The MFI-Cardiac application is intended to provide processing of rest and stress myocardial perfusion positron emission tomography (PET) images with approved radiotracers that have been acquired with a singlescan or fast back-to-back scans without waiting for radiotracer decay between scans. The application models measurements of tracer uptake over time to aid in the processing of the images. Co-registration or fusion of volumetric data is provided as a quality control. The processed output images are reviewed on other devices by qualified medical professionals trained in the use of medical imaging devices.

Device Description

MFI-Cardiac is a software medical device that facilitates the rapid acquisition and processing of rest and stress myocardial perfusion images (MPI) with positron emission tomography (PET) and approved radiotracers. The device processes rest+stress cardiac PET images that have been rapidly acquired using either a single scan with two administrations of the tracer (one at rest, the other at stress) or separate "back-to-back" rest and stress scans. The rapidly acquired rest and stress cardiac PET images are provided to MFI—Cardiac via digital image transfer in DICOM format.

In use, the device first performs a series of quality assurance tests to ensure data integrity and validity. The images are then processed to correct for residual activity from the 1st tracer administration (administered at rest) that affects the image obtained after the 2nd tracer injection (administered at stress). The device then outputs separated and corrected DICOM images at rest and stress; these images are offloaded to other devices for display and review by qualified healthcare professionals.

AI/ML Overview

Here's a detailed breakdown of the acceptance criteria and study information for the MFI-Cardiac device, based on the provided FDA 510(k) summary:

MFI-Cardiac Acceptance Criteria and Study Information

The MFI-Cardiac device underwent performance evaluations to demonstrate its safety and effectiveness, including simulation studies and evaluations using patient datasets. The device is classified as having a "moderate" level of concern, meaning a software failure could directly result in minor patient injury.

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary states that "Three performance evaluation studies were completed with all acceptance criteria met." However, the document does not explicitly list the quantitative acceptance criteria for each study. It describes the purpose of each study. Therefore, the "Reported Device Performance" column reflects that the studies were successful in meeting their unstated criteria.

Acceptance Criteria (Inferred from Study Purpose)	Reported Device Performance
Simulation Studies: Evaluate device performance across the full range of rest and stress myocardial blood flows anticipated clinically. (Implies accuracy and reliability of measurements under various physiological conditions).	All acceptance criteria met. (Device performed successfully across the full range of simulated blood flows.)
Patient Dataset with Synthesized Rest+Stress Images (Performance Evaluation): Evaluate the performance of MFI-Cardiac for producing output (corrected) rest and stress images that are equivalent to rest and stress images obtained from separate scans. (Implies accuracy of correction algorithm).	All acceptance criteria met. (Corrected images were equivalent to those from separate scans.)
Patient Dataset with Synthesized Rest+Stress Images (Co-registration Evaluation): Evaluate rest-stress image co-registrations performed by MFI-Cardiac for ensuring that the estimate for residual rest tracer activity is aligned with the stress-phase images before the correction is applied. (Implies accuracy of co-registration).	All acceptance criteria met. (Co-registration ensured proper alignment for correction.)

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

Test Set Sample Size: The document does not specify the exact number of cases or images used in the "patient dataset" for the performance evaluation and co-registration evaluation studies. It refers to "patient dataset with synthesized rest+stress images" in the plural, implying more than one, but no specific count.
Data Provenance: Not explicitly stated. The document mentions "patient dataset," but does not specify the country of origin or whether the data was retrospective or prospective. The term "synthesized rest+stress images" suggests that existing patient data might have been manipulated or combined to create the test cases.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide information on the number or qualifications of experts used to establish ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not provide information on any adjudication method used for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not explicitly mentioned or described in the provided text. The device is for image processing and output, which are then reviewed by qualified medical professionals. The focus of the studies described is on the algorithm's performance in processing and correcting images.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the performance evaluation studies described are essentially standalone (algorithm only) performance assessments.

"Simulation studies to evaluate device performance across the full range of rest and stress myocardial blood flows..."
"Performance evaluation using patient dataset with synthesized rest+stress images to evaluate the performance of MFI-Cardiac for producing output (corrected) rest and stress images..."
"Evaluation of rest-stress image co-registrations performed by MFI-Cardiac for ensuring that the estimate for residual rest tracer activity is aligned with the stress-phase images before the correction is applied."

These studies assessed the device's ability to process, correct, and align images autonomously, without direct human intervention in the real-time processing loop. The output images are then reviewed by humans, but the studies described focus on the algorithm's direct output.

7. The Type of Ground Truth Used

The ground truth appears to be established through simulation and comparison to "separate scans."

For the simulation studies, the ground truth would be the known, controlled parameters of the simulated myocardial blood flows.
For the performance evaluation using patient dataset with synthesized rest+stress images, the ground truth for the "corrected" images was implicitly the "rest and stress images obtained from separate scans." This suggests a comparison against an existing, established method or "gold standard" for acquiring uncorrected images.
For the co-registration evaluation, the ground truth would involve the accurate anatomical alignment of different image phases, likely assessed computationally against ideal alignment.

8. The Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set.

9. How the Ground Truth for the Training Set Was Established

The document does not provide any information on how the ground truth for the training set, if any, was established. Given the nature of the device (processing and correction based on physical models rather than deep learning for classification), it's possible that traditional algorithmic development and tuning did not involve a distinct "training set" in the same way a deep learning model would.

Summary

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February 5, 2018

Image /page/0/Picture/1 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 & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

MultiFunctional Imaging, LLC % Dan Kadrmas. Ph.D. Founder & Chief Science Officer 551 East 50 North NORTH SALT LAKE UT 84054

Re: K173512

Trade/Device Name: MFI-Cardiac Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ, KPS Dated: November 6, 2017 Received: December 7, 2017

Dear Dr. Kadrmas:

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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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.

For comprehensive regulatory information about mediation-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

Robert Ochs. 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

Expiration Date: 06/30/2020

See PRA Statement below.

510(k) Number (if known)

K173512 Device Name MFI-Cardiac

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

Date Prepared: November 6, 2017

1. General

510(k) Sponsor:	MultiFunctional Imaging, LLC551 E 50 NNorth Salt Lake, UT 84054
Contact Person:	Dan Kadrmas, PhDFounder and Chief Science Officer801-953-5655 (phone)Dan.Kadrmas@MFImage.com (email)
Prepared By:	Phil Triolo and Associates, LC
Trade/Device Name:	MFI-Cardiac
Common Name:	Software for processing PET images
Classification Name:	Emission computed tomography system / Picture archiving andcommunications system
Regulation number:	21 CFR 892.1200 / 21 CFR 892.2050
Product Code:	KPS / LLZ
Predicate Device:	Corridor4DM v2010 (K101279)
Associated FDADocument Number:	Q120397 (Pre-Sub dated Dec. 14, 2012)

2. Device Description

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3. Intended Use

The MFI–Cardiac application is intended to provide processing of the biodistribution of radionuclides in the body using tomographic images. The application models measurements of tracer uptake over time to aid in the processing of myocardial perfusion emission tomographic images. Co-registration or fusion of volumetric data is provided as a quality control. The processed output images are reviewed on other devices by qualified medical professionals trained in the use of medical imaging devices.

The intended use of the new device is the same, but not identical to that of the predicate device (Corridor 4DM v2010); however, the differences do not alter the intended therapeutic use of the device nor do they affect the safety and effectiveness of the subject device relative to the predicate. Both the subject and predicate devices are intended to provide processing of the biodistribution of radionuclides in the body using tomographic images and both are used for rest-stress myocardial perfusion imaging in nuclear cardiology.

Feature	Subject Device(MFI-Cardiac)	Predicate Device(Corridor4DM v2010)
Processes rest-stress myocardialperfusion images	Yes	Yes
DICOM image transfer capabilities	Yes	Yes
Functionality for processing images of tworadiotracer administrations during a singlescan	Yes	No
Processing of rest and stress myocardialperfusion images in preparation for review	Yes	Yes
Kinetic modeling of tracer uptake overtime	Yes	Yes
Quantification of myocardial blood flows	No	Yes
Co-registration of volumetric cardiacimages	Yes	Yes

4. Technological Comparison with Predicate Device

The chart below compares the subject device MFI-Cardiac to the predicate device Corridor4DM v2010.

Differences between the new and predicate devices do not raise different questions of safety and effectiveness.

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5. Performance Data

The performance data provided in this submission in support of the substantial equivalence determination are described in the subsections below:

Software Verification and Validation

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device is considered to pose a "moderate" level of concern, since a failure or latent flaw in the software could directly result in minor injury to the patient.

Performance Evaluations

Three performance evaluation studies were completed with all acceptance criteria met:

(1) Simulation studies to evaluate device performance across the full range of rest and stress myocardial blood flows that are anticipated to be encountered clinically;

(2) Performance evaluation using patient dataset with synthesized rest+stress images to evaluate the performance of MFI-Cardiac for producing output (corrected) rest and stress images that are equivalent to rest and stress images obtained from separate scans: and

(3) Evaluation of rest-stress image co-reqistrations performed by MFI-Cardiac for ensuring that the estimate for residual rest tracer activity is aligned with the stressphase images before the correction is applied. This evaluation was also performed using patient datasets with synthesized rest+stress images.

Human Factors / Usability Study

Human factors engineering for MFI-Cardiac included preliminary human factors analyses, formative evaluations, implementation of design changes that mitigate or eliminate use-related hazards, and human factors validation testing. The results of validation testing indicate that MFI-Cardiac is safe and effective for the intended users, uses and use environments. Residual risks that remain would not be further reduced by modifications of user interface design or labeling (User Manual and Supporting Documents), and are outweighed by the benefits that may be derived from the device's use.

Conclusion / Summary of Substantial Equivalence 6.

The results of the non-clinical, human factors engineering, and simulated use tests and software verification and validation studies demonstrate the safety and effectiveness of the subject device and equivalence with the predicate device. Based on the information and data provided and analyzed in this 510(k) premarket notification, MultiFunctional Imaging, LLC concludes that MFI-Cardiac is substantially equivalent to the predicate device and is safe and effective for its intended use.

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).