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 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.

When using device clinically, 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 interretations. Images that are printed to film must be printed using a FDA-approved printer for the diagital 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 on Linux is a standalone medical device software application that provides the same functionality of previous MIM predicates. MIM software was originally designed for use on both Windows and Mac computer systems. For this Special 510(k) submission, MIM has the capability to run on Linux-based operating systems. The rationale to allow MIM to run on Linux based workstations is to provide more flexibility and workstation options for end users.

Indications for use have not been modified. The intended use is the same as last 510(k) clearance for MIM software (K182624).

MIM on Linux utilizes the same technological characteristics that are included in past predicates, therefore, no engineering drawings, schematics, etc. are not applicable to the device.

AI/ML Overview

The provided document is a 510(k) premarket notification for "MIM on Linux," a medical imaging software. It primarily focuses on demonstrating substantial equivalence to previously cleared MIM software versions. However, it does not contain the detailed performance study information typically found when a novel device or a device with new functionality requires rigorous validation against acceptance criteria.

Specifically, the document states: "MIM on Linux utilizes the same technological characteristics that are included in past predicates, therefore, no engineering drawings, schematics, etc. are not applicable to the device." and "MIM Software Inc. conducted functional testing as a means of verification and validation on MIM software running on a Linux-based operating system workstation. The Linux distribution used was specifically Ubuntu 18.04. Functional testing was identical to that which is done with all major releases of MIM software running on Windows and Mac operating systems workstations. In all cases, MIM on Linux passed its performance requirements and met specifications."

This indicates that the submission relies on the established performance of the predicate devices and functional testing to confirm that the software operates correctly on a new operating system (Linux) without altering its core functionality or indications for use. Therefore, the requested information regarding specific acceptance criteria, test set sizes, ground truth establishment, expert adjudication, or MRMC studies is not present in this document because such detailed clinical performance studies were likely not required for this type of 510(k) submission (a Special 510(k) for a platform change).

Based on the provided text, I cannot extract the level of detail requested for a comprehensive performance study description. The document focuses on showing that the port of the existing software to Linux does not introduce new safety or effectiveness concerns, rather than new clinical performance validation.

Here's a breakdown of what can be inferred or what is explicitly stated, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for clinical tasks (e.g., sensitivity, specificity, accuracy). The acceptance criterion appears to be "passed its performance requirements and met specifications" in functional testing.
Reported Device Performance: "In all cases, MIM on Linux passed its performance requirements and met specifications."
- This is a general statement about functional integrity on the new OS, not detailed clinical performance data (e.g., no AUC, sensitivity, specificity, or clinically relevant error rates are provided).

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

Sample Size: Not specified. The document mentions "functional testing" but does not quantify the number of images, cases, or specific tests performed.
Data Provenance: Not specified. It only states that functional testing was "identical to that which is done with all major releases of MIM software running on Windows and Mac operating systems workstations." This implies a set of internal test data, but details are absent. The images used for functional testing are not described (e.g., real patient data, synthetic data, specific modalities).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not Applicable/Not Specified: Given the nature of the submission (porting to a new OS), the focus was on functional equivalency, not new clinical performance validation requiring expert-derived ground truth.

4. Adjudication Method for the Test Set:

Not Applicable/Not Specified: No mention of expert adjudication as this was functional, not clinical performance testing.

5. MRMC Comparative Effectiveness Study:

No: The document does not describe any MRMC study. It focuses on the software's functional performance on a new operating system, not its impact on human reader performance.

6. Standalone (Algorithm Only) Performance:

Not explicitly detailed as a separate study: The software itself is a standalone application, but the "performance data" section describes functional testing (i.e., software functions correctly) rather than a standalone clinical performance study with specific metrics (e.g., sensitivity/specificity of an automated detection algorithm). The device's primary function is as a PACS/post-processing tool aiding human users.

7. Type of Ground Truth Used:

Not Applicable/Not Specified: No clinical ground truth (e.g., expert consensus, pathology, outcome data) is mentioned for the "functional testing."

8. Sample Size for the Training Set:

Not Applicable/Not Specified: This document describes a software port and its validation (functional testing), not an AI/ML model development. Therefore, there's no "training set" in the machine learning sense.

9. How Ground Truth for Training Set was Established:

Not Applicable/Not Specified: As there's no mention of a traditional training set for an AI/ML model, this information is not relevant to the provided text.

In summary: The provided FDA 510(k) clearance letter and summary concern a regulatory submission for moving existing, cleared medical imaging software (MIM) to a new operating system (Linux). This type of submission relies on demonstrating that the core functionality and safety/effectiveness are preserved, not on conducting new clinical performance studies with detailed acceptance criteria, gold standards, or expert reviews as would be typical for a novel AI/driven diagnostic device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

MIM Software Inc. % Ms. Lynn Hanigan Quality Assurance Director 25800 Science Park Drive - Suite 180 CLEVELAND OH 44122

March 19, 2019

Re: K190379

Trade/Device Name: MIM on Linux Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: February 14, 2019 Received: February 19, 2019

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. 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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara
For

Thalia Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K190379

Device Name MIM on Linux

Indications for Use (Describe)