The Scenium display and analysis software has been developed to aid the Clinician in the assessment and quantification of pathologies taken from PET and SPECT scans.

The software is deployed via medical imaging workplaces and is organized as a series of workflows which are specific to use with particular drug and disease combinations.

The software aids in the assessment of human brain scans enabling automated analysis through quantification of mean pixel values located within standard regions of interest. It facilitates comparison with existing scans derived from FDG-PET, amyloid-PET, and SPECT studies, calculation of uptake ratios between regions of interest, and subtraction between two functional scans.

Device Description

Scenium VD10 display and analysis software enables visualization and appropriate rendering of multimodality data, providing a number of features which enable the user to process acquired image data.

Scenium VD10 consists of three workflows:

Database Comparison
Ratio Analysis
Subtraction

These workflows are used to assist the clinician with the visual evaluation, assessment and quantification of pathologies with different imaging agents, such as using Amyloid imaging agents for dementia and Alzheimer's Disease, DaTSCAN(1-123) for Parkinson's Disease and FDG-PET for epileptic seizures.

The modifications made to the Scenium VD10 software (K133654) to create the Scenium VD20 software include:

Customized databases can now be imported and exported in the Database Comparison workflow.
Three new FDG databases normalized to the region of the cerebellum, in addition to whole brain, were added to the Database Comparison workflow.
Deformable Registration for Amyloid PET has been integrated in the Ratio Analysis workflow with a different algorithm.
Launch performance decreased the time taken to display patient data in the Ratio Analysis workflow.

This change is based on current commercially available software features and does not change the technological characteristics of the device.

Scenium VD20 Analysis software is intended to be run on commercially available software platforms such as the Siemens syngo.MI Workflow software platform (K133644) or commercially available Siemens scanners (e.g. symbia Intevo (K142006), Biograph mCT (K123737).

AI/ML Overview

This document is a 510(k) premarket notification for the Scenium VD20 software. It claims substantial equivalence to the previously cleared Scenium VD10 software (K133654). The provided text does not include a detailed study proving the device meets specific acceptance criteria with reported performance metrics, expert qualifications, or detailed study methodologies. Instead, it focuses on demonstrating that the modifications introduced in Scenium VD20 do not alter the fundamental technological characteristics or indications for use compared to the predicate device, and thus do not raise new safety and effectiveness concerns.

Therefore, many of the requested details about acceptance criteria and a specific study are not present in this regulatory document.

However, based on the information provided, we can infer some aspects and highlight what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "All testing has met the predetermined acceptance values." This is a general statement and does not provide specific quantitative acceptance criteria or reported performance values.

Acceptance Criteria	Reported Device Performance
Not explicitly defined in terms of specific performance metrics (e.g., accuracy, sensitivity, specificity, processing time for new features). The general criterion is that new features do not raise new safety/effectiveness concerns and function as designed.	"All testing has met the predetermined acceptance values."
Launch performance decreased the time taken to display patient data in the Ratio Analysis workflow.	This indicates an improvement, but no specific quantitative performance (e.g., time reduced from X to Y seconds) is provided.
Functionality of new features (Customized databases import/export, new FDG databases, Deformable Registration for Amyloid PET with a different algorithm)	"functions work as designed," "performance requirements and specifications have been met." (No specific quantitative performance metrics are given for these new functionalities).

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

Sample Size for Test Set: Not specified. The document mentions "Verification and Validation activities" and "All testing," but does not detail the size of the dataset used for these tests.
Data Provenance: Not specified. There is no mention of the country of origin of the data or whether it was retrospective or prospective.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The document focuses on software changes and their implications, not on clinical validation involving human readers or expert consensus on a test set.

4. Adjudication Method:

Not specified. Since details about expert review or test sets are missing, an adjudication method is also not mentioned.

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

No, an MRMC comparative effectiveness study is not mentioned or described. The documentation focuses on demonstrating substantial equivalence based on technical modifications and internal verification/validation, not on comparing human reader performance with and without AI assistance for the new features.

6. Standalone (Algorithm Only) Performance Study:

No specific standalone performance study with detailed metrics (e.g., sensitivity, specificity, accuracy) is presented in this document. The verification and validation activities likely included internal testing of the algorithms, but explicit results demonstrating standalone performance are absent. The device itself is described as "display and analysis software" intended to "aid the Clinician," implying it is a tool for human-in-the-loop use rather than a fully autonomous diagnostic algorithm.

7. Type of Ground Truth Used:

Not specified. Given the focus on software modifications and features, the "ground truth" for the verification and validation tests would likely relate to the expected outputs of the algorithms, internal consistency, and comparison with previous versions, rather than a clinical ground truth like pathology or long-term outcomes data.

8. Sample Size for the Training Set:

Not applicable / Not specified. This device is described as "display and analysis software" and the modifications are primarily related to database functionalities, workflow integration, and an algorithmic change for deformable registration. There is no indication that this update involved a machine learning model that required a specific "training set" in the conventional sense of deep learning or AI model development. The "new FDG databases" are likely pre-computed reference datasets, not training data for a learning algorithm within Scenium VD20 itself.

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

Not applicable / Not specified. As there's no mention of a traditional training set for a new machine learning algorithm, there's no information on how a ground truth for such a set would have been established.

Summary of what the document focuses on instead:

The document primarily provides evidence for substantial equivalence to a predicate device (Scenium VD10, K133654) by stating that:

The modifications (customized database import/export, new FDG databases, deformable registration algorithm change, improved launch performance) do not change the technological characteristics of the device.
There are no differences in the Indications for Use.
No new issues of safety and effectiveness are raised by the modifications.
Risk Management (ISO 14971:2012) and adherence to industry standards (ISO 13485, IEC 62304) were followed.
Verification and Validation activities were successfully performed, and "All testing has met the predetermined acceptance values." This last point is the closest to an "acceptance criterion" statement, though it lacks specificity.

Summary

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Public Health Service

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

March 29, 2015

Siemens Medical Solutions USA, Inc. % Ms. Alaine Medio PET and PCS Regulatory Projects Manager 810 Innovation Drive KNOXVILLE TN 37932

Re: K150192

Trade/Device Name: Scenium Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: II Product Code: LLZ, KPS Dated: March 5, 2015 Received: March 9, 2015

Dear Ms. Medio:

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. Acting 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)

K150192

Device Name Scenium VD20 Software

Indications for Use (Describe)

The Scenium display and analysis software has been developed to aid the Clinician in the assessment and quantification of pathologies taken from PET and SPECT scans.

The software is deployed via medical imaging workplaces and is organized as a series of workflows which are specific to use with particular drug and disease combinations.

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

as required by 21 CFR Part 807.87(h)

Identification of the Submitter

Identification of the Submitter
Submitter:	Siemens Medical Solutions USA, Inc.Molecular Imaging810 Innovation DriveKnoxville, TN 37932
Primary Contact:	M. Alaine Medio, RACPET and PCS RegulatoryProjects ManagerSiemens Medical SolutionsUSA, Inc.Molecular Imaging810 Innovation DriveKnoxville, TN 37932
Alternate Contact:	Veronica PadhariaRegulatory Affairs SpecialistSiemens Medical SolutionsUSA, Inc.Molecular Imaging2501 Barrington RoadHoffman Estates, IL 60192
Telephone Number:	(865) 218-2703
	(630) 877-5761
Fax Number:	(865) 218-3019
	(847) 304-6023
Name / Address of Manufacturer	Siemens Medical Solutions USA, IncMolecular Imaging2501 N. Barrington RoadHoffman Estates, IL 60192USA
Date of Submission:	January 27, 2015
Identification of the product
Device Proprietary Name:	Scenium VD20
Common Name:	Image Processing Software
Classification Name:	Picture Archiving and Communication Systemper 21 CFR 892.2050
Product Code:	LLZ & KPS
Classification Panel:	Radiology
Device Class:	Class II

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Marketed Devices to which Equivalence is claimed

Device	Manufacturer	510(k) Number
Scenium VD10	Siemens Medical Solutions USA, Inc	K133654 (February 28, 2014)

Device Description:

Scenium VD10 display and analysis software enables visualization and appropriate rendering of multimodality data, providing a number of features which enable the user to process acquired image data.

Scenium VD10 consists of three workflows:

. Database Comparison
Ratio Analysis ●
Subtraction

The modifications made to the Scenium VD10 software (K133654) to create the Scenium VD20 software include:

Customized databases can now be imported and exported in the Database Comparison . workflow.
Three new FDG databases normalized to the region of the cerebellum, in addition to whole ● brain, were added to the Database Comparison workflow.
. Deformable Registration for Amyloid PET has been integrated in the Ratio Analysis workflow with a different algorithm.
. Launch performance decreased the time taken to display patient data in the Ratio Analysis workflow.

This change is based on current commercially available software features and does not change the technological characteristics of the device.

Indications for Use:

The Scenium display and analysis software has been developed to aid the Clinician in the assessment and quantification of pathologies taken from PET and SPECT scans.

The software is deployed via medical imaging workplaces and is organized as a series of workflows which are specific to use with particular drug and disease combinations.

The software aids in the assessment of human brain scans enabling automated analysis through quantification of mean pixel values located within standard regions of interest. It facilitates

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comparison with existing scans derived from FDG-PET, amyloid-PET, and SPECT studies, calculation of uptake ratios between regions of interest, and subtraction between two functional scans.

Technological Characteristics

The Scenium VD20 software modifications are based on the commercially available Scenium VD10 software (K133654). The features introduced into Scenium VD20 had no impact on the technological characteristics already present in the commercially available predicate system.

Performance Testing / Safety and Effectiveness:

Risk Management has been ensured via risk analyses in compliance with ISO 14971;2012 to identify and provide mitigation to potential hazards beginning early in the design cycle and continuing throughout the development of the product. Siemens Medical Solutions, USA Inc. adheres to recognized and established industry standards for development including ISO 13485 and IEC 62304.

Verification and Validation activities have been successfully performed on the software package, including assurance that functions work as designed, performance requirements and specifications have been met, and that all hazard mitigations have been fully implemented. All testing has met the predetermined acceptance values.

Traceability of the requirements specified in the requirement specifications and functional specifications is ensured during component integration, software validation and system testing.

The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device.

The device is designed and manufactured in accordance with Quality System Regulations as outlined in 21 CFR 820.

Statement Regarding Substantial Equivalence:

There are no differences in the Indications for Use or Fundamental Technological Characteristics of the Scenium VD20 software as compared to the currently commercially available Scenium VD10 software (K133654). Both devices are used to assist the Clinician with the visual evaluation, assessment and quantification of pathologies derived from brain scans.

Additionally, there have been no changes that raise any new issues of safety and effectiveness as compared to the predicate device. Based on this information, as well as the documentation in support of the modifications, it is Siemens' opinion that the Scenium VD20 software with the modifications outlined in this application is substantially equivalent to the predicate device.

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).