• Vascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis,

· Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiclogy (EP).

· Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures,

Combined with a qualified, compatible OR table, the Allura Xper FD OR Table series can be used for imaging in the Hybrid OR within the applications domains Neuro, Vascular, Non Vascular and Cardiac. The OR table can also be used standalone for surgical use in the OR.

Device Description

The Allura Xper FD OR Table series is a modular X-ray systems series, based on a set of components that can be combined into different single and biglane configurations to provide specialized anglography. It is identical to the Allura Xper FD systems series, to which a qualified, compatible OR table component is added.

These Allura Xper FD OR Table series X-ray systems are Angiographic X-ray Systems consisting of 1 or more of the following components: X-ray generator, X-ray tubelhousing assembly, beam limiting device, image receptor. X-ray control, frontal/lateral stand, patient support and a monitor ceiling suspension.

AI/ML Overview

The provided text describes a 510(k) submission for the Philips Allura Xper FD OR Table series, an angiographic X-ray system. However, it does not include detailed acceptance criteria or a specific study proving the device meets those criteria in terms of algorithm performance or clinical effectiveness beyond general safety and equivalence to predicate devices.

The document focuses on non-clinical verification and validation testing to ensure the system functions according to specifications and risk management requirements, aligning with various IEC and ISO standards. It explicitly states: "No clinical performance test was required to show safety and effectiveness of the Allura Xper FD OR Table series in the intended clinical environment." This means there is no study described here that would provide the kind of performance metrics you've requested (e.g., accuracy, sensitivity, specificity, or human reader improvement with AI assistance).

Therefore, I cannot provide the specific information requested in your prompt regarding acceptance criteria and performance data for an AI/algorithm-based device, as this document is for an X-ray system hardware and software system and not an AI-powered diagnostic algorithm.

Here's a breakdown of what can be extracted or inferred from the provided text, and where information is missing:

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

Acceptance Criteria (Inferred from standards compliance and substantial equivalence claim):
- Compliance with IEC 60601-1 (general safety), IEC 60601-1-1 (medical electrical systems safety), IEC 60601-1-2 (EMC), IEC 60601-1-3 (radiation protection), IEC 60601-1-4 (programmable electronic systems), IEC 60601-2-7 (high voltage generators safety), IEC 60601-2-28 (X-ray source assemblies safety), IEC 60601-2-32 (associated equipment safety), IEC 60601-2-43 (interventional procedures X-ray safety).
- Compliance with IEC 62304 (medical device software life cycle processes).
- Compliance with IEC 62366 (usability engineering).
- Compliance with ISO 14971 (risk management).
- Functional verification and validation for intended use relative to internal specifications.
- Substantial equivalence in safety and effectiveness to predicate devices (Philips Integris Allura series, Philips Allura Xper FD10, Philips Allura Xper FD20, Siemens Axiom Artis, Siemens Artis Zee family, Siemens Artis Zee / Zeego family).
Reported Device Performance: The document states, "Results of the conducted tests conclude that the Allura Xper OR Table series is substantial equivalent to its predicate device." No specific performance metrics (e.g., image quality measurements, diagnostic accuracy) are provided in this summary.

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

Not applicable for a clinical performance study. The document states, "No clinical performance test was required." The "test set" for the non-clinical verification and validation would refer to technical test cases and scenarios, not 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)

Not applicable. No clinical ground truth was established as no clinical performance study was conducted or required.

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

Not applicable. No clinical test set requiring adjudication was used.

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, an MRMC comparative effectiveness study was not done. The device itself is an X-ray imaging system, not an AI-powered diagnostic tool intended to assist human readers in interpreting images.

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

Not applicable. The device is an integral X-ray system, not a standalone algorithm.

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

Not applicable. No clinical ground truth was established or used for the purpose of a performance study. For non-clinical tests, ground truth would be based on engineering specifications and expected physical outputs.

8. The sample size for the training set

Not applicable. This document pertains to regulatory approval for an X-ray system, not an AI algorithm trained on a dataset.

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

Not applicable. No AI algorithm training set is referenced.

Summary

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Philips Medical Systems Nederland B.V. eenpluis 4-8, 5684-PC, Best The Netherlands

KID2005

D P

510(k) summary

AUG - 9 2010

The following information is submitted in accordance with the requirements of 21 CFR 807.92.

ldentification of manufacturer

Company:...................................................................................................................................................................... Address: ..................................................................................................................................................................... 5684-PC, Best, The Netherlands Registration number:............................ 3003768277

Identification of U.S. designated agent

Company:	Philips Medical Systems
Address:	22100 Bothell Everett HighwayBothell, WA 98021-8431, U.S.A.
Registration number:	1217116

Identification of official correspondent

Name:...................................................... Lynn Harmer Position: ................................................. Senior Manager, Regulatory Affairs Telephone:.................................................................................................................................................................... Date prepared:................................................................................................................................................................

Device identification

Trade name:	Philips
Device name:	Allura Xper FD OR Table series
Regulation description:	Angiographic X-ray System
Regulation number:	21CFR 892.1600
Class:	II
Product code:	90IZI

Legally marketed devices

Trade names:	Philips Integris Allura series, Philips Allura Xper FD10,Philips Allura Xper FD20,Siemens Axiom Artis, Siemens Artis Zee family,Siemens Artis Zee / Zeego family
Manufacturer:	Philips and Siemens
510(k) numbers:	K002016, K041949, K033737, K021021, K073290,K090745

Page 1 of 3

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Intended Use:

The Allura Xper FD OR Table series is intended for use on human patients (within the limits of the used OR table) to perform:

· Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures,

Device description:

Substantial equivalence:

The Allura Xper FD OR Table series was compared to its predicate devices. Evaluations were carried out based on the comparison of the intended uses and device descriptions from 510(k) summaries of the predicate devices versus the new Allura Xper FD OR Table series.

Philips Healthcare believes that the Allura Xper FD OR Table series is as safe and effective, and performs in a substantially equivalent manner to the predicate devices.

{2}------------------------------------------------

Summary of Non-Clinical and Clinical performance tests:

Non-clinical verification and validation tests were performed to verify and validate the system functionally for the intended use reiative to the specifications and risk management requirements. Results of the conducted tests conclude that the Allura Xper OR Table series is substantial equivalent to its predicate device. The following standards were used in the development of the product: or we could say the system conforms tot the following standards:

Standard:	Title
IEC 60601-1, 2nd Ed.+ Amendment No. 1+ Amendment No. 2 + Corrigendum	General requirements for safety
IEC 60601-1-1, 2nd Ed.	Collateral standard: Safety requirements for medicalelectrical systems
IEC 60601-1-2, ed 2.1	Collateral standard: Electromagnetic compatibility –Requirements and tests
IEC 60601-1-3, 1st Ed.	Collateral standard: General requirements for radiationprotection in diagnostic X-Ray equipment
IEC 60601-1-4 Ed 1.1	Collateral standard: Safety requirements for program-mable electronic systems
IEC 60601-2-7 2nd Ed.	Particular requirements for the safety of high voltagegenerators
IEC 60601-2-28, 1st Ed.	Particular requirements for the safety of X-ray sourceassemblies and X-ray tube assemblies for medical diag-nosis
IEC 60601-2-32 1st Ed.	Particular requirements for the safety of associatedequipment of X-ray equipment
IEC 60601-2-43, 1st Ed	Particular requirements for the safety of X-Ray equip-ment for Interventional procedures
IEC 62304, 1st Ed.+ Corrigendum NEN-EN-IEC 62304:2006/C11:2008	Medical device software – Software life cycle processes
IEC 62366, 1st Ed	Medical devices. Application of usability engineering tomedical devices
ISO 14971: 2007-10-01	Medical devices – Application of risk management tomedical devices

No clinical performance test was required to show safety and effectiveness of the Allura Xper FD OR Table series in the intended clinical environment.

Conclusion:

The testing reported in this 510(k) establishes that the Allura Xper FD OR Table series is safe and effective for its intended use and is substantially equivalent to the currently legally marketed devices.

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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

Philips Medical Systems North America c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313

JUL 1 9 2013

Re: K102005

Trade/Device Name: Allura Xper OR Table Series Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB. JAA Dated: July 14, 2010 Received: July 15, 2010

Dear Mr. Job:

This letter corrects our substantially equivalent letter of August 5, 2010.

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 subiect 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

Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or protecting another figure, which is a common representation of the department's mission to protect and promote the health of all Americans.

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Page 2 - M. Job

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 (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 tollfree 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" (21CFR 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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Flaming M. Menge

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

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Indications for Use

510(k) Number

Device Name

Allura Xper OR Table Series

Indications for Use

The Allura Xper OR Table Series is intended for use on human patients (within the limits of the used OR table) to perform:

• Vascular and neurovascular imaging applications, including diagnostic, interventional and minimally Invasive procedures. This includes, e.g., perigheral, cerebral, thoracic and abdominal anglography, as well as PTAs, stent placements, embolisations and thrombolysis.

· Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker Implantations, and electrophysiology (EP). · Non-vascular Interventions such as drainages, blopsies and vertebroplasties procedures.

Combined with a qualified, compatible OR table, the Allura Xper OR Table Series can be used for imaging in the Hybrid OR within the applications domains Neuro, Vascular and Cardlac. The OR table can also be used standalone for surgical use in the OR.

Device description:

The Allura Xper OR Table Series is a modular X-ray systems family, based on a set of components that can be combined into different single and biplane configurations to provide specialized anglography. It is identical to the Allura Xper Series, to which a qualified, compatible OR table component is added.

General Safety and Effectiveness:

To facilitate safe and efficacious operation of the system by a trained healthcare professional, instructions for use are provided as part of the device labelling, as well as a basic training at system handover.

AND/OR

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

office of in Vitro Dlagnostic Device

510(k) K02005

Appendix 005_Indications for Use Statement.docm

1/1

AUG - 9 2010

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.