention human experts establishing ground truth for the test set, as the evaluation is based on quantitative comparison of calculated doses.
Adjudication method for the test set:
- Not applicable as the ground truth wasn't based on expert adjudication of diagnostic interpretations, but rather on computational agreement with established dosimetry methods.
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 MRMC comparative effectiveness study was done. This device is a dose calculation software, not an AI diagnostic assistant for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the performance evaluation described (comparison to OLINDA/EXM, VSV, and GATE, along with particle history characterization) is a standalone algorithm-only performance assessment. The "MIM - Monte Carlo Dosimetry" is described as a "standalone software application."
The type of ground truth used:
- Computational Ground Truth: The ground truth was established by comparing the device's calculations to:
  - Model-based dosimetry from the predicate device OLINDA/EXM (K033960).
  - Voxel S-value (VSV) dose calculation from the predicate device MIM – Ablation (K220256).
  - A "well-established Monte Carlo dose calculation algorithm, GATE."
The sample size for the training set:
- The document does not mention a training set, as this is a physics-based dose calculation software, not a machine learning or AI model that requires a labeled training set in the typical sense. Its development would rely on physical models and algorithms rather than statistical learning from data.
How the ground truth for the training set was established:
- Not applicable, as there is no specific "training set" mentioned or implied for this type of software.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 13, 2024

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

Re: K232862

Trade/Device Name: MIM - Monte Carlo Dosimetry Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: April 9, 2024 Received: April 9, 2024

Dear Sydney Lindner:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

Submission Number (if known)

K232862

Device Name

MIM - Monte Carlo Dosimetry

Indications for Use (Describe)

MIM software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical images. The medical imaqe modalities include, but are not limited to, CT. MR. CR. DX. MG. US. SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0. MIM assists in the following indications:

· Receive, transmit, store, retrieve, display, print, and process medical images and DICOM objects. · Create, display, and print reports from medical images.
· Registration, fusion display, and review of medical images for diagnosis, treatment evaluation, and treatment planning.
· Evaluation of cardiac left ventricular function and perfusion, including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction.
· Localization and definition of objects such as tumors and normal tissues in medical images.
· Creation, transformation, and modification of contours for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management.
· Quantitative and statistical analysis of PET/SPECT brain scans by comparing to other registered PET/SPECT brain scans.
· Planning and evaluation of permanent implant brachytherapy procedures (not including radioactive microspheres).
· Calculating absorbed radiation dose as a result of administering a radionuclide.
Assist with the planning and evaluation of ablation procedures by providing visualization and analysis, including energy zone visualization through the placement of virtual ablation devices validated for inclusion in MIM-Ablation. The software is not intended to predict specific ablation zone volumes or predict ablation success.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Images that are printed to film must be printed using an FDAapproved printer for the diagnosis of digital mammography images. Mammographic images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images. The software is not to be used for mammography CAD.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/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.

510(k) Summary of Safety and Effectiveness (The following information is in conformance with 21 CFR 807.92)

Submitter

K232862

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

Phone:	216-455-0600
Fax:	216-455-0601
Contact Person:	Sydney Lindner
Date Summary Prepared:	April 9, 2024

Device Name

Trade Name:

Common Name:

Regulation Number / Product Code:

Classification Name:

MIM - Monte Carlo Dosimetry (K232862)

Medical Imaging Software

21 CFR 892.2050 Product Code LLZ

System, Imaging Processing, Radiological

Predicate Devices

Primary:	K220256	MIM – Ablation	MIM Software Inc.
Reference:	K033960	OLINDA/EXM	Vanderbilt University

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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, with a simple color palette.

Intended Use

MIM software is intended for trained medical professionals including, but not limited to. radiologists, oncologists, physicians, medical technologists, dosimetrists, and physicists.

MIM is a medical image and information management system that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, as well as create, display, and print reports from those images. The medical modalities of these medical imaging systems include, but are not limited to, CT, MR, CR, DX, MG, US, SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0.

MIM provides the user with the means to display, register and fuse medical images from multiple modalities. Additionally, it evaluates cardiac left ventricular function and perfusion, including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction.

The Region of Interest (ROI) feature reduces the time necessary for the user to define objects in medical image volumes by providing an initial definition of object contours. The objects include, but are not limited to, tumors and normal tissues.

MIM provides tools to quickly create, transform, and modify contours for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems and archiving contours for patient follow-up and management.

MIM aids in the assessment of PET/SPECT brain scans. It provides automated quantitative and statistical analysis by automatically registering PET/SPECT brain scans to a standard template and comparing intensity values to a reference database or to other PET/SPECT scans on a voxel-by-voxel basis, within stereotactic surface projections or standardized regions of interest.

MIM allows the dose distribution of an implant to be individually shaped for each patient and is a general-purpose brachytherapy planning system used for prospective and confirmation dose calculations for patients undergoing a course of brachytherapy using permanent implants of various radioisotopes (not including radioactive microspheres).

MIM allows voxel-based dose calculations for patients who have been administered radioisotopes or radioactive microspheres. MIM assists with the planning and evaluation of ablation procedures by allowing the energy zone that comprises the ablation zone to be visualized on medical imaging through the placement of virtual ablation devices for the purpose of confirming ablation zone placement.

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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, 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 the company's name.

Indications for Use

Receive, transmit, store, retrieve, display, print, and process medical images and . DICOM objects.
Create, display, and print reports from medical images.
Registration, fusion display, and review of medical images for diagnosis, treatment evaluation, and treatment planning.
Evaluation of cardiac left ventricular function and perfusion, including left . ventricular end-diastolic volume, end-systolic volume, and ejection fraction.
. Localization and definition of objects such as tumors and normal tissues in medical images.
Creation, transformation, and modification of contours for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management.
Quantitative and statistical analysis of PET/SPECT brain scans by comparing to ● other registered PET/SPECT brain scans.
. Planning and evaluation of permanent implant brachytherapy procedures (not including radioactive microspheres).
. Calculating absorbed radiation dose as a result of administering a radionuclide.
. Assist with the planning and evaluation of ablation procedures by providing visualization and analysis, including energy zone visualization through the placement of virtual ablation devices validated for inclusion in MIM-Ablation. The software is not intended to predict specific ablation zone volumes or predict ablation success.

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Image /page/6/Picture/0 description: The image is a logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the text "mim" in a 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.

Device Description

MIM - Monte Carlo Dosimetry (K232862) is a standalone software application that extends the functionality of the predicate device by providing:

· Dose calculation of radionuclides performed using a Monte Carlo method

Substantial Equivalence

MIM - Monte Carlo Dosimetry is substantially equivalent to the predicate devices, MIM – Ablation (K220256) and OLINDA/EXM (K033960).

ITEM	Subject Device:MIM - Monte CarloDosimetry(K232862)	Predicate Device:MIM - Ablation(K220256)	Reference Predicate:OLINDA/EXM(K033960)
Clearance Date	TBD	October 7, 2022	June 15, 2004
Intended Use	MIM software is intended fortrained medical professionalsincluding, but not limited to,radiologists, oncologists,physicians, medicaltechnologists, dosimetrists,and physicists.MIM is a medical image andinformation managementsystem that is intended toreceive, transmit, store,	MIM software is intended fortrained medical professionalsincluding, but not limited to,radiologists, oncologists,physicians, medicaltechnologists, dosimetrists,and physicists.MIM is a medical image andinformation managementsystem that is intended toreceive, transmit, store,	The purpose ofOLINDA/EXM is to estimateradiation doses received byinternal organs as a result ofadministering aradiopharmaceutical.

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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 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 text "SOFTWARE" in a smaller, sans-serif font.

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

retrieve, display, print andprocess digital medicalimages, as well as create,display, and print reportsfrom those images. Themedical modalities of thesemedical imaging systemsinclude, but are not limited to,CT, MR, CR, DX, MG, US,SPECT, PET and XA assupported by ACR/NEMADICOM 3.0.	retrieve, display, print andprocess digital medicalimages, as well as create,display, and print reportsfrom those images. Themedical modalities of thesemedical imaging systemsinclude, but are not limited to,CT, MR, CR, DX, MG, US,SPECT, PET and XA assupported by ACR/NEMADICOM 3.0.
MIM provides the user withthe means to display, registerand fuse medical imagesfrom multiple modalities.Additionally, it evaluatescardiac left ventricularfunction and perfusion,including left ventricularend-diastolic volume,end-systolic volume, andejection fraction.	MIM provides the user withthe means to display, registerand fuse medical imagesfrom multiple modalities.Additionally, it evaluatescardiac left ventricularfunction and perfusion,including left ventricularend-diastolic volume,end-systolic volume, andejection fraction.
The Region of Interest (ROI)feature reduces the timenecessary for the user todefine objects in medicalimage volumes by providingan initial definition of objectcontours. The objectsinclude, but are not limited to,tumors and normal tissues.	The Region of Interest (ROI)feature reduces the timenecessary for the user todefine objects in medicalimage volumes by providingan initial definition of objectcontours. The objectsinclude, but are not limited to,tumors and normal tissues.
MIM provides tools to quicklycreate, transform, and modifycontours for applicationsincluding, but not limited to,quantitative analysis, aidingadaptive therapy, transferringcontours to radiation therapytreatment planning systemsand archiving contours forpatient follow-up andmanagement.	MIM provides tools to quicklycreate, transform, and modifycontours for applicationsincluding, but not limited to,quantitative analysis, aidingadaptive therapy, transferringcontours to radiation therapytreatment planning systemsand archiving contours forpatient follow-up andmanagement.
MIM aids in the assessmentof PET/SPECT brain scans.It provides automatedquantitative and statisticalanalysis by automaticallyregistering PET/SPECT brainscans to a standard templateand comparing intensityvalues to a reference	MIM aids in the assessmentof PET/SPECT brain scans.It provides automatedquantitative and statisticalanalysis by automaticallyregistering PET/SPECT brainscans to a standard templateand comparing intensityvalues to a reference

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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 simple and modern, and the colors are eye-catching.

	database or to otherPET/SPECT scans on avoxel-by-voxel basis, withinstereotactic surfaceprojections or standardizedregions of interest.	database or to otherPET/SPECT scans on avoxel-by-voxel basis, withinstereotactic surfaceprojections or standardizedregions of interest.
	MIM allows the dosedistribution of an implant tobe individually shaped foreach patient and is ageneral-purposebrachytherapy planningsystem used for prospectiveand confirmation dosecalculations for patientsundergoing a course ofbrachytherapy usingpermanent implants ofvarious radioisotopes (notincluding radioactivemicrospheres).	MIM allows the dosedistribution of an implant tobe individually shaped foreach patient and is ageneral-purposebrachytherapy planningsystem used for prospectiveand confirmation dosecalculations for patientsundergoing a course ofbrachytherapy usingpermanent implants ofvarious radioisotopes (notincluding radioactivemicrospheres).
	MIM allows voxel-baseddose calculations for patientswho have been administeredradioisotopes or radioactivemicrospheres. MIM assistswith the planning andevaluation of ablationprocedures by allowing theenergy zone that comprisesthe ablation zone to bevisualized on medicalimaging through theplacement of virtual ablationdevices for the purpose ofconfirming ablation zoneplacement.	MIM allows voxel-baseddose calculations for patientswho have been administeredradioisotopes or radioactivemicrospheres. MIM assistswith the planning andevaluation of ablationprocedures by allowing theenergy zone that comprisesthe ablation zone to bevisualized on medicalimaging through theplacement of virtual ablationdevices for the purpose ofconfirming ablation zoneplacement.
Indications for Use	MIM software is used bytrained medical professionalsas a tool to aid in evaluationand information managementof digital medical images.The medical imagemodalities include, but arenot limited to, CT, MR, CR,DX, MG, US, SPECT, PETand XA as supported byACR/NEMA DICOM 3.0. MIMassists in the followingindications:• Receive, transmit, store.	MIM software is used bytrained medical professionalsas a tool to aid in evaluationand information managementof digital medical images.The medical imagemodalities include, but arenot limited to, CT, MR, CR,DX, MG, US, SPECT, PETand XA as supported byACR/NEMA DICOM 3.0. MIMassists in the followingindications:• Receive, transmit, store.	Estimates the absorbeddoses to several tissues of areference patient for aspecifiedradiopharmaceuticaldosage.

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Image /page/9/Picture/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the text "mim" in a sans-serif font, with the word "SOFTWARE" below it in a smaller font. The logo is simple and modern, with a focus on the company's name.

process medical images andDICOM objects.	process medical images andDICOM objects.
• Create, display, and printreports from medical images.	• Create, display, and printreports from medical images.
• Registration, fusion display,and review of medicalimages for diagnosis,treatment evaluation, andtreatment planning.	• Registration, fusion display,and review of medicalimages for diagnosis,treatment evaluation, andtreatment planning.
• Evaluation of cardiac leftventricular function andperfusion, including leftventricular end-diastolicvolume, end-systolic volume,and ejection fraction.	• Evaluation of cardiac leftventricular function andperfusion, including leftventricular end-diastolicvolume, end-systolic volume,and ejection fraction.
• Localization and definitionof objects such as tumorsand normal tissues inmedical images.	• Localization and definitionof objects such as tumorsand normal tissues inmedical images.
• Creation, transformation,and modification of contoursfor applications including, butnot limited to, quantitativeanalysis, aiding adaptivetherapy, transferring contoursto radiation therapy treatmentplanning systems, andarchiving contours for patientfollow-up and management.	• Creation, transformation,and modification of contoursfor applications including, butnot limited to, quantitativeanalysis, aiding adaptivetherapy, transferring contoursto radiation therapy treatmentplanning systems, andarchiving contours for patientfollow-up and management.
• Quantitative and statisticalanalysis of PET/SPECT brainscans by comparing to otherregistered PET/SPECT brainscans.	• Quantitative and statisticalanalysis of PET/SPECT brainscans by comparing to otherregistered PET/SPECT brainscans.
• Planning and evaluation ofpermanent implantbrachytherapy procedures(not including radioactivemicrospheres).	• Planning and evaluation ofpermanent implantbrachytherapy procedures(not including radioactivemicrospheres).
• Calculating absorbedradiation dose as a result ofadministering a radionuclide.	• Calculating absorbedradiation dose as a result ofadministering a radionuclide.
• Assist with the planning andevaluation of ablationprocedures by providingvisualization and analysis,including energy zone	• Assist with the planning andevaluation of ablationprocedures by providingvisualization and analysis,including energy zone

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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" in a smaller font below it. The logo is clean and modern, with a focus on simplicity and readability.

	visualization through theplacement of virtual ablationdevices validated forinclusion in MIM-Ablation.The software is not intendedto predict specific ablationzone volumes or predictablation success.	visualization through theplacement of virtual ablationdevices validated forinclusion in MIM-Ablation.The software is not intendedto predict specific ablationzone volumes or predictablation success.
	When using the deviceclinically, within the UnitedStates, the user should onlyuse FDA approvedradiopharmaceuticals. If usedwith unapproved ones, thisdevice should only be usedfor research purposes.	When using device clinically,within the United States, theuser should only use FDAapprovedradiopharmaceuticals. Ifusing with unapproved ones,this device should only beused for research purposes.
	Lossy compressedmammographic images anddigitized film screen imagesmust not be reviewed forprimary imageinterpretations. Images thatare printed to film must beprinted using anFDA-approved printer for thediagnosis of digitalmammography images.Mammographic images mustbe viewed on a displaysystem that has been clearedby the FDA for the diagnosisof digital mammographyimages. The software is notto be used for mammographyCAD.	Lossy compressedmammographic images anddigitized film screen imagesmust not be reviewed forprimary imageinterpretations. Images thatare printed to film must beprinted using anFDA-approved printer for thediagnosis of digitalmammography images.Mammographic images mustbe viewed on a displaysystem that has been clearedby the FDA for the diagnosisof digital mammographyimages. The software is notto be used for mammographyCAD.
OperatingPlatform	Microsoft Windows, Apple®OS X, Linux-based OS	Microsoft Windows, Apple®OS X, Linux-based OS	Microsoft Windows
SupportedImagingModalities	CT, MR, CR, DX, MG, US,NM, PET, XA, and otherDICOM modalities	CT, MR, CR, DX, MG, US,NM, PET, XA, and otherDICOM modalities	None
Receive, transmit,display, generalmanipulation(window/level,pan, zoom,cross-hairs, slicenavigation), andco-registration ofmedical images	Yes	Yes	No
3D image	Yes	Yes	No

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Image /page/11/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 cut out of the red square. To the right of the squares is the text "mim" in black, with the word "SOFTWARE" in smaller black letters below it. The logo is simple and modern, and the colors are eye-catching.

segmentation
Dose calculationof radionuclidesfrom activityimages	LDM, Monte Carlo derivedVSV, and full Monte Carlo	LDM and Monte Carloderived VSV	Model-based with MonteCarlo derived S-values

Testing and Performance Data

Software verification and validation testing included 4 main sections: 1) Comparison to model-based dose calculation with Monte Carlo derived S-values, 2) Comparison to voxel-based dose calculation with Monte Carlo derived voxel S-value (VSV), 3) Comparison to a well-established Monte Carlo dose calculation algorithm, 4) Characterization of user inputs for number of simulated particle histories, number of computational threads, and the simulation starting point.

MIM - Monte Carlo Dosimetry was compared to model-based dosimetry with Monte Carlo derived S-values in OLINDA/EXM (K033960) for Lu-177, I-131, and Y-90 activity maps. A testing dataset was created from an existing CT scan of the patient that was of height (1.7m) and weight (77kg) similar to the default Adult Male model in OLINDA (1.7m, 70kg). Each region was masked to a realistic relative activity per isotope with the rest-of-body reqion normalized to 1. Mean absorbed doses were compared for kidneys, spleen, lungs, liver, salivary glands, lacrimal glands, thyroid and tumors. For all structures and isotopes, the average, absolute percent difference between the dose calculation methods was 4.3%. The differences observed between MIM - Monte Carlo Dosimetry and OLINDA is within the expected range based on a similar study' conducted with 171Lu-DOTATATE data where the two methods differed by 5% on average.

There were high differences in lung dose at 18.1%, and 10.8% for Lu-177, I-131, and Y-90, respectively. Without those comparisons, the average difference drops to 2.5% across the other structures. The differences for Lu-177 and Y-90 lung dose can be attributed to the model-based dosimetry in OLINDA underestimating lung dose by not accounting for the cross-dose from the nearby tumors in the liver. The larger difference in lung dose for I-131 can be attributed to the greater amount of high energy photons in addition to differences in the OLINDA model and the patient-specific lung geometry (30% smaller) leading to the significantly higher amount of cross-dose from nearby high-activity structures to be underestimated.

Dose calculation in MIM - Monte Carlo Dosimetry was also compared to the predicate Voxel S-value (VSV) dose calculation in MIM – Ablation (K220256). The same patient data from the model-based dosimetry comparison was used for the VSV comparison.

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Image /page/12/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 word "mim" in black, sans-serif font. Below the word "mim" is the word "SOFTWARE" in a smaller, sans-serif font, with a registered trademark symbol to the right.

For all structures and isotopes, the average, absolute percent difference was 6.0%. This difference between a VSV method and a Monte Carlo method is consistent with previously published2 results for another commercial, voxel-based VSV software where organ dosimetry differed by ~10%.

The largest difference was seen for the lung dose using I-131 (61%). The average difference across all structures drops to 4.0% without the lung comparison for I-131. Larger differences in lung dose are expected when comparing Monte Carlo methods to VSV methods due to the overestimation of dose in structures significantly lower in density than the simulation material. The VSV kernel was generated assuming water density, thus, for energy deposited by beta and gamma particles in low density regions the VSV method overestimates dose as the particles travel further before being absorbed than they would in soft tissue. Whereas the Monte Carlo dose calculations account for density with the material simulation and more accurately estimate the deposited energy from beta and gamma particles in the low density tissue of the lungs. For I-131, there is a greater amount of high energy particles so the effect of nearby high-activity structures on the lung dose with the VSV approach is greater than Lu-177 or Y-90. This difference in lung dosimetry was expected and within the range of previously reported discrepancies in a study that investigated the effects of tissue inhomogeneities on the VSV method, where lung dose differed by 30-60% when compared to Monte Carlo dosimetry.

Lastly, MIM - Monte Carlo Dosimetry was compared directly to a well-established Monte Carlo dose calculation algorithm, GATE (GEANT4 Application for Tomographic Emission). The same patient data from the model-based dosimetry comparison was used in this comparison The two methods were in high agreement, with an average, absolute difference of 1.4% across all structures and isotopes. It was found that the Monte Carlo calculations differed by 2-3% for Lu-177, I-131, and Y-90.

Characterization of the user inputs to the simulation showed that the default setting for 1 x 10° particle histories is appropriate for accurate dose calculation and provided characterization for using more or less particles than the default. 1 x 10° particle histories results in less than 1% uncertainty in regions of interest and less than 1% difference between results when running multiple simulations with random simulation seeds.

Conclusion

Based on the Device Description and Testing and Performance Data above, the proposed device is determined to be as safe and effective as the predicate devices, MIM - Ablation (K220256) and OLINDA/EXM (K033960).

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Image /page/13/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 sans-serif font, with the word "SOFTWARE" below it in a smaller font.

References

1. Kim KM, Lee MS, Suh MS, et al. Comparison of voxel S -value methods for personalized voxel-based dosimetry of 177Lu-DOTATATE. Med Phys. 2022;49(3):1888-1901. doi:10.1002/mp.15444
1. Stamouli I, Nanos T, Chatzipapas K, et al. Dosimetric Evaluation of 171Lu Peptide Receptor Radionuclide Therapy Using GATE and Planet Dose. Appl Sci. 2023;13(17):9836. doi:10.3390/app13179836
1. Götz T, Schmidkonz C, Lang EW, Maier A, Kuwert T, Ritt P. A comparison of methods for adapting 171Lu dose-voxel-kernels to tissue inhomogeneities. Phys Med Biol. 2019;64(24):245011. doi:10.1088/1361-6560/ab5b81

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).