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 main workflows: Database Comparison Workflow, Ratio Analysis Workflow, and Subtraction Workflow. These workflows are used to assist the clinician with the visual evaluation, assessment and quantification of pathologies, such as dementia (ie. Alzheimer's), movement disorders (ie. Parkinson's), and seizure analysis (ie. Epilepsy).

AI/ML Overview

The provided text states that "Performance and functional testing were conducted for Scenium VD10, and all performance requirements and specifications were met." However, it does not provide specific acceptance criteria or detailed results of the study that proves the device meets these criteria. It primarily focuses on the device description, indications for use, and a comparison to predicate devices for substantial equivalence.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, and MRMC studies are not available in the given document.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified	"all performance requirements and specifications were met."

Explanation: The document generally states that performance and functional testing were conducted and that all requirements were met, but it does not list the specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or provide quantitative performance metrics for the device against these criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for the test set: Not specified.
Data provenance: Not specified (country of origin, retrospective or prospective).

3. 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)

Number of experts: Not specified.
Qualifications of experts: Not specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication method: Not specified.

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

MRMC study: Not mentioned or described. The document focuses on the device's ability to "aid the Clinician," suggesting it's a tool for assistance, but it does not quantify human reader improvement.
Effect size: Not specified.

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

Standalone performance: Not explicitly stated as a separate study with specific metrics. The device is described as "aids the Clinician" and "enabling automated analysis," which implies standalone functionality, but a dedicated standalone performance study with results is not detailed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of ground truth: Not specified.

8. The sample size for the training set

Sample size for training set: Not specified.

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

Ground truth for training set: Not specified.

Summary of available information regarding the study:

The document mentions that "Performance and functional testing were conducted for Scenium VD10, and all performance requirements and specifications were met." It also states that "risk management is ensured via a risk analysis in compliance with ISO 14971:2007 and ISO 14971:2012 to identify and provide mitigation to potential hazards."

However, this summary does not contain the detailed study plan, methodology, or results that would typically be present to demonstrate how the device meets specific acceptance criteria in terms of accuracy, sensitivity, specificity, etc., with human-read or pathology-confirmed ground truth. The information provided is high-level and confirms that internal testing was done and deemed successful by the manufacturer, but lacks the granular details requested.

Summary

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F23 Z 8 2014

Page 39 of 123

Scenium VD10
510(k) Premarket Notification

510(k) Summary

as required by 21 CFR Part 807.92(c)

Submitter:	Elaine ChangRegulatory Technical SpecialistSiemens Medical Solutions USA, Inc.Molecular Imaging2501 N. Barrington RoadHoffman Estates, IL 60192USA
Telephone Number:	(865) 218-2873
Fax Number:	(865) 218-3019
Name / Address ofManufacturer:	Siemens Medical Solutions USA, IncMolecular Imaging2501 N. Barrington RoadHoffman Estates, IL 60192USA
Date of Submission:	November 26, 2013
Identification of the product
Device Proprietary Name:	Scenium VD10
Common Name:	Picture Archiving and Communication System
Classification Name:	Picture Archiving and Communication System per 21CFR 892.2050Emission Computed Tomography System per 21 CFR892.1200
Product Code:	LLZ and KPS
Classification Panel:	Radiology
Device Class:	Class II

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Scenium VD10 510(k) Premarket Notification

Marketed Devices to which Equivalence is claimed

Device	Manufacturer	510(k) Number
Scenium 3.0	Siemens Medical Solutions USA, Inc	K121074
Neurogam Oasis	Segami Corporation	K071584
MIMNeuro	MIMVista Corp	K060816

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.

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 imaqing workplaces and is organized as a series of workflows which are specific to use with particular drug and disease combinations.

Performance Testing:

Performance and functional testing were conducted for Scenium VD10, and all performance requirements and specifications were met.

In addition, risk management is ensured via a risk analysis in compliance with ISO 14971:2007 and 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.

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

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Scenium VD10 510(k) Premarket Notification

Substantial Equivalence:

Scenium VD10 device has the same intended use and utilizes the same fundamental scientific technology as the predicate devices. Both the device and predicates are used to assist the Clinician with the visual evaluation, assessment and quantification of pathologies derived from brain scans. The primary difference lies in the addition of a new subtraction workflow which is based on the existing software architecture of the primary predicate device, Scenium 3.0. The subtraction workflow allows for the analysis of difference images for epilepsy analysis.

These changes do not affect the fundamental scientific technology of the device, and Siemens considers Scenium VD10 to be as safe, as effective, and with performance substantially equivalent to its predicate devices.

Safety and Effectiveness:

The device is designed and manufactured under Quality System Regulations as outlined in 21 CFR 820. All requirements of Emission Computed Tomography system standards (21 CFR 892.1200) and Picture Archiving and Communications System (21 CFR 892.2050) are met, and software is in compliance with ISO 14971 and ISO 62304.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, with three stylized wing-like shapes above a flowing, ribbon-like form.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

February 28, 2014

Siemens Medical Solutions USA, Inc. % Ms. Elaine Chang Regulatory Technical Specialist 2501 N. Barrington Road HOFFMAN ESTATES IL 60192

Re: K133654

Trade/Device Name: Scenium VD10 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ, KPS Dated: November 26, 2013 Received: November 27, 2013

Dear Ms. Chang:

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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Page 2-Ms. Chang

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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/Safetv/ReportaProblem/delault.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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fdagov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael D. O'Hara For

Janine M. Morris 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): K133654

Device Name: Scenium VD10

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 comparison with existing scans derived from FDGPET, and SFECT studies, calculation of uptake ratios between regions of interest, and subtraction between two functional scans.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Michael D. O'Hara

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) K133654

Page 1 of 1

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).