The SOMATOM P45 is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles. (*spiral planes: the axial planes resulting from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

Device Description

The Siemens SOMATOM P45 is a whole body X-ray Computed Tomography System, which features two continuously rotating tube-detector systems and functions according to the fan beam principle. The SOMATOM P45 produces CT images in DICOM format, which can be used by postprocessing applications commercially distributed by Siemens and other vendors. The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation. The new version of system software, SOMARIS/7 VA44, supports a Windows 7 operating system, additional scanning and evaluation techniques CARE (Combined Application to Reduce Exposure) and FAST (Fully Assisted Scanner Technology), and single click 3D reconstruction of Dual Energy Scans. The computer system delivered with the CT scanner is able to run the post processing applications optionally.

AI/ML Overview

Here's an analysis of the provided Siemens 510(k) submission for the SOMATOM P45 CT system, focusing on acceptance criteria and supporting studies:

This 510(k) submission is for a software update (SOMARIS/7 VA44) to an existing CT system (SOMATOM P45), not for a novel device. The primary argument for substantial equivalence relies on the fact that the changes are not significant in terms of materials, energy source, or technological characteristics compared to predicate devices. This means that extensive clinical studies with new acceptance criteria, as one might expect for a completely new AI algorithm or diagnostic device, are not detailed in this type of submission.

Therefore, many of the typical acceptance criteria and study details requested in your prompt (e.g., number of experts, adjudication methods, MRMC studies, standalone performance with novel AI) are not applicable to this specific 510(k) summary. The "acceptance criteria" here are primarily met through verification and validation of the software changes and phantom testing to ensure the updated system continues to perform as expected and safely.

Here's a breakdown based on your request, with an emphasis on what is and isn't present in this type of 510(k):

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a software update to an existing CT system, the "acceptance criteria" revolve around ensuring the updated system maintains the safety and effectiveness of the predicate device and that the new software functions correctly. The submission states:

Aspect	Acceptance Criteria (Implied / Stated)	Reported Device Performance (Summary)
Software Functionality	Meet all software specifications for SOMARIS/7 VA44.	"The testing results supports that all the software specifications have met the acceptance criteria."
Safety & Effectiveness (Overall System)	Maintain the safety and effectiveness profile of the predicate SOMATOM P45. Ensure no significant changes in materials, energy source, or technological characteristics affecting safety/performance.	"SOMATOM P45 configured with software version SOMARIS/7 VA44 does not have significant changes in materials, energy source, or technological characteristics when compared to the predicate devices. The intended use and fundamental scientific technology are similar to the predicate devices."
Risk Mitigation	All identified hazards are controlled; risk analysis completed.	"The risk analysis was completed and risk control implemented to mitigate identified hazards." (for identified risks associated with the modifications). "To minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards."
Compliance with Regulations	Compliance with all applicable regulatory standards and good manufacturing practices.	"Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence." (implied compliance with an overall regulatory framework).
New Features (CARE & FAST)	New features (CARE & FAST, single-click 3D reconstruction of Dual Energy Scans) operate as intended and safely.	The new software "supports ... CARE (Combined Application to Reduce Exposure) and FAST (Fully Assisted Scanner Technology), and single click 3D reconstruction of Dual Energy Scans." The overall verification/validation for the software covers these new features.

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

Sample Size: Not specified in terms of patient data. The testing mentioned is "non clinical tests" and "phantom testing." This suggests that the "test set" primarily consisted of:
- Software test cases for verification and validation.
- Physical phantoms for image quality and performance assessment.
Data Provenance: Not applicable in the context of clinical patient data for this submission. The tests are "non clinical" and involve "phantom testing" and internal "verification/validation." There's no mention of human subject data, country of origin, or retrospective/prospective clinical data for this specific 510(k) submission.

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

Not Applicable: This submission does not describe a clinical study requiring human expert assessment for ground truth. Verification and validation of CT system software and phantom performance typically rely on engineering specifications, physical measurements, and image quality metrics, not expert consensus on diagnostic interpretations of patient data.

4. Adjudication Method for the Test Set

Not Applicable: Since there's no expert-based ground truth establishment described for patient data, no adjudication method would be presented.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If so, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No, not specified and highly unlikely for this type of submission. This 510(k) is for a software update to an existing CT scanner, not a novel AI-driven diagnostic aid that would typically require an MRMC study to demonstrate clinical improvement. The new features (CARE, FAST, single-click 3D) are enhancements to existing CT capabilities, not AI for diagnostic interpretation.

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

Not Applicable for a novel diagnostic algorithm. The "algorithm" here refers to the CT system's operating software for image acquisition, reconstruction, and basic post-processing. Its performance is always "standalone" in the sense that the system itself generates the images, but it's not a standalone diagnostic algorithm in the way a CAD system would be. The focus is on the system's ability to produce images according to specifications, not on its isolated diagnostic performance.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Engineering Specifications and Physical Measurements: For the software, the "ground truth" is adherence to its predefined functional and performance specifications. For phantom testing, the "ground truth" would be expected physical measurements, known phantom properties, and established image quality metrics (e.g., spatial resolution, contrast-to-noise ratio, dose efficiency). There is no mention of expert consensus, pathology, or outcomes data, as those are typically relevant for diagnostic interpretation, which is not the focus of this particular 510(k) update.

8. The Sample Size for the Training Set

Not Applicable: This is not a machine learning or AI algorithm in the contemporary sense that requires a "training set" of data. It's an update to the operating software of a CT scanner. The software would have been developed and tested through traditional software engineering methods.

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

Not Applicable: As there's no "training set" in the context of machine learning, there's no ground truth established for one. The "ground truth" for software development would be its design specifications and requirements.

Summary

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SIEMENS

Special 510(k) Submission: SOMATOM Definition CT System

SEP 1 1

2012

510(K) SUMMARY FOR SOMATOM P45

Submitted by:

Siemens Medical Solutions USA, Inc.

51 Valley Stream Parkway

Malvern, PA 19355

Date Prepared: August 10, 2012

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

1. Contact Person:

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

2. Device Name and Classification

SOMATOM P45 Product Name: Propriety Trade Name: SOMATOM Definition Classification Name: Computed Tomography X-ray System Classification Panel: Radiology 21 CFR §892.1750 CFR Section: Device Class: Class II Product Code: 90JAK

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3. Substantial Equivalence:

SOMATOM P45 Computed Tomography Siemens X-ray systems. configured with software version SOMARIS/7 VA44 is substantially equivalent to the following medical devices in commercial distribution:

Predicate Device Name	FDA ClearanceNumber	FDA Clearance Date
Siemens SOMATOM P45	K052216	09/08/2005
Siemens SOMATOM DefinitionEdge	K120579	05/23/2012

4. Device Description:

The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation. The new version of system software, SOMARIS/7 VA44, supports a Windows 7 operating system, additional scanning and evaluation techniques CARE (Combined Application to Reduce Exposure) and FAST (Fully Assisted Scanner Technology), and single click 3D reconstruction of Dual Energy Scans. The computer system delivered with the CT scanner is able to run the post processing applications optionally.

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

SOMATOM P45 configured with software version SOMARIS/7 VA44 does not have significant changes in materials, energy source, or technological characteristics when compared to the predicate devices. The intended use and fundamental scientific technology are similar to the predicate devices;

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SIEMENS

therefore Siemens believes that they are substantially equivalent to the predicate devices.

6. Nonclinical Testing:

The modifications described in this premarket modification were supported with verification/validation as well as phantom testing. Non clinical tests are conducted for SOMATOM P45 configured with software version SOMARIS/7 VA 44 during product development. The risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results supports that all the software specifications have met the acceptance criteria.

Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence.

7. Indications for Use:

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

8. General Safety and Effectiveness Concerns:

The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device.

Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled during development, verification and validation testing. To minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of an eagle or bird-like figure, with three curved lines forming the body and wings. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Ms. Kimberly Mangum Technical Specialist, Regulatory Affairs Siemens Medical Systems, Inc. 51 Valley Stream Parkway MALVERN PA 19355

Re: K122471

Trade/Device Name: SOMATOM P45 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: August 10, 2012 Received: August 14, 2012

Dear Ms. Mangum:

We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your becaon of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the citerosule) to regarry manager date of the Medical Device American Comments, or to commerce prior to May 20, 1970, the chaoinen with the provisions of the Federal Food, Drug, devices may nave occh recuired in assess approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require apple of the general controls provisions of the Act. The r ou may, dicierore, market the act include requirements for annual registration, listing of general controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such If your device is classified (see above) into exass ff (Specifice (an be found in Title 21, additional controls. Dations (CFR), Parts 800 to 895. In addition, FDA may publish further Out of Peachar Regarning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please or advised that I DA s issuation of a state complies with other requirements of the Act that FDA has made a decemmanon that your contribution we rederal agencies. You must or any Federal statutes and regulations adminities, but not limited to: registration and listing (21)
comply with all the Act's requirements, including, but not limited to: r Comply with an the Act s requirements, and 809); medical device reporting (reporting of

SEP 11 2012

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice mouitements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirements as bet form in are qu your device as described in your Section 510(k) premarket while a to began mading of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 11 you dosire specific ad reserved In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket 5 150. Finds, prease note are of 97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the r ou may other other general and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: SOMATOM P45

Indications for Use:

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

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

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In vitro Diagnostic Device (OIVD)

Andrew D. Oja

of In Vitro Diagnostic Device

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.