Vitrea Software Toshiba Package is an application package developed for use on Vitrea®, a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea has the following additional indications:

The CT/XA Cerebral Artery Morphological Analysis application is intended to facilitate the extraction and segmentation of user identified aneurysms on the cerebral arteries. The software can be used as an adjunct to diagnosis for the purposes of measurement of size and aspect ratio.

The MR Wall Motion Tracking application is intended to assist physicians with performing cardiac functional analysis based upon magnetic resonance images. It provides measurements of global and regional myocardial function that is used for patients with suspected heart disease.

The MR Coronary Tracking application is intended to assist physicians with performing coronary artery analysis for MR heart images which are intended for the qualitative and quantitative analysis of coronary arteries.

Device Description

Vitrea Software Toshiba Package, VSTP-001A, an application package developed for use on Vitrea, a medical image processing software, marketed by Vital Images, Inc. Vitrea Software Toshiba Package, VSTP-001A, includes three post processing applications, CT/XA Cerebral Artery Morphological Analysis, MR Wall Motion Tracking, and MR Coronary Tracking which use brain and cardiac image data, obtained from CT/XA/MR systems, to assist physicians in performing specialized measurements and analysis.

AI/ML Overview

The provided text describes the Vitrea Software Toshiba Package, VSTP-001A, and its applications. The most relevant section for acceptance criteria and study details is Section 17, "TESTING," as well as the comparison table in Section 15. The device is a post-processing application, and the most detailed testing information pertains to the "MR Coronary Tracking" application, as the other two applications (CT/XA Cerebral Artery Morphological Analysis and MR Wall Motion Tracking) "remain unchanged" from previously cleared devices (K151093). Therefore, the information below focuses on the MR Coronary Tracking application.

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format. However, it indicates that "bench studies were conducted using numerical phantoms to analyze the accuracy of extraction/display of the coronary arteries as well as measurement calculations for lumen dimensions and areas." It also states that "clinical evaluations were conducted to demonstrate that the MR Coronary Tracking application performed as intended. The results confirmed that the MR Coronary Tracking application was comparable to commercially released software and user measurements."

Based on these statements, the implicit acceptance criteria are:

Accuracy of extraction/display of coronary arteries
Accuracy of measurement calculations for lumen dimensions and areas
Performance comparable to commercially released software
Performance comparable to user measurements

Given the provided text, a table of explicit acceptance criteria and specific reported device performance cannot be fully constructed with quantitative values. The document states that the "requirements for the MR Coronary Tracking application has been met" and that the results "confirmed that the MR Coronary Tracking application was comparable to commercially released software and user measurements." This implies successful meeting of the criteria.

Study Details

A table of acceptance criteria and the reported device performance
As explained above, explicit quantitative acceptance criteria and performance data are not provided in the text. The document broadly states that the requirements were met and the performance was comparable.
Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions both "numerical phantoms" for bench studies and "clinical evaluations" for the MR Coronary Tracking application.
- Numerical Phantoms: Used for bench studies to analyze accuracy of extraction/display and measurement calculations. The sample size for these phantoms is not specified.
- Clinical Evaluations: Performed to demonstrate the application "performed as intended." The sample size for the clinical evaluations is not specified.
- Data Provenance: The document does not specify the country of origin of the data or whether the clinical evaluations were retrospective or prospective.
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)
The document states that the results "confirmed that the MR Coronary Tracking application was comparable to... user measurements." This implies human experts were involved, likely for "user measurements" which served as a comparator. However, the number of experts and their specific qualifications are not specified.
Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not specify any adjudication method for the test set.
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
The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance vs. without AI assistance, nor does it provide an effect size. The study described focuses on the standalone performance and comparability of the software.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a form of standalone performance evaluation was done. The document states: "Bench studies were conducted using numerical phantoms to analyze the accuracy of extraction/display of the coronary arteries as well as measurement calculations for lumen dimensions and areas." This implies direct evaluation of the algorithm's output against a known ground truth (the phantom).
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "bench studies," the ground truth was derived from numerical phantoms. For the "clinical evaluations," the ground truth for comparison appears to be "commercially released software and user measurements," which implies human expert measurements or another established software's output served as a comparator for the clinical performance, rather than a definitive "ground truth" such as pathology.
The sample size for the training set
The document does not specify the sample size for the training set. It only describes testing for the MR Coronary Tracking application.
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 was established.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

June 8, 2017

Toshiba Medical Systems Corporation % Mr. Paul Biggins Director Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780

Re: K171222

Trade/Device Name: Vitrea Software Toshiba Package; VSTP-001 A Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 24, 2017 Received: April 26, 2017

Dear Mr. Biggins:

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.

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/ResourcesforYou/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.

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

510(k) Number (if known)

K171222

Device Name

Vitrea Software Toshiba Package; VSTP-001A

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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TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 730-5000

510(k) SUMMARY

SUBMITTER'S NAME: Toshiba Medical Systems Corporation 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550

2. OFFICIAL CORRESPONDENT: Naofumoi Watanabe Senior Manager, Regulatory Affairs and Vigilance

1. ESTABLISHMENT REGISTRATION: 9614698

4. CONTACT PERSON:

Paul Biggins, Director Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive Tustin, CA 92780 (714) 669-7808

5. Date Prepared:

April 21, 2017

6. TRADE NAME(S):

Vitrea Software Toshiba Package, VSTP-001A

7. COMMON NAME:

Radiological Image Processing Software

8. DEVICE CLASSIFICATION:

Class II (per 21 CFR 892.2050, Picture Archiving and Communications System)

9. PRODUCT CODE / DESCRIPTION:

90LLZ / Picture Archiving and Communications System

10. PERFORMANCE STANDARD:

None

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11. PREDICATE DEVICES:

Application	Predicate	510(k)Control #	Status
MR Wall Motion Tracking	VSTP-001A	K151093	Cleared
CT/XA Cerebral Artery Morphological Analysis	VSTP-001A	K151093	Cleared
MR Coronary Tracking	Fuji Synapse 3D	K120636	NEW

12. REASON FOR SUBMISSION:

Adding existing software applications to an imaging workstation (Vitrea; Product Code LLZ). MR Coronary Tracking which provides an analysis tool to determine the diameter and area of the coronary vessel lumen.

13. DEVICE DESCRIPTION:

14. INDICATIONS FOR USE:

15. SUBSTANTIAL EQUIVALENCE:

The software applications included in the Vitrea Software Toshiba Package, VSTP-001A, perform in a manner similar to and are intended for the same use as the predicate devices. These applications include previously cleared devices, CT/XA Cerebral Artery Morphological Analysis (K151093), and MR Wall Motion Tracking (K151093), remain unchanged.

The additional software, MR Coronary Tracking underwent both bench and clinical use study to verify its efficacy. The comparison of features to the predicate device, Fuji Synapse 3D (MR Coronary Analysis) demonstrates that substantial equivalence against commercially available

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products has been established. The subject and predicate device applications are post processing applications used to aid physicians with performing specialized measurement and analysis of MR image data.

Complete comparison tables are included in this submission. See below for a brief summary of technological characteristics of the software applications:

ltem	MR Coronary Tracking	Fuji Synapse 3D - MRCoronary Artery Analysis
510(k) Clearance	Subject Device	K120636
Type of Input Data	- A MR volume data of entireheart (Toshiba MRI)	- A MR volume data (Multiplevendors/systems)
Anatomical Region	Coronary Arteries	Coronary Arteries
Extraction ofcoronaryinformation	Centerline of coronary arteries(automatic and manual editing)Diameter measurement of lumenof coronary arteries by usingcontour (automatic and manualediting)	Centerline of coronary arteries(automatic and manual editing)Diameter measurement of lumenof coronary arteries (manualediting)
Measurement	Diameter and area of lumen	Diameter area and signal valueof lumenMeasures stenosis percentage

16. SAFETY:

The device is designed and manufactured under the Quality System Requlations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the IEC62304 and IEC62366.

17. TESTING

Risk analysis and verification/validation testing conducted through bench testing are included in this submission which demonstrates that the requirements for the MR Coronary Tracking application has been met. Bench studies were conducted using numerical phantoms to analyze the accuracy of extraction/display of the coronary arteries as well as measurement calculations for lumen dimensions and areas. Additionally, clinical evaluations were conducted to demonstrate that the MR Coronary Tracking application performed as intended. The results confirmed that the MR Coronary Tracking application was comparable to commercially released software and user measurements.

Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in

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Medical Devices Document" issued on May 11, 2005, is also included as part of this submission.

18. CONCLUSION

The software applications included in the Vitrea Software Toshiba Package, VSTP-001A, perform in a manner similar to and are intended for the same use as the predicate devices. Based upon this information, conformance to standards, successful completion of software validation, application of risk management and design controls and the performance data presented in this submission it is concluded that the subject device is substantially equivalent in safety and effectiveness to the predicate devices.

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).