ADMIRE by SIEMENS MEDICAL SYSTEMS, INC.

ADMIRE is a CT reconstruction software. The end user can choose to apply either ADMIRE or the weighted filter backprojection (WFBP) to the acquired raw data. Depending on the clinical task, patient size, anatomical location, and clinical practice, the use of ADMIRE can help to reduce radiation dose while maintaining pixel noise, low contrast detectability and high contrast resolution. Phantom measurements showed that high contrast resolution and pixel noise are equivalent between full dose WFBP images and reduced dose ADMIRE images. Additionally, ADMIRE can reduce spiral artifacts by using iterations going back and forth between image space and raw data space.

Images reconstructed with ADMIRE are not intended to be evaluated with syngo Osteo CT or syngo Calcium Scoring.

Device Description

Siemens ADMIRE is an extension of the previously cleared Sinogram Affirmed Iterative Reconstruction (SAFIRE) reconstruction algorithm. ADMIRE is a software option for CT operating systems that provides an improved image quality or reciprocally can allow the physician to acquire scans with reduced radiation dose without reduction of image quality compared to today's standard.

ADMIRE is designed to improved reconstructed image quality through the integration of additional processing steps in image reconstruction. These additional steps result in the following improvements in image quality:

. Higher pixel noise reduction
A noise texture closer to filtered back projection (FBP) .
. Improved resolution for high contrast edges

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria for device performance. Instead, it frames the performance improvements of ADMIRE relative to its predicate device (SAFIRE) and traditional methods (FBP/WFBP). The "acceptance criteria" are implied to be the successful demonstration of these improvements and equivalence for certain metrics.

Acceptance Criteria (Implied)	Reported Device Performance
Higher pixel noise reduction (especially in thicker slices)	ADMIRE provides higher pixel noise reduction in thicker slices (e.g., 3mm and 5mm) compared to SAFIRE. Additionally, it helps maintain pixel noise at reduced radiation doses compared to full dose WFBP images.
Noise texture closer to filtered back projection (FBP)	ADMIRE results in a noise texture closer to FBP, with fewer outliers, compared to SAFIRE.
Improved resolution for high contrast edges	ADMIRE shows improved resolution for high contrast edges compared to SAFIRE and weighted filtered back projection (WFBP). Phantom measurements showed that high contrast resolution is equivalent between full dose WFBP images and reduced dose ADMIRE images.
Ability to reduce radiation dose while maintaining image quality	The use of ADMIRE can help to reduce radiation dose while maintaining pixel noise, low contrast detectability, and high contrast resolution. Phantom measurements demonstrated equivalence in high contrast resolution and pixel noise between full dose WFBP images and reduced dose ADMIRE images.
Reduction of spiral artifacts	ADMIRE can reduce spiral artifacts by using iterations going back and forth between image space and raw data space.
Conformance with safety and performance standards	ADMIRE fulfills requirements of various standards (e.g., ISO 14971, IEC 62304, IEC 60601-1-4, IEC 60601-1-6, NEMA DICOM PS 3.1-3.18). Risk analysis was completed, and risk control implemented. EMC/electrical safety evaluated according to IEC Standards. All software specifications met acceptance criteria. Identified risk of electrical hazards mitigated.
Substantial equivalence to predicate device (SAFIRE)	Siemens is of the opinion that ADMIRE does not introduce any new potential safety risk and is substantially equivalent to and performs as well as the predicate devices.

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

Sample Size: Not explicitly stated for specific tests. The document mentions "phantom testing" and "sample clinical images." No specific number of patients or imaging studies are provided.
Data Provenance: The document does not specify the country of origin. It indicates that "phantom testing" was conducted and "sample clinical images were also provided within the submission." The general nature of the testing suggests it's likely internal Siemens data. The testing involves "simulated body and head phantoms."
Retrospective/Prospective: The nature of the testing described (phantom testing, bench testing, verification/validation) suggests a controlled, likely retrospective analysis of specific data, or controlled prospective phantom acquisitions. There's no mention of a large-scale, prospective clinical trial with human subjects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The evaluation primarily relies on phantom measurements and technical performance metrics (noise reduction, resolution, noise texture) rather than a subjective human reader assessment against a clinical ground truth.

4. Adjudication Method for the Test Set

This information is not provided. Given the focus on objective phantom measurements and technical image quality metrics, a formal human reader adjudication method like 2+1 or 3+1 is unlikely to have been used in the primary performance evaluations 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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study with human readers assessing AI-assisted vs. non-AI-assisted images is not mentioned or described in this 510(k) summary. The document focuses on the technical improvements of the reconstruction algorithm itself.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Yes, the performance described is primarily that of the standalone algorithm (ADMIRE). The improvements in pixel noise reduction, noise texture, high contrast resolution, and artifact reduction are inherent to the algorithm's processing of raw data. The statement "The end user can choose to apply either ADMIRE or the weighted filter back-projection (WFBP) to the acquired raw data" further reinforces its standalone nature as a reconstruction option.

7. The Type of Ground Truth Used

The ground truth used appears to be:

Physical Phantom Measurements: For metrics like pixel noise, high contrast resolution, and low contrast detectability. This involves comparing the device's output against known physical properties or reference measurements from phantoms.
Reference Reconstruction Methods: Comparisons are made against established methods like Filtered Back Projection (FBP) and Weighted Filtered Back Projection (WFBP) to demonstrate improvements or equivalence.
Compliance with Standards: Verification against various international standards for medical devices and software (ISO, IEC, NEMA).

There is no mention of "expert consensus," "pathology," or "outcomes data" being used as ground truth for the performance evaluation described in this summary.

8. The Sample Size for the Training Set

This information is not provided. The document outlines changes to a reconstruction algorithm rather than a machine learning model that would typically have a distinct training set. While reconstruction algorithms are developed and refined using data, the document doesn't use the terminology of "training set" in the context of deep learning.

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

This information is not provided, and the concept of a "training set" and associated ground truth, as typically understood in machine learning, is not discussed in this summary. The development process likely involved engineering and optimization against known physical models and existing reconstruction results, rather than labeled training data for a learning algorithm.

Summary

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JUN 2 0 2014

K133646
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510(K) SUMMARY FOR ADMIRE

Submitted by: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355

Date Prepared: May 5, 2014

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

1. General Information
  SIEMENS

Importer/Distributor: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355

Establishment Registration Number: 2240869

Manufacturing Site: SIEMENS AG, MEDICAL SOLUTIONS Siemensstrasse 1 91301 Forchheim, GERMANY

Establishment Registration Number: 3004977335

2. Contact Person:

Mrs. Kimberly Mangum Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway D02 Malvern, PA 19355-1406 Fax: (610) 448-1778 Phone: (610) 448-1772 Email: kimberly.mangum@siemens.com

Device Name and Classification 3.

Product Name:	ADMIRE
Propriety Trade Name:	ADMIRE
Classification Name:	Computed Tomography X-ray System
Classification Panel:	Radiology
CFR Section:	21 CFR §892.1750

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Device Class: Class II Product Code: 90JAK

Legally Marketed Predicate Devices Trade Name: SAFIRE 510(k)#: K103424 Clearance Date: Clearance Date: Classification Panel: Radiology Classification Regulation:21 CFR § 892.1750 Device Class: . Product Code: 90 JAK

4. Substantial Equivalence:

Siemens ADMIRE is substantially equivalent to the following medical devices in commercial distribution:

Predicate Device Name	FDA Clearance Number	FDA Clearance Date
SAFIRE	K103424	November 22, 2011

5. Device Description:

. Higher pixel noise reduction
A noise texture closer to filtered back projection (FBP) .
. Improved resolution for high contrast edges

Summary of Technical Characteristics of the Subject Device as 6. Compared with the Predicate Device:

ADMIRE reconstruction software do not have significant changes in the indications for use, materials, energy source, or technological characteristics when compared to the predicate device.

The additional/extended algorithm processing steps result in the following improvements in reconstructed image quality for ADMIRE in comparison to the predicate device SAFIRE:

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Higher pixel noise reduction in thicker slices (for example 3mm and . 5mm)
Less outliers in the noise texture resulting in a noise texture closer to . that of filtered back projection (FBP)
Improved Resolution at High Contrast Edges compared to weighted . filtered back projection (WFBP)

The intended use and fundamental scientific technology are similar to the predicate device; therefore Siemens believes that they are substantially equivalent to the predicate device.

7. Nonclinical Testing:

ADMIRE is designed to fulfill the requirements of following safety and performance standards:

RecognitionNumber	ProductArea	Title of Standard	ReferenceNumber andDate	PublicationDate	StandardsDevelopmentOrganization
5-40	General	Medical devices - Application ofrisk management to medicaldevices	14971 SecondEdition 2007-03-01	08/20/2012	ISO
13-8	Software	Medical device software -Software life cycle processes	62304 Firstedition 2006-05	08/20/2012	IEC
5-41	General	Medical electrical equipment -Part 1-4: General requirementsfor safety - Collateral standard:Programmable electrical medicalsystems, edition 1.1	60601-1-4:2000Consol.Ed 1.1	09/08/2009	IEC
	General	Medical electrical equipment -Part 1-6: General requirementsfor basic safety and performance	60601-1-6	2006	IEC
12-218	Radiology	Digital Imaging andCommunications in Medicine(DICOM)	PS 3.1 - 3.18(2008)	2008	NEMA

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This submission contains performance data to demonstrate continued conformance with special controls for medical devices containing software. Non clinical tests (integration and functional) and phantom testing were conducted for ADMIRE during product development. The modifications described in this Premarket Notification were supported with verification/validation testing.

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

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.

EMC/electrical safety was evaluated according to the IEC Standards. Siemens certify conformance to Voluntary Standards covering Electrical and Mechanical Safety. In conclusion, the identified risk of electrical hazards was mitigated and is substantially equivalent to the predicate device in terms of safety and effectiveness. All testing and validation has been completed.

Summary of Additional Testing

In addition to successful completion of verification and validation testing, additional bench testing was performed to substantiate performance claims and demonstrate substantial equivalence to the predicate device SAFIRE. Sample clinical images were also provided within the submission.

8. Indications for Use:

ADMIRE is a CT reconstruction software. The end user can choose to apply either ADMIRE or the weighted filter back-projection (WFBP) to the acquired raw data. Depending on the clinical task, patient size, anatomical location, and clinical practice, the use of ADMIRE can help to reduce radiation dose while maintaining pixel noise, low contrast detectability and high contrast resolution. Phantom measurements showed that high contrast resolution and pixel noise are equivalent between full dose WFBP images and reduced dose ADMIRE images. Additionally, ADMIRE can reduce spiral artifacts by using iterations going back and forth between image space and raw data space.

ADMIRE at highest noise reduction strength for thin (0.6 mm) reconstruction slices in simulated body and head phantoms for low contrast objects with different contrasts.

Images reconstructed with ADMIRE are not intended to be evaluated with syngo Osteo CT or syngo Calcium Scoring.

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K133646
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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, verification and validation testing. To minimize electrical, mechanical, and radiation hazards. Siemens adheres to recognized and established industry practice and standards.

10. Conclusion as to Substantial Equivalence

In summary, Siemens is of the opinion that the ADMIRE does not introduce any new potential safety risk and is substantially equivalent to and performs as well as the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Flealth Service

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

June 20, 2014

Siemens Medical Systems, Inc. % Ms. Kimberlv Mangum Regulatory Affairs Specialist 51 Valley Stream Parkway MALVERN PA 19301

K133646 Rc:

Trade/Device Name: ADMIRE Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: H Product Code: JAK Dated: May 8, 2014 Received: May 13, 2014

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 10 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 cither 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 complics 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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Page 2 - Ms. Kimberly Mangum

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,

Smh.7)

for

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K133646

Device Name ADMIRE

Indications for Use (Describe)

Images reconstructed with ADMIRE are not intended to be evaluated with syngo Osteo CT or syngo Calcium Scoring.

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

2 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)

Sm.h.7)

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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

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FORM FDA 3881 (1/14)

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.