MIM 5.2 software is intended for trained medical professionals including, but not limited to, radiologists, oncologists, physicians, medical technologists, dosimetrists and physicists.

MIM 5.2 is a medical image and information management system that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, as well as create, display and print reports from those images. The medical modalities of these medical imaging systems include, but are not limited to, CT, MRI, CR, DX, MG, US, SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0.

MIM 5.2 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 5.2 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.

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 5.2 is a software package designed for use in diagnostic imaging and oncology. It is a stand-alone package which operates on both Windows and Mac computer systems. MIM 5.2 aids the efficiency of medical professionals by providing various tools for display, registration and fusion of medical images from multiple modalities, 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 5.2 functions as a medical image and information management system intended to receive, transmit, store, retrieve, display, print and process digital medical images, as well as create, display and print reports from those images. MIM 5.2 is an expansion of MIM 4.1 (SEASTAR) software, which was granted marketing clearance to MIM Software Inc. (formerly MIMvista Corp.) on September 26, 2007 under 510(k) Accession Number 071964 with the following additional features and capabilities allowing it to become 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:

allows for structure contouring on a patient scan and specifying any implant vector for seed implant. MIM 5.2 will re-slice and display the scan orthogonal to the specified vector.
allows for automatic generation of 3D display of patient data and contours.
allows user to select an implant template from a template database. The template grid will be displayed upon patient scan. The user is able to align the template to the desired location.
allows user to specify the type of seed from a seed database. The user is able to manually place seeds either at locations specified by a template grid or at arbitrary locations within the scan. Based on the type and location of the seeds, MIM 5.2 will update the dose volume in real time to reflect current dose coverage. MIM 5.2 allows the user to change isodose line settings.
allows saving the treatment plan. The saved plan can be loaded for evaluation and modification.
allows generation of seed planning report which contains information of template type, seed type, seed locations, needle configuration, screen captures, 3D displays, and re-slicing vector. The report can be exported as an electronic file (e.g. PDF or DICOM SR) and easily transferred to seed vendor.

AI/ML Overview

The MIM Software Inc. 510(k) summary for MIM 5.2 (Brachy) states, "MIM Software Inc. has conducted performance and functional testing on the MIM 5.2 software. In all cases, the software passed its performance requirements and met specifications." However, the document does not explicitly present a table of acceptance criteria with reported device performance, nor does it describe a specific study that proves the device meets those criteria.

Instead, the submission relies on the concept of substantial equivalence to predicate devices (MIM 4.1 (SEASTAR), Brachyvision 6.0, and VariSeed 7.1). This means the manufacturer is asserting that their new device is as safe and effective as existing legally marketed devices, primarily by demonstrating that the new features and capabilities are similar to or extensions of those found in the predicate devices.

Given the information provided in the document, here's what can be inferred or explicitly stated regarding your questions, with the caveat that detailed study methodologies and results are absent:

A table of acceptance criteria and the reported device performance
- Not provided within the document. The document generally states that "the software passed its performance requirements and met specifications," but it does not enumerate these specifications or present a comparative table.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided within the document. The document does not describe a "test set" in terms of patient data or image datasets used for a performance study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not provided within the document. There is no mention of experts or ground truth establishment for a specific test set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided within the document. No information on adjudication is present.
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
- Not provided within the document. This type of study is not mentioned, nor is any AI component clearly highlighted in the sense of directly assisting human readers for a measured improvement. The software provides tools to aid medical professionals, but not necessarily in an "AI vs. without AI assistance" comparative effectiveness study format in this submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not provided within the document. The device is described as a tool for medical professionals, implying human-in-the-loop use. No standalone algorithm-only performance is detailed.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not provided within the document. Given the lack of a described performance study or test set, the type of ground truth is not specified.
The sample size for the training set
- Not provided within the document. Information regarding a "training set" is not included because the submission does not detail the development or validation of a machine learning or AI model in the way implied by this question. The product is an "expansion" of existing software with added functionality.
How the ground truth for the training set was established
- Not provided within the document. Similar to point 8, this information is not applicable given the content of this 510(k) summary.

Summary of available information regarding acceptance criteria and study:

The document states: "MIM Software Inc. has conducted performance and functional testing on the MIM 5.2 software. In all cases, the software passed its performance requirements and met specifications."

This statement indicates that internal testing was performed, and the software met unstated internal requirements. However, the 510(k) summary does not include the details of these tests, such as the specific acceptance criteria, methodology, datasets used, or the results of these tests beyond the general statement of compliance. The primary argument for clearance rests on its substantial equivalence to previously cleared predicate devices, rather than a detailed presentation of a specific clinical or performance study with quantified acceptance criteria.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for MIM Software. The logo consists of a geometric shape on the left and the text "mim SOFTWARE." on the right. The geometric shape is made up of two overlapping rounded squares, with a circle cut out of the top square.

103576

Page 1 of 4

FEB_11:8; 2011 :

510(k) Summary of Safety and Effectiveness

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

Submitter:

MIM Software Inc. 25200 Chagrin Blvd. Suite 200 Cleveland, OH 44122

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

Contact Person:

Lynn Hanigan

Dec 2, 2010

Date Summary Prepared:

Device Name

Trade Name:	MIM 5.2 (Brachy)
Common Name:	Medical Imaging Software
Classification Name:	System, Imaging Processing, Radiological

Predicate Devices

K071964	MIM 4.1 (SEASTAR)	MIM Software Inc. (formerly MIMvista Corp.)
K992762	Brachyvision 6.0	Varian Medical Systems
K030534	VariSeed 7.1	Varian Medical Systems

Intended Use

MIM 5.2 software is intended for trained medical professionals including, but not limited to, radiologists, oncologists, physicians, medical technologists, dosimetrists and physicists.

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Image /page/1/Picture/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping squares, one of which is shaded and has a white circle in the center. To the right of the squares is the text "mim" in a stylized font, with the word "SOFTWARE" in smaller letters below it.

MIM 5.2 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 5.2 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 5.2 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 5.2 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.

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.

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Image /page/2/Picture/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping squares, one gray and one black, with a white circle in the center. To the right of the squares is the text "mim SOFTWARE.", with "mim" in a larger font than "SOFTWARE."

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.

Device Description

allows for structure contouring on a patient scan and specifying any implant . vector for seed implant. MIM 5.2 will re-slice and display the scan orthogonal to the specified vector.
allows for automatic generation of 3D display of patient data and contours. .

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Image /page/3/Picture/1 description: The image shows the logo for MIM Software. The logo consists of two overlapping squares, one light and one dark, with a white circle in the center. To the right of the squares is the text "mim SOFTWARE" in a bold, sans-serif font.

allows user to select an implant template from a template database. The . template grid will be displayed upon patient scan. The user is able to align the template to the desired location.
allows user to specify the type of seed from a seed database. The user is able to . manually place seeds either at locations specified by a template grid or at arbitrary locations within the scan. Based on the type and location of the seeds, MIM 5.2 will update the dose volume in real time to reflect current dose coverage. MIM 5.2 allows the user to change isodose line settings.
allows saving the treatment plan. The saved plan can be loaded for evaluation . and modification.
allows generation of seed planning report which contains information of . template type, seed type, seed locations, needle configuration, screen captures, 3D displays, and re-slicing vector. The report can be exported as an electronic file (e.g. PDF or DICOM SR) and easily transferred to seed vendor.

Substantial Equivalence

MIM 5.2 is substantially equivalent to a combination of the predicate devices MIM 4.1 (SEASTAR) - K071964, Brachyvision 6.0 - K992762, and VariSeed 7.1 - K030534.

MIM 5.2 extends the MIM 4.1 software application by adding functionality to act as a general purpose brachytherapy planning system providing prospective and confirmation dose calculations for patients undergoing a course of brachytherapy using permanent implants of various radioisotopes. This functionality is substantially equivalent to Brachyvision 6.0 and VariSeed 7.1.

Performance Data

MIM Software Inc. has conducted performance and functional testing on the MIM 5.2 software. In all cases, the software passed its performance requirements and met specifications.

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Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. The eagle is facing to the right.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Ms. Lynn Hanigan Quality Manager MIM Software, Inc. 25200 Chagrin Blvd., Suite 200 CLEVELAND OH 44122

FEB 1 8 201

Re: K103576

Trade/Device Name: MIM 5.2 (Brachy) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 8, 2011 Received: February 9, 2011

Dear Ms. 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. 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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Mary S. Pastel

Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): TBD

MIM 5.2 (Brachy) Device Name:

Indications for Use:

MIM 5.2 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 5.2 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.

(continued on next page)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K103576

Page 1 of 2

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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.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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).