Multitom Rax is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency applications, lymphography, endoscopy, myelography, arthrography, interventional radiology, digital angiography, and digital subtraction angiography (DSA). The system may be used on pediatric patients. The Multitom Rax is not for mammography examinations.

The True2scale Body Scan functionality (ie., slot-scanning-based acquisition and reconstruction technique) of the Multitom Rax is intended to be used for the generation of a geometrically accurate (in scanning direction) 2-D representation of the spine, the lower limbs or the full body which may be used for the assessment of body axes and skeletal alignment. The True2scale Body Scan feature is not intended to be used for interventional purposes.

Device Description

The Multitom Rax is a stationary X-ray system for radiography and fluoroscopy. The Multitom Rax consists of a floor mounted patient table (option) and ceiling suspended Xray tube and a ceiling suspended Solid State X-ray Imager (SSXI). Together with an X-ray generator and a digital imaging system, the Multitom Rax provides comprehensive image acquisition modes to support radiographic and fluoroscopic imaging procedures. X-ray tube and SSXI suspension movements are synchronized to provide rotation around a center. Series imaging acquired during the rotation are provided to 3D post-processing workstations.

With the new True2scale Body Scan technology, the Multitom Rax performs a continuous scan that moves along the patient's vertical axis with a highly collimated radiation beam along a line trajectory using the system's two telescopic arms. The projections, which are acquired during the scanning process, form the basis for a reconstruction to obtain a 2D representation of the scanned object.

AI/ML Overview

The provided text describes the acceptance criteria and a study to prove the device, Multitom Rax with True2scale Body Scan Option, meets those criteria. However, it does not contain a typical "acceptance criteria table" with numerical metrics and their corresponding performance. Instead, it focuses on the equivalence to a predicate device and clinical image quality.

Here's an attempt to extract and synthesize the information based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria (Inferred from Study Purpose)	Reported Device Performance (Summary of Findings)
Acceptable clinical image quality to allow detection and evaluation of vertebral alignment in each projection plane.	All ten (10) anonymized clinical image sets were found to be of acceptable clinical image quality by expert, board-certified radiologists.

Study Details:

A table of acceptance criteria and the reported device performance: See table above. The document emphasizes the new True2scale Body Scan technology's ability to provide "geometrically accurate (in scanning direction) 2-D representation of the spine, the lower limbs or the full body which may be used for the assessment of body axes and skeletal alignment." The primary "acceptance criteria" for the clinical evaluation, therefore, was the subjective assessment of image quality for enabling this assessment.
Sample size used for the test set and the data provenance:
- Sample Size: Ten (10) anonymized clinical image sets.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only states "anonymized clinical image sets."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not explicitly stated, but referred to as "expert, board-certified radiologists" (plural).
- Qualifications: "expert, board-certified radiologists." No detail on years of experience is provided.
Adjudication method for the test set: Not explicitly detailed. The statement "all image sets were found to be of acceptable clinical image quality" suggests a consensus or majority opinion, but the specific adjudication method (e.g., 2+1, 3+1) is not provided.
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, an MRMC comparative effectiveness study was not performed as described. The clinical evaluation was focused on the image quality of the new technology itself, without comparing human readers with and without AI assistance. The True2scale Body Scan is described as a "slot-scanning-based acquisition and reconstruction technique" for generating images, not an AI-assisted diagnostic tool for interpretation.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The study was effectively a standalone performance assessment of the image generation capability of the True2scale Body Scan technology. The focus was on the machine's output (image quality) rather than a diagnostic algorithm's performance. The "human experts" were evaluating the output of the device itself.
The type of ground truth used:
- Expert Consensus/Subjective Assessment: The ground truth for the clinical image evaluation was established through the subjective assessment of "expert, board-certified radiologists" who determined if the images were of "acceptable clinical image quality" for vertebral alignment detection and evaluation. It's not based on pathology or outcomes data.
The sample size for the training set:
- The document does not mention a training set or machine learning model training in the context of the True2scale Body Scan clinical evaluation. The "software VF11 design was completed in accordance with Siemens Quality Management System Design Controls and verification and validation testing were successfully conducted" but it does not specify if this included a machine learning component requiring a training set. The True2scale Body Scan is described as an "acquisition and reconstruction technique," suggesting image processing rather than AI-driven interpretation.
How the ground truth for the training set was established:
- Not applicable, as no training set for a machine learning model is mentioned in the context of this premarket submission.

Summary

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February 18, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

Siemens Medical Solutions % Ms. Denise Adams Regulatory Affairs Professional 40 Liberty Boulevard MALVERN PA 19355

Re: K212212

Trade/Device Name: Multitom Rax with True2scale Body Scan Option Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, JAA Dated: January 13, 2022 Received: January 14, 2022

Dear Ms. Adams:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Laurel Burk Assistant Director Diagnostic X-ray Systems Team Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212212

Device Name

Multitom Rax with True2scale Body Scan Option

Indications for Use (Describe)

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)

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510(k) Summary: Multitom Rax with True2scale Body Scan Option

Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355

Date Prepared: January 10, 2022

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

1. General Information:

Importer / Distributor:

Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Establishment Registration Number: 2240869

Location of Manufacturing Site:

Siemens Healthcare GmbH Siemensstr. 1 91301 Forchheim, Germany Establishment Registration Number: 3004977335

2. Contact Person:

Denise Adams, RAC Regulatory Affairs Professional Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355, US adams.denise@siemens-healthineers.com

Alternate Contact Person:

Martin Rajchel Senior Regulatory Affairs Manager Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355, US martin.rajchel@siemens-healthineers.com

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1. Device Name and Classification :

Trade Name:	Multitom Rax with True2Scale Body Scan Option
Classification Name:	Image-intensified fluoroscopic x-ray system
Classification Panel:	Radiology
Classification Regulation:	21 CFR §892.1650
Device Class:	II
Product Code:	OWB
Secondary Product Code:	JAA

1. Legally Marketed Predicate Device:

Trade Name	SONIALVISION G4 by SHIMADZU corporation
510(k) Number	K190373
DeviceClassificationName	Image-intensified fluoroscopic X-ray system
RegulationNumber	892.1650
Review Panel	Radiology
Product Code	JAA
Device Class	2

న. Device Description:

6. Indication for Use:

Multitom Rax is a device intended to visualize anatomical structures by converting an Xray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial. skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency

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applications, lymphography, endoscopy, myelography, venography, art interventional radiology, digital angiography, and digital subtraction angiography (DSA). The system may be used on pediatric, adult, and bariatric patients. The Multitom Rax is not for mammography examinations.

The True2scale Body Scan functionality (i.e., slot-scanning-based acquisition and reconstruction technique) of the Multitom Rax is intended to be used for the generation of a geometrically accurate (in scanning direction) 2-D representation of the spine, the lower limbs or the full body which may be used for the assessment of body axes and skeletal alignment. The True2scale Body Scan is not intended to be used for interventional purposes.

7. Substantial Equivalence:

The new feature True2scale Body Scan adds a term to the indication for use that is similar to the one of the predicate.

The device remains within the same classification for the same technology as the predicate device. The new system software design was completed in accordance with Siemens Quality Management System Design Controls comparable to the processes available for the predicate device. The scope of internationally recognized standards compliance was updated to the standards recognized at the time of the design of the new software.

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

The subject device with the new software VF11 uses the same X-ray scanning technology as the predicate device. There are substantial differences in the mechanical design of the subject device as compared to the predicate device design. Additional testing was conducted to provide evidence for the robustness of the subject device. Tomosynthetic reconstruction provides a similar image result and there are similarities in the patient environment and the type of user interface.

The following table compares the main performance data of the subject device with the predicate device to substantiate equivalence of the subject device and predicate device.

Comparison of the Subject Device (Multitom Rax with True2scale Body Scan) to Predicate Device (SONIALVISION G4 by SHIMADZU corporation)

Feature	Predicate device	Subject device	Comment
	SONIALVISION G4(K190373) bySHIMADZU corporation	Multitom Rax withTrue2scale Body Scan
RegulationDescription	Image-intensifiedfluoroscopic X-ray system	Image-intensifiedfluoroscopic X-ray system	Same
RegulationNumber	892.1650	892.1650	Same
ClassificationProduct Code	JAA	OWB	The predicatedevice is not
SubsequentProduct Code	N/A	JAA	for inter-ventional usetherefore itonly has theJAA procode
Indicationsfor use for theSlottechnologyonly	The equipment is intendedto be used for thefluoroscopy/ radiographydiagnosis in hospital.The equipment must onlybe operated by qualifiedpersonnel, such asradiography technicians orthose with equivalentqualificat-ions. Theequipment is used for totalpatient population.The equipment is NOTintended to be used forMammography screening.The equipment is NOTintended to be used forinterventional procedure.The equipment is used forradiographic, fluoroscopic,angiographic and pediatricexaminations. Storedimages in the equipmentcan be used for re-monitoring, imageprocessing, storing tooptical media (CD/DVD),and sending to DICOMserver.The Tomosynthesisoption for theSONIALVISION G4 isintended to generatetomographic images ofhuman anatomy	Multitom Rax is a deviceintended to visualizeanatomical structures byconverting an X-ray patterninto a visible image. Thesystem has medicalapplications ranging fromgastrointestinal examinationsto cranial, skeletal, thoracicand lung exposures as well asexaminations of theurogenital tract. The unit mayalso be used in emergencyapplications, lymphography,endoscopy, myelography,venography, arthrography,interventional radiology,digital angiography, anddigital subtractionangiography (DSA). Thesystem may be used onpediatric, adult, and bariatricpatients.The True2scale Body Scanfeature employs a slot-scanning-based acquisitionand reconstruction techniqueto produce a 2Drepresentation of the scannedobject which is intended forthe assessment of body axesand skeletal alignment.The True2scale Body Scanfeature itself is not intended	The subjectdevice has abroader rangeof applications.Thetomosynthesisfeature and thesubject of thisapplication issimilar to thepredicate
	including chest orextremities.Tomosynthesis techniqueis used to produce aspecific cross-sectionalplane of the body byreconstruction oftomographic acquisition.The device is not intendedfor mammographicapplications	to be used for interventionalpurposes.
MechanicalSystem design	Remotely controlledFluoroscopy Table	Twin robotic arms suspendedfrom ceiling with floor-mounted table, remotelycontrolled	Differentdesign requiresadditional testsfor mechanicalintegrity
X-ray beamgeometry	Slot technology	Slot technology	Same
High voltagegenerator	80 kW	65 kW or 80 kW	Similar
X-Ray Tube	Max anode heat capacity750 kHUFocal size: 0.7 / 1.2 mm	Max anode heat capacity 820kHUFocal size: 0.6 / 1.0 mm	Similar
Slot imagingcoverage	Max.141cm × 42cm	Max.170cm × 43cm	Similar
X-ray detector	Solid State X-ray Imager	Solid State X-ray Imager	Same
Imageprocessing	Image reconstruction withtomosynthesis	Image reconstruction withtomosynthesis	Same
Imagegeometry	True 1:1 in scan direction	True 1:1 in scan direction	Same
Slot width	40 mm in HS mode40 mm in HO mode	50 mm	Similar

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Summary of Non-Clinical Tests: 9.

The software VF11 design was completed in accordance with Siemens Quality Management System Design Controls and verification and validation testing were successfully conducted. The following performance tests were conducted:

Testing was conducted with a metal ruler to present the linear movement of the system and ● the robustness for the intended application

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X-ray exposure dose evaluations provide evidence of the low dose claim when compared . to current technologies with tube tilt and image stitching.

10. Summary of Tests to comply with International Standards

The devices operating with software VF10 comply with the voluntary standards as listed in the following table:

Standards DevelopmentOrganizationandReference Number	Title of Standard
ANSI AAMI60601-1, 2012 Ed. 3.1	Medical Electrical Equipment - Part 1: GeneralRequirements for Safety
IEC 60601-1-2 2014 Ed 4.0	Medical Electrical Equipment - Part 1-2: Generalrequirements for basic safety and essential performance -Collateral Standard: Electromagnetic Compatibility --Requirements and Tests
IEC 60601-1-3:Edition 2.1, 2013	Medical electrical equipment - Part 1-3: Generalrequirements for basic safety and essential performance -Collateral Standard: Radiation protection in diagnostic X-ray equipment
IEC 60601-2-28, 2017	Medical electrical equipment - Part 2-28: Particularrequirements for the basic safety and essentialperformance of X-ray tube assemblies for medicaldiagnosis
IEC 60601-2-542018, Edition 1.2	Medical electrical equipment - Part 2-54: Particularrequirements for the basic safety and essentialperformance of X-ray equipment for radiography andradioscopy
IEC 60601-1-62013 Ed 3.1	Medical electrical equipment - Part 1-6: Generalrequirements for basic safety and essential performance -Collateral standard: Usability
IEC 62366-1 2015 Ed 1.0	Medical devices – Application of usability engineering tomedical devices
ISO 14971: 2019	Medical devices - application of risk management tomedical devices
IEC 62304 2015, Ed.1.1	Medical device software - Software life cycle processes
IEC 61910-1: 2014, Ed 1.0	Medical electrical equipmentRadiation dosedocumentation - Part 1: Radiation dose structured reportsfor radiography and radioscopy
NEMA PS 3.1 - 3.20 2016	Digital Imaging and Communications in Medicine(DICOM) Set
IEC 60601-2-43: 2017	Medical electrical equipment – Part 2-43: Particularrequirements for the safety of X-ray equipment forinterventional procedures
ISO EN ISO 15223-12017-04	Medical devices - Symbols to be used with medicaldevice labels, labelling and information to be supplied -Part 1: General requirements
IEC 62220-1-1:2015	Medical electrical equipment – Characteristics of digitalX-ray imaging devices – Part 1-1:Determination of the detective quantum efficiency –Detectors used in radiographic imaging

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11. Summarv of Clinical Tests:

For the subject of this premarket submission, Siemens did an evaluation of the clinical image quality as the True2scale Body Scan technology is new.

The purpose of this clinical image evaluation was to show that even though the two orthogonal views (a.p. & lateral) are acquired sequentially, the resulting images are correlating sufficiently to allow a detection and evaluation of the vertebral alignment in each projection plane.

The evaluation of ten (10) anonymized clinical image sets by expert, board-certified radiologists has shown that all image sets were found to be of acceptable clinical image quality.

12. General Safety and Effectiveness Concerns:

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. Several safety features including visual and audible warnings are incorporated into the system design. In addition, the device is continually monitored, and if an error occurs, the system functions will be blocked, and an error message will be displayed.

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.

13. Conclusion as to Substantial Equivalence:

The Multitom Rax with the True2scale Body Scan feature is intended for similar indications for use as the predicate device. There are substantial differences in the mechanical design of the subject device as compared to the predicate device design. Additional testing was conducted to provide evidence for the robustness of the subject device. The operating environment is the same and the technology similar. Siemens concludes via the documentation provided in this 510(k) submission that the True2scale Body Scan feature of the Multitom Rax is substantially equivalent to the predicate device SONIALVISION G4.

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14. Guidance documents

The following FDA guidance documents were utilized in this Premarket Notification:

Content of Premarket Submission for Management of Cybersecurity in Medical Devices -Guidance for Industry and Food and Drug Administration Staff Document Issued on October 2, 2014

Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices - Guidance for Industry and Food and Drug Administration Staff Document issued on July 11, 2016

Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on May 11, 2005

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff Document issued on September 14, 2018.

The 510(k) Program: Evaluation Substantial Equivalent in Premarket Notifications 510(k) - Guidance for Industry and Food and Drug Administration Staff Document issued on July 28. 2014

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.