ARTIS ONE by SIEMENS MEDICAL SOLUTIONS USA, INC.

Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

Procedures that can be performed with the Artis one include cardiac angiography, neuro-angiography, general angiography, rotational multipurpose bodv angiography, radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities.

Additional procedures that can be performed include angiography in the operating room, image guided surgery by x-ray, by image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions.

The Artis one can also support the acquisition of position triggered imaging for spatial data synthesis.

Device Description

Siemens Medical Solutions USA, Inc. intends to market an angiography x-ray system the Artis one Angiographic System, SW Version VA10. This 510(k) submission describes several modifications to the previously cleared predicate devices the Artis zee/ zeego K122644; Artis Q and Q.Zen- Modular Angiographic System K123529 and the X-LEONARDO Workstation K042995. The following modifications are made to the cleared predicate devices and developed into the Subject Device the Artis one:

1). A modified Flat Panel detector Trixell pixium 2630S; 2). A modified collimator MFD; 3). A modified x-ray tubes assembly MEGALIX Cat Plus 125/40/90-125GW; 4). A modified Software Version VA10; 5). A modified C-Arm stand; 6). A new patient table; 7). A modified imaging processing system; 8). A modified display; 9). Modified user Control Modules; 10). Integrated 3D imaging; 11). Proposed product claims associated with the above device modifications (see Section 13 Labeling).

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Artis one Angiographic System:

It's important to note that this 510(k) summary focuses on substantial equivalence to predicate devices rather than independent performance validation against specific acceptance criteria for a new medical AI device. The Artis one is an angiography system, not an AI algorithm in the contemporary sense of the request. Therefore, direct answers to several of your questions regarding AI-specific criteria, such as MRMC studies, standalone algorithm performance, and sample sizes for training/test sets of an AI, are not applicable or not explicitly stated in this document.

The document primarily details modifications to existing, cleared angiography systems and asserts their continued safety and effectiveness through comparison.

Acceptance Criteria and Reported Device Performance (Summary based on the provided text):

Since the device is an angiography system and not a new diagnostic AI, the "acceptance criteria" are framed around maintaining safety and effectiveness, and achieving diagnostic image quality comparable to predicate devices.

Acceptance Criteria Category	Reported Device Performance (Artis one)
Safety	- Conforms to IEC 60601-1-2, 60601-1-3, 60601-2-28, 60601-2-43, 60601-2-54, ISO 14971, AAMI ANSI ISO 10993-1. - Risk analysis completed, hazards mitigated. - No adverse effects or complications observed during studies. - Conforms to EMC/electrical safety standards.
Effectiveness / Performance	- "Image quality has been considered of diagnostic quality and adequate for guidance during interventional procedures" (from Clinical Use Test). - Software specifications met acceptance criteria (from software testing). - Functionally comparable to predicate devices.
Substantial Equivalence	- Indication for use is the same as predicate device (Artis zee/zeego K122644). - Technological characteristics are the same. - Post-processing and 3D imaging substantially equivalent to predicate systems.

Study Information Pertaining to the Artis one Angiographic System:

Sample sizes used for the test set and the data provenance:
- Test Set (Clinical Use Test): The document mentions "normal and obese adult patients" were part of a "Clinical Use Test," but does not specify the sample size (number of patients).
- Data Provenance: Not explicitly stated, but given Siemens Medical Solutions USA, Inc. is the importer/distributor in Malvern, PA, and the manufacturing site is in Shenzhen, China, the data's country of origin is not specified. The study was "retrospective" or "prospective" is also not stated. The test is described as a "Clinical Use Test," implying prospective collection for the purpose of the test.
- Bench Test (Concurrent Study): Phantom images were used for a "Concurrent Study" (bench test). No sample size (number of phantom images) specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided as the evaluation appears to be a general assessment of "diagnostic quality" by implied clinical users rather than a specific ground truth labeling task for an AI. The document states "the operators are health care professionals familiar with and responsible for the evaluating and post processing of X-ray images."
Adjudication method for the test set:
- Not explicitly stated. Given the nature of a "Clinical Use Test" for an angiography system, it's likely that a consensus of clinicians or their individual assessments during use determined diagnostic quality, but no formal adjudication method (like 2+1) is described.
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. This type of study is relevant for evaluating the impact of AI algorithms on human reader performance, which is not the focus of this 510(k) for an updated angiography system.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. The Artis one is an angiography system, not a standalone AI algorithm. Its performance is intrinsically tied to human operation and interpretation.
The type of ground truth used:
- For the "Clinical Use Test," the "ground truth" for effectiveness was the subjective assessment that "image quality has been considered of diagnostic quality and adequate for guidance during interventional procedures."
- For the "Concurrent Study" (bench test), it involved phantom images and likely objective measurements against expected performance parameters for an imaging system, not a diagnostic 'ground truth' in the clinical sense.
The sample size for the training set:
- Not applicable. This document describes a traditional medical device (angiography system) clearance, not the development of an AI algorithm that would typically have a distinct training set. The "software version VA10" was developed and tested, but no AI training set is mentioned.
How the ground truth for the training set was established:
- Not applicable. As no AI training set is described, there's no ground truth establishment method for it.

Summary

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K133580 APR 2 8 2014

510(k) Summary: Artis one

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

Date Prepared: March 25, 2014

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

1. General Information:

Importer / Distributor: Siemens Medical Solution USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355 Establishment Registration Number: 2240869

Manufacturing Site:

Siemens Shenzhen Magnetic Resonance Ltd. Siemens MRI Center, Gaoxin C. Ave., 2nd, Hi-Tech Industrial Park 518057 Shenzhen, China Establishment Registration Number: 3004754211

2. Contact Person:

Ms. Patricia D Jones Technical Specialist, Regulatory Submissions Siemens Medical Solutions USA, Inc., 51 Valley Stream Parkway Malvern, PA 19355 Fax: (610) 448-1787 Phone: (610) 448 -3536 Email: patricia.d.jones@siemens.com

Device Name and Classification: 3.

Trade Name:	Artis one Angiographic System
Classification Name:	Angiographic X-Ray System
	Image intensified fluoroscopic x-raysystem
Common Name:	Angiographic X-Ray System
Classification Panel:	Radiology
Classification Regulation:	21 CFR §892.1600
	21 CFR §892.1650
Device Class:	Class II
Product Code	OWB. JAA. IZI

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Legally Marketed Predicate Devices 4. Trade Name:
510(k) Clearance: Clearance Date: Classification Name:

Classification Panel: CFR Section: Device Class: Product Code:

Trade Name:

510(k) Clearance: Clearance Date: Classification Name:

Classification Panel: Classification Regulation:

Device Class: Product Code:

Trade Name: 510(k) Clearance: Clearance Date: Classification Name:

Classification Panel: Classification Requlation: Device Class: Product Code:

Artis zee/ zeego with CSX-10 Detector SW VC21 K122644 May 20, 2013 Image intensified fluoroscopic x-ray system Radiology 21 CFR §892.1600 Class II OWB

Artis Q and Q.zen - Modular Angiographic System K123529 February 26, 2013 Angiographic X-Ray System Image intensified fluoroscopic x-ray svstem Radiology 21 CFR §892.1600 21 CFR §892.1650 Class II OWB, JAA, IZI

X-LEONARDO Workstation K042995 November 24, 2004 Picture archiving and communications svstem Radiology 21 CFR 8892.2050 Class II LLZ

5. Device Description:

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8). A modified display; 9). Modified user Control Modules; 10). Integrated 3D imaging; 11). Proposed product claims associated with the above device modifications (see Section 13 Labeling).

6. Indication for Use:

Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

The Artis one can also support the acquisition of position triggered imaging for spatial data synthesis.

7. Substantial Equivalence:

The Artis one Angiography System is substantially equivalent to the commerically available Siemens' Artis zee/ zeego with CSX-10 Detector SW VC21( K122644) angiographic x-ray system with same indication for use for single plane x-ray systems and similar components. The Artis one contains a similar post processing (AXIS Imaging system SW Version VA10); Clear and Care dose reduction features and similar product labeling claims as cleared in the Artis Q and Zen- Modular Angiographic System 510(k) (K123529). The Artis one also produces 3D imaging similar to the cleared X-LEONARDO Workstation 510(k) (K042995). Provided in Table 1 is a list of all predicate devices for the subject device the Artis one.

Predicate Device Nameand Manufacturer	510(k)Number	ClearanceDate	Comparable Properties
Artis zee/ zeego with CSX-10 Detector SW VC21	K122644	05/20/2013	• Indication for use• Hardware components
Artis Q and Q.zen- ModularAngiographic System	K123529	02/26/2013	• Post processing(AXIS Imaging System)• Clear and Care features• Product Labeling Claims
X-LEONARDO Workstation	K042995	11/24/2004	• 3D imaging

Table 1 List of the predicate devices

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

Artis one Angiography System is designed as a set of components (C-arm, Xray tube and housing, flat detector, digital imaging system, collimator, generator etc.) that are configured to provide specialized angiography systems. These components are further development of the predicate ones and include minor modifications to existing components.

Discussion:

The components of the subject device have the same technological characteristics as the ones from the predicate device. The technological characteristics do not differ from the predicate systems.

Many comparable parameters remain the same, some differ slightly as shown in the comparison tables (indicated as "similar").

Testing and validation have been completed. A "Concurrent Study" (bench test) as well a Clinical Use Test have been performed on normal and obese adult patients. The image quality has been considered of diagnostic quality and adequate for guidance during interventional procedures. During these studies no adverse effects or complications have been observed and therefore the device is considered safe and effective.

The tests did show that the subject device Artis one with all its components is comparable to the predicate ones and therefore substantial equivalent to the predicate device.

The subject device Àrtis one does not affect the indication for use nor the intended use of the device nor does it alter its fundamental scientific technology from the 510(k) cleared predicate device Artis zee/ zeego K122644.

Non- Clinical Performance Testing 9.

Non-clinical tests were conducted for the Artis one configured with software version VA10 during product development. The modifications described in this Premarket Notification were supported with verification/validation testing and a concurrence study was performed with phantom images.

Siemens claims conformance to a signed statement of conformance to performance standards as follows: IEC 60601-1-2; IEC 60601-1-3; IEC 60601-2-28; IEC 60601-2-43; IEC 60601-2-54; NEMA PS 3.1 - 3.20; ISO 14971; AAMI ANSI ISO 10993-1.

Software documentation for a Major Level of Concern per FDA's Guidance Document "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests (integration and functional) were conducted on the Artis one software during product development.

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The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results supports that all 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.

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

Clinical testing was not applicable as the Artis one has no new indication for use nor new clinical applications were introduced to the system.

General Safety and Effectiveness Concerns: 10.

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.

Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing. To minimize electrical, mechanical and radiation hazards, Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing. Furthermore the operators are health care professionals familiar with and responsible for the evaluating and post processing of X-ray images.

Conclusion as to Substantial Equivalence: 11.

The Artis one Angiography System has the same indication for use as the predicate device Artis zee floor from the Artis zee / zeego family K122644.

The components of the subject device have the same technological characteristics as the ones from the predicate device. The technological characteristics do not differ from the predicate systems.

Testing and validation have been completed. A "Concurrent Study" (bench test) as well a Clinical Use Test did show that the subject device Artis one with all its components is comparable to the predicate ones and therefore substantial equivalent to the predicate device.

The Artis one Angiography System with SW VA10 is substantially equivalent to the commercially available Artis zee/zeego K122644 with all its components as described in the Device Description.

The CARE and CLEAR features are substantially equivalent to the commercially available Artis Q and Artis Q.zen Modular Angiography System

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K123529. Postprocessing and 3D Imaging is substantially equivalent to the commercially available X-LEONARDO Workstation K042995.

It is Siemens opinion, that the Artis one Angiography System is substantially equivalent to the listed predicate devices in Table 1.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

April 28, 2014

Siemens Medical Solutions USA, Inc. Patricia Jones 51 Valley Stream Pkwy. Malvern, PA 19355 US

Re: K133580

Trade/Device Name: Artis one Regulation Number: 21 CFR 892.1650 Regulation Name: Interventional Fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, JAA Dated: March 21, 2014 Received: March 26, 2014

Dear Ms. Jones:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. 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.

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Please be advised that I DA'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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also. please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Sm.h.7)

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K133580

Device Name Artis One .

Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

Procedures that can be performed with the Artis one include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whold body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities.

Additional procedures that can be performed include angiography in the operating room, image guided surgery by X-ray, by image fusion, and by navigation systems. The examination able as an integrated part of the system can be used for Xray imaging, surgery and interventions.

The Artis one can also support the acquisition of position triggered imaging for spatial data systhesis.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Smh.P.

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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.