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 (includinq desktops, laptops and workstations) that meet minimal hardware reguirements. Symbia.net is a solution for SPECT and SPECT-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 imaqe quality degradation on any of the imaqes shown in the clients compared to the images shown on the server related to resolution, color and timing.

AI/ML Overview

The provided document does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The document is a 510(k) summary for the Siemens Symbia.net, which is a Picture Archiving and Communication System (PACS) for SPECT and SPECT-CT systems. It primarily focuses on demonstrating substantial equivalence to predicate devices and provides details regarding regulatory classification, manufacturer information, and indications for use.

Here's a breakdown of what is and is not in the provided text, in relation to your request:

1. A table of acceptance criteria and the reported device performance

Not found. This document does not specify any performance-based acceptance criteria (e.g., accuracy, sensitivity, specificity, or image quality metrics) or report any performance metrics against such criteria.

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

Not found. There is no mention of a test set, sample size, or data provenance. This is a claim of substantial equivalence for a PACS system, not a clinical performance study of a diagnostic algorithm.

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)

Not found. Since no test set is described, there's no information about ground truth establishment or experts.

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

Not found. No test set or adjudication method is 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

Not found. No MRMC study is mentioned. This device is a PACS, which facilitates image display and analysis, but the document does not describe an "AI" component that would assist human readers in a diagnostic capacity or any comparative effectiveness study. The "MI Applications software" is described as a "display and analysis package intended to aid the clinician in the assessment and quantification of pathologies," but this refers to standard PACS functionality, not necessarily an AI-powered diagnostic aid requiring MRMC studies.

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

Not found. No standalone algorithm performance study is described.

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

Not found. No ground truth type is mentioned as no study is described.

8. The sample size for the training set

Not found. No training set is mentioned.

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

Not found. No training set or ground truth establishment method is mentioned.

Summary of available information related to the device:

Device Name: Symbia.net
Classification: Picture Archiving and Communication System (PACS), Class II
Purpose: Introduces client/server functionality for Siemens' MI Applications product, allowing it to be deployed on various hardware (desktops, laptops, workstations). It's a solution for SPECT and SPECT-CT systems.
Key Claim for Equivalence: "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."
Safety and Effectiveness: "Risk Management is ensured via a risk analysis in compliance with ISO 14971... 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."
Predicate Devices: Symbia 4.0 (MI Applications 2009A) and Visage PACSICS.

The regulatory review for this type of device (a PACS system that provides client/server functionality for existing applications) typically focuses on software validation, security, data integrity, and ensuring that the new deployment method does not degrade image quality or introduce new risks, rather than extensive clinical performance studies of diagnostic accuracy by "algorithms" or "AI." The claim of "no image quality degradation" suggests that internal technical evaluations would have been performed to verify this, but the details of such evaluations are not provided in this 510(k) summary.

Summary

{0}------------------------------------------------

Klooiq

Siemens Symbia.net
Special 510(k) Premarket Notification

Strictly Confidential

510(k) Summary

as required by 21 CFR Part 807.87(h)

MAY - 7 2010

Submitter:	Elaine ChangRegulatory Technical SpecialistSiemens Medical Solutions USA, Inc.Molecular Imaging810 Innovation DriveKnoxville, TN 37932
Telephone Number:	(865) 898-4170
Fax Number:	(865) 218-3019
Name / Address ofManufacturer	Siemens Medical Solutions USA, IncMolecular Imaging2501 N. Barrington RoadHoffman Estates, IL 60192USA
Date of Submission:	March 3, 2010
Identification of the product
Device Proprietary Name:	Symbia.net
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

{1}------------------------------------------------

Marketed Devices to which Equivalence is claimed

Device	Manufacturer	510(k) Number
Symbia 4.0 (MIApplications 2009A)	Siemens Medical Solutions	K082506
Visage PACSICS	Mercury Computer Systems, Inc	K072205

Device Description:

Safety and Effectiveness:

Risk Management is ensured via a risk analysis in compliance with ISO 14971 to identify and provide mitiqation to potential hazards beginning early in the design cycle 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:

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

MAY - 7 2010

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. Molecular Imaging Group 2501 North Barrington Road HOFFMAN ESTATES IL 60192 .

Re: K100619

Trade/Device Name: Symbia.net Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 7, 2010 Received: April 8, 2010

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

{3}------------------------------------------------

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,

Donald J. Bohn

Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

INDICATIONS FOR USE

510(k) Number (if known): K1006 19

Device Name: Symbia.net

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 ORH, Office of Device Evaluation (ODE)

Booker
Rbott
K 100619

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).