The Siemens Symbia series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.

Software: The MI Applications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies taken from SPECT, PET, CT and other imaging modalities.

Device Description

Symbia.net introduces client/server functionality allowing the MI Applications product to be deployed on any compatible hardware (including desktops, laptops and workstations) that meet minimal hardware requirements. Symbia.net is a solution for SPECT. SPECT-CT. PET. and PET-CT systems.

The software application is provided on a server. Clients running on any personal computer or Mac, meeting minimum requirements, can have access to the system. The rendered images on the client and server side are clinically equivalent with each other. No image quality deqradation on any of the images shown in the clients compared to the images shown on the server related to resolution, color and timing.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Symbia.net VA10B device.

Important Note: The provided document is a 510(k) Summary and FDA Clearance Letter. These documents primarily focus on demonstrating substantial equivalence to predicate devices and confirming regulatory compliance, rather than detailing the specifics of performance studies in the same way a clinical trial report would. Therefore, much of the requested information regarding sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not explicitly present in this type of regulatory filing.

However, based on the principle of substantial equivalence, the performance of Symbia.net VA10B is implicitly accepted as equivalent to its predicate devices. The study performed focuses on demonstrating that the new client-server architecture does not degrade image quality compared to the established predicate system.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Image Quality: No image quality degradation related to resolution, color, and timing when rendered on client-side compared to server-side.	"The rendered images on the client and server side are clinically equivalent with each other. No image quality degradation on any of the images shown in the clients compared to the images shown on the server related to resolution, color and timing."

Study Details (Based on available information)

Sample size used for the test set and the data provenance:
- Test set sample size: Not explicitly stated in the provided document. The study likely involved a set of images or image series that were rendered on both the server and client.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective). Given this is a software update for an existing system, it's highly probable that existing clinical image data was used, but details are not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not explicitly stated.
- Qualifications of experts: Not explicitly stated. However, for a "clinical equivalence" assessment in medical imaging, it is standard practice to involve qualified medical professionals (e.g., radiologists, nuclear medicine physicians) to evaluate image quality and interpret findings.
Adjudication method for the test set:
- Not explicitly stated. Given the nature of comparing rendered images for degradation, it would likely involve visual comparison by experts. Common methods include blinded review, side-by-side comparison, or comparing quantitative metrics if applicable, but the specific adjudication method is not described.
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, an MRMC comparative effectiveness study was not explicitly done or mentioned. This submission is for a client/server deployment of an existing MI Applications product, not a new AI-based diagnostic tool. The focus is on ensuring the new deployment method does not degrade the established performance. Therefore, there's no "AI assistance" component to measure improvement from.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in spirit. The core of the performance demonstration is a technical validation that directly compares the output of the software (rendered images) in two different deployment configurations (server vs. client). While humans are undoubtedly involved in assessing the equivalence, the "algorithm" (i.e., the rendering and display functionality) is being evaluated for its standalone output characteristics (resolution, color, timing) across the two environments. No human interaction is part of the core algorithm's performance in this context, rather the display output of the software itself is being assessed.
The type of ground truth used:
- Expert Consensus/Visual Inspection and Technical Comparison. The "ground truth" here is the original image quality and clinical appearance as displayed on the server. The study aims to demonstrate that the client display maintains this original quality. This is typically assessed by experts visually confirming clinical equivalence and potentially through technical measurements of image parameters (resolution, color fidelity, timing).
The sample size for the training set:
- Not applicable/Not explicitly stated. This device is a Picture Archiving and Communication System (PACS) and image display/analysis software. It's not described as using machine learning or AI models that require a "training set" in the conventional sense. The "training" would be more akin to software development and testing cycles using various image types, rather than a data-driven machine learning training set.
How the ground truth for the training set was established:
- Not applicable/Not explicitly stated. As there is no mention of a traditional machine learning training set, the concept of establishing ground truth for it is not relevant to the provided text. The "truth" for the development of such a system resides in ensuring the software correctly processes, renders, and displays medical images according to established DICOM standards and clinical requirements.

Summary

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K 110844

APR 2 0 2011

Symbia.net VA10B Special 510(k) Premarket Notification

Strictly Confidential

510(k) Summary as required by 21 CFR Part 807.87(h) Elaine Chang Submitter: Regulatory Technical Specialist Siemens Medical Solutions USA, Inc. 2501 N. Barrington Road · Hoffman Estates, IL 60192 .. USA Telephone Number: (847) 304-7516 Fax Number: (865) 218-3019 Siemens Medical Solutions USA, Inc Name / Address of Molecular Imaging Manufacturer 2501 N. Barrington Road Hoffman Estates, IL 60192 USA Date of Submission: March 25, 2011 ldentification of the product Device Proprietary Name: Symbia.net VA10B Common Name: Picture Archiving and Communication System Classification Name: Picture Archiving and Communication System per 21 CFR 892.2050 Product Code: LLZ Classification Panel: Radiology Device Class: Class II

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Marketed Devices to which Equivalence is claimed

Device	Manufacturer	510(k) Number
Symbia.net (2009A)	Siemens Medical Solutions USA,Inc	K100619
Symbia 4.0 (MIApplications 2009A)	Siemens Medical Solutions USA,Inc	K082506

Device Description:

Safety and Effectiveness:

Risk Management is ensured via a risk analysis in compliance with ISO 14971 to identify and provide mitigation to potential hazards beginning early in the design cvcle and continuing throughout the development of the product. Siemens considers that the proposed device does not introduce new safety concerns, and is substantially the same in indications for use, design, materials, energy sources and technology as the predicate devices. Siemens believes that Symbia.net is substantially equivalent to the predicate devices.

Indications for Use:

Software: The MI Applications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies taken from SPECT. PET. CT and other imaging modalities.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

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

APR 2 0 2011

Re: K110844

Trade/Device Name: Symbia.net VA10B Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 25, 2011 Received: March 28, 2011

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 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/cdrh/industry/support/index.html.

Sincerely Yours,

Mary Patel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): K11 U 8-4 Y

Device Name: Symbia.net VA10B

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D) OR

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 Devices (OIVD)

Mary S. Patel

510K K110 844

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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).