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, MRI, CR, DX, MG, US, SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0. MIM assists in the following indications:

· Receive, transmit, store, retrieve, display, print, and process medical images and DICOM objects.

· 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, 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 PE7/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 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 device clinically, within the United States, the user should only use FDA approved radionly, If using with unapproved ones, this device should only be used for research purposes.

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

Device Description

MIM - Ablation is a standalone software application that allows for the planning and evaluation of ablation procedures. This is achieved by utilizing the following functionality:

. Manual and automatic tools for normal structure, target region, and ablation zone segmentation
lmage re-slicing and reorientation orthogonally to a user-defined angle to give a . "probe's-eye view" image for planning
Manual and constraint-driven placement of virtual ablation devices on medical . imaging in order to visualize the ablation energy zones.
. The calculation of the percentage of designated structures that are covered by each energy zone during planning, as well as a calculation of the final ablation zone coverage after the ablation has been performed
Multimodality image registration, including rigid and deformable fusion, for the . comparison of images taken at different times during the ablation planning and treatment administration
MIM - Ablation is run on a dedicated workstation in the hospital healthcare environment and can be used with an 3D DICOM image. The software can be used on image data for any patient demographic that is undergoing ablation treatment with devices validated for inclusion in MIM - Ablation.

AI/ML Overview

The acceptance criteria and study proving MIM-Ablation meets these criteria are detailed below, based on the provided FDA 510(k) summary.

MIM-Ablation Acceptance Criteria and Performance Study

The MIM-Ablation software, as described in the 510(k) summary, demonstrates its efficacy and safety through specific performance testing. The core functionality validated is the accurate representation and calculation of "energy zones" (simulated ablation zones) based on manufacturer specifications of validated ablation devices within the software.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Energy Zone Dimensions	Dimensions of imported 3D energy zone objects in MIM match manufacturer specifications.	CAD Measurement vs. MIM Contour Measurement:- Percent difference ranged from -3.75% to 1.53%, falling within the manufacturer tolerance.
Image Resolution Independence	Volume of imported 3D energy zone objects in MIM is independent of image resolution (0.5mm, 1.0mm, 1.5mm).	Percent Difference in Volume:- At 0.5 mm: -1.65% to 0.29%- At 1.0 mm: -0.87% to -0.6%- At 1.5 mm: -0.70% to 0.00%.This demonstrates consistency across various resolutions.
Contour Resolution Independence	Dimensions of imported 3D energy zone objects in MIM match manufacturer specifications, independent of contour resolution.	Percent Difference in Dimensions:- At 0.25 mm: -1.43% to -0.43%- At 0.5 mm: -1.16% to 0.00%- At 1.0 mm: -2.15% to -0.38%.This indicates independence from contour resolution.
Image Modality Independence	Dimensions of 3D energy zone objects in MIM match manufacturer specifications across four image modalities.	Percent Difference in Dimensions:- Ranged from 0.64% to 0.89%.This highlights the minimal effect of image modality on contour dimensions.
Percent Coverage Calculation	Accuracy of "Percent Coverage" statistic (volume of structure covered by energy zone) with one or multiple ablation probes.	Percent Difference in Calculation:- With one ablation probe: 0.00% to 1.57%- With two ablation probes: 0.00% to 0.19%.This validates the accuracy of the coverage calculation feature.
HIFU Energy Zone Dimensions	Dimensions of the unique HIFU energy zone (3cm and 4cm transducer treatment heights, overlap) match manufacturer specifications.	Percent Error in Measurements (MIM vs. SonoBlate):- Ranged from 0.00% to 6.00%.These measurements fell within the manufacturer tolerance, verifying consistency in HIFU dimensions.
Constraint-Driven Planning	Constraint-driven planning functionality places energy zones that adhere to user-set constraints, and indicates when planning is not possible.	Verified Functionality:- The work verified that energy zones adhere to constraints and that an "unattainable plan" is indicated when a scenario is not possible, ensuring appropriate targeting and preventing impossible planning.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify the exact sample size for the test set in terms of an overall number of cases or images. Instead, the testing appears to be highly controlled and synthetic or semi-synthetic, focusing on the accuracy of internal calculations and representations based on input parameters (manufacturer specifications, different resolutions, different contour resolutions, multiple modalities, and various probe configurations).

Data Provenance: The data provenance is primarily "internal" verification data, based on manufacturer specifications (user guides, marketing material) of the Varian V-Probes and SonaBlate HIFU system. This suggests a controlled environment, likely using simulated or canonical data derived from these specifications. The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective clinical data. Given the "verification and validation testing" language and the precise percentage differences, it points towards rigorous technical and performance testing rather than a clinical study on patient data.

3. Number of Experts and Qualifications for Ground Truth

The document does not describe the establishment of ground truth through expert consensus for the performance testing. The ground truth for the device's calculations and representations of ablation zones is explicitly stated as the manufacturer specifications of the validated ablation devices (Varian V-Probes and SonaBlate HIFU system). This is a technical ground truth rather than a clinical one from human experts evaluating medical images.

4. Adjudication Method for the Test Set

No adjudication method is mentioned, as the ground truth is derived from manufacturer specifications rather than subjective expert interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The study described focuses on the device's technical performance in accurately representing and calculating energy zones, not on its impact on human reader performance or the improvement of human readers with AI assistance.

6. Standalone Performance (Algorithm Only)

The testing described is primarily focused on the standalone performance of the algorithm in generating and calculating energy zones based on defined inputs (manufacturer specifications, different image/contour resolutions, etc.). It verifies the internal consistency and accuracy of the software's representations independent of a human operator, beyond the initial input parameters.

7. Type of Ground Truth Used

The ground truth used for this study is manufacturer specifications (from user guides and marketing material) of the validated ablation devices. This serves as the engineering/technical ground truth against which the software's generated energy zone dimensions and volumes are compared.

8. Sample Size for the Training Set

The document does not describe a "training set" in the context of a machine learning model that learns from data. MIM-Ablation's functionality, as described, appears to be based on predefined models and algorithms derived from the physical specifications of ablation devices, rather than a data-driven machine learning approach requiring a training set. The descriptions point to a rule-based or model-based system.

9. How Ground Truth for the Training Set Was Established

As no training set (for machine learning) is implied, there is no mention of how ground truth for a training set was established. The "ground truth" for the device's functionality is the engineering specifications of the ablation devices, which were used to "generate models and import into MIM-Ablation."

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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below.

MIM Software, Inc. % Daniel Darkow Clinical Science Team Lead 25800 Science Park Drive - Suite 180 CLEVELAND OH 44122

Re: K220256

October 7, 2022

Trade/Device Name: MIM-Ablation Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QTZ, LLZ Dated: September 2, 2022 Received: September 6, 2022

Dear Daniel Darkow:

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 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)

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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 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,

Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products 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

510(k) Number (if known) K220256

Device Name MIM - Ablation

Indications for Use (Describe)

· 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, 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.

· Quantitative and statistical analysis of PE7/SPECT brain scans by comparing to other registered PET/SPECT brain scans.

· Planning and evaluation of permanent implant brachytherapy procedures (not including radioactive microspheres).

· Calculating absorbed radiation dose as a result of administering a radionuclide.

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

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/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 in the red square. To the right of the squares is the text "mim SOFTWARE" in black, with "SOFTWARE" in a smaller font size than "mim".

510(k) Summary

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

Submitter:

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

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

Contact Person:

Daniel Darkow

Date Summary Prepared:

10/04/2022

Device Name

510(k) Number:	K220256
Trade Name:	MIM – Ablation
Common Name:	Medical Imaging Software
Primary Regulation Number/Product Code:	21 CFR 892.2050 Product Code QTZ
Primary Classification Name:	Radiological Image Processing Software for Ablation Therapy Planning and Evaluation
Secondary Regulation Number / Product Code:	21 CFR 892.2050 Product Code LLZ
Secondary Classification Name:	System, Imaging Processing, Radiological

Predicate Devices

Primary:K190379	MIM on Linux	MIM Software Inc.
Secondaries:K202297	Aline Ablation Intelligence	Mirada Medical Ltd.

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

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Image /page/5/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 cut out of the corner. To the right of the squares is the text "mim SOFTWARE" in black font. The word "SOFTWARE" is in a smaller font than "mim".

well as create, display, and print reports from those images. The medical modalities of these medical imaging systems include, but are not limited to. CT, MRI, CR, DX, MG, US, SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0.

MIM 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 eiection 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.

Indications For Use

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• 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.

• 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 device clinically, within the United States, the user should only use FDA approved radiopharmaceuticals. If using 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.

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Image /page/7/Picture/0 description: The image shows the logo for MIM Software. The logo consists of a red square with rounded corners and a white circle cut out of the top right corner. To the left of the red square is a gray square with rounded corners. To the right of the squares is the text "mim SOFTWARE" in black font.

ITEM	MIM – Ablation(K220256)	MIM on Linux(K190379)	Mirada AlineAblation Intelligence(K202297)
Clearance Date	TBD	03-19-2019	09-11-2020
Intended Use	MIM software is intendedfor trained medicalprofessionals including,but not limited to,radiologists, oncologists,physicians, medicaltechnologists, dosimetristsand physicists.MIM is a medical imageand informationmanagement system thatis intended to receive,transmit, store, retrieve,display, print and processdigital medical images, aswell as create, display andprint reports from thoseimages. The medicalmodalities of thesemedical imaging systemsinclude, but are not limitedto, CT, MRI, CR, DX, MG,US, SPECT, PET and XAas supported byACR/NEMA DICOM 3.0.MIM provides the userwith the means to display,register and fuse medicalimages from multiplemodalities.Additionally, it evaluatescardiac left ventricularfunction and perfusion,including left ventricular	MIM software is intendedfor trained medicalprofessionals including,but not limited to,radiologists, oncologists,physicians, medicaltechnologists, dosimetristsand physicists.MIM is a medical imageand informationmanagement system thatis intended to receive,transmit, store, retrieve,display, print and processdigital medical images, aswell as create, display andprint reports from thoseimages. The medicalmodalities of thesemedical imaging systemsinclude, but are not limitedto, CT, MRI, CR, DX, MG,US, SPECT, PET and XAas supported byACR/NEMA DICOM 3.0.MIM provides the userwith the means to display,register and fuse medicalimages from multiplemodalities.Additionally, it evaluatescardiac left ventricularfunction and perfusion,including left ventricular	Not listed
ITEM	MIM - Ablation(K220256)	MIM on Linux(K190379)	Mirada AlineAblation Intelligence(K202297)
	end-diastolic volume, end-systolic volume, andejection fraction.	end-diastolic volume, end-systolic volume, andejection fraction.
	The Region of Interest(ROI) feature reduces thetime necessary for theuser to define objects inmedical image volumesby providing an initialdefinition of objectcontours. The objectsinclude, but are not limitedto, tumors and normaltissues.	The Region of Interest(ROI) feature reduces thetime necessary for theuser to define objects inmedical image volumesby providing an initialdefinition of objectcontours. The objectsinclude, but are not limitedto, tumors and normaltissues.
	MIM provides tools toquickly create, transform,and modify contours forapplications including, butnot limited to, quantitativeanalysis, aidingadaptive therapy,transferring contours toradiation therapytreatment planningsystems and archivingcontours for patient follow-up and management.	MIM provides tools toquickly create, transform,and modify contours forapplications including, butnot limited to, quantitativeanalysis, aiding adaptivetherapy, transferringcontours to radiationtherapy treatmentplanning systems andarchiving contours forpatient follow-up andmanagement.
	MIM aids in theassessment ofPET/SPECT brain scans.It provides automatedquantitative andstatistical analysis byautomatically registeringPET/SPECT brain scansto a standard templateand comparing intensityvalues to a reference	MIM aids in theassessment ofPET/SPECT brain scans.It provides automatedquantitative and statisticalanalysis by automaticallyregistering PET/SPECTbrain scans to a standardtemplate and comparingintensity values to areference database or to
ITEM	MIM – Ablation(K220256)	MIM on Linux(K190379)	Mirada AlineAblation Intelligence(K202297)
	database or to otherPET/SPECT scans on avoxel by voxel basis,within stereotactic surfaceprojections orstandardized regions ofinterest.MIM allows the dosedistribution of an implantto be individually shapedfor each patient and is ageneral purposebrachytherapyplanning system used forprospective andconfirmation dosecalculations for patientsundergoing a course ofbrachytherapy usingpermanent implants ofvarious radioisotopes (notincluding radioactivemicrospheres).MIM allows voxel-baseddose calculations forpatients who have beenadministeredradioisotopes orradioactive microspheres.MIM assists with theplanning and evaluation ofablation procedures byallowing the energy zonethat comprises theablation zone to bevisualized on medicalimaging through theplacement of virtual	other PET/SPECT scanson a voxel by voxel basis,within stereotactic surfaceprojections orstandardized regions ofinterest.MIM allows the dosedistribution of an implantto be individually shapedfor each patient and is ageneral purposebrachytherapy planningsystem used forprospective andconfirmation dosecalculations for patientsundergoing a course ofbrachytherapy usingpermanent implants ofvarious radioisotopes (notincluding radioactivemicrospheres).MIM allows voxel-baseddose calculations forpatients who have beenadministeredradioisotopes orradioactive microspheres.
ITEM	MIM – Ablation(K220256)	MIM on Linux(K190379)	Mirada AlineAblation Intelligence(K202297)
	ablation devices for thepurpose of confirmingablation zone placement.
Indications for Use	MIM software is used bytrained medicalprofessionals as a tool toaid in evaluation andinformation managementof digital medical images.The medical imagemodalities include but arenot limited to, CT, MR,CR, DX, MG, US, SPECT,PET and XA as supportedby ACR/NEMA DICOM3.0. MIM assists in thefollowing indications:• Receive, transmit,store, retrieve, display,print, and process medicalimages and DICOMobjects.• Create, display andprint reports from medicalimages.• Registration, fusiondisplay, and review ofmedical images fordiagnosis, treatmentevaluation, and treatmentplanning.• Evaluation of cardiacleft ventricular functionand perfusion, includingleft ventricular end-diastolic volume, end-systolic volume, andejection fraction.	MIM software is used bytrained medicalprofessionals as a tool toaid in evaluation andinformation managementof digital medical images.The medical imagemodalities include, but arenot limited to, CT, MRI,CR, DX, MG, US, SPECT,PET and XA as supportedby ACR/NEMA DICOM3.0. MIM assists in thefollowing indications:• Receive, transmit,store, retrieve, display,print, and process medicalimages and DICOMobjects.• Create, display andprint reports from medicalimages.• Registration, fusiondisplay, and review ofmedical images fordiagnosis, treatmentevaluation, and treatmentplanning.• Evaluation of cardiacleft ventricular functionand perfusion, includingleft ventricular end-diastolic volume, end-systolic volume, andejection fraction.	Aline Ablation Intelligenceis a ComputedTomography (CT) andMagnetic Resonance(MR) image processingsoftware packageavailable for use withablation procedures.Aline Ablation Intelligenceis controlled by the uservia a user interface on aworkstation.Aline Ablation Intelligenceimports images from CTand MR scanners andfacility PACS systems fordisplay and processingduring ablationprocedures.Aline Ablation Intelligenceis used to assistphysicians in planningablation procedures,including identifyingablation targets and virtualablation needleplacement. Aline AblationIntelligence is used toassist physicians inconfirming ablation zones.The software is notintended for diagnosis.
ITEM	MIM – Ablation(K220256)	MIM on Linux(K190379)	Mirada AlineAblation Intelligence(K202297)
	• Localization anddefinition of objects suchas tumors and normaltissues in medical images.• Creation,transformation, andmodification of contoursfor applications including,but not limited to,quantitative analysis,aiding adaptive therapy,transferring contours toradiation therapytreatment planningsystems, and archivingcontours for patient follow-up and management.• Quantitative andstatistical analysis ofPET/SPECT brain scansby comparing to otherregistered PET/SPECTbrain scans.• Planning andevaluation of permanentimplant brachytherapyprocedures (not includingradioactive microspheres).• Calculating absorbedradiation dose as a resultof administering aradionuclide.• Assist with theplanning and evaluation ofablation procedures byproviding visualization andanalysis, including energyzone visualization throughthe placement of virtualablation devices validatedfor inclusion in MIM-	• Localization anddefinition of objects suchas tumors and normaltissues in medical images.• Creation,transformation, andmodification of contoursfor applications including,but not limited to,quantitative analysis,aiding adaptive therapy,transferring contours toradiation therapytreatment planningsystems, and archivingcontours for patient follow-up and management.• Quantitative andstatistical analysis ofPET/SPECT brain scansby comparing to otherregistered PET/SPECTbrain scans.• Planning andevaluation of permanentimplant brachytherapyprocedures (not includingradioactive microspheres).• Calculating absorbedradiation dose as a resultof administering aradionuclide.	The software is notintended to predictablation volumes orpredict ablation success.
ITEM	MIM - Ablation(K220256)	MIM on Linux(K190379)	Mirada AlineAblation Intelligence(K202297)
	Ablation. The software isnot intended to predictspecific ablation zonevolumes or predictablation success.	When using deviceclinically, the user shouldonly use FDA approvedradiopharmaceuticals.
	When using the deviceclinically, within the UnitedStates, the user shouldonly use FDA approvedradiopharmaceuticals.	If using with unapprovedones, this device shouldonly be used for researchpurposes.
	If using with unapprovedones, this device shouldonly be used for researchpurposes.	Lossy compressedmammographic imagesand digitized film screenimages must not bereviewed for primaryimage interpretations.
	Lossy compressedmammographic imagesand digitized film screenimages must not bereviewed for primaryimage interpretations.	Images that are printed tofilm must be printed usingan FDA-approved printerfor the diagnosis of digitalmammography images.
	Images that are printed tofilm must be printed usinga FDA-approved printerfor the diagnosis of digitalmammography images.	Mammographic imagesmust be viewed on adisplay system that hasbeen cleared by the FDAfor the diagnosis of digitalmammography images.
	Mammographic imagesmust be viewed on adisplay system that hasbeen cleared by the FDAfor the diagnosis of digitalmammographyimages. The software isnot to be used formammography CAD.	The software is not to beused for mammographyCAD.
ITEM	MIM – Ablation(K220256)	MIM on Linux(K190379)	Mirada AlineAblation Intelligence(K202297)
Operating Platform	Microsoft Windows,Apple® OS X	Microsoft Windows,Apple® OS X	Unknown
Receive, transmit, displayand general manipulation(window/level, pan, zoon,cross-hairs, slicenavigation) of medicalimages	Yes	Yes	Yes
Supported ImagingModalities	CT, MR, CR, DX, MG, US,NM, PET, XA, and otherDICOM modalities	CT, MR, CR, DX, MG, US,NM, PET, XA, and otherDICOM modalities	CT and MR
Image Segmentation	Tools for segmenting 3Dstructures, includingnormal structures, lesions,and ablation zones.(This functionality isunchanged from MIM onLinux)	Tools for segmenting 3Dstructures, includingnormal structures, andlesions.	Tools for segmenting 3DVOIs, including targettissues and ablationzones.
ITEM	MIM - Ablation(K220256)	MIM on Linux(K190379)	Mirada AlineAblation Intelligence(K202297)
Derive volume statisticsfrom segmentations	Yes(This functionality isunchanged from MIM onLinux)	Yes	Yes
Automated ablationmargin creation throughthe expansion of adesignated segmentation	Yes(This functionality isunchanged from MIM onLinux)	Yes	Yes
Image re-slicingorthogonally to a user-defined angle to give a"probe's-eye view" imagefor planning	Yes(This functionality isunchanged from MIM-Brachy (K103576) whichis a precursor 510(k) toMIM on Linux)	Yes	No

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Image /page/8/Picture/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" underneath in a smaller font. The logo is simple and modern, with a focus on clean lines and geometric shapes.

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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 SOFTWARE" in black. The font is sans-serif and the word "SOFTWARE" is smaller than "mim".

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Image /page/10/Picture/0 description: The image shows the logo for MIM Software. The logo consists of a gray square overlapping a red rounded square with a white circle cut out of it, followed by the text "mim SOFTWARE" in black. The "mim" is in a larger, bolder font than the "SOFTWARE" text.

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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, with a white circle where they overlap. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" underneath in a smaller font. The logo is simple and modern, with a focus on the company's name.

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Image /page/12/Picture/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" underneath in a smaller font. The logo is simple and modern, with a focus on clean lines and geometric shapes.

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Image /page/13/Picture/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping squares, one gray and one red, with a white circle cut out of the red square. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" below it in a smaller font.

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Image /page/14/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 cut out of the top right corner. To the left of the red square is a gray square that is partially obscured by the red square. To the right of the squares is the text "mim" in a bold, sans-serif font. Below the text "mim" is the text "SOFTWARE" in a smaller, sans-serif font.

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Image /page/15/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 bold, sans-serif font, with the word "SOFTWARE" underneath in a smaller font.

ITEM	MIM = Ablation(K220256)	MIM on Linux(K190379)	Mirada AlineAblation Intelligence(K202297)
Placement of pre-definedenergy zone volumes perspecified grid locations ona medical image	Yes	No	Yes
Registration of planningimaging to in-procedureand/or post-ablationimaging for the purpose ofablation zone confirmation	Yes(Image registrationfunctionality is unchangedfrom MIM on Linux)	Yes	Yes

Device Description

MIM - Ablation is a standalone software application that allows for the planning and evaluation of ablation procedures. This is achieved by utilizing the following functionality:

. Manual and automatic tools for normal structure, target region, and ablation zone segmentation
lmage re-slicing and reorientation orthogonally to a user-defined angle to give a . "probe's-eye view" image for planning
Manual and constraint-driven placement of virtual ablation devices on medical . imaging in order to visualize the ablation energy zones.
. The calculation of the percentage of designated structures that are covered by each energy zone during planning, as well as a calculation of the final ablation zone coverage after the ablation has been performed

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Image /page/16/Picture/0 description: The image shows the logo for MIM Software. The logo consists of a red square with a white circle in the corner, and a gray square overlapping the red square. To the right of the squares is the text "mim SOFTWARE" in black font. The word "mim" is in a larger font than the word "SOFTWARE".

Multimodality image registration, including rigid and deformable fusion, for the . comparison of images taken at different times during the ablation planning and treatment administration
MIM - Ablation is run on a dedicated workstation in the hospital healthcare environment and can be used with an 3D DICOM image. The software can be used on image data for any patient demographic that is undergoing ablation treatment with devices validated for inclusion in MIM - Ablation.

Substantial Equivalence

MIM - Ablation is substantially equivalent to a combination of the primary predicate device MIM on Linux (K190379) and Aline Ablation Intelligence (K202297).

Testing and Performance Data

MIM Software Inc. has conducted performance and integration testing on MIM -Ablation software that fully evaluated all the functions. The data support verification in energy zone dimensions, image resolution independence, contour resolution independence, image modality independence, percent coverage of regions, HIFU energy zone dimensions, and constraint driven planning. The verification and validation testing follow 21 CFR part 820.30 and satisfies the FDA "Guidance on Software Contained in Medical Devices" requirements. Potential risks were mitigated and reflected in the device labeling and design.

The ablation devices that were included in the verification and validation of MIM-Ablation are the Varian V-Probes (part of the CryoCare Touch System, K201588) and the SonaBlate HIFU system (K160942). The specific energy zone characteristics that were used to generate models and import into MIM-Ablation were taken from user quides and marketing material for each ablation device.

The dimensions of the energy zones that are imported as 3D objects in MIM match the dimensions for that energy zone as specified by the ablation device manufacturer. The measurements of the initial 3D models of the energy zones in the CAD (computer-aided design) software and the MIM contour measurements fell within the range of the manufacturer tolerance. In addition, the CAD measurement had a range of -3.75% to 1.53% percent difference compared to MIM contour measurements.

The volume of the energy zones that are imported as 3D objects in MIM are independent of image resolution. This work compared expected volumes to MIM volume at 0.5 mm. 1.0 mm. and 1.5 mm image resolutions to verify consistency. Percent difference ranged from -1.65 % to 0.29%, at 0.5 mm. -0.87% to -0.6% at 1.0 mm, and -0.70% to 0.00% at 1.5 mm image resolution.

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Image /page/17/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 corner. To the right of the squares is the text "mim SOFTWARE" in black font.

The dimensions of the energy zones that are imported as 3D objects in MIM match the dimensions for that energy zone as specified by the ablation device manufacturer independent of contour resolution. Percent difference ranged from -1.43% to -0.43% at 0.25 mm, -1.16% to 0.00% at 0.5 mm, and -2.15% to -0.38% at 1.0 mm contour resolution.

The dimensions of the energy zones as 3D objects in MIM match the dimensions of the energy zone as specified by the ablation device manufacturer across four image modalities. Percent difference ranged from 0.64% - 0.89%. This highlights the minimal effect image modality has on contour dimensions.

MIM provides the statistic "Percent Coverage" that indicates the volume of the structure being covered by the volume of the energy zone. The percent coverage statistic with one or multiple ablation probes placed on an image was verified. Percent difference ranged from 0.00% to 1.57%. with one ablation probe and 0.00% to 0.19% with two ablation probes.

The dimensions of the unique energy zone, HIFU, are generated as specified by the ablation probe manufacturer. The 3cm transducer treatment zone height, 4cm transducer treatment zone height, and overlap were measured in MIM and in Sonablate to verify that they matched the manufacturer's dimensions. Percent error ranged from 0.00% to 6.00%. These measurements fell within the range of the manufacturer tolerance. This work verified the consistency in HIFU dimensions compared to the manufacturer's measurements.

This work verified that the constraint-driven planning functionality places energy zones that adhere to the constraints as set by the user. These constraints ensure ablation probes target the appropriate region of interest. In addition, this work verified that an unattainable plan occurs when the scenario is not possible.

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 on Linux (K190379) and Aline Ablation Intelligence (K202297).

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).