This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

The images delivered by the system can be used by a trained staff as an aid in diagnosis and treatment as well as for diagnostic and therapeutic interventions.

This CT system can be used for low dose lung cancer screening in high risk populations*.

As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

Device Description

The subject device NAEOTOM Alpha with software version SOMARIS/10 syngo CT VB10 is a Computed Tomography X-ray system which features two continuously rotating tube-detector systems, denominated as A- and B-systems respectively (dual source CT scanner system). The detectors' function is based on photon-counting technology. The NAEOTOM Alpha with SOMARIS/10 syngo CT VB10 produces CT images in DICOM format, which can be used by trained staff for postprocessing applications commercially distributed by Siemens and other vendors as an aid in diagnosis and treatment as well as for diagnostic and therapeutic interventions. The computer system delivered with the CT scanner is able to run optional post-processing applications.

The platform software for the NAEOTOM Alpha is syngo CT VB10 (SOMARIS/10 syngo CT VB10). It is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.

The software platform provides plugin software interfaces that allow for the use of specific commercially available post-processing software algorithms in an unmodified form from the cleared stand-alone post-processing version.

AI/ML Overview

The provided text describes the Siemens NAEOTOM Alpha CT Scanner System with software version SOMARIS/10 syngo CT VB10. While it details extensive non-clinical testing and verification/validation activities, it does not include acceptance criteria for specific AI/software performance metrics (e.g., sensitivity, specificity, accuracy) nor does it describe a comparative clinical study (MRMC or standalone AI performance) with human readers or clinical outcomes. The submission focuses on demonstrating substantial equivalence to predicate devices through engineering verification and validation of new and modified features, rather than a clinical performance study of an AI-powered diagnostic aid.

Therefore, many of the requested details regarding AI performance acceptance criteria and a study proving device performance in a clinical AI context are not present in the provided document. The document primarily describes the general engineering and regulatory testing performed for a CT system and its software updates.

However, I can extract information related to the non-clinical testing performed to support the modifications, as well as the types of ground truth used where applicable.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent:

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

The document defines "acceptance criteria" generally as part of the system validation tests (workflow and user manual tests, legal and regulatory tests) and system verification tests (system integration, functionality verification, image quality evaluation). For specific new/modified features, the acceptance criteria are generally qualitative or comparative relative to the predicate device, demonstrating comparability or improvement.

Feature/Non-clinical Supportive Testing	Acceptance Criteria (Implicit/Explicit)	Reported Device Performance and Conclusion
FAST 3D Camera / FAST Integrated Workflow	Accuracy of sub-features (FAST Isocentering, FAST Range, FAST Direction) should be comparable to the predicate device with syngo CT VA50.	"The FAST Isocentering accuracy of the subject device with syngo CT VB10 is comparable to the predicate device with syngo CT VA50, regardless of the camera mounting position." "For the FAST Range feature, the detection accuracy of all body region boundaries is comparable between the subject device with syngo CT VB10 and predicate device with syngo CT VA50." "The FAST Direction pose detection results are of comparable accuracy for subject and predicate device, regardless of the camera mounting position." "Overall, the SOMARIS/10 syngo CT VB10 delivers comparable accuracy to the SOMARIS/10 syngo CT VA50 predicate for the new FAST 3D Camera hardware."
Multi-Purpose Table (Vitus)	Provides sufficient freedom of movement for a mobile C-arm X-ray system to be used for clinical routine without any significant limitations for my needle Laser or 3D Camera.	"Based on the test results it can be concluded that a CT scanner, equipped with a Multi-Purpose (Vitus) Patient Table, which is installed with enhanced distance (674 mm) to the CT gantry and offers the iCT mode functionality, provides sufficient freedom of movement for a mobile C-arm X-ray system to be used for clinical routine without any significant limitations for my needle Laser or 3D Camera."
ZeeFree (Cardiac Stack Artefact Correction)	1. Reduction of stack misalignment artifacts (discontinuities in vessel structures, anatomical steps, doubling of anatomy). 2. No new artifacts introduced. 3. Equivalent image quality in quantitative standard physics phantom-based measurements (noise, homogeneity, high-contrast resolution, slice thickness, CNR) compared to non-corrected standard reconstruction. 4. Equivalent image quality in quantitative and qualitative phantom-based measurements with respect to metal objects. 5. Algorithm can be successfully applied to phantom data from motion phantom.	"If misalignment artefacts are identified in non-corrected standard ECG-gated reconstructed sequence or spiral images, the feature 'Cardiac Stack Artefact Correction' (SAC, marketing name: ZeeFree) enables optional stack artefact corrected images, which reduce the number of alignment artefacts." "The SAC reconstruction does not introduce new artefacts, which were previously not present in the non-corrected standard reconstruction." "The SAC reconstruction does realize equivalent image quality in quantitative standard physics phantom-based measurements (ACR, Gammex phantom) in terms of noise, homogeneity, high-contrast resolution, slice thickness and CNR compared to a non-corrected standard reconstruction." "The SAC reconstruction does realize equivalent image quality in quantitative and qualitative phantom-based measurements with respect to metal objects compared to a non-corrected standard reconstruction." "The SAC algorithm can be successfully applied to phantom data if derived from a suitable motion phantom demonstrating its correct technical function on the tested device."
myNeedle Guide (with myNeedle Detection)	1. Accuracy of automatic needle detection algorithm. 2. Reduction of necessary user interactions for navigating to a needle-oriented view.	"It has been shown that the algorithm was able to consistently detect needle-tips over a wide variety of scans in 90.76% of cases." "Further, the results of this bench test clearly shows that the auto needle detection functionality reduces the number of interactions steps needed to generate a needle-aligned view in the CT Intervention SW. Zero user interactions are required and a needle-aligned view is displayed right away after a new scan, if auto needle detection is switched on in the SW configuration."
Quantum Spectral Imaging	1. T3D reconstructions in Quantumpeak mode possible with sharpest available kernels. 2. Quantumpeak scan mode allows monoenergetic images from 40 to 190 keV. 3. Monoenergetic reconstructions free of artifacts. 4. Measured CT values precisely match reference values. 5. Accuracy of monoenergetic reconstructions in iodine and calcium inserts comparable or better than secondary predicate.	"The results showed that: with T3D reconstructions from Quantumpeak scan modes, high resolution images with sharp kernel up to Br98 are obtained. The resolution is comparable to other Highresolution scan modes of the NAEOTOM Alpha." "Monoenergetic reconstructions from Quantumpeak scan modes are free of artifacts. Measured CT values precisely match the reference values." "The accuracy of monoenergetic reconstructions in iodine and calcium inserts at the NAEOTOM Alpha is comparable or better than on the secondary predicate device SOMATOM Force."
Quantum HD Cardiac	Substantial equivalence in image quality (UHR and standard resolution spectral images) compared to single source spectral capable 120x0.2mm UHR scan mode.	"Based on the results it can be concluded that substantial equivalence in image quality is achieved by the images derived from the spectral capable cardiac acquisition mode 96x0.2mm for both, the high-resolution UHR and the standard resolution spectral image cases, compared to the single source spectral capable 120x0.2mm UHR scan mode."
HD FoV (High Definition Field of View)	HU accuracy in extended field of view region.	"In the phantom study, an HU value accuracy of about +/- 40 HU was achieved with skin-line accuracy of about +/- 3 mm." "HD FoV enables the reconstruction of images while significantly improving the visualization of anatomy in the regions outside the scan field of view of 50 cm."

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

Sample Size: Not specified in terms of patient counts for clinical validation, as this document focuses on non-clinical (phantom and bench) testing. For the "myNeedle Guide" feature, it states "a wide variety of scans" were used, and the success rate was "90.76% of cases" but doesn't quantify the number of cases. Phantom studies are mentioned for other features without specific numbers of scans/readings.
Data Provenance: The testing described is non-clinical (phantom, bench, and system integration/verification testing). There is no mention of human patient data or its country of origin. The manufacturing site is Siemens Healthcare GmbH in Forchheim, Germany, implying the testing likely occurred there.
Retrospective or Prospective: Not applicable as it's non-clinical 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)

Number of Experts: Not specified.
Qualifications of Experts: Not specified.
Role of Experts: For the non-clinical tests, "ground truth" generally refers to the known physical properties of the phantoms or the expected performance based on engineering specifications. Human experts are mentioned as trained staff who would use the device, but not as part of a formal ground truth establishment process for the performance studies presented.

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

Adjudication Method: Not applicable, as no multi-reader human-based test set or clinical study is described. The assessment of performance is based on measurements from phantoms and internal engineering verification.

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

MRMC Study: No MRMC comparative effectiveness study is mentioned. The document focuses on demonstrating that new/modified features of the CT system are comparable to or improve upon the predicate device through non-clinical testing. The device is a CT system, not an AI-powered diagnostic assist that would typically be evaluated with MRMC. The "myNeedle Detection" feature is a software algorithm within the CT system to aid in procedures, but its evaluation is described as a bench test of its detection accuracy and reduction of user interaction steps, not an MRMC study.

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

Standalone Performance: The performance data provided is for the CT system and its integrated software features, including algorithms like ZeeFree and myNeedle Detection. The "algorithm only" performance is implicitly covered in the bench testing of these features (e.g., myNeedle Detection achieving 90.76% detection accuracy). However, this is not presented as a "standalone AI" product in the sense of a distinct AI diagnostic algorithm being submitted for clearance. It's an integrated feature of the CT system.

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

Type of Ground Truth: For the non-clinical tests described, the ground truth is primarily based on:
- Known physical properties of phantoms: Used for evaluating image quality metrics (noise, homogeneity, resolution, CNR, HU accuracy, etc.) and quantitative measurements.
- Engineering specifications and expected functional behavior: For features like FAST 3D Camera accuracy and Multi-Purpose Table movement.
- Reference values: For monoenergetic reconstructions in Quantum Spectral Imaging.
- Manual verification/observation: For testing user interaction steps in myNeedle Guide.

8. The sample size for the training set

Training Set Sample Size: Not specified. The document does not describe the development or training of AI models. It focuses on the verification and validation of specific software features within the CT system.

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

Training Set Ground Truth Establishment: Not specified, as no training set or AI model development is described in this document.

Summary

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Image /page/0/Picture/0 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 28, 2024

Siemens Medical Solutions USA, Inc. % Tabitha Estes Regulatory Affairs Proffecional 810 Innovation Drive KNOXVILLE, TN 37932

Re: K233657

Trade/Device Name: NAEOTOM Alpha Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: February 22, 2024 Received: February 23, 2024

Dear Tabitha Estes:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K233657

Device Name

NAEOTOM Alpha

Indications for Use (Describe)

This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

The images delivered by the system can be used by a trained staff as an aid in diagnosis and treatment as well as for diagnostic and therapeutic interventions.

This CT system can be used for low dose lung cancer screening in high risk populations*.

As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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K233657

Image /page/3/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the text is a graphic of orange dots arranged in a circular pattern.

510(k) Summary for

NAEOTOM Alpha CT Scanner System

with software version SOMARIS/10 syngo CT VB10

Date Prepared: March 22, 2024

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.

l. Submitter

Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville, TN 37932 Establishment Registration Number: 1034973

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 -OR- Rittigfeld 1 D-91301 Forchheim, Germany Establishment Registration Number: 3004977335

Note: Descriptions in this submission use the short company name Siemens. Brand name on all products is Siemens Healthineers.

Submitter Contact Person: Tabitha Estes Regulatory Affairs Siemens Medical Solutions USA, Inc. (865) 804-4553 (work cell) tabitha.estes@Siemens-healthineers.com

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Image /page/4/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" are several orange dots arranged in a circular pattern.

II. Device Name and Classification

Product Name:	NAEOTOM Alpha
Trade Name:	NAEOTOM Alpha
Classification Name:	Computed Tomography X-ray System
Classification Panel:	Radiology
Regulation Number:	21 CFR §892.1750
Device Class:	Class II
Product Code:	JAK

III. Predicate Device

Primary Predicate Device:
Trade Name:	NAEOTOM Alpha, Scan&GO
510(k) Number:	K220814
Clearance Date:	July 12, 2022
Classification Name:	Computed Tomography X-ray System
Classification Panel:	Radiology
Regulation Number:	21 CFR §892.1750
Device Class:	Class II
Product Code:	JAK
Recall Information:	All predicate device recalls have been considered in the subjectdevice design.
Secondary Predicate Device:
Trade Name:	SOMATOM Force
510(k) Number:	K230421
Clearance Date:	June 16, 2023
Classification Name:	Computed Tomography X-ray System
Classification Panel:	Radiology
Regulation Number:	21 CFR §892.1750
Device Class:	Class II
Product Code:	JAK
Recall Information:	All predicate device recalls have been considered in the subjectdevice design.

Note: K230421 was a bundle submission with various Siemens CT Scanner Systems, including the dual source CT scanner systems SOMATOM Drive, SOMATOM Force, SOMATOM Definition Flash and the single source CT scanner CT systems SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open.

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Image /page/5/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" are a series of orange dots arranged in a circular pattern.

IV. Device Description

Siemens intends to market a new software version, SOMARIS/10 syngo CT VB10, for the Dual Source CT system NAEOTOM Alpha based on the SOMARIS/10 platform.

Only trained and qualified users, certified in accordance with country-specific regulations, are authorized to operate the system. For example, physicians, radiologists, or technologists. The user must have the necessary U.S. qualifications in order to diagnose or treat the patient with the use of the images delivered by the system.

Software version syngo CT VB10 (SOMARIS/10 syngo CT VB10) is a modified software version of the primary predicate device, syngo CT VA50 (SOMARIS/10 syngo CT VA50) cleared in K220814.

Software version SOMARIS/10 syngo CT VB10 will be offered ex-factory and as optional upgrade for the existing NAEOTOM Alpha systems.

The subject device NAEOTOM Alpha will support previously cleared software and hardware features in addition to the applicable modifications as described within this submission. The intended use and the indications for use remain unchanged compared to the predicate devices.

V. Indications for Use

This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

The images delivered by the system can be used by a trained staff as an aid in diagnosis and treatment as well as for diagnostic and therapeutic interventions.

This CT system can be used for low dose lung cancer screening in high risk populations*.

As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

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Image /page/6/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots.

VI. Indications for Use Comparison

Subject Device Indications for Use:

This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

The images delivered by the system can be used by a trained staff as an aid in diagnosis and treatment as well as for diagnostic and therapeutic interventions.

This CT system can be used for low dose lung cancer screening in high risk populations*.

As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

Primary Predicate Device Indications for Use:

This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

The images delivered by the system can be used by a trained staff as an aid in diagnosis and treatment as well as for diagnostic and therapeutic interventions.

This CT system can be used for low dose lung cancer screening in high risk populations*.

As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

Secondary Device Indications for Use:

This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment and radiation therapy planning as well as for diagnostic and therapeutic interventions.

This CT system can be used for low dose lung cancer screening in high risk populations.*

*As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

Comparison:

The subject device Indications for Use is the exact same as the primary predicate's Indications for Use (K220814), however it is slightly different than the secondary predicate's Indications for Use.
Compared to the secondary predicate device, the subject device does not contain the phrase "radiation therapy planning" in the sentence "The images delivered by the system can be used by a trained staff as an aid in diagnosis and treatment as well as for diagnostic and therapeutic interventions." because NAEOTOM Alpha does not support radiation therapy planning.

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Image /page/7/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a graphic of orange dots arranged in a circular pattern.

None of the intended uses include computed tomography as the principal means of guidance in invasive procedures (involving the introduction of a device, such as a needle or a catheter into the body of the patient).

The NAEOTOM Alpha is not the principal means of guidance, because the CT System does not guide the invasive procedures, the needle orientation and the needle advance, and handling is always done under the physicians control.

VII. Comparison of Technological Characteristics with the Predicate Device

Supported by the subject device, SOMARIS/10 syngo CT VB10 software version is a further development of the SOMARIS/10 syngo CT VA50 software version which is cleared in K220814.

The NAEOTOM Alpha with SOMARIS/10 syngo CT VB10 software version provides the same technological characteristics in terms of materials, energy source, and control mechanisms when compared to the predicate devices. The software features of NAEOTOM Alpha have been modified or improved in comparison to the predicate devices to support enhanced device functionality compared to the predicate devices.

The new syngo CT VB10 software reuses all unmodified software features of the legacy software syngo CT VA50 cleared in K220814. Additionally, no features present in the predicate device are descoped.

Software version SOMARIS/10 syngo CT VB10 is designed to reuse hardware independent extended functionalities and GO technologies provided by Siemens cleared software applications.

The intended use and fundamental scientific technology for the NAEOTOM Alpha remain unchanged from the predicate devices.

At a high level, the subject and predicate devices are based on the same subset of technological elements:

. Scanner Principle – Whole body X-Ray Computed Tomography Scanner
System Acquisition Continuously rotating tube detector system ●
Iterative Reconstruction – Support of various iterative reconstruction principles
Workplaces – Support of workplaces that include reconstruction and image evaluation software
Patient table
Patient table foot switch for movement
Tin filtration technology
Vectron X-ray Tube
Power Generator
Scan&GO
Mobile workflow (Tablet) ●
Optional injector arm
Optional support of CT guided intervention workflow (myNeedle Guide)
Optional support of FAST 3D Camera operation for fast patient positioning workflow
Scanner display and control functionality
Remote Scan Control
Long scan range

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Image /page/8/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a cluster of orange dots.

The subject device NAEOTOM Alpha with SOMARIS/10 syngo CT VB10 will support the modifications/further developments in comparison to the predicate devices as listed in the tables under subsections 1) Modified Hardware and 2) Modified Software below.

The configuration table and comparison table use the following terms to describe various technological characteristics in comparison to the primary and secondary predicate devices information:

Term	Definition
New	The feature is newly supported for Siemens CT Scanners and the subject device
Modified	This feature is a modified form of a feature cleared within the predicate devices
Enabled	This feature is currently supported by other cleared Siemens CT systems orcleared Siemens stand-alone software applications.

1) Modified Hardware

Table 2: Overview of hardware modifications of NAEOTOM Alpha supported by software version SOMARIS/10 syngo CT VB10 compared to the predicate/secondary devices.

	Hardware properties	NAEOTOM AlphaSOMARIS/10 syngo CT VB10(subject device)
1.	Tin Filtration	modified
2.	FAST 3D Camera	modified
3.	Multi-Purpose Table (Vitus)	modified

2) Modified Software (syngo CT VB10)

Table 3: Overview of software modifications of NAEOTOM Alpha supported by software version SOMARIS/10 syngo CT VB10 compared to the predicate/secondary devices.

	Software properties	NAEOTOM AlphaSOMARIS/10 syngo CT VB10(subject device)
1.	ZeeFree	new
2.	FAST Integrated Workflow	modified
3.	myNeedle Guide (with MyNeedle Detection)	modified
4.	myExam Companion – myExam Cockpit/myExamCompass	modified
5.	Recon&GO	modified

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Image /page/9/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern.

	Software properties	NAEOTOM AlphaSOMARIS/10 syngo CT VB10(subject device)
6.	CT View&GO	modified
7.	Scan&GO	enabled
8.	Quantum Spectral Imaging	modified
9.	Quantum HD Cardiac	modified
10.	HD FoV	enabled
11.	Multi-Threshold Acquisition	modified
12.	myExam Satellite (Remote Recon)	modified

A tabular summary of the comparable hardware and software properties between the subject device NAEOTOM Alpha with software version syngo CT VB10 and primary/secondary predicate device are listed in Table 4 and Table 5 below (modifications are in gray shaded sections).

Table 4: Technical hardware characteristics for the subject device NAEOTOM Alpha (software version SOMARIS/10 syngo CT
VB10) compared to the predicate devices.

Hardwareproperty	Subject device	Primary predicatedevice	Secondary predicatedevice
	NAEOTOM AlphaSOMARIS/10 syngo CTVB10	NAEOTOM AlphaSOMARIS/10 syngo CTVA50(K220814)	SOMATOM ForceSOMARIS/7 syngo CT VB30(K230421)
Scanner	whole body X-raycomputedtomography scanner	whole body X-raycomputedtomography scanner	whole body X-raycomputed tomographyscanner
Systemconfiguration	Dual Source	Dual Source	Dual Source
Environment ofUse	ProfessionalHealthcare Facility	ProfessionalHealthcare Facility	Professional HealthcareFacility
Generatormax. power (kW)	2x 120	2x 120	2x 120
Detectortechnology	QuantaMax	QuantaMax	UFC(Ultra Fast Ceramic)
Hardwareproperty	Subject device	Primary predicatedevice	Secondary predicatedevice
	NAEOTOM Alpha	NAEOTOM Alpha	SOMATOM Force
	SOMARIS/10 syngo CTVB10	SOMARIS/10 syngo CTVA50(K220814)	SOMARIS/7 syngo CT VB30(K230421)
	Direct Conversionwith "QuantumTechnology"	Direct Conversionwith "QuantumTechnology"
Detectorvolume coverage(mm)	2x 57.6	2x 57.6	2x 57.6
Detectorphysical rows	2x 288	2x 288	2x 96
Detectorslice width (mm)	0.2	0.2	0.6(optional: 0.4, 0.5)
Detector	2752 (A system)	2752 (A system)	920 (A system)
DAS channel no.	1984 (B system)	1984 (B system)	640 (B system)
Tubetechnology	VECTRON	VECTRON	VECTRON
TubekV steps	70, 90, 100, 120, 140,150(150 kV only availableon the smaller tube-detector system (Bsystem) and only incombination with theadditional Sn filter, 0.7mm)	70, 90, 100, 120, 140	70, 80, 90, 100, 110, 120,130, 140, 150
Tubemax. current(mA)	2x 1300	2x 1300	2x 1300
Tube	0.4 x 0.5/8°	0.4 x 0.5/8°	0.4 x 0.5/8°
tube focus (mm)	0.6 x 0.7/8°	0.6 x 0.7/8°	0.6 x 0.7/8°
	0.8 x 1.1/8°	0.8 x 1.1/8°	0.8 x 1.1/8°
Hardwareproperty	Subject device	Primary predicatedevice	Secondary predicatedevice
	NAEOTOM Alpha	NAEOTOM Alpha	SOMATOM Force
	SOMARIS/10 syngo CTVB10	SOMARIS/10 syngo CTVA50(K220814)	SOMARIS/7 syngo CT VB30(K230421)
	(for both tubes)	(for both tubes)	(for both tubes)
Tubeheat capacity	higher than 30 MHU	higher than 30 MHU	Higher than 30 MHU
Gantrybore size (cm)	82	82	78
GantryScan FoV (cm)	50	50	50
Gantryrotation time(sec)	0.25, 0.5, 1.0	0.25, 0.5, 1.0	0.25, 0.285, 0.325, 0.5,1.0(*optional)
GantryTilt (degree)	N/A	N/A	N/A
Maximumtemporalresolution in ECGgated ortriggeredexamination(ms)	mono-segment: 66bi-segment: 33	mono-segment: 66bi-segment: 33	mono-segment, standard:75mono-segment, optional:66bi-segment, standard: 38bi-segment, optional: 33
Maximum scanspeed at pitch(mm/s at pitch x)	737 mm/s at pitch 3.2	737 mm/s at pitch 3.2	737 mm/s at pitch 3.2
Patient TableType	Vario 2.DVitus	Vario 2.DVitus	PHS5MPT4
Max. Scan lengthTopogram (mm)	Vario 2.D: 2080Vitus: 2080	Vario 2.D: 2080Vitus: 2080	PHS5: 1970MPT4: 1970
Max. Scan length	Vario 2.D: 2000	Vario 2.D: 2000	PHS5: 1953
Hardwareproperty	Subject device	Primary predicatedevice	Secondary predicatedevice
	NAEOTOM AlphaSOMARIS/10 syngo CTVB10	NAEOTOM AlphaSOMARIS/10 syngo CTVA50(K220814)	SOMATOM ForceSOMARIS/7 syngo CT VB30(K230421)
Image acquisition(mm)	Vitus: 2000	Vitus: 2000	MPT4: 1953
Patient table	Vario 2.D: 307	Vario 2.D: 307	PHS5: 227
Max. weightcapacity (kg)	Vitus: 307 or 340	Vitus: 307	MPT4: 227 or 307 (withbariatric/trauma table top)
Patient tableInstallationoption	Regular installation(Vario 2.D and Vitus):474 mm	Regular installation(Vario 2.D and Vitus):474 mm	Regular installation (PHS5and MPT4):400 mm
	Installation optionwith extendeddistance (Vitus):674 mm (474 mm +200 mm)
Spectralfiltration	Tin Filter for bothtubes:0.4 mmadditional Tin Filterfor the smaller tube-detector system (Bsystem) only:0.7 mm	Tin Filter for bothtubes:0.4 mm	Tin Filter for both tubes:0.6 mm
FAST 3D Camerafor patientpositioning	option for patientpositioning with 3DCameraceiling mounted,modified design	option for patientpositioning with 3DCameraceiling mounted	option for patientpositioning with 3D Cameraceiling mounted
X-ray foot switch	Option to triggerhands-free scanning	Option to triggerhands-free scanning	Option to trigger hands-free scanning
Hardwareproperty	Subject device	Primary predicatedevice	Secondary predicatedevice
	NAEOTOM AlphaSOMARIS/10 syngo CTVB10	NAEOTOM AlphaSOMARIS/10 syngo CTVA50(K220814)	SOMATOM ForceSOMARIS/7 syngo CT VB30(K230421)
Table foot switch	Option for tablepatient movement	Option for tablepatient movement	N/A
Tablet dock forpatient table	Option for mountingof the tablet on thepatient table.	Option for mountingof the tablet on thepatient table.	N/A
InterventionalJoystick (IVJ)	Option to move thetable duringmyNeedle Guideprocedures in theexamination room.electrical connectionfor the tablet dockwhich allows chargingthe tablet whenmounted.	Option to move thetable duringmyNeedle Guideprocedures in theexamination room.electrical connectionfor the tablet dockwhich allows chargingthe tablet whenmounted.	i-control:option to operate some ofthe CT functions includingpatient table movement asan alternative to the gantryoperating panel and theinput units at the console.
Laser supportedworkflow	Laser in combinationwith FASTIsocentering visualizecoordinates forpatient isocenterposition;myNeedle Laservisualizes a plannedneedle path forinterventions	Laser in combinationwith FASTlsocentering visualizecoordinates forpatient isocenterposition;myNeedle Laservisualizes a plannedneedle path forinterventions	Laser in combination withFAST Isocentering visualizecoordinates for patientisocenter position;
Software property	Subject device	Primary predicatedevice	Secondary predicatedevice
	NAEOTOM AlphaSOMARIS/10 syngo CTVB10	NAEOTOM AlphaSOMARIS/10 syngo CTVA50(K220814)	SOMATOM ForceSOMARIS/7 syngo CTVB30(K230421)
Operating System	Windows basedSOMARIS/10 syngo CTVB10Note: the short versionsyngo CT VB10 is alsoused as labelinginformation	Windows basedSOMARIS/10 syngo CTVA50Note: the short versionsyngo CT VA50 is alsoused as labelinginformation	Windows basedSOMARIS/7 syngo CTVB30Note: the short versionsyngo CT VB30 is alsoused as labelinginformation
Workplace	syngo AcquisitionWorkplace (ICS) namedas "myExam Console"Image Reconstructionfor QuantumTechnology (IRS)2nd workplace optionnamed as "myExamSatellite" with RemoteRecon function	syngo AcquisitionWorkplace (ICS) namedas "myExam Console"Image Reconstructionfor QuantumTechnology (IRS)2nd workplace optionnamed as "myExamSatellite"	syngo AcquisitionWorkplace (AWP)Optional secondoperating system(Remote ReconWorkplace, RRWP)
Standard systemsoftware	• syngo Examination• syngo Viewing• syngo Filming• syngo Archiving &Network	• syngo Examination• syngo Viewing• syngo Filming• syngo Archiving &Network	• syngo Examination• syngo Viewing• syngo Filming• syngo Archiving &Network
Detectorfirmware	QuantaMax detectorfirmware supported	QuantaMax detectorfirmware supported	Stellar detectorfirmware supported
Teamplay	Support teamplayProtocols	Support teamplayProtocols	Support teamplayProtocols
Protocols	Support of:• Protocol supportingcontrast bolus-triggered dataacquisition	Support of:• Protocol supportingcontrast bolus-triggered dataacquisition	Support of:• Protocolssupporting contrastbolus-triggered dataacquisition
Software property	Subject device	Primary predicate device	Secondary predicate device
	NAEOTOM AlphaSOMARIS/10 syngo CTVB10	NAEOTOM AlphaSOMARIS/10 syngo CTVA50(K220814)	SOMATOM ForceSOMARIS/7 syngo CTVB30(K230421)
	Contrast media protocols (including coronary CTA) Pediatric Protocols Flex Dose Profile Turbo Flash Spiral Dual Energy acquisition Dynamic imaging (Flex 4D Spiral) Protocols supporting CT Intervention, Cardiac Scanning, Spectral imaging for child examination, Spectral imaging with high resolution Protocols for Quantum Imaging modes: Quantum Quantumplus Quantum HD (previously: Quantum High resolution) Quantum HD Cardiac (previously High resolution Dual Source Cardiac modes). In addition, a spectral image results from dual source 96x0.2mm ultra high-resolution mode can optionally be obtained	Contrast media protocols (including coronary CTA) Pediatric Protocols Flex Dose Profile Turbo Flash Spiral Dual Energy acquisition Dynamic imaging (Flex 4D Spiral) Protocols supporting CT Intervention, Cardiac Scanning, Spectral imaging for child examination, Spectral imaging with high resolution Protocols for Quantum Imaging modes: Quantum Quantumplus Quantum High resolution High resolution Dual Source Cardiac modes	Contrast media protocols (including coronary CTA) Pediatric Protocols Turbo Flash Spiral Dual Source Dual Energy protocols Adaptive 4D Spiral Protocols for Radiation Therapy Planning Dual Source Dual Energy protocols for Radiation Therapy Planning Protocols for CT intervention, Cardiac Scanning
Software property	Subject device	Primary predicate device	Secondary predicate device
	NAEOTOM Alpha	NAEOTOM Alpha	SOMATOM Force
	SOMARIS/10 syngo CT VB10	SOMARIS/10 syngo CT VA50	SOMARIS/7 syngo CT VB30
		(K220814)	(K230421)
	- Quantumpeak(Quantumpeak mode isidentical to the Dual SourceDual Energy modes atSOMATOM Dual Source Scannersin K230421
Advanced Reconstruction	Recon&GO:- Spectral Recon (DualEnergy Reconstructionfrom photon-countingdata) / including VirtualUnenhanced,Monoenergetic plus- Inline Results DE SPP(Spectral Post-Processing with photon-counting image data)- Inline Anatomicalranges (Parallel/Radial)incl. VirtualUnenhanced,Monoenergetic plus(already cleared withthe stand-alone medicaldevice syngo.via(K191040)- Inline Spine and RibRanges (already clearedwith the stand-alonemedical device syngo.CTApplications (syngo.CTBone Reading)K220450))	Recon&GO:- Spectral Recon (DualEnergy Reconstructionfrom photon-countingdata) / including VirtualUnenhanced,Monoenergetic plus- Inline Results DE SPP(Spectral Post-Processing withphoton-counting imagedata)	Advancedreconstruction toolssupported:The syngo acquisitionworkplace providesimage reconstructionand routinepostprocessing.
Software property	Subject device	Primary predicatedevice	Secondary predicatedevice
	NAEOTOM Alpha	NAEOTOM Alpha	SOMATOM Force
	SOMARIS/10 syngo CTVB10	SOMARIS/10 syngo CTVA50	SOMARIS/7 syngo CTVB30
		(K220814)	(K230421)
	- Inline table and boneremoval (alreadycleared with the stand-alone medical devicesyngo.CT ExtendedFunctionality (K221727))
Image viewing	CT View&GO offers:	CT View&GO offers:	syngo Viewing offers:
	- basic post-processingviewer (CT View&GO)	- basic post-processingviewer (CT View&GO)	- 2D and 3D (MPR, VRT,MIP and minIP)
	- 2D and 3D (MPR, VRT,MIP and minIP)	- 2D and 3D (MPR, VRT,MIP and minIP)	- Evaluation tools,Filming, Printing
	- Evaluation tools,Filming, Printing	- Evaluation tools,Filming, Printing
	- Interactive SpectralImaging (ISI)
	- Basic visualizationtools: Endoscopic View
	- Basic manipulationtools: DE ROI, ROI HUThreshold, Average
	- Automated table andbone removal(already cleared withthe stand-alone medicaldevice syngo.CTExtended Functionality(K221727))
Post-Processinginterface	• Recon&GO InlineResults:Software interface topost-processingalgorithms which areunmodified whenloaded onto the CT	• Recon&GO InlineResults:Software interface topost-processingalgorithms which areunmodified whenloaded onto the CT	syngo.via - Wide Rangeof individualapplications, syngo.viais a software solutionintended to be used forviewing, manipulation,communication, and
Software property	Subject device	Primary predicatedevice	Secondary predicatedevice
	NAEOTOM Alpha	NAEOTOM Alpha	SOMATOM Force
	SOMARIS/10 syngo CTVB10	SOMARIS/10 syngo CTVA50	SOMARIS/7 syngo CTVB30
		(K220814)	(K230421)
	cleared as medicaldevices in their ownright.• software interfacesfor post-processingfunctionalities toprovide advancedvisualization tools toprepare and processmedical images fordiagnostic purpose.Note: The clearance ofstandalone AdvancedVisualization Applicationsoftware is mandatoryprecondition.These advancedvisualization tools aredesigned to support thetechnician & physicianin the qualitative andquantitativemeasurement & analysisof clinical data acquiredand reconstructed byComputed Tomographyscanners. Additionalinformation regardingthe points of interfaceand inputs for thisfeature is provided inSection 16.	cleared as medicaldevices in their ownright.• software interfacesfor post-processingfunctionalities toprovide advancedvisualization tools toprepare and processmedical images fordiagnostic purpose.Note: The clearance ofstandalone AdvancedVisualizationApplication software ismandatoryprecondition.These advancedvisualization tools aredesigned to supportthe technician &physician in thequalitative andquantitativemeasurement &analysis of clinical dataacquired andreconstructed byComputed Tomographyscanners. Additionalinformation regardingthe points of interfaceand inputs for thisfeature is provided inSection 16.	images. It can be usedas a standalone deviceor together with avariety of cleared andunmodified syngobased softwareoptions.
Cybersecurity	IT Hardening	IT Hardening	IT Hardening
HD FoV	supported	N/A	supported
Software property	Subject device	Primary predicate device	Secondary predicate device
	NAEOTOM AlphaSOMARIS/10 syngo CT VB10	NAEOTOM AlphaSOMARIS/10 syngo CT VA50(K220814)	SOMATOM ForceSOMARIS/7 syngo CT VB30(K230421)
Standardtechnologies	FAST technologies CARE technologies GO technologies CARE keV	FAST technologies CARE technologies GO technologies CARE keV	FAST technologies CARE technologies
myExamCompanion –myExamCompass/myExamCockpit	myExam Compass collects information about the current patient to dynamically adapt the scan parameters or exchange recon jobs according to the patient's characteristics myExam Cockpit option of displaying, modifying, creating, and deleting Clinical Decision Trees (CDTs). myExam Compass functionality offers the possibility to activate/deactivate diagnostic scan ranges, Bolus Tracking and Test Bolus ranges. myExam Cockpit allows to define these new settings.	myExam Compass collects information about the current patient to dynamically adapt the scan parameters or exchange recon jobs according to the patient's characteristics myExam Cockpit option of displaying, modifying, creating, and deleting Clinical Decision Trees (CDTs).	N/A
Scan&GO	Scan&GOWith software version syngo CT VB10, the previously stand-alone Scan&GO software functionality is fully incorporated into the subject device CT scanner system. The	Scan&GO	N/A
Software property	Subject device	Primary predicate device	Secondary predicate device
	NAEOTOM AlphaSOMARIS/10 syngo CT VB10	NAEOTOM AlphaSOMARIS/10 syngo CT VA50(K220814)	SOMATOM ForceSOMARIS/7 syngo CT VB30(K230421)
	functionality remains unchanged.
Reconstruction Options for Cardiac Imaging	• Standard (renamed from “TrueStack ‘off’” on the primary predicate device)• TrueStack (renamed from “TrueStack ‘on’” on the primary predicate device)• ZeeFree allows the reconstruction of ECG-gated spiral or ECG-triggered sequence data in a cardiac cycle-to-cycle border aligned fashion	• TrueStack “off”• TrueStack “on”	• TrueStack “off”• TrueStack “on”
Iterative Reconstruction Methods	Quantum Iterative ReconstructioniMAR	Quantum Iterative ReconstructioniMAR	ADMIRESAFIREiMAR
Precision Matrix	Precision Matrix resolutionsupport image matrix sizes of:512 x 512 pixels768 x 768 pixels1024 x 1024 pixels	Precision Matrix resolutionsupport image matrix sizes of:512 x 512 pixels768 x 768 pixels1024 x 1024 pixels	Precision Matrix resolutionsupport image matrix sizes of:512 x 512 pixels768 x 768 pixels1024 x 1024 pixels
Multi-Threshold Acquisition			N/A
Software property	Subject device	Primary predicate device	Secondary predicate device
	NAEOTOM AlphaSOMARIS/10 syngo CT VB10	NAEOTOM AlphaSOMARIS/10 syngo CT VA50(K220814)	SOMATOM ForceSOMARIS/7 syngo CT VB30(K230421)
	acquisition, storage, and reconstruction of projection raw data of different energy thresholds (T1, T2, T3 and T4) projection raw data of the three higher energy thresholds (T2, T3, and T3) can be reconstructed by offline reconstruction tools or on the CT system	acquisition, storage, and reconstruction of projection raw data of different energy thresholds (T1, T2, T3 and T4) projection raw data of the three higher energy thresholds (T2, T3, and T3) are reconstructed by offline reconstruction tools.
myNeedle Guide	plan the needle path and perform control scans (i-Sequence, i-Spiral, i-Fluoro) myNeedle Detection algorithm (modification of the myNeedle Guide 3D software)	plan the needle path and perform control scans (i-Sequence, i-Spiral, i-Fluoro)	N/A
FAST 3D Camera with FAST Integrated Workflow	FAST Integrated Workflow including the sub-features FAST Range, FAST Isocentering and FAST DirectionFAST Range, FAST Isocentering and FAST Direction algorithms	FAST Integrated Workflow including the sub-features FAST Range, FAST Isocentering and FAST Direction	FAST Integrated Workflow including the sub-features FAST Range, FAST Isocentering and FAST Direction
Software property	Subject device	Primary predicatedevice	Secondary predicatedevice
	NAEOTOM AlphaSOMARIS/10 syngo CTVB10	NAEOTOM AlphaSOMARIS/10 syngo CTVA50(K220814)	SOMATOM ForceSOMARIS/7 syngo CTVB30(K230421)
	from the redesignedcamera.

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Table 5: Software characteristics for the subject device NAEOTOM Alpha (software version SOMARIS/10 syngo CT VB10) compared to the predicate devices.

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Any differences in technological characteristics do not raise different questions of safety and effectiveness. Testing and validation is completed. Test results show that the subject device, the NAEOTOM Alpha with syngo CT VB10, is comparable to the predicate devices in terms of technological characteristics and safety and effectiveness and therefore are substantially equivalent to the predicate devices.

VIII. Performance Data

Non-Clinical Testing

Non-clinical testing, (integration and functional) including phantom tests were conducted for the NAEOTOM Alpha during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.

The general purpose of each test is to verify and validate the functionality of the subject device modifications.

Testing will cover all related subsystems that contribute to the device modifications. Test levels are defined. For each test level several test activities are performed. The test specification and acceptance criteria are related to the corresponding requirements. Various test activities are performed to specific modifications on different test levels to ensure safe and effective integration in the system. Three test levels are defined:

System Validation test:

Acceptance test (workflow and user manual test)
. Legal and Regulatory test

System Verification test:

System Integration Test (functional)
. Functionality verification
. Image Quality (IQ) Evaluation

Tests are conducted for all software components developed in product development and for the complete product itself. Several activities are considered for this process, including creation of test specifications that relate to software/hardware requirements including tests to address risk mitigations that are identified, documented, and traced by hazard keys.

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Additional evaluation tests are performed as bench tests to support the new device or device modification on Non-Clinical Performance Testing as listed in Table 6 below.

Table 6: Non-clinical performance testing (bench testing).

Feature/Non-clinicalsupportive testing	Bench Testing performed
FAST 3D Camera /FAST IntegratedWorkflow	The bench test evaluates and compares the accuracy of the three sub-features FAST Isocentering, FAST Range, and FAST Direction to theaccuracy of the predicate device with syngo CT VA50 using the oldcamera hardware and the then only available ceiling mount.
	The objectives of the bench test are to demonstrate that the FAST 3DCamera feature of the subject device with SOMARIS/10 syngo CT VB10,where the algorithms have been optimized for a new camera hardwarein two mounting positions, achieves comparable results as the predicatedevice with syngo CT VA50.
	The FAST Isocentering accuracy of the subject device with syngo CT VB10is comparable to the predicate device with syngo CT VA50, regardless ofthe camera mounting position.
	For the FAST Range feature, the detection accuracy of all body regionboundaries is comparable between the subject device with syngo CTVB10 and predicate device with syngo CT VA50.
	The FAST Direction pose detection results are of comparable accuracy forsubject and predicate device, regardless of the camera mountingposition.
	Overall, the SOMARIS/10 syngo CT VB10 delivers comparable accuracy tothe SOMARIS/10 syngo CT VA50 predicate for the new FAST 3D Camerahardware.
	Multi-Purpose Table
The range of possible movement for the mobile C-arm in differentpositions between CT gantry and patient table was tested anddocumented by measurement of angles.
Based on the test results it can be concluded that a CT scanner, equippedwith a Multi-Purpose (Vitus) Patient Table, which is installed withenhanced distance (674 mm) to the CT gantry and offers the iCT modefunctionality, provides sufficient freedom of movement for a mobile C-arm X-ray system to be used for clinical routine without any significantlimitations for my needle Laser or 3D Camera.
ZeeFree	The bench tests evaluate the performance of ZeeFree reconstruction.
	The objectives of the tests are to demonstrate:
	•that the number of artefacts which can be attributed to a stackmisalignment (e.g. discontinuities in vessel structures,anatomical steps at air-soft-tissue interfaces, doubling of vessel
Feature/Non-clinicalsupportive testing	Bench Testing performed
	or other anatomy) and which are often caused by incomplete patient breath-hold can be reduced in a "Cardiac Stack Artefact Correction" (SAC) reconstruction compared to the standard reconstruction with otherwise matching reconstruction parameters.that no artefacts are introduced by a SAC reconstruction. The test results show: If misalignment artefacts are identified in non-corrected standard ECG-gated reconstructed sequence or spiral images, the feature "Cardiac Stack Artefact Correction" (SAC, marketing name: ZeeFree) enables optional stack artefact corrected images, which reduce the number of alignment artefacts. The SAC reconstruction does not introduce new artefacts, which were previously not present in the non-corrected standard reconstruction. The SAC reconstruction does realize equivalent image quality in quantitative standard physics phantom-based measurements (ACR, Gammex phantom) in terms of noise, homogeneity, high-contrast resolution, slice thickness and CNR compared to a non-corrected standard reconstruction. The SAC reconstruction does realize equivalent image quality in quantitative and qualitative phantom-based measurements with respect to metal objects compared to a non-corrected standard reconstruction. The SAC algorithm can be successfully applied to phantom data if derived from a suitable motion phantom demonstrating its correct technical function on the tested device. The SAC algorithm is independent from the physical detector width of the acquired data
myNeedle Guide(with myNeedleDetection)	Tests were performed to ensure clinical usability of the myNeedle Guide needle detection algorithm. Two individual tests were performed. The accuracy of the automatic needle detection algorithm was tested. The reduction of necessary user interactions for navigating to a needle-oriented view with and without the support of the automatic needle detection algorithm was analyzed.It has been shown that the algorithm was able to consistently detect needle-tips over a wide variety of scans in 90.76% of cases.Further, the results of this bench test clearly shows that the auto needle detection functionality reduces the number of interactions steps needed to generate a needle-aligned view in the CT Intervention SW. Zero user interactions are required and a needle-aligned view is displayed right away after a new scan, if auto needle detection is switched on in the SW
Feature/Non-clinicalsupportive testing	Bench Testing performed
	configuration. Therefore, the test is already passed if only a single userinteraction is necessary to achieve a needle-oriented view in the manualworkflow.
Quantum SpectralImaging	Tests were performed to demonstrate that:T3D reconstructions in Quantumpeak mode are possible with the sharpest available kernels up to Qr89, Br98, etc. Quantumpeak scan mode allows reconstructions of monoenergetic images at energy levels from 40 to 190 keV. The evaluation has been performed based on phantom studies.The results showed that: with T3D reconstructions from Quantumpeak scan modes, high resolution images with sharp kernel up to Br98 are obtained. The resolution is comparable to other Highresultra scan modes of the NAEOTOM Alpha. Monoenergetic reconstructions from Quantumpeak scan modes are free of artifacts. Measured CT values precisely match the reference values. The accuracy of monoenergetic reconstructions in iodine and calcium inserts at the NAEOTOM Alpha is comparable or better than on the secondary predicate device SOMATOM Force.
Quantum HD Cardiac	Quantitative assessment in terms of image noise and a visual assessmentof the image quality in ECG gated acquisitions between different scanmodes is performed: standard acquisition mode with spectral and non-spectral reconstruction, ultra-high resolution acquisition mode with non-spectral reconstruction (120x0.2 mm and 96x0.2 mm) and spectral imagereconstruction (limited to 96x0.2 mm).Based on the results it can be concluded that substantial equivalence inimage quality is achieved by the images derived from the spectralcapable cardiac acquisition mode 96x0.2mm for both, the high-resolution UHR and the standard resolution spectral image cases,compared to the single source spectral capable 120x0.2mm UHR scan mode.
HD FoV	Tests were performed to evaluate the performance of HD FoV onNAEOTOM Alpha.For this purpose, the HU accuracy in the extended field of view regionwas measured based on phantom studies. The phantom diameteraccuracy has been also evaluated.Based on the results it can be concluded that HD FoV enables thereconstruction of images while significantly improving the visualization
Feature/Non-clinicalsupportive testing	Bench Testing performed
	of anatomy in the regions outside the scan field of view of 50 cm. In thephantom study, an HU value accuracy of about $\pm$ 40 HU was achievedwith skin-line accuracy of about $\pm$ 3 mm.

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A list of recognized and general consensus standards considered for the subject devices is provided as Table 7 and Table 8 below.

Table 7: Recognized Consensus Standards.

Date of Entry	RecognitionNumber	StandardDevelopingOrganization	StandardDesignation Numberand Date	Title of Standard
12/19/2022	12-349	NEMA	PS 3.1 - 3.20 2022d	Digital Imaging andCommunications inMedicine (DICOM) Set
07/06/2020	12-325	NEMA	XR 25-2019	ComputedTomography DoseCheck
07/06/2020	12-330	NEMA	XR 28-2018	SupplementalRequirements forUser Information andSystem FunctionRelated to Dose in CT
12/23/2019	12-328	IEC	61223-3-5 Edition2.0 2019-09	Evaluation androutine testing inmedical imagingdepartments - Part 3-5: Acceptance testsand constancy tests -Imaging performanceof computedtomography X-rayequipment [Including:TechnicalCorrigendum 1(2006)]
03/14/2011	12-226	IEC	61223-2-6 SecondEdition 2006-11	Evaluation androutine testing inmedical imagingdepartments - Part 2-6: Constancy tests -Imaging performanceof computedtomography X-rayequipment
Date of Entry	RecognitionNumber	StandardDevelopingOrganization	StandardDesignation Numberand Date	Title of Standard
01/14/2014	12-269	IEC	60601-1-3 Edition2.1 2013-04	Medical electricalequipment - Part 1-3:General requirementsfor basic safety andessential performance- Collateral Standard:Radiation protectionin diagnostic X-rayequipment
06/27/2016	12-302	IEC	60601-2-44 Edition3.2: 2016	Medical electricalequipment - Part 2-44: Particularrequirements for thebasic safety andessential performanceof x-ray equipmentfor computedtomography
12/23/2019	5-125	ANSI AAMIISO	14971: 2019	Medical devices -Applications of riskmanagement tomedical devices
		ISO	14971 Third Edition2019-12	Medical devices -Application of riskmanagement tomedical devices
01/14/2019	13-79	ANSI AAMIIEC	62304:2006/A1:2016	Medical devicesoftware - Softwarelife cycle processes[IncludingAmendment 1 (2016)]
		IEC	62304 Edition 1.12015-06CONSOLIDATEDVERSION	Medical devicesoftware - Softwarelife cycle processes
07/09/2014	19-46	ANSI AAMI	ES60601-1:2005/(R)2012 &A1:2012,C1:2009/(R)2012 &A2:2010/(R)2012(Cons. Text) [Incl.AMD2:2021]	Medical electricalequipment - Part 1:General requirementsfor basic safety andessential performance(IEC 60601-1:2005,MOD) [IncludingAmendment 2 (2021)]
Date of Entry	RecognitionNumber	StandardDevelopingOrganization	StandardDesignation Numberand Date	Title of Standard
09/17/2018	19-36	ANSI AAMIIEC	60601-1-2:2014[Including AMD1:2021]	Medical electricalequipment - Part 1-2:General requirementsfor basic safety andessential performance- Collateral Standard:Electromagneticdisturbances -Requirements andtests
		IEC	60601-1-2 Edition4.1 2020-09CONSOLIDATEDVERSION	Medical electricalequipment - Part 1-2:General requirementsfor basic safety andessential performance- Collateral Standard:Electromagneticdisturbances -Requirements andtests
12/23/2016	5-129	ANSI AAMIIEC	62366-1:2015+AMD1:2020(Consolidated Text)	Medical devices Part1: Application ofusability engineeringto medical devices,including Amendment1
		IEC	62366-1 Edition 1.12020-06CONSOLIDATEDVERSION	Medical devices - Part1: Application ofusability engineeringto medical devices
07/09/2014	12-273	IEC	60825-1 Edition 2.02007-03	Safety of laserproducts - Part 1:Equipmentclassification, andrequirements
12/21/2020	5-132	IEC	60601-1-6 Edition3.2 2020-07CONSOLIDATEDVERSION	Medical electricalequipment - Part 1-6:General requirementsfor basic safety andessential performance- Collateral standard:Usability
Date of Entry	RecognitionNumber	StandardDevelopingOrganization	StandardDesignation Numberand Date	Title of Standard
12/23/2019	12-309	IEC	60601-2-28 Edition3.0 2017-06	Medical electricalequipment - Part 2-28: Particularrequirements for thebasic safety andessential performanceof X-ray tubeassemblies formedical diagnosis
12/20/2021	12-341	IEC	62563-1 Edition 1.22021-07CONSOLIDATEDVERSION	Medical electricalequipment - Medicalimage display systems- Part 1: Evaluationmethods

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Table 8: General Use Consensus Standards.

StandardDevelopingOrganization	Standard DesignationNumber and Date	Title of Standard	How was Standard Used
IEC	60601-1:2005+A1:2012+A2:2020	Medical electricalequipment - part 1:general requirementsfor basic safety andessential performance	ANSI AAMI ES60601-1:2005/(R)2012 &A1:2012,C1:2009/(R)2012 &A2:2010/(R)2012 (Cons.Text) [Incl. AMD2:2021]
IEC/ISO	17050-1	Conformity Assessment– Supplier's declarationof conformity – Part 1:General requirements	Declaration ofconformance to FDArecognized consensusstandards.
IEC/ISO	17050-2	Conformity assessment– Supplier's declarationof conformity - Part 2:Supportingdocumentation.	General consensusstandards not currentlyrecognized by FDA.

A list of applicable guidance documents considered for this submission is provided as Table 9 below. Table 9: FDA Guidance Document and Effective Date

FDA Guidance Document	Issue date
User Fees and Refunds for Premarket Notification Submissions (510(k)s	10/05/2022
Refuse to Accept Policy for 510(k)s	04/21/2022

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FDA Guidance Document	Issue date
Electronic Submission Template for Medical Device 510(k) Submissions	10/2/2023
Deciding When to Submit a 510(k) for a Change to an Existing Device	10/25/2017
The 510(k) Program: Evaluating Substantial Equivalence in PremarketNotifications [510(k)]	07/28/2014
Content of Premarket Submissions for Device Software Functions	06/14/2023
Off-The-Shelf Software Use in Medical Devices	09/27/2019
Applying Human Factors and Usability Engineering to Medical Devices	02/03/2016
Pediatric Information for X-ray Imaging Device Premarket Notifications	11/28/2017
Cybersecurity in Medical Devices: Quality System Considerations and Contentof Premarket Submissions	09/27/2023
Electromagnetic Compatibility (EMC) of Medical Devices	06/06/2022
Design Considerations and Pre-market Submission Recommendations forInteroperable Medical Devices	09/06/2017
Appropriate Use of Voluntary Consensus Standards in Premarket Submissionsfor Medical Devices	09/14/2018

Verification and Validation

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

Cybersecurity

Siemens conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient.

Wireless Coexistence Testing

Additionally, Siemens conforms to the requirements for Radio Frequency Wireless Technology as defined in FDA guidance document "Radio Frequency Wireless Technology in Medical Devices, Guidance for Industry and Food and Drug Administration Staff, issued on August 14, 2013" by adhering to the EMC and risk based verification and validation requirements in design, testing, and labeling of the wireless remote control components of the subject devices.

The Radio Frequency Wireless Technology of the optional Remote Scan Control and supporting Control Device iPad for Scan&GO complies to 47 CFR part 15 subpart c – Intentional Radiators. All Radio device labels will show an FCC ID code to show compliance. Shielding requirement applicable to the NAEOTOM Alpha and respective Scatter Radiation diagrams for typical room installations are provided in the User Documentation and Planning Guide of the intended Scanners in accordance with IEC60601-2-44.

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Siemens has considered several measures to address wireless coexistence by design to ensure the safe operation of the wireless components in combination with the applicable system supported functionality. Wireless technology in the system setup to perform a task in a given shared environment where other systems have an ability to perform their tasks and may or may not be using the same set of rules has been considered. According to FDA guidance 'Radio Frequency Wireless Technology in Medical Devices" Siemens has addressed the safety, effectiveness, and high likelihood of coexistence with other devices of this technology in our product design by our Risk Management Process, Failure Mode and Effects Analysis (FMEA) Process, and Requirement Engineering Process. As part of the risk management process, hazardous situations associated with the Scan&GO and its connection to the host system via Wi-Fi were addressed as part of the Risk Management process.

Testing for co-existence considered for following scenarios:

Co-Channel Testing
. Adjacent Channel Testing
. RF Interference Testing
Separation Distance/Location Testing

Scan&GO is designed to allow dynamic frequency selection and transmission power control by default in accordance with IEEE 802.11h. Adjacent channel testing is addressed by the fact that Scan&GO does not support shared medium access to Siemens Wi-Fi network. RF interference was tested by successfully ensuring that wireless communications were actively transmitting in situations where possible interference may exist. Recommended distance and router locations requirements are documented in the user documentation.

Summary

The features described in this premarket notification are supported with verification and validation testing, dosimetry and imaging performance, and analysis of phantom images to assess device and feature performance during product development. 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 claim of substantial equivalence.

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 system related risk analysis, which is used to identify potential hazards. These potential hazards are controlled during development, verification and validation testing according to the risk management process. In order to minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.

IX. Conclusions

The non-clinical data supports the safety of the device and the hardware and software verification and validation demonstrates that the NAEOTOM Alpha performs as intended in the specified use conditions. Verification and validation, clinical/patient and phantom testing were performed. The

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data included in this submission demonstrates that the NAEOTOM Alpha with described modifications performs comparably to the predicate devices currently marketed for the same intended use. The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate devices.

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.