2D Quantitative Analysis is a post processing software medical device intended to assist physicians through providing quantitative information as additional input for their comprehensive diagnosis decision making process and planning during cardiovascular procedures and for post procedural evaluation. 2D Quantitative Analysis consists of six applications:

The 2D Quantitative Coronary Analysis application is intended to be used for quantification of coronary artery dimensions (approximately 1 to 6 mm) from 2D angiographic images.

The 2D Quantitative Vascular Analysis application is intended to be used for quantification of aortic and peripheral artery dimensions (approximately 5 to 50 mm) from 2D angiographic images.

The 2D Left Ventricle Analysis and the Biplane 2D Left Ventricle Analysis applications are intended to be used for quantification of left ventricular volumes and local wall motion from biplane angiographic series. respectively.

The 2D Right Ventricle Analysis and the Biplane 2D Right Ventricle Analysis applications are intended to be used for quantification of right ventricular volumes and local wall motion from biplane angiographic series, respectively.

Device Description

2D Quantitative Analysis is a software application that assists the user with quantification of

· vessels and vessel obstructions,
· ventricular volumes and
ventricular wall motion

from angiographic X-ray images. The software provides semi-automatic contour detection of vessels, catheters and the left ventricle in angiographic X-ray images, where the end-user is able to edit the contours. 2D Quantitative Analysis implements computational models for the quantification of vessels, obstructions in vessels, ventricular volumes and ventricular local wall motion from 2D contours.

The proposed 2D Quantitative Analysis will be offered as an optional accessory to the Philips Interventional X-ray systems.

AI/ML Overview

This looks like a 510(k) premarket notification for a medical device called "2D Quantitative Analysis" from Philips Medical Systems. Let's break down the information to answer your request.

It's important to note that this document is a 510(k) summary, which often focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive de novo clinical studies with detailed acceptance criteria and performance tables as might be expected for novel devices or PMAs.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) for the device's performance, nor does it provide a direct quantifiable "reported device performance" against such criteria in the context of human-level tasks. Instead, the "acceptance criteria" appear to be met through demonstration of compliance with standards and successful completion of verification and validation testing, confirming it "conforms to its specifications" and "intended use and user needs."

The primary performance claim for the 2D Quantitative Analysis device is its ability to quantify:

Vessel and vessel obstructions
Ventricular volumes
Ventricular wall motion

From angiographic X-ray images, with semi-automatic contour detection and user editing capabilities.

The document states:

"Dedicated phantom based algorithm validation testing has been performed to ensure sufficient accuracy and agreement with the predicate device. Results demonstrated that the algorithm confirms to its specifications."
"Non-clinical software validation testing covered the intended use and commercial claims as well as usability testing with representative intended users. Results demonstrated that the 2D Quantitative Analysis conforms to its intended use and user needs."

Therefore, the acceptance criteria are implicitly satisfied by the successful completion of these tests and demonstrating substantial equivalence. Specific numerical performance metrics against defined thresholds are not provided in this summary.

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

The document mentions "Dedicated phantom based algorithm validation testing" and "Non-clinical software validation testing." However, it does not specify the sample size (number of cases/patients or phantoms) used for these test sets.

The data provenance is also not explicitly stated as retrospective or prospective clinical data from specific countries. The testing appears to be primarily phantom-based and non-clinical software validation, rather than clinical studies using patient data.

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

The document does not specify the number of experts or their qualifications used to establish ground truth for any test set. The validation appears to be against "specifications" and "predicate device agreement," which for phantom studies would likely involve known measurements or highly controlled scenarios rather than expert consensus on clinical images in the traditional sense.

4. Adjudication Method for the Test Set

Since the document does not describe the use of human experts to establish ground truth on clinical images, an "adjudication method" for a test set (like 2+1 or 3+1) is not applicable or mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

The document explicitly states: "2D Quantitative Analysis, did not require clinical data since substantial equivalence to the currently marketed Allura Xper FD series and Allura Xper OR Table series was demonstrated..."

Therefore, an MRMC comparative effectiveness study, particularly one measuring the effect size of human readers with vs. without AI assistance, was not performed or, at least, not presented in this 510(k) summary. The device is a "post processing software medical device intended to assist physicians through providing quantitative information," implying it's a tool for physicians, but its impact on human reader performance was not quantified in a comparative study here.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

The document states: "Dedicated phantom based algorithm validation testing has been performed to ensure sufficient accuracy and agreement with the predicate device. Results demonstrated that the algorithm confirms to its specifications."

This "phantom based algorithm validation testing" could be considered a form of standalone performance assessment, as it would evaluate the algorithm's output against known phantom measurements or the predicate's performance, without direct human interaction during the measurement process. However, the device is described as having "semi-automatic contour detection... where the end-user is able to edit the contours," indicating a human-in-the-loop design in its intended clinical use. The "standalone" testing here would likely refer to the algorithm's ability to generate measurements from specific inputs accurately.

7. The Type of Ground Truth Used

For the "dedicated phantom based algorithm validation testing," the ground truth was likely derived from known physical dimensions or precisely measured values from the phantoms. For "non-clinical software validation testing," ground truth would be based on the established "intended use and user needs" and the device's functional specifications. Pathology or outcomes data are not mentioned.

8. The Sample Size for the Training Set

The document does not provide any information about the sample size used for a training set. This is typical for 510(k) submissions focusing on substantial equivalence, especially for devices that may not rely on machine learning models trained on large datasets in the way that some modern AI devices do. The description of the device's functionality (semi-automatic contour detection, computational models) suggests a more rule-based or traditional image processing approach rather than deep learning, though the exact methodologies are not detailed.

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

Since no training set information is provided, how its ground truth was established is also not discussed.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

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

July 29, 2016

Philips Medical Systems Nederland BV % Ms. Jeanette Becker Regulatory Affairs Manager Veenpluis 4-6 Best NL 5684PC NETHERLANDS

Re: K161839

Trade/Device Name: 2D Quantitative Analysis Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, LLZ Dated: June 30, 2016 Received: July 05, 2016

Dear Ms. Becker:

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

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

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 (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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

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

http://www.fda.gov/MedicalDevices/Safety/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 Industry and Consumer Education 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.

Michael D'Hara

For

Robert 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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Indications for Use

510(k) Number (if known)

K16183

Device Name

2D Quantitative Analysis

Indications for Use (Describe)

The 2D Quantitative Coronary Analysis application is intended to be used for quantification of coronary artery dimensions (approximately 1 to 6 mm) from 2D angiographic images.

The 2D Quantitative Vascular Analysis application is intended to be used for quantification of aortic and peripheral artery dimensions (approximately 5 to 50 mm) from 2D angiographic images.

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)

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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:	June 30, 2016
Manufacturer:	Philips Medical Systems Nederland B.V.Veenpluis 4-65684 PC BestThe NetherlandsEstablishment Registration Number: 3003768277
Primary ContactPerson:	Ms. Jeanette BeckerRegulatory Affairs ManagerPhone: +31 611386380E-mail: jeanette.becker@philips.com
Secondary ContactPerson:	Ms. Liselotte Kornmann, PhDSenior Manager Regulatory AffairsPhone: +31 611621238E-mail: liselotte.kornmann@philips.com
Device:	Trade Name: 2D Quantitative AnalysisClassification Name: Image-intensified fluoroscopic x-ray systemClassification Regulation: 21 CFR, Part 892.1650Classification Panel: RadiologyDevice Class: Class IIPrimary Product Code: OWB (Interventional Fluoroscopic X-Ray systemSecondary Product Code: LLZ (System, Image Processing, Radiological)
Predicate Device:	Trade Name: Allura Xper FD series / Allura Xper OR Table seriesManufacturer: Philips Medical Systems Nederland B.V.510(k) Clearance: K141979 (Aug 19, 2014)Classification Name: Image-intensified fluoroscopic x-ray systemClassification Regulation: 21 CFR, Part 892.1650Classification Panel: RadiologyDevice Class: Class IIProduct Code: OWB, JAA

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Device description: 2D Quantitative Analysis is a software application that assists the user with quantification of

· vessels and vessel obstructions,
· ventricular volumes and
ventricular wall motion

The proposed 2D Quantitative Analysis will be offered as an optional accessory to the Philips Interventional X-ray systems. Currently, the Quantitative Analysis functionality (Pie Medical Imaging, K100292) is embedded in the software of the currently marketed and predicate Allura Xper FD series / Allura Xper OR table series (K141979).

Indications for Use: The 2D Quantitative Analysis, provided as optional accessory to the Philips Interventional X-ray system, has the following indications for use:

2D Quantitative Analysis is a post processing software medical device intended to assist physicians through providing quantitative information as additional input for their comprehensive diagnosis decision making process and planning during cardiovascular procedures and for post procedural evaluation. 2D Ouantitative Analysis consists of six applications:

The 2D Quantitative Coronary Analysis application is intended to be used for quantification of coronary artery dimensions (approximately 1 to 6 mm) from 2D angiographic images.

The 2D Quantitative Vascular Analysis application is intended to be used for quantification of aortic and peripheral artery dimensions (approximately 5 to 50 mm) from 2D angiographic images.

The indications for use statement of the 2D Quantitative Analysis is not similar compared to the currently marketed Allura Xper FD series / Allura Xper OR Table series containing the embedded Quantitative Analysis functionality since the indications of the predicate's Quantitative Analysis functionality was not described specifically in the indications for use of the Allura Xper FD series / Allura Xper OR Table series. However, the difference in wording of the indications for use does not raise any new safety and effectiveness questions since the indications for use of the new device falls within the intended use of the predicate device and, therefore, the two devices have the same intended use. Both the predicate and subject device offer similar Quantitative Analysis functionality

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and are intended to support the physician by providing vessel and ventricle dimensions from angiographic X-ray images.

Based on the information provided above, 2D Quantitative Analysis is substantially equivalent to the currently marketed Allura Xper FD series / Allura Xper OR Table series in terms of Indications for Use.

2D Quantitative Analysis employs comparable technology as the Quantitative Technological Analysis functionality embedded in the currently marketed Allura Xper FD series characteristics: and Allura Xper OR Table series:

· Both tools provide the same Quantitative Analysis programs: Quantitative Coronary Analysis (QCA), Quantitative Vascular Analysis (QVA), Left Ventricle Analysis (LVA), Right Ventricle Analysis (RVA), LVA biplane and RVA biplane.
Both tools support the same methods for ventricle volume estimation: Area . length (for monoplane LVA and biplane LVA/RVA). Simpson (for monoplane LVA and biplane RVA) and Pyramid (Monoplane RVA).
. Both tools support the same methods for wall motion analysis: Centerline and Slager (LVA only).
. Both tools provide quantification of vessel and ventricle parameters based on semi-automatic analysis of 2D angiographic X-ray images.
Both tools offer the same workflow: select image calibrate measure -. correct / adjust - report.
. Both tools provide automatic calibration based on iso-centering
. Both tools provide manual calibration based on known dimensions of catheters, sphere phantoms or user defined reference distance.
Both tools provide customizable settings for the implemented methods
Both tools provide a task oriented user interface with guidance instructions ●

The technological differences between 2D Quantitative Analysis and the Quantitative Analysis functionality embedded in the currently marketed Allura Xper FD series and Allura Xper OR Table series are noted below:

The Quantitative Analysis functionality of the predicate device supports two additional methods for ventricle volume estimation, the Multiple Slices (Biplane RVA) and Two Chamber (Monoplane RVA) method, which are not supported by 2D Quantitative Analysis. Philips determined that the three available methods in 2D Quantitative Analysis are sufficient to support the intended use.
· The Quantitative Analysis functionality of the predicate device supports one additional methods for wall motion analysis, Regional, which is not supported by 2D Quantitative Analysis. Philips determined that the available methods in 2D Quantitative Analysis are sufficient to support the intended use.
· 2D Quantitative Analysis generates a detailed report whereas the Quantitative Analysis functionality of the predicate device provides both a detailed and summary report. The detailed report was considered to be sufficient to support the intended use of 2D Quantitative analysis.
. 2D Quantitative Analysis includes an in-application help function with animations which is not available in the Quantitative Analysis functionality of the predicate device.

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The differences between the 2D Quantitative Analysis and the predicate device do not raise any new questions regarding safety or effectiveness. Based on the information provided above, 2D Quantitative Analysis is substantially equivalent to the currently marketed device in terms of technological characteristics.

Non-clinical performance testing has been performed on 2D Quantitative Summary of Non-Clinical Performance Analysis and demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance documents: Data:

IEC 62304 Medical device software Software life cycle processes (Ed. 1.0, . 2006),
IEC 62366 Medical devices – Application of Usability engineering to medical devices (Ed. 1.0, 2007),
ISO 14971 Medical devices Application of risk management to medical ● devices (Ed. 2.0, 2007),
. Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. May 11, 2005 (document number 337).
. Guidance for Industry and FDA Staff - Applying Human Factors and Usability Engineering to Medical Devices, February 3, 2016 (document number 1757)

Software verification testing has been performed to cover system level requirements as well as risk control measures. Results demonstrated that all executed tests were passed.

Dedicated phantom based algorithm validation testing has been performed to ensure sufficient accuracy and agreement with the predicate device. Results demonstrated that the algorithm confirms to its specifications.

Non-clinical software validation testing covered the intended use and commercial claims as well as usability testing with representative intended users. Results demonstrated that the 2D Quantitative Analysis conforms to its intended use and user needs.

Therefore, 2D Quantitative Analysis is substantially equivalent to the currently marketed Allura Xper FD series and Allura Xper OR Table series in terms of safety and effectiveness.

Summary of Clinical 2D Quantitative Analysis, did not require clinical data since substantial Performance Data: equivalence to the currently marketed Allura Xper FD series and Allura Xper OR Table series was demonstrated with the following attributes:

. Indication for use:
Technological characteristics;
. Non-clinical performance testing; and
Safety and effectiveness. .

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Substantial Equivalence Conclusion:

2D Quantitative Analysis is substantially equivalent to the currently marketed Allura Xper FD series / Allura Xper OR Table series containing the embedded Quantitative Analysis functionality in terms of indications for use, technological characteristics and safety and effectiveness.

Additionally, substantial equivalence was demonstrated by non-clinical performance tests provided in this 510(k) premarket notification. These tests demonstrate that 2D Quantitative Analysis complies with the user needs requirements as well as the requirements specified in the international and FDArecognized consensus standards. 2D Quantitative Analysis is as safe and effective as its predicate device and does not raise any new safety and/or effectiveness questions.

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Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.