The Allura Xper series and the Allura Xper OR Table series (within the limits of the used OR table) are intended for use on human patients to perform: Vascular, cardiovascular 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 electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. Additionally: The Allura Xper and Allura Xper OR Table series is compatible with a hybrid Operating Room. Allura Xper FD10 is compatible with specified magnetic navigation systems. 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. Non Vascular and Cardiac. The OR table can also be used standalone for surgical use in the OR.

Device Description

The Allura Xper family consists of the Allura Xper FD series and the Allura Xper OR Table series and is identified as Allura Xper FD R8.2. The Allura Xper FD R8.2 is a modular angiographic X-ray system, based on a set of components that can be combined into different single and biplane configurations to provide specialized angiography. Combined with a qualified, compatible OR table. the Allura Xper FD R8.2 can also be used for imaging in the Hybrid OR. The Allura Xper FD R8.2 is optionally provided with ClarityIQ technology, which utilizes the advanced XRES4 noise reduction algorithms to reduce quantum noise in X-ray images.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Philips Allura Xper FD series and Allura Xper OR Table series:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific acceptance criteria for performance in the same way a de novo or PMA would. Therefore, explicit, quantifiable acceptance criteria with corresponding performance metrics are not detailed in this submission.

Instead, the "acceptance criteria" are implicitly met by demonstrating compliance with recognized standards and guidance documents. The reported device performance is that it "Meets the acceptance criteria and is adequate for its intended use."

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with IEC 60601-2-43 (Medical Electrical Equipment - Specific Requirements for the Safety of X-Ray Equipment for Interventional Procedures)	Complies with IEC 60601-2-43
Compliance with IEC 60601-2-28 (Medical Electrical Equipment - Specific Requirements for the Safety of X-Ray Source Assemblies and X-Ray Tube Assemblies for Medical Diagnosis)	Complies with IEC 60601-2-28
Compliance with ISO 14971 (Medical devices - Application of risk management to medical devices)	Complies with ISO 14971
Compliance with IEC 62304 (Medical device software - Software life cycle processes)	Complies with IEC 62304
Compliance with FDA Guidance document: "Guidance for the Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005)	Complies with FDA Software Guidance
Compliance with FDA Guidance document: "General Principles of Software Validation: Final Guidance for Industry and FDA Staff" (January 11, 2002)	Complies with FDA Software Validation Guidance
Compliance with FDA Guidance document: "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" (August 6, 1999)	Complies with FDA Solid State X-ray Imaging Devices Guidance
Adequate for intended use	"Is adequate for its intended use"
Substantially equivalent to predicate devices in terms of safety and effectiveness	"Substantially equivalent to the currently marketed and predicate devices in terms of safety and effectiveness."

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

The document explicitly states: "The subject of this premarket submission, the Allura Xper FD R8.2, did not require clinical studies to support substantial equivalence."

Instead, "Sample clinical images that demonstrate diagnostic quality of the images are provided." This implies a limited, illustrative set of images rather than a formally sized test set for a performance study.

Therefore, for the device, there is no formally defined "test set" with a specified sample size or data provenance in the context of a clinical performance study. The data provenance for the "sample clinical images" is not specified (e.g., country of origin, retrospective/prospective).

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

Since no formal clinical study with a dedicated test set and ground truth establishment was conducted for this 510(k) submission, this information is not applicable or provided.

4. Adjudication Method for the Test Set

As no formal test set and clinical study were conducted for this submission, no adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect size of how much human readers improve with AI vs without AI assistance

The document states that "The subject of this premarket submission, the Allura Xper FD R8.2, did not require clinical studies to support substantial equivalence." Furthermore, the device is an X-ray system with enhanced noise reduction (ClarityIQ technology), not an AI-assisted diagnostic tool for human readers in the typical sense of an MRMC study measuring reader improvement. Therefore, no MRMC comparative effectiveness study was done regarding human reader improvement with AI assistance.

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

The device itself is an angiographic X-ray system that produces images. The ClarityIQ technology utilizes "advanced XRES4 noise reduction algorithms" to improve image quality. While these are algorithms, the performance assessment described is in the context of the device producing diagnostically acceptable images, not a standalone diagnostic algorithm being evaluated for its own performance metrics (e.g., sensitivity, specificity). The focus is on the image quality produced by the system.

7. The Type of Ground Truth Used

Given that no formal clinical studies were performed for substantial equivalence and "sample clinical images" were provided to demonstrate "diagnostic quality," the concept of a formal "ground truth" as established in clinical trials is not directly applicable or described. The qualitative assessment of "diagnostic quality" would implicitly rely on expert interpretation, but the process is not detailed.

8. The Sample Size for the Training Set

The document mentions that the ClarityIQ technology utilizes "advanced XRES4 noise reduction algorithms." While algorithms often involve training data, the submission does not provide any information about the sample size used for the training set of these algorithms.

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

Similar to the above, since details about the training set are not provided, information on how its ground truth was established is not available in this document.

Summary

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HILIPS
K'133292
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510(k) Summary

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.

Date Prepared:	January 27, 2014
Manufacturer:	Philips Medical Systems Nederland B.V.Veenpluis 4-65684-PC, Best, The NetherlandsEstablishment Registration Number: 3003768277
Contact:	Mr. Klien van Dam, PhDRegulatory Affairs Manager+3140 2795225
Device TradeNames:	Allura Xper FD seriesAllura Xper OR Table series
Classification	Classification Name: Image-intensified fluoroscopic X-ray systemClassification Regulation: 21 CFR 892.1650Classification Panel: RadiologyDevice Class: IIPrimary product code: OWBSecondary product code JAA
Predicate Device #1	Device Name AlluraClarity Xper FD series X-ray systemManufacturer Philips Medical Systems Nederland B.V.510(k) number K130638Classification Regulation 21 CFR 892.1650Device Class: IIProduct Code: OWB
Predicate Device #2	Device Name Allura Xper FD OR Tables SeriesManufacturer Philips Medical Systems Nederland B.V.510(k) number K102005Classification Regulation 21 CFR 892.1650Device Class: 11Product Code: Primary code: OWBSubsequent code: JAA
Device Description:	The Allura Xper family consists of the Allura Xper FD series andthe Allura Xper OR Table series and is identified as Allura Xper FDR8.2. The Allura Xper FD R8.2 is a modular angiographic X-raysystem, based on a set of components that can be combined intodifferent single and biplane configurations to provide specializedangiography. Combined with a qualified, compatible OR table. theAllura Xper FD R8.2 can also be used for imaging in the HybridOR. The Allura Xper FD R8.2 is optionally provided with ClarityIQtechnology, which utilizes the advanced XRES4 noise reductionalgorithms to reduce quantum noise in X-ray images.
Indications for Use:	The Allura Xper series and the Allura Xper OR Table series (withinthe limits of the used OR table) are intended for use on humanpatients to perform:Vascular, cardiovascular and neurovascular imagingapplications. including diagnostic, interventional andminimally invasive procedures. This includes. e.g..peripheral, cerebral, thoracic and abdominal angiography, aswell as PTAs, stent placements, embolisations andthrombolysis. Cardiac imaging applications including diagnostics.interventional and minimally invasive procedures (such asPTCA. stent placing, atherectomies), pacemakerimplantations, and electrophysiology (EP). Non-vascular interventions such as drainages, biopsies andvertebroplasties procedures. Additionally:The Allura Xper and Allura Xper OR Table series iscompatible with a hybrid Operating Room. Allura Xper FD10 is compatible with specified magneticnavigation systems. Combined with a qualified, compatible OR table, the AlluraXper OR Table series can be used for imaging in the HybridOR within the applications domains Neuro, Vascular. NonVascular and Cardiac. The OR table can also be usedstandalone for surgical use in the OR.
Technology:	The Allura Xper FD R8.2 has the same technological characteristicscompared to the predicate devices. Modifications implemented inthe Allura Xper FD R8.2 include the introduction of a new, state ofthe art FD20 X-ray detector with passive cooling, and a higher DQE.Additionally, a new high voltage X-ray generator with reduced sizeis introduced.
	Based on the information provided in this premarket notification, theAllura Xper FD R8.2 is considered substantially equivalent to thecurrently marketed and predicate devices in terms of:Design and functionality Indications for use Fundamental Scientific Technology Performance specifications and testing
Non-clinicalPerformance Data:	The Allura Xper R8.2 complies with the following international andFDA recognized consensus standard and FDA GuidanceDocuments:IEC 60601-2-43. IEC 60601-2-28. ISO 14971: IEC 62304. FDA Guidance document entitled, "Guidance for the

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PHILIPS

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	Premarket Submissions for Software Contained in MedicalDevices" issued May 11, 2005.FDA Guidance document entitled, "General Principals of♥software Validation: Final Guidance for Industry and FDAStaff' issued January 11, 2002.FDA Guidance document entitled, "Guidance for theSubmission of 510(k)'s for Solid State X-ray Imaging
	Devices" issued August 6, 1999.The test results demonstrate that the Allura Xper FD R8.2:Complies with the aforementioned international and FDA-recognized consensus standards and/or FDA guidancedocumentsMeets the acceptance criteria and is adequate for its intendeduse.Therefore, the Allura Xper FD R8.2 is substantially equivalent to the
ClinicalPerformance Data:	currently marketed and predicate devices in terms of safety andeffectiveness.The subject of this premarket submission, the Allura Xper FD R8.2.did not require clinical studies to support substantial equivalence.Sample clinical images that demonstrate diagnostic quality of theimages are provided.
Conclusion:	The Allura Xper FD R8.2 is substantially equivalent to the predicatedevices in terms of design features, fundamental scientifictechnology, indications for use and safety and effectiveness.The changes implemented in the Allura Xper FD R8.2 System donot render the system to be Not Substantial Equivalent.

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HUMAN SERVI

Public Health Service

Food and Diug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002

March 5. 2014

Philips Medical Systems Nederland B.V. % Klien van Dam, Ph.D. Veenpluis 4-6 5684 PC Best THE NETHERLANDS

Rc: K133292

Trade/Device Name: Allura Xper FD scries; Allura Xper OR Table series Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: 11 Product Code: OWB, JAA Dated: January 27, 2014 Received: February 7. 2014

Dear Dr. van Dam:

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 cither 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Klien van Dam, Ph.D.

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.lda.gov/MedicalDevices/ResourcesforYou/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/Safetv/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Sm.p)

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known)

K133292

Device Name

Allura Xper series and Allura Xper OR Table series

Indications for Use (Describe)

The Allura Xper series and the Allura Xper OR Table series (within the limits of the used OR use on human patients to perform:

• Vascular, cardiovascular and neurovascular imaging diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, choracic and abdominal angiography, as well as PT As. stent placements,

embolisations and thrombolysis.

· Cardiac imaging applications including diagnosics, interventional and minimally invasive procedures (such as not placing, atherectomies), pacemaker implantations, and electrophysiology (EP).

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

Additionally:

· The Allura Xper and Allura Xper OR Table series is compatible with a hybrid Operating Room.

· Allura Xper FD10 is compatible with specified magnetic navigation systems.

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

Type of Use (Select one or both, as applicable)

[x] 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

FORM FDA 3881 (9/13)

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.