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.

The SUREVolume Synthesis application is intended to load volume images acquired by whole-body X-ray CT scanners, X-ray angiography systems, and MRI systems and displays fusion images.

The Angio Viewer application displays image data acquired using an X-ray angiography system. It supports cine display, subtraction, and distance measurement.

The US Cardiac Fusion application enables fusion display of the analysis results obtained using the US 3D Wall Motion Tracking application and the CT Coronary Artery Analysis application.

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, currently 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 document describes the Vitrea Software Toshiba Package, VSTP-001A, which includes several applications. The information regarding acceptance criteria and studies is provided for the new applications being submitted: SUREVolume Synthesis, US Cardiac Fusion, and Angio Viewer.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

Application	Acceptance Criteria (Implied from Study Objectives/Outcomes)	Reported Device Performance
SUREVolume Synthesis	Able to successfully fuse various combinations of data sets at an acceptable level. Automatic alignment is desirable; manual alignment should be successful if automatic fails.	Successfully fused various combinations of data sets at an acceptable level. In cases where automatic alignment was not obtainable, manual alignment was successful on all cases.
US Cardiac Fusion	Successful alignment of CCTA images and 3D Wall motion tracking images. Automatic alignment is desirable; manual alignment should be successful if automatic fails.	Automatic alignment success: 74% (64 to 89%). Successful manual adjustment: 90% (86 to 93%).
Angio Viewer	Replicate image measurements from the predicate device within a stated tolerance (implied to be ≤ 1%).	Possible to replicate image measurements from the predicate device within the stated tolerance of less than or equal to 1%, demonstrating successful integration of the INFX-8000F software to the VSTP-001A application.
CT/XA Cerebral Artery Morphological Analysis, MR Wall Motion Tracking, MR Coronary Tracking	(Not explicitly stated for these applications, as they were previously cleared and unchanged. Bench testing mentioned for accuracy of extraction/display of aneurysm shaped regions, and measurement calculations, cardiac function, and strain.)	Bench studies were conducted using numerical phantoms to analyze the accuracy of extraction/display of aneurysm shaped regions as well as measurement calculations and to analyze cardiac function and strain. (Specific acceptance criteria or performance numbers are not detailed for these previously cleared features in this submission.)

2. Sample size used for the test set and the data provenance

SUREVolume Synthesis & US Cardiac Fusion:
- Sample size: Not explicitly stated as a number of cases or images. The text mentions "various combinations of data sets" for SUREVolume Synthesis and "CCTA images and 3D Wall motion tracking images" for US Cardiac Fusion.
- Data provenance: Not explicitly stated (e.g., country of origin). The studies were described as "clinical evaluations conducted at clinical sites" for both. The text does not specify retrospective or prospective.
Angio Viewer:
- Sample size: Not explicitly stated. The text mentions "repeated measurements."
- Data provenance: Not explicitly stated. The evaluation was "conducted head on against the predicate device at the design site." Implies retrospective use of existing data for comparison.
CT/XA Cerebral Artery Morphological Analysis, MR Wall Motion Tracking, MR Coronary Tracking:
- Sample size: Not explicitly stated. The text mentions "numerical phantoms."
- Data provenance: Not explicitly stated. These were "bench studies."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

SUREVolume Synthesis & US Cardiac Fusion: The text states, "In both studies users of varying levels of experience reviewed all images and performed manual alignments as required." It does not specify the exact number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience").
Angio Viewer, CT/XA Cerebral Artery Morphological Analysis, MR Wall Motion Tracking, MR Coronary Tracking: Not specified for these applications.

4. Adjudication method for the test set

SUREVolume Synthesis & US Cardiac Fusion: For these clinical evaluations, "users of varying levels of experience" performed manual alignments when automatic alignment was not successful. This implies that the initial "ground truth" for success/failure of automatic alignment might have been based on their interpretation, and their subsequent manual alignments formed a manual "ground truth" for comparison. An explicit adjudication method like 2+1 or 3+1 is not mentioned.
Angio Viewer: The evaluation involved "repeated measurements" against a predicate device. This suggests a direct comparison rather than an adjudication process by multiple experts.
CT/XA Cerebral Artery Morphological Analysis, MR Wall Motion Tracking, MR Coronary Tracking: These involved bench studies with numerical phantoms. Adjudication by experts is not applicable here.

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

No MRMC comparative effectiveness study, evaluating human reader improvement with or without AI (or in this case, the software applications), is described in the provided text. The studies primarily focused on the performance of the software applications themselves, or direct comparison against a predicate device, rather than a reader study.

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

SUREVolume Synthesis & US Cardiac Fusion: The studies mention "automatic alignment success" which represents a standalone algorithm performance metric. However, it also clarifies that "users of varying levels of experience" performed manual alignments when automatic alignment failed, indicating that human-in-the-loop performance (manual adjustment) was also evaluated as a fallback.
Angio Viewer: The "bench testing at the design site against its predicate device" and replicating measurements implies a standalone comparison of the software's measurement capabilities.
CT/XA Cerebral Artery Morphological Analysis, MR Wall Motion Tracking, MR Coronary Tracking: Bench studies using "numerical phantoms to analyze the accuracy of extraction/display... as well as measurement calculations" clearly represent standalone algorithm performance.

7. The type of ground truth used

SUREVolume Synthesis & US Cardiac Fusion: The ground truth for fusion success and alignment appears to be based on the assessment of "users of varying levels of experience" at clinical sites. This would fall under an expert consensus/assessment type of ground truth, though the number of experts and their specific consensus method are not detailed.
Angio Viewer: The ground truth for measurement accuracy was the "predicate device" (Infinix Celeve-I: INFX-8000F) based on measurements obtained from it.
CT/XA Cerebral Artery Morphological Analysis, MR Wall Motion Tracking, MR Coronary Tracking: The ground truth for these bench studies was "numerical phantoms" and "measurement calculations," implying a precisely defined, known truth.

8. The sample size for the training set

The provided document does not mention the sample size used for the training set for any of the applications. It focuses on the validation/verification studies.

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

The provided document does not mention how the ground truth for the training set was established, as it does not discuss the training process.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 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 features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' in blue, with the word 'ADMINISTRATION' underneath.

January 31, 2018

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

Re: K173088

Trade/Device Name: Vitrea Software Toshiba Package VSTP-001A Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 27, 2017 Received: December 28, 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 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.

{1}------------------------------------------------

Page 2 - Mr. Paul Biggins

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K173088

Device Name

Vitrea Software Toshiba Package; VSTP-001A

Indications for Use (Describe)

The SUREVolume Synthesis application is intended to load volume images acquired by whole-body X-ray CT scanners, X-ray angiography systems, and MRI systems and displays fusion images.

The Angio Viewer application displays image data acquired using an X-ray angiography system. It supports cine display, subtraction, and distance measurement.

The US Cardiac Fusion application enables fusion display of the analysis results obtained using the US 3D Wall Motion Tracking application and the CT Coronary Artery Analysis application.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Toshiba. The word "TOSHIBA" is in large, red, bold letters. Below that, in smaller, black, bold letters, is the phrase "Leading Innovation" followed by three right-pointing arrows that fade from black to gray.

Image /page/3/Picture/1 description: The image shows the Canon Group logo. The word "Canon" is in red, with a stylized font. Below the word "Canon" is the word "GROUP" in black, sans-serif font. The logo is simple and modern.

510(k) SUMMARY

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

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

1. ESTABLISHMENT REGISTRATION: 9614698
1. CONTACT PERSON:

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

5. Date Prepared:

September 25, 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

{4}------------------------------------------------

11. PREDICATE DEVICES:

Application	Predicate	510(k) Control#	Classification and Product Code	Status
MR Wall Motion Tracking	VSTP-001A	K151091	21 CFR 892.205090LLZ	Cleared
CT/XA Cerebral ArteryMorphological Analysis	VSTP-001A	K151091	21 CFR 892.205090LLZ	Cleared
MR Coronary Tracking	VSTP-001A	K171222	21 CFR 892.205090LLZ	Cleared
SUREVolume Synthesis	Miranda XD	K101228	21 CFR 892.205090LLZ	New
Angio Viewer	ToshibaINFX-8000F	K081624		New
US Cardiac Fusion	GE CardIQFusion	K061370	21 CFR 892.205090LLZ	New

12. REASON FOR SUBMISSION:

New software applications

13. DEVICE DESCRIPTION:

14. INDICATIONS FOR USE:

The SUREVolume Synthesis application is intended to load volume images acquired by wholebody X-ray CT scanners,

{5}------------------------------------------------

X-ray angiography systems, and MRI systems and displays fusion images.

The Angio Viewer application displays image data acquired using an X-ray angiography system. It supports cine display, subtraction, and distance measurement.

The US Cardiac Fusion application enables fusion display of the analysis results obtained using the US 3D Wall Motion Tracking application and the CT Coronary Artery Analysis application.

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), MR Wall Motion Tracking (K151093) and MR Coronay Tracking (K171222), remain unchanged.

There are three additional software applications that are being included in this submission. Volume Synthesis and US Cardiac Fusion both underwent user evaluation at clinical sites, while the Angio Viewer software package underwent bench testing at the design site against its predicate device, to verify efficacy. The comparison of each new application to its respective predicate device demonstrates that substantial equivalance against commercially available products have been established. The subject and predicated devices are all post processing applications that are used to aid physicians with performing measurement and analysis of diagnotic images.

Item	Angio Viewer	Infinix Celeve-I: INFX-8000F
510(k) Clearance	(Subject Device)	(K081624)
Anatomical Region	whole body	whole body
Input	XA 2D image	XA 2D image
Image Display	2D	2D
Subtraction	DSA image subtraction	DSA image subtraction
Pixel-Shift	automaticmanual	automaticmanual
Distance	manual	manual
Angle	manual	manual

A complete comparison table is included in this submission. See below for a brief summary of technological characteristics of the devices:

{6}------------------------------------------------

Item	SUREVolume Synthesis	Mirada XD
510(k) Clearance	(Subject Device)	(K101228)
Anatomical region	whole body	whole body
Input	- CT, XA, MR (DICOM format)- Rendering information	- CT, MR,PET, SPECT, planar NM(DICOM format)
Registration	Rigid-RegistrationManual adjustment	Rigid-RegistrationNone- Rigid-RegistrationManual adjustment
Image Display	MPR / 3D	MPR

ltem	US Cardiac Fusion	GE: CardIQ Fusion
510(k) Clearance	(Subject Device)	(K061370)
Anatomical Region	Heart	Heart
Input	- CT, US (DICOM format)	- CT, PET, SPECT
Image Display	MPR / 3D / polar plot	MPR / 3D / polar plot
Registration	Automatic	Automatic
	Manual	Manual

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 applications have been met. Bench studies were conducted using numerical phantoms to analyze the accuracy of extraction/display of aneurysm shaped regions as well as measurement calculations and to analyze cardiac function and strain. Additionally, clinical evaluations were conducted to demonstrate that the SUREVolume Synthesis and US Cardiac Fusion applications performed as intended. The results confirmed that SUREVolume Synthesis was able to successfully fuse various combinations of data sets at an acceptable level. In those cases were automatic alignment was not obtainable the evaluation showed that manual alignment was successful on all cases. US Cardiac Fusion was successfully evaluated to show successful alignment of CCTA images and 3D Wall motion tracking images as follows; Automatic alignment success of 74% (64 to 89%) and successful manual adjustment of 90% (86 to 93%). In both studies users of varying levels of experience reviewed all images and performed manual alignments as required. The Angio Viewer evaluation was conducted head on against the predicate device using repeated measurements. The test concluded that it was possible to replicate the image measurements from one device to the other within the stated tolerance of less than or equal to 1% which demonstrated successful integration of the INFX-8000F software to the VSTP-001A application.

{7}------------------------------------------------

This device is not subject to Cybersecurity Requirements as it has no access to an outside environment. All images being queued by the VSTP-001A are resident on the host Vitrea platform. The host Vitrea platform conducts all external data transactions.

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