Procedures that can be performed with the AXIOM Artis family include cardiac angiography, neuro-angiography, general angiography, operating room angiography, multipurpose angiography and radiographic/fluoroscopic procedures e.g. gastro-intestinal imaging, skeletal imaging etc.

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

The intended use and indications for use of the AXIOM Artis with wireless footswitch and with voice control as described in its labeling have not changed from its predicate device the AXIOM Artis Modular Angiographic System.

Device Description

The Wireless Footswitch uses RF technology in order to establish a short-range, low-power radio communication link between the footswitch (transmitter) and AXIOM Artis system (receiver). Additional hardware (independent of microcontroller) and Siemens own communication protocol layers will provide a safety-oriented signal transmission.

The Voice Control for the AXIOM Artis family allows for the control of selected functions by voice commands. The primary focus will be on image processing functions. Safety relevant functions such as X-ray release and movement control will not be included in the voice control functions.

Both Wireless Footswitch and Voice Control will be made available on the currently marketed Siemens AXIOM Artis family of products.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Siemens AXIOM Artis with Wireless Footswitch and Voice Control. This submission primarily focuses on establishing substantial equivalence to predicate devices for these new features rather than presenting a detailed clinical study with acceptance criteria and performance data for a diagnostic algorithm.

Therefore, much of the requested information (acceptance criteria table, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not available in the provided document, as it is generally not required for this type of submission.

Here's an analysis of the information that can be extracted or inferred from the document:

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

This information is not provided in the document. The submission is for a wireless footswitch and voice control system, which are input devices, not diagnostic algorithms with performance metrics like sensitivity, specificity, or accuracy. The "acceptance criteria" for such devices would typically relate to their functional reliability, safety (e.g., freedom from interference, proper signal transmission), and usability, rather than diagnostic performance. The document states:

"The Wireless Footswitch and Voice Control are designed for use with the commercially available AXIOM Artis Modular Angiographic systems."
"Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner."
"Several safety features including visual and audible warnings are incorporated into the system design."
"In addition the AXIOM Artis Modular Angiography System is continually monitored, and if an error occurs, the system functions will be blocked and an error message will be displayed."
"Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing."

These statements suggest that functional performance and safety were evaluated against internal specifications and recognized industry standards, but specific quantitative acceptance criteria and detailed performance results are not reported in this 510(k) summary.

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

This information is not provided and is not relevant for this type of device submission. There was no "test set" in the context of evaluating a diagnostic algorithm's performance on patient data.

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)

This information is not provided and is not relevant for this type of device submission. No ground truth was established for a diagnostic algorithm.

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

This information is not provided and is not relevant for this type of device submission. No adjudication method was used for a diagnostic algorithm.

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

This information is not provided and is not relevant for this type of device submission. The device is not an AI-assisted diagnostic tool; it is a wireless input system (footswitch and voice control).

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

This information is not provided and is not relevant for this type of device submission. The device is not an algorithm, and it explicitly describes a "human-in-the-loop" usage scenario (physician using footswitch and voice commands).

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

This information is not provided and is not relevant for this type of device submission.

8. The sample size for the training set

This information is not provided and is not relevant for this type of device submission. There was no "training set" in the context of machine learning for diagnostic purposes.

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

This information is not provided and is not relevant for this type of device submission.

Summary of what the document does provide regarding device evaluation:

The substantial equivalence determination for the Siemens AXIOM Artis with Wireless Footswitch and Voice Control is based on:

Comparison to Predicate Devices:
- Wireless Footswitch: Substantially equivalent to the Stryker Wireless footswitch (K033135).
- Voice Control: Substantially equivalent to the voice control used on the SIOS - Siemens Integrated Operation System (K994231) and the Philips iU22 Ultrasound System (K042540).
Safety Features:
- Uses RF technology for short-range, low-power communication with a safety-oriented signal transmission due to additional hardware and Siemens' proprietary communication protocol.
- Voice control is limited to image processing functions; "Safety relevant functions such as X-ray release and movement control will not be included in the voice control functions."
- Instructions for use, visual and audible warnings.
- System monitoring with blockage of functions and error messages if an error occurs.
- Adherence to recognized industry practices and final performance testing of all equipment.
Intended Use: The intended use and indications for use "have not changed from its predicate device," the AXIOM Artis Modular Angiographic System. This implies that the new features do not introduce new risks or indications that would require extensive new clinical validation studies.

In essence, the "study" proving the device meets criteria is primarily a comparative analysis demonstrating substantial equivalence in terms of technological characteristics and safety profiles to existing cleared devices, coupled with a declaration of internal safety and performance testing according to recognized standards. It's not a clinical performance study of a diagnostic AI.

Summary

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K052202

MAR 7 2006 510(K) SUMMARY FOR

SIEMENS AXIOM ARTIS

WIRELESS FOOTSWITCH AND VOICE CONTROL

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

August 1, 2005

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:

Mr. Gary Johnson Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions USA, Inc 51 Valley Stream Parkway E-50 Malvern, PA 19355-1406 Phone:(601) 448-1778 Fax: (610) 448-1787

2. Device Name and Classification

Product Name:	AXIOM Artis - Modular Angiographic System
Classification Name:	Angiographic X-ray System
Classification Panel:	Radiology
CFR Section:	21 CFR §892.1600
Device Class:	Class II
Product Code:	90 JAA (90 IZI with flat Panel Detector)

3. Intended Use:

AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures.

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

4. Device Description:

Both Wireless Footswitch and Voice Control will be made available on the currently marketed Siemens AXIOM Artis family of products.

ട്. Substantial Equivalence:

The Wireless Footswitch and Voice Control are designed for use with the commercially available AXIOM Artis Modular Angiographic systems.

The Siemens wireless footswitch is substantially equivalent to the Stryker Wireless footswitch, 510(k) K033135 with a clearance date of August 9, 2004.

Siemens Voice Control is substantially equivalent to the voice control used on the SIOS -Siemens Integrated Operation System discussed in 510(k) K994231 "cleared on August 10, 2000 and the Philips iU22 Ultrasound System, 510(k) W0425401 with a clearance date of October 04, 2004.

These systems will be incorporated for use with SIEMENS AXIOM Artis Modular Angiographic System cleared via 510(k), K010721 on March 30, 2001 and the SIEMENS AXIOM Artis with FD, 510(k) K021021 with a clearance date of June 6, 2002. The Indication for use of the AXIOM Artis does not change with the above-mentioned additions.

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Summary of Technological Characteristics of the Principal Device as compared with 6. the Predicate Device:

A Wireless Footswitch and a Voice Control will be made available for the AXIOM Artis family. Many of the components used in AXIOM Artis with the Wireless Footswitch and Voice Control are either commercially available with current Siemens systems or include minor modifications to existing components.

General Safety and Effectiveness Concerns: 7.

Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner. Several safety features including visual and audible warnings are incorporated into the system design. In addition the AXIOM Artis Modular Angiography System is continually monitored, and if an error occurs, the system functions will be blocked and an error message will be displayed.

Furthermore the operators are health care professionals familiar with and responsible for the X-ray examinations to be performed. To minimize electrical, mechanical and radiation hazards. Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing.

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Image /page/3/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle or bird with its wings spread, depicted in a simple, abstract design. The image is in black and white.

Public Health Service

MAR 7 2006 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Gary Johnson Technical Specialist, Regulatory Submissions Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway E-50 MALVERN PA 19355-1406

Re: K052202

Trade/Device Name: AXIOM Artis with Wireless Footswitch and Voice Control Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: II Product Code: IZI and JAA Dated: February 16, 2006 Received: February 17, 2006

Dear Mr. Johnson:

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.

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

Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device (o proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Nancy C. Bigelow

Nanev C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION 3 INDICATION FOR USE

510(k) Number (if known): KOS 2202____________________________________________________________________________________________________________________________________________________________________

AXIOM Artis with Wireless Footswitch and Voice Control Device Name:

AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures.

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

(Please do not write below this line - continue on another page if needed)

Concurrence of the CDRH, Office of Device Evaluation (ODE)

Prescription Use _

Over-The-Counter Use

(Per 21 CFR §801.109)

Nancy Brogdon

(Division Sian-Off Division of Reproductive, A bdominal and Radiological Devices 510(k) Number

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.