The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro- intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients.

Device Description

The Cios Alpha mobile fluoroscopic C-arm X-ray System is designed for the surgical environment. The Cios Alpha provides comprehensive image acquisition modes. The system consists of two major components:
a) The C-arm with an X-ray source on one side and the flat panel detector on the opposite side. The c-arm can be angulated in both planes and lifted vertically, shifted to the side and moved forward/backward by an operator.
b) The second component is the image display station with a moveable trolley that holds the image processing and storage system, and the image display. Both components are connected to each other with a cable.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information provided in the document for the Cios Alpha (VA30) device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for quantitative performance metrics in a pass/fail format. Instead, it presents a comparison of the Subject Device's (Cios Alpha (VA30)) performance to its Predicate (Cios Alpha (VA10)) and Reference Devices for Solid State X-Ray Imaging (SSXI) specifications. The implication is that comparable or better performance is the acceptance criterion for the SSXI metrics.

SSXI Metric	Acceptance Criteria (Implied - Comparable or Better)	Reported Cios Alpha (VA30) Performance	Predicate Cios Alpha (VA10) Performance	Reference Ziehm Vision RFD Performance	Reference Ziehm Solo FD Performance
Imaging Modes	Pulsed fluoroscopy	Pulsed fluoroscopy	Pulsed fluoroscopy	Pulsed fluoroscopy	Pulsed Fluoroscopy, Digital Spot
DQE	Comparable or better than Predicate (76%) and Reference (70%)	75% (small), 72% (large)	76%	Information Not Available	70%
Dynamic Range	Comparable or better than Predicate (94dB) and Reference (Equivalent)	96dB	94dB	Information Not Available	Equivalent
Modulation Transfer Function (MTF)	Comparable or better than Predicate (55% at 1 Lp/mm) and Reference (4 Lp/mm)	60% at 1 lp/mm (small), 58% at 1 lpmm (large)	55% at 1 Lp/mm	Information Not Available	4lp/mm
Digitization Depth	16 bit	16 bit	16 bit	16 bit	16 bit
Pixel Pitch	Not explicitly stated as a target, but the change from 194μm (Predicate) to 152μm (Subject) is a technological characteristic shown as an improvement.	152 μm	194μm	194 μm	100 μm
Field of View	Matching the predicate and reference devices.	Small FD: 20x20, 15x15, 10x10; Large FD: 30x30, 20x20	Small FD: 20x20, 15x15, 10x10; Large FD: 30x30, 20x20	FPD 20 cm: 20, 15, 10	FPD 20 cm: 20, 15, 10

Additional Acceptance Criteria (General):

Compliance with voluntary standards (Table 3), FDA Guidance Documents (Table 4).
Software verification and validation meeting acceptance criteria.
Risk analysis completed and hazards mitigated.
Human Factors Usability Validation showing addressing human factors and successful clinical use tests.
Cybersecurity requirements met.

Study Proving Device Meets Acceptance Criteria:

The document describes several non-clinical performance tests and analyses to demonstrate that the Cios Alpha (VA30) meets the acceptance criteria, primarily for substantial equivalence to its predicate devices.

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

Test Set Sample Size: The document does not specify a distinct "test set" sample size in terms of patient data or number of images for evaluating the SSXI metrics. The performance evaluation seems to be based on engineering bench testing of device capabilities rather than a separate clinical image set.
Data Provenance: The data provenance for the SSXI metrics and other performance tests is non-clinical bench testing. The document states: "Performance tests were conduct[ed] to test the functionality of the Cios Alpha (VA30)." It also mentions "Additional engineering bench testing was performed including: the non-clinical testing identified in the guidance for submission of 510(k) s for Solid State X-Ray Imaging Devices (SSXI); demonstration of system performance; and an imaging performance evaluation."
- The "clinical images are not required" statement further confirms the non-clinical nature of the specific SSXI evaluation.
- The Human Factor Usability Validation mentions "clinical use tests with customer report and feedback form," which implies some level of prospective, real-world (or simulated real-world) interaction, but specific sample sizes are not provided.
- The origin of the data is Siemens Healthcare GmbH Corporate Testing Laboratory and internal verification/validation processes.

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

The document does not describe the use of experts to establish ground truth for a test set in the traditional sense of image interpretation for diagnostic accuracy. The testing primarily focuses on technical specifications of the imaging system itself.
For the Human Factors Usability Validation, "customer report and feedback form" are mentioned, implying input from users (healthcare professionals), but no specific number or detailed qualifications are provided.

4. Adjudication Method for the Test Set

Given that the primary performance evaluation described is non-clinical bench testing of engineering specifications (SSXI metrics), an adjudication method for a test set based on expert consensus would not be applicable or mentioned. The "ground truth" for these metrics is objectively measured device performance.

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 MRMC comparative effectiveness study is mentioned. This submission is for an imaging system (C-arm X-ray system), not an AI-powered diagnostic algorithm that assists human readers. While it includes "new software functions" like "Target Pointer," which "enables the automatic detection of K-wires and displays the trajectory," the document does not present a study evaluating the impact of this feature on human reader performance or diagnostic accuracy.

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

The document evaluates the Cios Alpha as an imaging system, not a standalone AI algorithm. While it contains new software features, the performance metrics discussed (e.g., DQE, MTF) are system-level imaging characteristics. The "Target Pointer" feature performs automatic detection, but its standalone performance (e.g., accuracy of K-wire detection) is not detailed in the provided text. The overall context is regulatory clearance for hardware and software modifications of an existing medical device, not a new AI-enabled diagnostic device undergoing standalone performance evaluation.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the SSXI performance metrics (DQE, Dynamic Range, MTF, etc.), the "ground truth" is based on objective physical measurements and technical standards. These are inherent properties of the imaging system's detector and processing.
For software functions, "ground truth" is established through detailed software testing to confirm they "worked as intended" according to specifications and requirements.
For Human Factors, ground truth would relate to usability and safety observations and feedback during "clinical use tests."

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This is expected as the submission primarily concerns an imaging system rather than a machine learning algorithm requiring a distinct training phase with annotated data. Although new software features are present, the submission focuses on their validation as part of the overall device.

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

Since no training set is discussed, the method for establishing its ground truth is also not applicable in this document.

Summary

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Siemens Medical Systems USA, Inc. Patricia Jones Sr. Regulatory Affairs Technical Specialist 40 Liberty Boulevard, 65-1A Malvern, Pennsylvania 19355

October 24, 2018

Re: K181560

Trade/Device Name: Cios Alpha Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, OXO Dated: June 12, 2018 Received: June 14, 2018

Dear Patricia 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Picture/7 description: The image shows the name "Michael D. O'hara -S" in a large font. To the right of the name is a digital signature block that includes information such as the date, time, and other details related to the digital signature. The date of the signature is 2018.10.24 at 07:53:42 -04'00'.

Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Traditional 510(k) Submission: Cios Alpha (VA30)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use	Form Approved: OMB No. 0910-0120
	Expiration Date: 06/30/2020
	See PRA Statement below.

510(k) Number (if known)	K181560
Device Name	Cios Alpha
Indications for Use (Describe)	The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro- intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients.
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."

FORM FDA 3881 (7/17)	Page 1 of 1
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Image /page/3/Picture/0 description: The image displays the Siemens Healthineers logo, with "SIEMENS" in teal and "Healthineers" in orange. To the right of the logo are orange dots arranged in a pattern. Below the logo, the text "510(k) Summary: Cios Alpha" is written in bold.

Siemens Medical Solutions USA, Inc. Company: 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Establishment Registration Number: 2240869

Date Prepared: October 2, 2018

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 Systems USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Establishment Registration Number: 2240869
  Location of Manufacturing Site/Manufacturer: SIEMENS AG Sector Healthcare Röntgenstrasse 19 - 21 D-95478 Kemnath, Germany Establishment Registration Number: 3002466018

2. Contact Person:

Ms. Patricia D Jones Technical Specialist, Regulatory Submissions Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Phone: (610) 448-6474 Email: patricia.d.jones@siemens-healthineers.com

3. Device Name and Classification:

Trade Name: Cios Alpha Classification Name: Image-intensified Fluoroscopic X-Ray

System

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

Radiology 21 CFR §892. 1650 Class II OWB, OXO

1. Legally Marketed Predicate Devices Trade Name: Cios Alpha 510(k) Clearance K132094 Clearance Date 03/11/2014

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Classification Name:	Image-intensified Fluoroscopic X-Ray
	System
Classification Panel:	Radiology
Regulation Number:	21 CFR §892.1650
Device Class:	Class II
Product Code:	OWB, OXO
Recall Information:	All product Recall incidents are considered
	during the Design Input phase of development
	to ensure the latest models will not be affected
	by any of the applicable issues.
Trade Name:	ARTIS pheno
510(k) Clearance	K163286
Clearance Date	03/09/2017
Classification Name:	Image-intensified Fluoroscopic X-Ray
	System
Classification Panel:	Radiology
Regulation Number	21 CFR §892.1650
Device Class:	Class II
Product Code:	OWB, JAA
Recall Information:	All product Recall incidents are considered
	during the Design Input phase of development
	to ensure the latest models will not be affected
	by any of the applicable issues.
Trade Name:	ARCADIS Avantic
510(k) Clearance	K051133
Clearance Date	03/09/2017
Classification Name:	Image-intensified Fluoroscopic X-Ray
	System
Regulation Number:	21 CFR §892.1650
Device Class:	Class II
Product Code:	OWB, JAA
Recall Information:	No recalls

5. Device Description:

a) The C-arm with an X-ray source on one side and the flat panel detector on the opposite side. The c-arm can be angulated in both planes and lifted vertically, shifted to the side and moved forward/backward by an operator.
b) The second component is the image display station with a moveable trolley that holds the image processing and storage system, and the image display. Both components are connected to each other with a cable.

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ineers

The main C-arm component is connected to the main power outlet and the trolley is connected to a data network.

The following modifications were made to the predicate device the Cios Alpha. Siemens Medical Solutions USA, Inc. submits this Traditional 510(k) to request clearance for the Subject Device the Cios Alpha (VA30) for the following device modifications made to the Predicate Device (Cios Alpha (VA10).

The following software and hardware modifications are included in the Subject Device, Cios Alpha (VA30):

A new system software version (VA30) contains new software and hardware features for a new flat panel detector; new features Target Pointer, Cios Open Apps and Digital Cine Mode.

In addition to software changes this submission contains the following new hardware features: a remote control unit mounted on the cart; an anti-microbial coating on the C-arm and trolley, a wireless footswitch and a proposed claims list.

The modified Subject Device Cios Alpha is within the same classification regulation with the same indication for use as the predicate devices.

6. Indications for Use:

The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients.

7. Substantial Equivalence:

The Cios Alpha (VA30) is substantially equivalent to the commercially available primary predicate device Siemens Cios Alpha (VA10), cleared 11/03/2014 with K132094.

Indication for use remains unchanged the technology is similar. The predicate Flat Panel detector (a-Si technology) has been replaced by a CMOS Flat Panel detector. X-ray generation and control used with the Cios Alpha is similar to the technology used with the primary predicate device Cios Alpha. Table 1 provides primary and secondary Predicate Device comparable information.

Predicate Device Name andManufacturer	510(k)Number	Clearance Date	Comparable Properties
Siemens : Cios AlphaProduct Codes: OWB, OXO	K132094	March 11, 2014	-Indications for Use

Table 1: Primary and Secondary Comparable Properties

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Predicate Device Name andManufacturer	510(k)Number	Clearance Date	Comparable Properties
Primary Predicate			-System for Image Acquisition- Post processing software-Detector
Siemens: ARTIS phenoProduct Codes: OWB, JAASecondary Predicate	K163286	March 09, 2017	-Anti-Microbial Coating-Anti-Microbial Coating Claims-Cleaning Instructions
Siemens : ARCADIS AvanticProduct Codes: OXOSecondary Predicate	K051133	June 01, 2005	-Digital Cine Mode (DCM)
Reference 510(k) Information
ZIEHM IMAGING GMBHReference 510(k): ZIEHMVision RFD Product Codes:OWB, OXO JAA	K132904	December 12, 2013	-Detector Information
ZIEHM IMAGING GMBHReference 510(k):Solo FD Mobile ImagingSystemProduct Codes:OWB, OXO JAA	K161976	October 6, 2016	-Detector Information

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

The Subject Device Cios Alpha (VA30) is substantially equivalent to the commercially available Siemens Cios Alpha (VA10), cleared 03/11/2014 with K132094 since the Indications for Use remains unchanged and technology and design of the Cios Alpha (VA30) is based on the Cios Alpha (VA10).

The predicate Flat Panel detector (a-Si technology) has been replaced by a CMOS Flat Panel detector and an optional available wireless footswitch is being introduced.

An anti-microbial coating is being added to the Cios Alpha (VA30) trolley. The anti-microbial coating and associated claims were cleared in the secondary Predicate Device the ARTIS pheno (K163286) on March 9, 2017.

A software function, Digital Cine Mode (DCM) the same function as the DCM Mode that was cleared in the secondary predicate device the ARCADIS Avantic (K051133) on June 1, 2005, was also added.

Table 2 below provides comparison of the Subject Device modification to the Predicate Devices.

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SIEMENS Healthineers

Comparison of Technological Characteristics Table 2:

Subject DeviceCios Alpha (VA30)Indications For Use Statement			Primary Predicate DeviceCios Alpha (VA10) K132094 Indications For Use Statement				ComparisonResults
The Cios Alpha is a mobile X-Ray systemdesigned to provide X-ray imaging of theanatomical structures of patient during clinicalapplications. Clinical applications may includebut are not limited to: interventionalfluoroscopic, gastro-intestinal, endoscopic,urologic, pain management, orthopedic,neurologic, vascular, cardiac, critical care andemergency room procedures. The patientpopulation may include pediatric patients.			The Cios Alpha is a mobile X-Ray systemdesigned to provide X-ray imaging of theanatomical structures of patient during clinicalapplications. Clinical applications may include butare not limited to: interventional fluoroscopic,gastro-intestinal, endoscopic, urologic, painmanagement, orthopedic, neurologic, vascular,cardiac, critical care and emergency roomprocedures. The patient population may includepediatric patients.				Same
Property	Subject DeviceCios Alpha(VA30)	PrimaryPredicateDeviceCios Alpha(VA10)K132094	SecondaryPredicateDeviceArtis PhenoK163286	SecondaryPredicateDeviceARCADISAvanticK051133	Comparison Results
1. SystemSoftware	New SoftwareVersion VA30	VersionVA10	N/A	N/A	VA30 was developed tosupport identifiedmodifications (a-d).Testing requirements areacceptable per Softwareand SSXI guidancerequirements.
	a) Two New FlatPanelDetectors NewDetectorXINEOS-3030HS andXINEOS2222HS(Software &Hardware)	a-Sitechnology	CSX-30DetectorCMOSTechnology	N/A	Equivalent image qualitydoes not raise any newissues of safety ofeffectiveness. Non-clinical testing wasconducted and isacceptable per SSXIGuidance Document
	b) Target Pointer(Software)Thisapplicationenables theautomaticdetection ofK-wires anddisplays thetrajectory asa projectionto theoppositeedge of theimage.Displayingthe trajectoryis intended tohelp thesurgeon tobetter predictthe positionof the K-wire	N/A	N/A	N/A	Testing requirements areacceptable per SoftwareGuidance, does not raiseany new issues of safetyof effectiveness.
Property	Subject DeviceCios Alpha(VA30)	PrimaryPredicateDeviceCios Alpha(VA10)K132094	SecondaryPredicateDeviceArtis PhenoK163286	SecondaryPredicateDeviceARCADISAvanticK051133	Comparison Results
		in an earlyphase of theinsertion.
		c) Cios OpenApps –(Hardware &Software)	N/A	N/A	N/A	Testing requirements areacceptable per SoftwareGuidance, does not raiseany new issues of safetyof effectiveness.
		d) Digital CineMode (DCM)(Software)			Softwarefunction DCMmode	Same functionality ascleared in the secondaryPredicate Device. Doesnot raise any new safetyor effectiveness issues
2.	RemotecontrolUnit	Remote controlunit available(unmodified); maybe mounted ontable oradditionally onremote control unitcart	Remotecontrol unitavailable; maybe mountedon patienttable	N/A	N/A	Does not raise any newsafety or effectivenessissues
3.	Additionalof OptionalAnti-MicrobialCoating	Optional Anti-Microbial Coating(C-arm & Trolley)w/ cleaninginstructions	N/A	Optional Anti-MicrobialCoating (C-arm & TableBase)	N/A	Same Coating andCleaning Instructionscleared in Artis pheno510(k) K163286
4.	Footswitch	Wired footswitch	Wiredfootswitch	N/A	N/A	Same
		Optional wirelessfootswitch	Wiredfootswitch	N/A	N/A	Optional wirelessfootswitch with samefunctionality like wiredfootswitch. Wirelessversion does not raiseany new safety oreffectiveness issues.
5.	Product Claims List: Product claims list along with supportive information.

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The subject device modifications do not alter the fundamental scientific technology from the 510(k) cleared primary predicate device Siemens Cios Alpha (VA10), K132094 and secondary predicate devices Siemens ARTIS pheno K163286 and Siemens ARCADIS Avantic K051133.

9. Non-Clinical Performance Testing :

The Cios Alpha is certified by Siemens Healthcare GmbH Corporate Testing Laboratory to comply with the following voluntary standards listed in Table 3 below:

Table 3: Conformance Standards

Standards Development Organization Standards Development Organization Reference Number and Date Reference Number and Date

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SIEMENS .::

Standards Development OrganizationReference Number and Date		Standards Development OrganizationReference Number and Date
1	AAMI ANSI ES60601-1:2005/(R)2012	7	IEC 60601-2-28:2010
2	AMI ANSI IEC 60601-1-2:2014	8	IEC 60601-2-43:2017(recognized 2010)
3	IEC 60601-1-3:2013	9	IEC 60601-2-54:2009/A1:2015
4	IEC 60601-1-6:2010/A1:2013	10	ISO 14971:2007
5	IEC 60825-1:2014(recognized: 2007)	11	IEC 62366-1:2015/Cor1:2016
6	IEC 62304:2015

Table 4: FDA Guidance Documents

FDA Guidance Documents and Effective Date
1.	Guidance for Industry and FDA Staff - User Fees and Refunds for PremarketNotification Submissions 510(k)Document issued on October 2, 2017
2.	Guidance for Industry and Food and Drug Administration Staff: Refuse to AcceptPolicy for 510(k)sDocument issued on January 30, 2018
3.	Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated510(k)s - Guidance for Industry and FDA StaffDocument issued on August 12, 2005
4.	Guidance for Industry and FDA Staff: Deciding when to submit a 510(k) for achange to an existing device.Document issued on October 25, 2017
5.	Guidance for Industry and Food and Drug Administration Staff: The 510(k)Program: Evaluating Substantial Equivalence in Premarket Notifications[510(k)]Document Issued on July 28, 2014
6	Guidance for Industry and FDA Staff: Guidance for the Submission Of 510(k)'sfor Solid State X-ray Imaging (SSXI) DevicesDocument issued on September 1, 2016
7.	Guidance for Industry and FDA Staff: Guidance for the Content of PremarketSubmission for Software in Medical DevicesDocument issued on May 11, 2005
8.	Guidance for Industry and FDA Staff: Guidance for Off-The-Shelf Software Usein Medical DevicesDocument issued on September 9, 1999
9.	Guidance for Industry and FDA Staff: Applying Human Factors and UsabilityEngineering to Medical Devices.Document issued February 3, 2016
10	Guidance for Industry and FDA Staff: Pediatric Information for X-ray ImagingDevice Premarket Notifications.Document issued on November 28, 2017
11.	Guidance for Industry and FDA Staff: Content of Premarket Submissions forManagement of Cybersecurity in Medical devices.Document issued on October 2, 2014
12.	Guidance for Industry and FDA Staff: Radio Frequency Wireless Technology

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Image /page/10/Picture/0 description: The image contains 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.

FDA Guidance Documents and Effective Date
in Medical DeviceDocument issued on August 14, 2007.
13.	Guidance for Industry and FDA Staff: Information to Support a Claim ofElectromagnetic Compatibility (EMC) of Electrically-Powered MedicalDevices

Document issued on July 11, 2016

Verification and validation:

Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 and "Off-The-Shelf Software Use in Medical Devices" 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 were conducted on the Subject Device Cios Alpha software version VA30 during product development.

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

The Cios Alpha software VA30 was tested and found to be safe and effective for intended users, uses and use environments through the design control verification and validation process. All new software functions present in the Subject Device (Cios Open-Apps, Target Pointer, and Digital Cine Mode) have been validated through detailed software testing and it was founded they worked as intended. The Human Factor Usability Validation showed that Human factors are addressed in the system test according to the operator's manual and in clinical use tests with customer report and feedback form. Customer employees are adequately trained in the use of this equipment.

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. Provided in this submission is a cybersecurity statement that considers IEC 80001-1:2010. The responsibility for compliance with IEC 80001-1-2010 is the hospital. Provided in the Software Section, is the required cybersecurity information.

Additional engineering bench testing was performed including: the non-clinical testing identified in the guidance for submission of 510(k) s for Solid State X-Ray Imaging Devices (SSXI); demonstration of system performance; and an imaging performance evaluation.

With regards to the flat panel detector (SSXI), the test documentation provided in this submission demonstrates compliance of the Cios Alpha to "Guidance for the

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SIEMENS Healthineers

Submission of 510(k)'s for Solid State X-ray Imaging Devices". The evaluation includes but is not limited to the following performance specifications identified in the SSXI guidance, showing comparable or better performance of the Cios Alpha to its predicate and referenced devices. Provided in Table 5 is comparative information showing the equivalence between the Subject and Predicate Device detectors.

		Table 5: SSXI Specifications
--	--	------------------------------

	Cios Alpha Performance compared to Predicate and Reference Devices
SSXI Metrics	Subject DeviceCios Alpha(VA30)	PredicateDevice CiosAlpha (VA10)K132094	ReferenceDeviceZiehm VisionRFDK132904	Reference DeviceZiehm Solo FDK161976
ImagingModes	Pulsedfluoroscopy	Pulsedfluoroscopy	PulsedFluoroscopy	Pulsed FluoroscopyDigital Spot
DQE	Single images75% (small)72% (large)	Single images76%	Digital SpotInformation NotAvailable	70%
DynamicRange	96dB	94dB	Information NotAvailable	Equivalent
ModulationTransferFunction(MTF)	60% at 1 lp/mm(small)58% at 1 lpmmlarge)	55% at 1 Lp/mm	Information NotAvailable	4lp/mm
Digitizationdepth	16 bit	16 bit	16 bit	16 bit
Pixel Pitch	152 μm	194μm	194 μm	100 μm
Field of View	Small FD:* 20 cm x 20 cm* 15 cm x 15 cm* 10 cm x 10 cmLarge FD:* 30 cm x 30 cm* 20 cm x 20 cm	Small FD:* 20 cm x 20 cm* 15 cm x 15 cm* 10 cm x 10 cmLarge FD:* 30 cm x 30 cm* 20 cm x 20 cm	FPD 20 cm:• 20 cm• 15 cm• 10 cm	FPD 20 cm:• 20 cm• 15 cm• 10 cm

Since Cios Alpha's' new flat panel detector does not change the system's intended use and was found to be equivalent in technological characteristics, with the predicate device after conducting the test in the SSXI Guidance, clinical images are not required.

Summary:

Performance tests were conduct to test the functionality of the Cios Alpha (VA30). Results of all conducted testing were found acceptable and do not raise any new issues of safety or effectiveness.

10. General Safety and Effectiveness Concerns:

Instructions for use are included in the device labeling section. The labeling information provided will enable the user to operate the device in a safe and

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

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 and mechanical 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.

11. Conclusion as to Substantial Equivalence:

The Predicate Devices were cleared based on non-clinical supportive information and clinical images and data. Similar non-clinical test results demonstrate that the Cios Alpha (VA30) acceptance criteria are adequate for the intended use of The comparison of technological characteristics, non-clinical the device. performance data and software validation demonstrates that the Subject Devices are as safe and effective when compared to the Predicate Devices that are currently marketed for the same intended use.

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.