The Siemens SOMATOM Definition Flash system is 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 commandbased 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 Flash CT system. syngo® VA48 (SOMARIS/7 VA48) is a further development to the SOMARIS/7 operating software cleared as part of the predicate devices.

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

1). New system scanner software version 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

-Temporal MIP (t-MIP)
-TrueD 4D Viewer
2). ADMIRE Iterative Reconstruction (option)
3). iMAR Improved Metal Artifact Reduction (option)
4). MARIS (Metal Artifact Reduction in Image Space) Option
5). HandCARE Quantitative Dose Reduction Option
6). CARE Dose4D Dose Reduction Option

There are no modifications to the hardware of the SOMATMOM Definition Flash.

AI/ML Overview

The provided text is a 510(k) premarket notification for the Siemens SOMATOM Definition Flash CT system. It describes the device, its intended use, and its equivalence to previously cleared predicate devices. However, it does not contain the specific details required to fully address your request regarding acceptance criteria and the study that proves the device meets them.

The document states:

"The test results show that all of 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." (Page 6)
"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." (Page 7)

While it confirms that tests were conducted and acceptance criteria were met for software specifications and overall functionality, it does not explicitly list the acceptance criteria themselves, nor does it provide detailed study data, sample sizes, ground truth establishment methods, or specific performance metrics (like sensitivity, specificity, or AUC) that you'd expect from a clinical performance study.

Therefore, I cannot populate the table or answer most of your detailed questions based solely on the provided text. The document focuses on regulatory compliance (510(k) pathway for substantial equivalence) rather than a detailed clinical performance study report.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Cannot provide. The document states that acceptance criteria were met for software specifications and device functionality, but it does not specify what those criteria were (e.g., specific quantitative thresholds for image quality, diagnostic accuracy, or dose reduction) or the numerical 'reported device performance' against them.

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

Cannot provide. The document mentions "non-clinical tests (integration and functional)" and "Performance tests" but does not detail the nature of these tests in terms of patient data (if any), sample sizes, or data provenance. The focus is on software and system functionality testing.

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):

Cannot provide. The document does not describe any expert-reviewed test sets or ground truth establishment relevant to clinical performance.

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

Cannot provide. Not applicable as no expert-reviewed test set is detailed.

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:

Cannot provide. No mention of MRMC studies or AI assistance for human readers. The device is a CT scanner system with new software features, not an AI-assisted diagnostic tool in the sense of improving human reader performance.

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

Cannot provide. While there were "Performance tests" and "software verification and validation," the document doesn't provide details to assess if these were purely standalone performance evaluations of an algorithm in a clinical context (e.g., detecting specific pathologies). The tests appear to be primarily functional and integration tests for a CT system's software update.

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

Cannot provide. No information on ground truth for clinical performance.

8. The sample size for the training set:

Cannot provide. The document describes software updates for a CT system, not an AI/machine learning model that would typically have a "training set."

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

Cannot provide. See answer to point 8.

In summary: The provided document is a regulatory submission for a CT system upgrade, demonstrating substantial equivalence through non-clinical and functional testing against recognized standards. It does not contain the detailed clinical performance study information you are seeking.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the logo.

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

April 16, 2015

Siemens Medical Solutions USA, Inc. % Ms. Kimberly Mangum Regulatory Affairs Specialist 51 Valley Stream Parkway, D-02 MALVERN PA 19355

Re: K143416

Trade/Device Name: Somatom Definition Flash Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: February 18, 2015 Received: February 26, 2015

Dear Ms. Mangum:

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) K143416

Device Name SOMATOM Definition Flash

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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V: SOMATOM Definition Flash

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

November 24, 2014 Date Prepared:

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: lmporter / 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

1. Device Name and Classification:
- Product Name: Trade Name: Classification Name: Classification Panel: Classification Regulation: Device Class: Product Code:

SOMATOM Definition Flash SOMATOM Definition Flash Computed Tomography X-Ray System Radiology 21 CFR §892.1750 Class II JAK

1. Legally Marketed Predicate Devices SOMATOM Definition Flash with Stellar Trade Name: Detector (SOMARIS/7 VA44) 510(k) #: K121072 Clearance Date: May 8, 2012 Classification Name: Computed Tomography X-ray System Classification Panel: Radiology

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Image /page/4/Picture/0 description: The image shows the word "SIEMENS" in a large, teal font. Below the word, the text "CFR Section:" and "Device Class:" are written in a smaller, black font. The text is aligned to the left and appears to be part of a document or presentation.

Device Class: Product Code: Recall Information:

Trade Name: 510(k) #: Clearance Date: Classification Name: Classification Panel: CFR Section: Device Class: Product Code: Recall Information:

21 CFR §892.1750 Class II JAK This predicate device has not been the subject of any design related recalls.

SOMATOM Definition AS Open (VA46) K130901 January 2, 2014 Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II 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 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

-Temporal MIP (t-MIP)
-TrueD 4D Viewer
2). ADMIRE Iterative Reconstruction (option)
3). iMAR Improved Metal Artifact Reduction (option)
4). MARIS (Metal Artifact Reduction in Image Space) Option
5). HandCARE Quantitative Dose Reduction Option
6). CARE Dose4D Dose Reduction Option

There are no modifications to the hardware of the SOMATMOM Definition Flash.

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SIEMENS

Indication for Use: 6.

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

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

The SOMATOM Definition Flash configured with software version syngo® SOMARIS/7 VA48 does not have significant changes in materials, energy source, or technological characteristics when compared to the predicate devices. Both the subject device and predicate devices are computed tomography scanners that support various visualization and evaluation tools. The intended use and fundamental scientific technology are similar to the predicate devices.

Subject and Predicate Device Compared Technological Characteristics

Subject Device:SOMATOM DefinitionFlash withSOMARIS/7 VA48	Primary PredicateDevice: SOMATOMDefinition Flash withStellar Detector(VA44)	Secondary PredicateDevice: SOMATOMDefinition AS Open(VA46)
New system scannersoftware versionsyngo® VA48(SOMARIS/7 VA48)with supportedsoftware options	System scannersoftware versionsyngo® VA44(SOMARIS/7 VA44)with supportedsoftware options	System scannersoftware syngo® VA44(SOMARIS/7 VA44)with supportedsoftware options
New Iterative	Iterative	Iterative
Reconstruction	Reconstruction	Reconstruction
ADMIRE (option)	SAFIRE (option)	SAFIRE (option)
iMAR Iterative MetalArtifact Reduction(option) or MARISMetal ArtifactReduction (option)	N/A	MARIS Metal ArtifactReduction (option)
HandCARE withQuantitative DoseReduction Option	N/A	HandCARE withQuantitative DoseReduction Option
CARE Dose4DQuantitative DoseReduction Option	N/A	CARE Dose4DQuantitative DoseReduction Option

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MATOM Definition Flash configured with software version syngo® VA48 complies with 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 Images (JPEG): 1994-02

The Risk analysis was completed, and risk control implemented, to mitigate identified hazards. The test results show that all of 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 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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Image /page/7/Picture/0 description: The image contains the word "SIEMENS" in large, bold, teal-colored font. Below the word "SIEMENS" is the word "Summary" in a smaller, black font. The word "Summary" appears to be a subtitle or descriptor for the word "SIEMENS".

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 as well as 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, verification and validation testing. In order to minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.

10. Conclusion as to Substantial Equivalence:

The predicate devices were 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 Flash configured with software version syngo® VA48 has the same intended use and indication for use as the predicate devices.

The non-clinical data support the safety of the device and the software verification and validation demonstrate that the SOMATOM Definition Flash 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.