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 and calculation of uptake ratios between regions of interest.

Device Description

Scenium 3.0 display and analysis software enables visualization and appropriate rendering of multimodality data, providing a number of features which enable the user to process the acquired image data. Scenium 3.0 is post processing and does not control the scanning features of the system.

AI/ML Overview

The provided text is a 510(k) summary for the Scenium 3.0 device. A 510(k) submission generally establishes substantial equivalence to a predicate device and does not typically involve the presentation of detailed acceptance criteria or extensive clinical studies in the same way a PMA submission might.

Based on the provided document, here's what can be inferred about acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists no specific quantitative acceptance criteria or detailed device performance metrics in a tabular format. The submission focuses on demonstrating substantial equivalence to predicate devices (Scenium 2.0, NeuroTrans3D, Brass) rather than proving performance against predefined clinical thresholds.

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

The document does not specify any sample size used for a test set or the provenance of any data used for testing (e.g., country of origin, retrospective or prospective). This type of information would typically be detailed in a separate clinical or performance evaluation report, which is not part of this 510(k) summary.

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

The document does not mention the use of experts to establish ground truth for a test set or their qualifications. The submission is based on the functional and technological equivalence of the Scenium 3.0 software to predicate devices for aiding clinicians in assessment and quantification, not on a new clinical claim requiring expert-adjudicated ground truth.

4. Adjudication Method for the Test Set:

No adjudication method (e.g., 2+1, 3+1, none) is mentioned because the document does not describe a clinical test set that would require such a method.

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

The document does not describe an MRMC comparative effectiveness study or indicate an effect size for human readers improving with or without AI assistance. This type of study is more common for devices making claims about improving diagnostic accuracy or efficiency with AI. Scenium 3.0 is described as post-processing software that aids in analysis and quantification, implying it's a tool for clinicians rather than an AI-driven diagnostic system in the conventional sense that would undergo MRMC.

6. Standalone (Algorithm Only) Performance Study:

The document does not describe a standalone performance study of the algorithm without human-in-the-loop performance. The device is presented as a tool to "aid the Clinician" and "facilitates comparison," indicating it's designed to be used in conjunction with human interpretation.

7. Type of Ground Truth Used:

The document does not specify the type of ground truth used as it does not detail a study that would necessitate it. The focus is on the software's ability to "enable automated analysis through quantification of mean pixel values located within standard regions of interest" and "facilitate comparison with existing scans," suggesting its functionality is related to data processing and visualization rather than a direct diagnostic output requiring a definitive ground truth.

8. Sample Size for the Training Set:

The document does not provide information on the sample size for a training set. This is because the submission emphasizes the software's functionality and its substantial equivalence to predicate devices, not the development and validation of a new machine learning algorithm that would require a distinct training set.

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

As no training set is mentioned, there is no information on how its ground truth was established.

Summary of Device and Evidence:

The Scenium 3.0 is a Picture Archiving and Communication System (PACS) and emission computed tomography system software. It's designed to aid clinicians in the assessment and quantification of pathologies from PET and SPECT brain scans by enabling automated analysis through quantification of mean pixel values in regions of interest and facilitating comparison with existing scans.

The study presented in the 510(k) summary is a demonstration of substantial equivalence to legally marketed predicate devices (Scenium 2.0, NeuroTrans3D, Brass). The evidence provided focuses on:

Indications for Use: The Scenium 3.0's indications are similar to those of the predicate devices, aiding clinicians in assessment and quantification of PET/SPECT brain scans.
Technological Characteristics: The software is described as similar in uses and applications to the predicate devices, all assisting clinicians with visual evaluation, assessment, and quantification.
Safety and Effectiveness: The device is stated to be designed and manufactured under Quality System Regulations (21 CFR 820) and complies with relevant standards (21 CFR 892.1200, 21 CFR 892.2050, ISO 14971, ISO 62304).

The acceptance criteria for a 510(k) submission like this are implicit: demonstrating that the new device is as safe and effective as a legally marketed predicate device, and does not raise new questions of safety or effectiveness. The study's "acceptance" is the FDA's clearance, indicating that Siemens Medical Solutions USA, Inc. successfully demonstrated substantial equivalence. Quantitative performance data, clinical study details, and expert adjudication are generally not required for this type of submission unless the new device introduces novel technology or makes new clinical claims that fall outside the scope of predicate devices.

Summary

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K123528

Scenium 3.0 Special 510(k) Premarket Notification

510(k) Summary

as required by 21 CFR Part 807.87(h)

DEC 2 0 2012

Elaine Chang Submitter: Regulatory Technical Specialist Siemens Medical Solutions USA, Inc. 810 Innovation Dr Knoxville, TN 37932 USA Telephone Number: (865) 218-2873 (865) 218-3019 Fax Number: Siemens Medical Solutions USA, Inc Name / Address of Manufacturer: Molecular Imaging 2501 N. Barrington Road Hoffman Estates, IL 60192 USA Date of Submission: November 15, 2012 ldentification of the product Device Proprietary Name: Scenium 3.0 Picture Archiving and Communication System Common Name: Picture Archiving and Communication System per 21 Classification Name: CFR 892.2050 Emission Computed Tomography System per 21 CFR 892.1200 Product Code: LLZ and KPS Classification Panel: Radiology Device Class: Class II

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Scenium 3.0 Special 510(k) Premarket Notification

Marketed Devices to which Equivalence is claimed

Device	Manufacturer	510(k) Number
Scenium 2.0	Siemens Medical Solutions USA, Inc	K121074
NeuroTrans3D	Segami Corporation	K043441
Brass	Hermes Medical Solutions	K021656

Device Description:

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.

Technoloqical characteristics:

The software is similar in uses and applications to 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.

Safety and Effectiveness:

The device is designed and manufactured under Quality System Requlations 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.

Substantial Equivalence:

Based on the above considerations, Siemens Medical Solutions USA, Inc believes that the Scenium 3.0 software is substantially equivalent to the predicate devices. The device and the

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Scenium 3.0 Special 510(k) Premarket Notification

predicate devices are all post-processing and provide similar features of visualization and numerical data.

Page 24 of 1082

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 20, 2012

Siemens Medical Solutions USA, Inc. % Ms. Elaine Chang Regulatroy Technical Specialist 810 Innovation Drive KNOXVILLE TN 37932

Re: K123528

Trade/Device Name: Scenium 3.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ and KPS Dated: November 15, 2012 Received: November 16, 2012

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 or any I catal 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 de rece related adverse overals)S) regulation (21 CFR Part 820); and if applicable, the electronic form in and quality of cromp (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/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 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.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Janine M. Morris -S

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):

Scenium 3.0 Device Name:

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.

Prescription Use_ × (Part 21 CFR 801 Subpart D)

Ov
(21

Over the Counter Use (21 CFR 801 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) Division of

Office of In Vitro Diagnostics and Radiological Health

510(k) K123528

Page 1 of

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).