SAFIRE is a CT reconstruction software. The end user can choose to apply either SAFIRE 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 SAFIRE 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 SAFIRE images. Additionally, SAFIRE can reduce spiral artifacts by using iterations going back and forth between image space and raw data space.

A Model Observer evaluation showed that equivalent low contrast detectability can be achieved with 54% to 60% less dose using SAFIRE 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 SAFIRE are not intended to be evaluated with syngo Osteo CT or syngo Calcium Scoring.

Device Description

Siemens SAFIRE is a software option to for CT operating system SOMARIS/7. It provides an improved image quality. Reciprocally the use SAFIRE allows the physician to acquire scans with reduced radiation dose without reduction of image quality compared to today's standard.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the SAFIRE device, based on the provided text:

SAFIRE Device Performance and Acceptance Criteria

The SAFIRE software is designed to improve image quality and enable radiation dose reduction in CT scans. The acceptance criteria focus on maintaining or improving image quality metrics (pixel noise, low contrast detectability, high contrast resolution) while allowing for significant dose reduction.

Table of Acceptance Criteria and Reported Device Performance:

Performance Metric	Acceptance Criteria (Stated Goal)	Reported Device Performance
Radiation Dose Reduction	Reduce radiation dose without reduction of image quality compared to today's standard.	Achieved 54% to 60% less dose for equivalent low contrast detectability using SAFIRE at highest noise reduction strength (for thin (0.6 mm) reconstruction slices in simulated body and head phantoms for low contrast objects). Clinical environment evaluation confirmed use of up to 60% less radiation dose with SAFIRE provided images with same results in terms of pixel noise and spatial resolution compared to today's standard scan techniques.
Pixel Noise	Maintain Pixel noise with reduced radiation dose.	Phantom measurements showed pixel noise in images is equivalent for full dose WFBP images and SAFIRE images acquired with reduced dose. Clinical evaluation confirmed same results in terms of pixel noise with reduced dose and SAFIRE.
Low Contrast Detectability	Maintain low contrast detectability with reduced radiation dose.	Model Observer evaluation showed equivalent low contrast detectability can be achieved with 54% to 60% less dose using SAFIRE at highest noise reduction strength.
High Contrast Resolution	Maintain high contrast resolution with reduced radiation dose.	Phantom measurements showed high contrast resolution in images is equivalent for full dose WFBP images and SAFIRE images acquired with reduced dose.
Spiral Artifact Reduction	Reduce spiral artifacts.	SAFIRE can reduce spiral artifacts by using iterations. Validated in clinical images and simulations with established image quality phantoms.

Study Details:

Based on the provided text, the verification and validation efforts included non-clinical tests, a Model Observer evaluation, phantom measurements, and clinical environment evaluations.

Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The text does not explicitly state a numerical sample size for the "test set" in terms of number of patient cases or images. It mentions "simulated body and head phantoms" for the Model Observer evaluation and "clinical images" for artifact reduction.
- Data Provenance: The data provenance is mixed:
  - Phantoms: Simulated body and head phantoms.
  - Clinical Data: "Clinical environment" and "clinical images," suggesting prospective or retrospective data from a healthcare setting, likely within Germany (manufacturing site SIEMENS AG Healthcare Sector Siemensstrasse 1 D-91301 Forchheim) or where Siemens conducts clinical studies. The specific country of origin is not detailed.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- The document does not provide information regarding the number of experts or their qualifications used to establish ground truth for any clinical test set. The Model Observer evaluation uses a quantitative, objective metric (low contrast detectability) and phantoms, which typically do not involve human experts for ground truth establishment in the same way clinical image interpretation would.
Adjudication Method for the Test Set:
- The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study is not explicitly mentioned. The document focuses on demonstrating that SAFIRE allows for dose reduction while maintaining image quality metrics (pixel noise, low contrast detectability, high contrast resolution) through phantom studies and some clinical evaluation of pixel noise/spatial resolution. It doesn't describe a study comparing human reader performance with and without AI assistance to quantify an "effect size" of improvement.
Standalone Performance (Algorithm only without human-in-the-loop performance):
- Yes, a standalone performance evaluation was done. The Model Observer evaluation and the phantom measurements for pixel noise, low contrast detectability, and high contrast resolution are examples of standalone algorithm performance. These evaluations assess the algorithm's direct impact on image characteristics without involving human interpretation until later clinical validation steps.
Type of Ground Truth Used:
- The ground truth used appears to be primarily established physical properties and objective measurements from phantoms (e.g., known contrasts in phantoms for low contrast detectability) and computational models (Model Observer).
- For "spiral artifacts," the ground truth was also established through "simulations with established image quality phantoms" and "clinical images," indicating a qualitative assessment potentially against a reference or expert understanding of artifact presence.
Sample Size for the Training Set:
- The document does not provide any information about the sample size used for the training set. SAFIRE is "iterative reconstruction" software, and while it learns and refines, the text doesn't detail a traditional machine learning "training set" in the sense of a distinct dataset used for supervised learning.
How the Ground Truth for the Training Set Was Established:
- As no information on a distinct "training set" is provided, there is no information on how its ground truth was established. Iterative reconstruction algorithms like SAFIRE often use mathematical models of physics and image formation, rather than relying on labeled training data with external ground truth in the same way many modern AI systems do.

Summary

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

Image /page/0/Picture/0 description: The image shows the word "SIEMENS" in bold, black letters. The letters are large and evenly spaced, filling most of the frame. A thin black line runs underneath the word, emphasizing the text.

Section 5: 510(k) Summary

NOV 2 2 2011

510(k) Summary For SAFIRE

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

September 25, 2010

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.

l. General Information

Importer / Distributor

Siemens Medical Solutions, Inc. 51 Valley Stream Parkway, E-50 Malvern, PA 19355 Establishment Registration Number 2240869

Manufacturing Site

SIEMENS AG Healthcare Sector Siemensstrasse 1 D-91301 Forchheim

2. Contact Person:

Mrs. Alicia Bustos-Juergensen Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway E-50 Malvern, PA 19355-1406 Phone:(610) 448-4056 Fax: (610) 448-1778

3. Device Name and Classification

SAFIRE Product Name: Propriety Trade Name: SAFIRE Classification Name: Computed Tomography X- ray System Classification Panel: Radiology 21 CFR §892.1750 CFR Section: Device Class: Class II Product Code: 90 JAK

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

4. Device Description

5. Intended Use

SAFIRE is a CT reconstruction software. The end user can choose to apply either SAFIRE or the weighted filter back-projection (WFBP) to the acquired raw data.

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

Substantial Equivalence: 6.

Siemens Computed tomography X-ray systems, configured with software version SOMARIS/7 including SAFIRE are substantially equivalent to the following medical device in commercial distribution

Predicate Device Name	FDA Clearance Number	FDA Clearance Date
SOMATOM Definition Flash	K082220	10/10/2008

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

SAFIRE is an option within the image reconstruction module of the CT operating system SOMARIS/7 that can be selected by the user in addition to conventional image reconstruction technique (Weighted Filtered Back Projection). It improves image quality and allows for radiation dose reduction. The iterative steps include the validation of current images compared with measured raw data, and reconstruction of differences to an updated image, which is added to the previous image.

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

8. Verification and Validation

Non clinical tests were conducted for SAFIRE software package during product development. Additionally, a Model Observer evaluation showed that equivalent low contrast detectability can be achieved with 54% to 60% less dose using SAFIRE at highest strength for thin reconstruction slices in body and in head region compared to weighted filtered backprojection (WFBP). At the same time phantom measurements showed that high contrast resolution and pixel noise in the images is equivalent for full dose WFBP images and SAFIRE images acquired with reduced dose.

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.

Additionally the iterative reconstruction technique was evaluated in clinical environment. The results show that the use of up to 60% less radiation dose compared to today's standard scan techniques in combination with the use of SAFIRE provides images with the same results in terms of pixel noise and spatial resolution. Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence.

The reduction of spiral artifacts was validated in clinical images and in simulations with established image quality phantoms.

General Safety and Effectiveness Concerns 9.

Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner.

Furthermore the operators are health care professionals familiar with and responsible for the X-ray examinations to be performed. To minimize electrical, mechanical and radiation hazards, Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing.

10. Conclusion as to Substantial Equivalence

Siemens Computed tomography X-ray systems, configured with software version SOMARIS/7 including SAFIRE are intended for the same indications for use as the predicate. device

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

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three overlapping, curved lines forming its body and wings. The bird is facing left. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

NOV 2 2 2011

Mrs. Alicia Bustos-Juergensen Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway, E-50 MELVERN PA 19355-1406

Re: K103424

Trade/Device Name: Safire Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: October 27, 2011 Received: October 28, 2011

Dear Mrs. Bustos-Juergensen:

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

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

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 S 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

{5}------------------------------------------------

FMENS

510(k) Number (if known): K103424

Device Name: SAFIRE

Indications for Use:

SAFIRE is a CT reconstruction software. The end user can choose to apply either SAFIRE or the weighted filter back-projection (WFBP) to the acquired raw data.

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

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

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 Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K103424

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.