The Siemens SOMATOM Definition AS Open systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles.

(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

Device Description

New software version syngo® VA48 (SOMARIS/7 VA48) is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation that will be available on the SOMATOM Definition AS Open Computed Tomography systems. syngo® VA48 (SOMARIS/7 VA48) is a further development to the SOMARIS/7 operating software cleared as part of the predicate device.

syngo® VA48 is scanner platform software that supports the following device features:

1). New system scanner software version synqo® VA48 (SOMARIS/7 VA48) which includes:
- -Respiratory Analysis of Respiratory Rate & Pitch Adjustment -FAST 3D Reconstruction (FAST 3D Align)
- -Multiphase reconstruction with extended Field of View
- -FAST DE Results (Dual Energy PACS-ready images)
- -FAST contact
- -Iterative Reconstruction with extended Field of View
- -OEM Varian RGSC Online Mode
- -Full 4D Lung Scan
- -Applications at CT syngo.via client
- -TrueD 4D Viewer
2). ADMIRE Iterative Reconstruction (Option)
3). iMAR Improved Metal Artifact Reduction (Option)

There are no modifications to the hardware of the device.

AI/ML Overview

This document, a 510(k) Summary for the Siemens SOMATOM Definition AS Open CT system with software version syngo® VA48, primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study demonstrating improved human reader performance with AI assistance. It describes software updates and their verification and validation against technical standards.

Therefore, many of the requested details, such as specific acceptance criteria for AI performance, clinical study design for improved human reader performance, sample sizes for test sets in an MRMC study, expert qualifications for ground truth in a clinical context, or the effect size of AI assistance on human reader performance, are not explicitly available within this document. This submission is for a computed tomography x-ray system, and the "AI" or "machine learning" components mentioned (e.g., ADMIRE Iterative Reconstruction, iMAR Improved Metal Artifact Reduction) are features of the imaging system and reconstruction algorithms, not typically standalone AI interpretation tools that would undergo an MRMC study in the way a diagnostic AI would.

Given the information provided, here's what can be extracted and inferred, with limitations noted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a table of performance acceptance criteria in the sense of a diagnostic AI's clinical metrics (e.g., sensitivity, specificity, AUC). Instead, it refers to acceptance criteria for software specifications and conformance to technical standards.

Acceptance Criterion (Inferred from Document)	Reported Device Performance (Inferred from Document)
Conformance to IEC 60601-2-44	"SOMATOM Definition AS/AS+ configured with software version syngo® VA48 is designed to fulfill the requirements... The test results show that all the software specifications have met the acceptance criteria."
Conformance to IEC 61223-3-5	"SOMATOM Definition AS/AS+ configured with software version syngo® VA48 is designed to fulfill the requirements... The test results show that all the software specifications have met the acceptance criteria."
Conformance to NEMA XR-25	"SOMATOM Definition AS/AS+ configured with software version syngo® VA48 is designed to fulfill the requirements... The test results show that all the software specifications have met the acceptance criteria."
Conformance to IEC 61223-2-6	"SOMATOM Definition AS/AS+ configured with software version syngo® VA48 is designed to fulfill the requirements... The test results show that all the software specifications have met the acceptance criteria."
Conformance to NEMA PS 3.1 3.18 (DICOM)	"SOMATOM Definition AS/AS+ configured with software version syngo® VA48 is designed to fulfill the requirements... The test results show that all the software specifications have met the acceptance criteria."
Conformance to IEC 62304 Ed. 1.0	"SOMATOM Definition AS/AS+ configured with software version syngo® VA48 is designed to fulfill the requirements... The test results show that all the software specifications have met the acceptance criteria."
Conformance to IEC 60601-1	"SOMATOM Definition AS/AS+ configured with software version syngo® VA48 is designed to fulfill the requirements... The test results show that all the software specifications have met the acceptance criteria."
Conformance to ISO 14971 (Risk Management)	"The Risk analysis was completed, and risk control implemented, to mitigate identified hazards." (Implies acceptance criteria for risk mitigation were met)
Conformance to NEMA XR-29	"SOMATOM Definition AS/AS+ configured with software version syngo® VA48 is designed to fulfill the requirements... The test results show that all the software specifications have met the acceptance criteria."
Conformance to ISO/IEC 10918-1 (JPEG)	"SOMATOM Definition AS/AS+ configured with software version syngo® VA48 is designed to fulfill the requirements... The test results show that all the software specifications have met the acceptance criteria."
Software specifications functionality	"The test results show that all the software specifications have met the acceptance criteria."
Software verification and validation acceptability	"Verification and validation testing of the device was found acceptable to support the claims of substantial equivalence."
Performance as intended	"The results of these tests demonstrate that the subject device performs as intended. The result of all conducted testing was found acceptable to support the claim of substantial equivalence."

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

The document refers to "Performance tests" and "Non-clinical tests (integration and functional)" but does not specify a sample size for a clinical test set of patient data, nor its provenance (country, retrospective/prospective). This type of information would be expected for a diagnostic AI device, not typically for a CT system software update focusing on features like iterative reconstruction or metal artifact reduction.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable to this type of submission. There is no mention of human experts establishing ground truth for a diagnostic test set in the context of this 510(k). The "ground truth" here likely refers to technical specifications and expected performance characteristics of the CT system and its software, validated through engineering and phantom testing, rather than clinical interpretation.

4. Adjudication Method for the Test Set:

Not applicable. No clinical adjudication process is described as there isn't a stated clinical test set requiring human interpretation for ground truth.

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

No, an MRMC study was explicitly not done or described in this document. This regulatory submission is for a computed tomography x-ray system, specifically a software update (syngo® VA48) that includes features like iterative reconstruction (ADMIRE) and metal artifact reduction (iMAR). These are image processing and acquisition technologies, not AI-driven diagnostic assistance tools designed to change human reader performance in a comparative effectiveness study.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

The document describes "Performance tests" to "test the functionality of the SOMATOM Definition AS Open configured with software version syngo VA48." While not using the term "standalone performance" in the context of a diagnostic AI, the testing described appears to be algorithm-only, focused on the technical performance and functional verification of the software features themselves (e.g., image reconstruction quality, artifact reduction effectiveness) against technical standards. "The results of these tests demonstrate that the subject device performs as intended."

7. Type of Ground Truth Used:

The ground truth for this submission appears to be based on:

Technical specifications and engineering standards: Conformance to various IEC and NEMA standards (e.g., IEC 60601-2-44, IEC 61223-3-5, NEMA XR-25, DICOM).
Internal software specifications and functional requirements: "The test results show that all the software specifications have met the acceptance criteria."
Risk analysis and mitigation: "The Risk analysis was completed, and risk control implemented, to mitigate identified hazards." (The "ground truth" here is the identified hazards and their successful mitigation).

There is no mention of expert consensus, pathology, or outcomes data as a ground truth for clinical performance in this document.

8. Sample Size for the Training Set:

Not applicable. This document is not describing a machine learning model that was "trained" on a dataset in the way a diagnostic AI would be. The software updates described (like ADMIRE and iMAR) are based on algorithms and iterative processes, but the traditional concept of a "training set" for a deep learning model isn't presented here.

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

Not applicable, as there is no described training set for an AI model in this document.

Summary

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

March 26, 2015

Siemens Medical Solutions USA, Inc. % Ms. Eve Davis Regulatory Affairs Specialist 51 Valley Stream Parkway MALVERN PA 19355

Re: K143409

Trade/Device Name: SOMATOM Definition AS Open (VA48) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: February 20, 2015 Received: February 23, 2015

Dear Ms. Davis:

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,

Robert A Ocks

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) K143409

Device Name SOMATOM Definition AS Open

Indications for Use (Describe)

(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary: SOMATOM Definition AS Open

Company: Siemens Medical Systems USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355

Date Prepared: February 12, 2015

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

1. General Information:
  Importer / Distributor: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355 Establishment Registration Number: 2240869

Location of Manufacturing Site SIEMENS AG Healthcare Siemensstrasse 1 D-91301 Forchheim, Germany Establishment Registration Number: 3004977335

2. Contact Person:

Eve Davis Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway, D-02 Malvern, PA 19355 Phone: (610) 219-7133 Fax: (610) 448-1787 Email: eve.davis@siemens.com

3. Device Name and Classification:

SOMATOM Definition AS Open Product Name: Proprietary Trade Name: SOMATOM Definition AS Open Classification Name: Computed Tomography X-Ray System Classification Panel: Radiology Classification Regulation: 21 CFR §892.1750 Device Class: Class II Product Code: JAK

Legally Marketed Predicate Device
Trade Name: 4.

Trade Name:	SOMATOM Definition AS Open (VA46)
510(k) #:	K130901
Clearance Date:	January 2, 2014
Classification Name:	Computed Tomography X-ray System
Classification Panel:	Radiology
CFR Section:	21 CFR §892.1750
Device Class:	Class II

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Product Code: Recall Information:

JAK This predicate device has not been the subject of any design related recalls.

5. Device Description:

syngo® VA48 is scanner platform software that supports the following device features:

1). New system scanner software version synqo® VA48 (SOMARIS/7 VA48) which includes:
- -Respiratory Analysis of Respiratory Rate & Pitch Adjustment -FAST 3D Reconstruction (FAST 3D Align)
- -Multiphase reconstruction with extended Field of View
- -FAST DE Results (Dual Energy PACS-ready images)
- -FAST contact
- -Iterative Reconstruction with extended Field of View
- -OEM Varian RGSC Online Mode
- -Full 4D Lung Scan
- -Applications at CT syngo.via client
- -TrueD 4D Viewer
2). ADMIRE Iterative Reconstruction (Option)
3). iMAR Improved Metal Artifact Reduction (Option)

There are no modifications to the hardware of the device.

6. Indication for Use:

The Siemens SOMATOM Definition AS Open systems are intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles.

(*spiral planes: the axial planes resulted from the continuous rotation of detectors and xray tube, and the simultaneous translation of the patient.)

7. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device:

The SOMATOM Definition AS Open configured with software version syngo® VA48 does not have significant changes in materials, energy source, or technological characteristics when compared to the predicate device. Both the subject device and predicate device are computed tomography scanners that support various visualization and evaluation tools. The intended use and fundamental scientific technology are similar to the predicate device. The table below provides a comparison of the primary features of the subject device in comparison to the predicate device.

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Subject Device Feature	Predicate Device Feature
New system scanner software version syngo®VA48 (SOMARIS/7 VA48) with supportedsoftware options	System scanner software syngo® VA44(SOMARIS/7 VA44) with supported softwareoptions
New Iterative Reconstruction ADMIRE(option)	Iterative Reconstruction SAIRE (option)
iMAR Iterative Metal Artifact Reduction(option)	MARIS Metal Artifact Reduction (option)

and Predicate Device Compared Technological Characteristics

8. Nonclinical Testing

SOMATOM Definition AS/AS+ configured with software version syngo® VA48 is designed to fulfill the requirements of the following standards:

IEC 60601-2-44: Medical electrical equipment Part 2-44: Particular . requirements for the safety of X-ray equipment for computed tomography - Ed. 2.1
IEC 61223-3-5: Evaluation and routine testing Evaluation and routine testing in ● medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment CORRIGENDUM 1
NEMA XR-25: Computed Tomography Dose Check ●
IEC 61223-2-6: Evaluation and routine testing in medical imaging departments -● Part 2-6: Constancy tests – Imaging performance of computed tomography X-ray equipment
NEMA PS 3.1 3.18: Digital Imaging and Communications in Medicine (DICOM) ● Set
IEC 62304 Ed. 1.0: Medical device software software life cycle processes ●
. IEC 60601-1: Medical electrical equipment - Part 1: General requirements for Safety, 1988, Amendment 1, 1991-11, Amendment 2, 1995
. ISO 14971: Medical devices - Application of risk management to medical devices
NEMA XR-29: Standard Attributes on CT Equipment Related to Dose ● Optimization and Management
ISO/IEC 10918-1: Digital Compression and Coding of Continuous-Tone Still . lmages (JPEG); 1994-02

The Risk analysis was completed, and risk control implemented, to mitigate identified hazards. The test results show that all the software specifications have met the acceptance criteria. Verification and validation testing of the device was found acceptable to support the claims of substantial equivalence.

Software Verification and Validation

Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission.

Non-clinical tests (integration and functional) were conducted during the SOMATOM Definition Flash product development. The performance data demonstrates continued conformance with special controls for medical devices containing software.

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Summary

Performance tests were conducted to test the functionality of the SOMATOM Definition AS Open configured with software version syngo VA48. These tests have been performed to test the ability of the included features of the subject device. The results of these tests demonstrate that the subject device performs as intended. The result of all conducted testing was found acceptable to support the claim of substantial equivalence.

9. General Safety and Effectiveness Concerns:

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

Risk management is ensured via a hazard analysis which is used to identify potential hazards. These potential hazards are controlled during development and verification and validation testing. To minimize electrical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.

10. Conclusion as to Substantial Equivalence:

The predicate device was cleared based on non-clinical data as specified by recognized standards. Non-clinical data for the subject device was also gathered in this way The SOMATOM Definition AS Open configured with software version syngo® VA48 has the same intended use and indication for use as the predicate device.

The non-clinical data support the safety of the device and the software verification and validation demonstrate that the SOMATOM Definition AS Open configured with software version syngo® SOMARIS/7 VA48 should perform as intended in the specified use conditions.

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.