Segment CMR is a software that display and analyzes medical images in DICOM-format using multi-slice, multi-frame and velocity encoded MR images. Segment CMR provides features for analysis of cardiac function, such as cardiac pumping and blood flow. The ventricular analysis is provided for usage in both pediatric (from newborn) and adult population. Images and associated data analysis can be stored, communicated, rendered, and displayed within the system and across PACS system. The data produced by Segment CMR is intended to support qualified cardiologist, radiologist or other licensed professional healthcare for clinical decision making. It is a support tool that provides relevant clinical data as a resource to the clinician and is not intended to be a source of medical advice or to determine or recommend a course of action or treatment for a patient.

Device Description

Segment CMR is a software that displays and analyzes multi-slice, multiphase and velocity encoded DICOM compatible medical MR images. Segment CMR provides quantitative measures for analysis of function of the cardiovascular system. The data produced by Segment CMR is intended to be used to support qualified cardiologist, radiologist or other professional healthcare practitioners for clinical decision making. Functional, flow, valve, vessel, and tissue analysis is performed using standardized algorithms and user input. The quantification methods are validated and reproducible. The ventricular analysis is provided for usage in both pediatric (from newborn) and adult population. MR images may be imported from various sources including images stored on portable media, network storage devices, and other vendor systems and supports cardiovascular MR images from all of the major MRI scanner vendors.

AI/ML Overview

The provided text describes the acceptance criteria and a study proving the device meets them for "Segment CMR", a cardiovascular MRI analysis software.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a discrete table of acceptance criteria with numerical targets and corresponding device performance metrics. Instead, it makes a general statement about the device's performance relative to reference methods and its predicate device. This is typical for a 510(k) submission where substantial equivalence is demonstrated rather than meeting specific performance thresholds for a novel device.

Acceptance Criteria (Implied from the text):

Safety and Effectiveness: Segment CMR should be as safe and effective as the predicate devices.
Agreement with Reference Methods: Values from the evaluated features in Segment CMR should be in good agreement with values from established reference methods.
No Adverse Events/Complications: No adverse events or complications associated with the device should be observed in studies.
Acceptable Residual Risk: All identified hazards should be mitigated to accepted levels of residual risk, and the overall risk evaluation should conclude that the risk is acceptable.
Benefit Outweighs Risk: Specifically for pediatric use, the benefits should outweigh the risks.
Performance in Accordance with Intended Use: The device performs in accordance with its intended use and similarly to existing cardiovascular MRI image analysis products.
No Alteration of MRI Data: The device should not alter MRI imaging data in the analytical process.

Reported Device Performance:

"The results by the studies show that the values from the evaluated features in Segment CMR were in good agreement with values from the reference method." (Page 6)
"No adverse advents or complications associated with the subject device were observed in the studies." (Page 6)
"Based on the clinical performance as documented in the performance studies, Segment CMR was found to have a safety and effectiveness profile that is similar to the predicate device." (Page 6)
"We conclude that the subject device Segment CMR is as safe and effective as the predicate devices." (Page 7)
"All identified hazards for Segment CMR have been mitigated to accepted levels of the residual risk and the overall risk residual evaluation concluded that the risk of Segment CMR is acceptable." (Page 7)
"The extension of pediatric use for the left ventricular analysis did not, according to the hazard analysis, increase the overall residual risk and by evaluating safety and effectiveness, the benefits with pediatric use can be considered to outweigh the risks." (Page 7)
"Segment CMR performs in accordance with its intended use as well as the cardiovascular MRI image analysis products currently on the market." (Page 7)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not explicitly stated in terms of a specific number of cases or patients. The document refers to "studies" in the plural, implying multiple tests and evaluations.
Data Provenance: "The studies were performed in US or in Europe." The text does not specify whether the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: Not explicitly stated for establishing ground truth.
Qualifications of Experts: Not explicitly stated. The device is intended to support "qualified cardiologist, radiologist or other licensed professional healthcare practitioners for clinical decision making." This implies that the reference methods or ground truth would be established by such qualified professionals.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not explicitly stated.

5. 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

MRMC Study: The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study designed to measure the improvement of human readers with AI assistance. The focus is on the standalone performance of the software in agreement with established methods. The device is presented as a "support tool" that provides data "as a resource to the clinician," implying it does not replace human interpretation but assists it.
Effect Size of Human Reader Improvement: Not applicable, as no such MRMC study is described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Yes, the performance data presented (e.g., "values from the evaluated features in Segment CMR were in good agreement with values from the reference method") primarily focuses on the standalone performance of the algorithms within the software compared to established reference methods or predicate devices. The software "provides quantitative measures for analysis," suggesting its output is directly compared.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: "establish methods as reference standard." This implies ground truth was based on validated and recognized clinical methods, likely expert interpretations, other validated software, or established measurement techniques. The specific nature (e.g., expert consensus vs. pathology) is not detailed.

8. The sample size for the training set

Sample Size for Training Set: Not explicitly stated. The document mentions that the predicate device Segment, "on which Segment CMR is built upon, is used by more than 200 research groups," which suggests a large body of data might have been implicitly involved in the development and refinement of the underlying algorithms, but a specific "training set" for this device (Segment CMR) is not quantified.

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not explicitly described. The general statement about "establish methods as reference standard" likely applies to both training and testing, but the process of establishing ground truth specifically for a training set (if one was formally used) is not detailed.

Summary

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

April 5, 2017

Medviso AB % Einar Heiberg, Ph.D. Founder, Vice President, CTO Griffelvägen 3 Lund SE-224 67 SWEDEN

Re: K163076 Trade/Device Name: Segment CMR Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 3, 2016 Received: March 14, 2017

Dear Dr. Heiberg:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K163076

Device Name Segment CMR

Indications for Use (Describe)

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

X 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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510 (k) Summary 5

5.1 Submitter

Medviso AB Griffelvägen 3 SE-224 67 Lund, Sweden +46-76-1836442

Date Prepared: October 1, 2016

Contact Person: Einar Heiberg, PhD, Founder, CTO, +46-76-1836442, einar@medviso.com

5.2 Device

Device Trade Name: Segment CMR

Device Common Name: Cardiovascular MRI analysis software

Classification Name: Class II - System, Image Processing

Regulation Number: 892.2050

Product Code: LLZ

5.3 Predicate Device

. Segment (K090833) Medviso AB Griffelvägen 3 224 67 Lund Sweden
CMRtools and plugins Ventricular tools and Thalassemia tools ● (K073194) Cardiovascular Imaging Solutions Ltd 53 Cavendish Road London SW12 0BL UK
Virtue including module HARP (K111833, K100352) ● Myocardial solutions 1204 Village Market Pl 290 Morrisville, NC 27560 USA

MEDVISO AB Griffelvägen 3 SE-224 67 Lund, Sweden tel: +46-76-1836442 www.medviso.com

Image /page/3/Picture/18 description: The image shows the word "MEDVISO" in a light blue color. The word is surrounded by a pattern of small, light blue squares that form an oval shape. The squares are more concentrated near the word and become more sparse as they move away from it.

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Device Description 5.4

Device Description

MR images may be imported from various sources including images stored on portable media, network storage devices, and other vendor systems and supports cardiovascular MR images from all of the major MRI scanner vendors.

ર.5 Intended Use

Indications for Use

Segment CMR is a software that display and analyzes medical images in DICOM-format using multi-slice, multi-frame and velocity encoded MR images. Segment CMR provides features for analysis of cardiac function, such as cardiac pumping and blood flow. The ventricular analysis is provided for usage in both pediatric (from newborn) and adult population. Images and associated data analysis can be stored, communicated, rendered, and displayed within the system and across PACS system. The data produced by Segment CMR is intended to be used to support qualified cardiologist, radiologist or other licensed professional healthcare practitioners for clinical decision making. It is a support tool that provides relevant clinical data as a resource to the clinician and is not intended to be a source of medical advice or to determine or recommend a course of action or treatment for a patient.

MEDVISO AB Griffelvägen 3 SE-224 67 Lund, Sweden tel: +46-76-1836442 www.medviso.com

Image /page/4/Picture/10 description: The image shows the word "MEDVISO" in a light blue color. The word is surrounded by a pattern of small squares, also in light blue, that create a curved shape above and below the text. The squares appear to be fading or dissolving away from the center towards the edges of the curved shape.

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Application Specification

The medical purpose for Segment CMR is to analyze Cardiac Magnetic Resonance (CMR) images. Conditions or disease to be diagnosed by CMR imaging are heart diseases such as myocardial infarction, cardiac failure, cardiomyopathy and valvular disease.

Patient Population

Segment CMR is intended for use in both pediatric population (from newborn to adolescent) and adult population.

Comparison to Predicate Device

Both Segment CMR and the predicate devices are support tools which provide the clinician with relevant clinical data to support diagnoses by analyzing CMR images. All analysis features provided by Segment CMR are also provided by one or more of the predicate device. The difference in the indications for use is the extension of the patient population to also include pediatric population for the ventricular analysis. According to validation in scientific publications and the risk management analysis for Segment CMR, the inclusion of pediatric population does not affect the safety and effectiveness of the device.

5.6 Technological Characteristics

Seqment CMR and the predicate device are both software packages that can be used for the analysis of multi-slice, multi-frame and phase encoded DICOM-compliant MR image data sets. None of the devices comes into direct contact with the patient.

The proposed and predicate devices provide a user interface with items for selecting images and adjusting image viewing. They perform data analysis by using standardized algorithms and user inputs to delineate the myocardial and vascular walls from surrounding tissue and blood (wall contours). The proposed and predicate devices render wall contours either fully automatically, semi-automatically, manually or in combination providing clinically relevant data. The technological differences between Segment CMR and the predicated devices are that different algorithms in use for the automatic seqmentation approaches and relaxometry measurements. The proposed and predicate devices can be operated from a personal computer. Segment CMR has substantially equivalent features and specifications to the predicate devices.

MEDVISO AB Griffelvägen 3 SE-224 67 Lund, Sweden tel: +46-76-1836442 www.medviso.com

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5.7 Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documented according ty FDA's Guidance "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices". It was concluded that Segment CMR was considered as "moderate" level of concern. Extensive testing of the software package is performed by an automated test suite prior to commercial release, exactly like the predicate device Segment. As a complement to this, manual testing is performed by programmers and the program is evaluated by two beta test sites. In addition, the predicate device Segment, on which Segment CMR is built upon, is used by more than 200 research groups.

Bench, Animal and Clinical Studies

Each of the features for Segment CMR has been clinically evaluated by using both bench, animal and clinical studies. The studies are validation or application studies using establish methods as reference standard. Since the subject device is no treatment device there is no randomized control in the studies. The studies were performed in US or in Europe. Since the subject device is not intended to be used for treatment, the identification of primary safety endpoint and primary effectiveness endpoint are not applicable. The results by the studies show that the values from the evaluated features in Segment CMR were in good agreement with values from the reference method. No adverse advents or complications associated with the subject device were observed in the studies. Based on the clinical performance as documented in the performance studies, Segment CMR was found to have a safety and effectiveness profile that is similar to the predicate device.

MEDVISO AB Griffelvägen 3 SE-224 67 Lund, Sweden tel: +46-76-1836442 www.medviso.com

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5.8 Conclusion

We conclude that the subject device Segment CMR is as safe and effective as the predicate devices. All identified hazards for Segment CMR have been mitigated to accepted levels of the residual risk and the overall risk residual evaluation concluded that the risk of Segment CMR is acceptable. The risks associated with the use of Segment CMR are acceptable when weighted against the benefits of the patient. The extension of pediatric use for the left ventricular analysis did not, according to the hazard analysis, increase the overall residual risk and by evaluating safety and effectiveness, the benefits with pediatric use can be considered to outweigh the risks. Segment CMR performs in accordance with its intended use as well as the cardiovascular MRI image analysis products currently on the market. Identical to the predicate devices, Segment CMR does not in any way alter the MRI imaging data in the analytical process. Segment CMR provides assistance to a professionally trained physician and all of the information is subject to his/her oversight and control. Medviso AB considers the features of Segment CMR to be substantially equivalent to the subset of features in common with the predicate devices Segment. CMRtools and Virtue including module HARP.

MEDVISO AB Griffelvägen 3 SE-224 67 Lund, Sweden tel: +46-76-1836442 www.medviso.com

Image /page/7/Picture/5 description: The image shows the word "MEDVISO" in a light blue color. The word is surrounded by a pattern of small, light blue squares that form a curved shape above and below the word. The squares are arranged in a way that creates a sense of movement or flow around the word. The background of the image is white.

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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).