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 Cerebral Aneurysm 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.

The Ultrasound Clinical Applications are indicated for the visualization of structures, and dynamic processes with the human body using saved ultrasound DICOM images to provide image information for diagnosis.

Device Description

Vitrea Software 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 seven post processing applications, CT/XA Cerebral Artery Morphological Analysis, MR Wall Motion Tracking, MR Coronary Tracking and Ultrasound Applications Package, which use brain, body or cardiac image data, obtained from CT/XA/MR/US systems, to assist physicians in performing specialized measurements and analysis.

AI/ML Overview

The provided text describes a 510(k) submission for the Vitrea Software Package, VSTP-001A. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria beyond general statements about equivalence to a predicate device through "bench testing" and "regression testing".

The document states:

"Risk analysis and regression testing was 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 sample data sets from the predicate device verification activities (K173090) and verifying that the outputs for both devices were substantially the same."
"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 device."

This indicates that the primary method of demonstrating performance was through comparative bench testing against a predicate device, focusing on "substantially the same" outputs. It does not provide the quantitative details typically associated with acceptance criteria tables and clinical/algorithm performance studies as outlined in your request.

Therefore, I cannot populate the requested tables and specific study details.

Here's why and what's missing, based on your request:
1. A table of acceptance criteria and the reported device performance:
* Not Available: The document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, measurement accuracy thresholds) or corresponding reported performance metrics for any specific application within the Vitrea Software Package. It only mentions that "requirements...have been met" through bench testing.

2. Sample size used for the test set and the data provenance:
* Not Available: The document mentions "sample data sets from the predicate device verification activities (K173090)" were used for bench testing. It does not specify the sample size, country of origin, or if 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:
* Not Applicable/Not Available: The testing described is "bench testing" comparing outputs to a predicate device. This implies a technical verification of outputs rather than an expert-driven "ground truth" establishment for diagnostic accuracy, as would be the case for an AI-driven diagnostic aid. No experts are mentioned in the context of ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not Applicable/Not Available: Adjudication methods are typically used when multiple human readers interpret data to establish a consensus ground truth. This type of study is not described.

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: The document does not describe an MRMC study. The device is a "post-processing application" to "assist physicians in performing specialized measurements and analysis," but no study on human performance improvement with or without the device is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Yes (partially, but no detailed metrics): The "bench testing" implicitly acts as a "standalone" performance check in that it verifies the software's outputs against known outputs from the predicate device. However, no specific standalone performance metrics (like accuracy for a classification task) are provided, only that the outputs were "substantially the same."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* Not explicitly stated/Implied "Predicate Device Outputs": The "ground truth" for the bench testing appears to be the outputs generated by the predicate device (K173090). This is a technical comparison rather than a clinical ground truth like pathology or expert consensus.

8. The sample size for the training set:
* Not Applicable/Not Available: This device is described as software for "post-processing" and "analysis" that applies "formulas, algorithms and measurements" similar to a predicate. There is no mention of machine learning or deep learning, and therefore no "training set" in the sense of an ML model.

9. How the ground truth for the training set was established:
* Not Applicable/Not Available: As no training set for an ML model is mentioned, this question is not applicable.

In conclusion, the 510(k) summary focuses on demonstrating substantial equivalence primarily through technical bench testing against a predicate device, and it does not provide the detailed performance study results that would typically be associated with AI-driven devices requiring specific quantitative acceptance criteria and clinical validation studies.

Summary

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510(k) Summary

1. SUBMITTER'S NAME Canon Medical Systems Corporation 1385 Shimoishiqami Otawara-Shi, Tochigi-ken, Japan 324-8550
1. OFFICIAL CORRESPONDENT Naofumi Watanabe Senior Manager, Regulatory Affairs and Vigilance
1. ESTABLISHMENT REGISTRATION 9614698
1. CONTACT PERSON Paul Biggins Director Regulatory Affairs Canon Medical Systems USA, Inc.
1. DATE PREPARED March 19, 2018
1. TRADE NAME(S) Vitrea Software Package, VSTP-001A
1. COMMON NAME Radiological Image Processing Software
1. 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

11. PREDICATE DEVICES

Application	Predicate	510(k)Control#	Status
MR Wall Motion Tracking	VSTP-001A	K151093	Cleared
Cerebral Aneurysm Analysis(CT/XA Cerebral ArteryMorphological Analysis)	VSTP-001A	K151093	Cleared
MR Coronary Tracking	VSTP-001A	K171222	Cleared
SUREVolume Synthesis	VSTP-001A1	K173088	Cleared
Angio Viewer	VSTP-001A	K173088	Cleared
US Cardiac Fusion	VSTP-001A	K173088	Cleared
Ultrasound Application Package	Aplio-i, TUS-i9002	K173090	Cleared

Primary Predicate Device VSTP-001A - K173088

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2Secondary Predicate Device Aplio-i: TUS-i900 -K173090

12. REASON FOR SUBMISSION

Modification - Porting of application software from a different class device.

13. DEVICE DESCRIPTION

14. INDICATIONS FOR USE

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.

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SUBSTANTIAL EQUIVALANCE

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. The Ultrasound Clinical Applications Package utilizes the same formulas, algorithms and measurements as found on the predicate device. The porting of this software to the Vitrea Workstation required modifications to the GUI and acquiring images from the Vitrea Image Database. The subject and predicated devices are all post processing applications that are used to aid physicians with performing measurement and analysis of diagnotic images.

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

Primary Predicate:

The primary predicate device is the previous version of the device as cleared by PMN 510(k) K173088 The only changes to primary predicate device are the additions of the software that are described below in the secondary predicate device.

Item	Ultrasound Clinical Application Package(Subject Device)	Aplio i900 Model TUS-AI900
	K173090
anatomical region	whole body	whole body
Main feature	Image processing (Visualization of structure and dynamic processes with the human body to provide image information for diagnosis)	Scanning human body using ultrasound probeImage Processing (Visualization of structure and dynamic processes with the human body to provide image information for diagnosis)
Image data format for image processing	DICOM format of ultrasound image data	Original format of ultrasound image data
	- 2D image viewing- 4D / Cardiac 4D image viewing- Stress Echo- Tissue Intensity Analysis- Time Curve Analysis- Automated Cardiac flow Measurement- Cardiac Wall Motion Tracking- Mitral valve analysis	- 2D image viewing- 4D / Cardiac 4D image viewing- Stress Echo- Tissue Intensity Analysis- Time Curve Analysis- Automated Cardiac flow Measurement- Cardiac Wall Motion Tracking- Mitral valve analysis
	- Vitrea based interface is employed	- Ultrasound System interface is employed.

Secondary Predicate:

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15. SAFETY

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

16. TESTING

Risk analysis and regression testing was 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 sample data sets from the predicate device verification activities (K173090) and verifying that the outputs for both devices were substantially the same.

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 and the Cybersecurity documentation is included for the Vitrea.

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.

17. 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 device 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 device.

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

March 30, 2018

Re: K180323

Trade/Device Name: Vitrea Software Package: VSTP-001A Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 31, 2018 Received: February 5, 2018

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. Iisting 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,

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)

Device Name

Vitrea Software Package; VSTP-001A

Indications for Use (Describe)

The Cerebral Aneurysm Analysis application is intended to facilitate the extraction 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 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.

The Ultrasound Clinical Applications are indication of structures, and dynamic processes with the human body using saved ultrasound DICOM images to provide image information for diagnosis.

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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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).