Segment is a software that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. Segment specifically analyzes the function of the heart and its major vessels using multi-slice, multi-frame and velocity encoded MR images. It provides clinically relevant and reproducible data for supporting the evaluation of the function of the chambers of the heart such as left and right ventricular volumes, ejection fractions, stroke volumes, peak ejection and filling rates, myocardial mass, regional wall thickness, fractional thickening and wall motion. It also provides quantitative data on blood flow and velocity in the arterial vessels and at the heart valves. Segment is tested on MR images acquired from both 1.5 T and 3 T MR scanners. The data produced by Segment 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.

Device Description

Segment is a software for analysis of cardiovascular MR images. Segment provides clinical quantitative data by analyzing multi-slice, multi-phase DICOM compatible cardiovascular MR images. Functional and blood flow analysis is performed using 2D, 3D and 4D data sets using standard algorithms and user input. MR images may be imported from various sources including images stored on portable media, network storage devices, PACS, and other vendor systems and supports cardiovascular MR images from all of the major MRI scanner vendors. Segment can be used for quantitative and qualitative analysis of cardiovascular MR images.

AI/ML Overview

The provided text is a 510(k) Summary for the Medviso AB Segment software, dating from 2009. It focuses on demonstrating substantial equivalence to predicate devices (MRI-MASS and MRI-FLOW) rather than providing detailed acceptance criteria and a specific study proving the device meets those criteria with statistical significance as typically found in more recent submissions for AI/ML devices.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or a table of reported device performance in the way a modern AI/ML device submission would. Instead, the "performance" is implicitly tied to demonstrating substantial equivalence to the predicate devices and general claims of clinical utility and reproducibility.

Criterion	Acceptance Criteria	Reported Device Performance
Functional Equivalence	Substantially equivalent to predicate devices (MRI-MASS and MRI-FLOW) in analyzing multi-slice, multi-frame, and phase-encoded DICOM-compliant MR images, utilizing standard algorithms and user inputs for delineation of myocardial and arterial vascular walls.	"Segment has substantially equivalent features and specifications to the predicate device." "Segment performs in accordance with its intended use as well as the Medis MRI-MASS and MRI-FLOW cardiovascular MRI image analysis products currently on the market."
Clinical Utility (Qualitative)	Provides clinically relevant and reproducible data for supporting evaluation of heart and major vessel function.	"It provides clinically relevant and reproducible data for supporting the evaluation of the function of the chambers of the heart..." "The image analysis provided by Segment makes the images more clinically useful for the physician in making his diagnosis."
Clinical Utility (Quantitative)	Provides quantitative data for metrics such as LV/RV volumes, EF, stroke volumes, peak ejection/filling rates, myocardial mass, wall thickness, fractional thickening, wall motion, blood flow, and velocity in vessels/valves.	"It provides clinically relevant and reproducible data for supporting the evaluation of the function of the chambers of the heart such as left and right ventricular volumes, ejection fractions, stroke volumes, peak ejection and filing rates, myocardial mass, reqional wall thickness, fractional thickening and wall motion. It also provides quantitative data on blood flow and velocity in the arterial vessels and at the heart valves."
Image Compatibility	Compatible with DICOM-compliant cardiovascular MR images from various sources (portable media, network, PACS, other vendor systems) and tested on 1.5 T and 3 T MR scanners.	"MR images may be imported from various sources including images stored on portable media, network storage devices, PACS, and other vendor systems and supports cardiovascular MR images from all of the major MRI scanner vendors." "Segment is tested on MR images acquired from both 1.5 T and 3 T MR scanners."
Safety and Effectiveness (Hazard Mitigation)	All identified hazards mitigated to minor levels of concern.	Hazards identified in Hazard Analysis (section 16.3) and controlled by design controls, protective measures, and warnings to users, mitigating them to "minor levels of concern."
Interoperability	Runs on standard PC hardware and Microsoft Windows XP or Vista.	"Segment runs on standard PC hardware and Microsoft Windows XP or Microsoft Windows Vista operating system software."

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

The document does not specify a sample size for any formal "test set" in the context of validating performance against ground truth. The submission predates the common expectations for rigorous AI/ML performance validation studies. It states that "Extensive testing of the software package is performed by programmers, by non-programmers, quality assurance staff and by potential customers prior to commercial release." This refers to internal software quality assurance and user acceptance testing, not a clinical performance validation study with a defined test set and ground truth.

There is no mention of data provenance (e.g., country of origin or retrospective/prospective nature) for any data used in testing.

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

The document does not mention using experts to establish ground truth for a test set. This type of submission relies on the established clinical utility of MRI images and the predicate devices' method of analysis, with the software acting as a tool to aid qualified professionals. The output is "intended to be used to support qualified cardiologist, radiologist or other licensed professional healthcare practitioners."

4. Adjudication Method:

Given that no formal expert-derived ground truth test set is described, there is no mention of an adjudication method (e.g., 2+1, 3+1).

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

No, a MRMC comparative effectiveness study was not done (or at least, not reported in this 510(k) summary). The submission focuses on substantial equivalence based on features and functionality, not on comparing reader performance with and without AI assistance. Therefore, no effect size calculation for human reader improvement with AI assistance is provided.

6. Standalone (Algorithm Only) Performance Study:

No, a standalone performance study was not explicitly described in the context of quantitative performance metrics against a defined ground truth. The document states, "Segment is used for image analysis and quantification... and all of the information is subject to his/her oversight and control." This indicates that the device is intended as a support tool, not a fully autonomous diagnostic algorithm. The "extensive testing" mentioned is internal software testing and potential customer feedback, not a formal standalone clinical performance study.

7. Type of Ground Truth Used:

No specific "ground truth" (e.g., pathology, outcomes data, or expert consensus specifically for a test set) is described as being used to validate the device's performance. The basis for safety and effectiveness is largely on clinical acceptance of MRI imaging itself and substantial equivalence to existing, legally marketed devices. The software "does not in any way alter the images" and provides "clinically relevant numeric computations."

8. Sample Size for the Training Set:

The document does not mention a training set or its sample size. This is consistent with the era and type of device; Segment is an image analysis software based on "standard algorithms and user input," rather than a machine learning model that requires a "training set" in the modern sense.

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

As no training set is discussed, no information is provided on how its ground truth would have been established.

Summary

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Section 5

MAY 12 2009

510(k) Summary

510 (k) Summary 5

Submitter:

Medviso AB Thulehemsvägen 157 SE-224 67 Lund, Sweden +46-76-1836442

Date Prepared: May 11, 2009

Contact Person(s): Einar Heiberg, President +46-76-1836442 einar@medviso.com

Device Trade Name: Segment (Segment)

Device Common Name: Cardiovascular image analysis software

Classification Name: Class II - System, Image Processing

Product Code / Regulation Number: LLZ / 892.2050

Substantially Equivalent To:

MRI-MASS and MRI-FLOW Medis Medical Imaging Systems BV Schuttersveld 9 2316 XG Leiden The Netherlands

Device Description:

MEDVISO AB Thulehemsvägen 157 SE-224 67 Lund, Sweden tel: +46-76-1836442 www.medviso.com

MEDVISO

Page 5-1 Segment FDA 510(k) Submission

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Section 5

KC90833
Page 2 of 4
510(k) Summary

Intended Use:

Segment is a software that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. Segment specifically analyzes the function of the heart and its major vessels using multi-slice, multi-frame and velocity encoded MR images. It provides clinically relevant and reproducible data for supporting the evaluation of the function of the chambers of the heart such as left and right ventricular volumes, ejection fractions, stroke volumes, peak ejection and filing rates, myocardial mass, reqional wall thickness, fractional thickening and wall motion. It also provides quantitative data on blood flow and velocity in the arterial vessels and at the heart valves. Segment is tested on MR images acquired from both 1.5 T and 3 T MR scanners. The data produced by Segment 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.

Technological Comparison to Predicate Device:

The proposed and predicate devices are both devices that can be used for the analysis of multi-slice, multi-frame and phase encoded DICOM-compliant MR image data sets. Both complete their analysis of these data sets using standard algorithms and user inputs to delineate the myocardial and arterial vascular wall from surrounding tissue and blood (wall contours.) Both render wall contours either fully automatically, semi-automatically, manually or in combination providing clinically relevant data. Both devices allow user input to recalculate rendered numeric output based on a qualified user's expertise. The proposed and predicate device can be operated from a personal computer. Segment has substantially equivalent features and specifications to the predicate device.

Laboratory and Clinical Testing:

Segment is a software intended for analyzing DICOM-compliant cardiovascular images acquired from MRI scanners. Segment does not in any way alter the images. Images from MRI scanners have been proven and accepted clinically.

Segment is used for image analysis and quantification of cardiovascular images providing clinically relevant numeric computations that support a cardiologist or radiologist in their diagnosis of heart disease. Segment contains no image digitizers and uses only lossless compression. On this basis, Medviso AB believes that clinical investigation is not necessary.

MEDVISO AB Thulehemsvägen 157 SE-224 67 Lund, Sweden tel: +46-76-1836442 www.medviso.com

MEDVISO

Page 5-2 Segment FDA 510(k) Submission

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Section 5

K090833
Page 3 of 4
510(k) Summary

Extensive testing of the software package is performed by programmers, by non-programmers, quality assurance staff and by potential customers prior to commercial release (see Section 16.9). We conclude that the subject device, Segment is as safe and effective as the predicate device and posses no new questions of safety and effectiveness.

Adverse Affects on Health:

The potential hazards are identified in the Hazard Analysis (section 16.3) and are controlled by:

· Designing controls directed at the cause and/or
Introducing protective measures and/or
· Warning the Users

All identified hazards are mitigated to minor levels of concern.

Summary of Safety and Effectiveness:

The intended use of Segment is for analyzing selected DICOM-compliant cardiovascular MRI. It is a support tool that provides relevant data for the clinician that is evaluating a patient's cardiovascular system using functional data such as ejection fraction, stoke volumes and cardiac output. The image analysis provided by Segment makes the images more clinically useful for the physician in making his diagnosis. Segment does not in any way alter the MRI imaging data in the analytical process. Segment provides assistance to a professionally trained physician and all of the information is subject to his/her oversight and control. Any potential hazard and for reduction in effectiveness that may be due to the failure of the hardware or software components of Seament will be mitigated by the user of the device.

Segment runs on standard PC hardware and Microsoft Windows XP or Microsoft Windows Vista operating system software. The use of these industry standard components provide for maximum availability and reliability making Segment more effective for its intended use. The predicate device also uses standard PC hardware and another industry standard operating system, UNIX. The current versions of these industry standard products used for the operation Segment are of greater effectiveness and any safety concerns caused by failure of the off-the-shelf components and the Segment software component are no greater than the predicate device.

See Substantial Equivalence Chart in Section 12 and copies of the 510(k) Premarket Notification summaries for the predicate devices in Appendices F and G for comparison to the intended use Segment and discussions of hazard and safety concerns.

MEDVISO AB Thulehemsvägen 157 SE-224 67 Lund, Sweden tel: +46-76-1836442 www.medviso.com

MEDVISO

Page 5-3 Segment FDA 510(k) Submission

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Image /page/3/Picture/0 description: The image shows handwritten text on a white background. The text includes "K090833" on the top line, followed by "Page 4 of 4" on the second line. The bottom line reads "510(k) Sum".

Conclusions:

We conclude that the subject device Segment is as safe and effective as the predicate device and poses no new questions of safety and effectiveness. Segment performs in accordance with its intended use as well as the Medis MRI-MASS and MRI-FLOW cardiovascular MRI image analysis products currently on the market. Medviso AB considers the features of the Segment to be substantially equivalent to the subset of features in common with the MRI-MASS (510(k) 994283) and MRI-FLOW (510(k) 994282)

MEDVISO AB Thulehemsvägen 157 SE-224 67 Lund, Sweden tel: +46-76-1836442 www.medviso.com

MEDVISO

Page 5-4 Segment FDA 510(k) Submission

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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. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the body and wings of the bird.

DEPARTMENT OF HEALTH & HUMAN SERVICES

MAY 12 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Einar Heiberg President, CEO Medviso Thulehemsvagen 157 Lund SE-224 67 SWEDEN

Re: K090833

Trade/Device Name: Segment / Image Processing System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system

Regulatory Class: II Product Code: LLZ Dated: March 18, 2009 Received: March 26, 2009

Dear Mr. 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 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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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxx 21 CFR: 884.xxx 21 CFR 892.xxx Other

(Gastroenterology/Renal/Urology) (Obstetrics/Gynecology) (Radiology)

(240) 276-0115 (240) 276-0115 (240) 276-0120 (240) 276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use 4

Indications for Use Statement

K090833 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Segment / Image Processing System

Indications For Use:

Prescription Use

(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1

MEDVISO AB		Page 4-1
Thulehemsv\u00e4gen 157	(Division Sign-Off)	Segment
SE-224 67 Lund, Sweden		FDA 510(k) Submission
tel: +46-76-1836442	Division of Reproductive, Abdominal and
www.medviso.com	Radiological Devices	2009-05-11

	510(k) Number	K090833

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).