The Plaque Analysis option is a non-invasive diagnostic reading software intended for use by cardiologists and radiologists as an interactive tool for viewing and analyzing cardiac CT data for determining the presence and extent of coronary plaques.

Philips' Comprehensive Cardiac Analysis (CCA) Plaque Assessment tool is a noninvasive diagnostic reading software intended to provide cardiologists and radiologists with an optimized non-invasive application to provide accurate quantification and characterization of coronary plaque. It is an interactive post-processing tool for viewing and analyzing cardiac CT image data for determining the presence and extent of coronary plaques.

Device Description

The Plaque Analysis option was added to the Comprehensive Cardiac Analysis option (a.k.a. CCA) predicate device. It provides analysis of the vessel lumen and wall and makes it easier to detect findings in the coronary vessels.

The Plaque Analysis application calculates lumen and vessels contours, detects findings along the vessel wall by a single click algorithm and provides a set of measurements for all the detected findings. The option includes visualization and manual correction tools.

Outputs of the application include coronary findings segmentation and quantification.

AI/ML Overview

1. Table of acceptance criteria and reported device performance:

The provided 510(k) summary (K092742) for Philips' Comprehensive Cardiac Analysis (CCA) Plaque Assessment Tool does not explicitly state specific quantitative acceptance criteria or the numerical performance results of a study designed to meet such criteria. The document focuses on demonstrating substantial equivalence to predicate devices based on safety and effectiveness considerations, rather than reporting on a specific performance study with defined metrics.

However, based on the description of the device's function, we can infer the intent of performance from the device description and indications for use. The device "provides analysis of the vessel lumen and wall and makes it easier to detect findings in the coronary vessels," and its intended use is to "provide accurate quantification and characterization of coronary plaque."

Therefore, for the purpose of this exercise, we will conceptualize the implied performance and how it might be assessed, even though the specific metrics and results are not present in the provided text.

Acceptance Criteria (Implied from Device Description)	Reported Device Performance (Not explicitly stated with quantitative values in the 510(k))
Accurate detection of coronary plaques	Device "detects findings along the vessel wall by a single click algorithm"
Accurate quantification of coronary plaques	Device "provides a set of measurements for all the detected findings"
Accurate characterization of coronary plaques	Device intended to "provide accurate quantification and characterization of coronary plaque"
Facilitates analysis of vessel lumen and wall	"provides analysis of the vessel lumen and wall and makes it easier to detect findings"
Non-invasive diagnostic reading software for cardiologists and radiologists	Intended for use by "cardiologists and radiologists as an interactive tool"
Substantially equivalent to predicate devices for safety and effectiveness	"is substantially equivalent in safety and effectiveness to the predicate devices"

2. Sample size used for the test set and data provenance:

The provided document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective) for a performance study. The 510(k) focuses on demonstrating substantial equivalence through a comparison of technological characteristics, safety, and intended use to predicate devices, rather than presenting a detailed clinical performance study with test sets.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:

The document does not mention any ground truth establishment process, the number of experts involved, or their qualifications. As no specific performance study is detailed, the information regarding ground truth is absent.

4. Adjudication method for the test set:

Since no specific performance study or test set is described, there is no mention of an adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was performed. The focus is on the device's standalone capabilities and its equivalence to other legally marketed devices, not on its assistive impact on human readers in a comparative setting.

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

The 510(k) summary does not explicitly state that a standalone (algorithm-only) performance study was conducted with quantitative results. While it describes the algorithm's capabilities ("detects findings along the vessel wall by a single click algorithm" and "calculates lumen and vessels contours"), it does not provide metrics of its performance purely in an automated fashion. The device is described as an "interactive tool," implying human involvement in its intended use.

7. The type of ground truth used:

The document does not specify the type of ground truth used as no explicit performance study with ground truth is detailed.

8. The sample size for the training set:

The document does not provide any information regarding the sample size for a training set. As this is a 510(k) summary focused on substantial equivalence rather than a detailed technical report of algorithm development, such information is typically not included.

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

The document does not describe how the ground truth for a training set was established, as no training set or its associated ground truth process is mentioned.

Summary

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K092742

510(k) Summary Philips Medical Systems (Cleveland) Inc. Philips' Comprehensive Cardiac Analysis (CCA) Plaque Assessment Tool

This summary of this 510(k) provides safety and effectiveness information submitted in accordance with the requirements of 21 CFR 807.92.

Submitter 1.

Philips Medical Systems (Cleveland), Inc. 595 Miner Road Cleveland, OH 44143 (440) 483-3000

OCT - 9 2009

Contact: .

	Michael A. Chilbert, Ph.D., P.E.
Telephone:	440 483 3284
FAX:	440 483 4918
Email:	Michael.chilbert@philips.com

Date of Summary: March 1, 2009

2. Device Name and Classification

Device Name:	Philips' Comprehensive Cardiac Analysis (CCA) PlaqueAssessment tool
Classification Name:	Computed Tomography X-Ray System

The FDA has classified the Computed Tomography X-Ray System and its accessories as Class II in 21 CFR 892.1750 (Product Code 90 JAK)

Predicate Device Information 3.

In the opinion of Philips Medical Systems Inc., the "Philips' Comprehensive Cardiac Analysis (CCA) Plaque Assessment tool is of comparable type and substantially equivalent to the legally marketed devices currently in commercial distribution, namely:

Philips Medical Systems (Cleveland), Inc., Brilliance CT, Private Practice . CV Configuration, K042293
Shina Systems Ltd., CardioCT, K070226 .
GE- CardlQ Fusion, K061370 .
GE Advanced Vessel Analysis LI, K060779 .
. Vital Imaging - Vitrea2 Ver. 3.9, K061624 (specifically the SUREPlaque tools)
Siemens syngo Circulation, K063762 �

Comprehensive Cardiac Analysis (CCA) - Plaque Assessment tool

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4. Device Description

Outputs of the application include coronary findings segmentation and quantification.

5. Indications for Use of the device

6. Intended Use of the device

7. Comparison to Predicate Devices

In the opinion of Philips Philips' Comprehensive Cardiac Analysis (CCA) Plaque Assessment tool is of comparable type and substantially equivalent to the legally marketed devices described in paragraph 3 above.

The "Philips' Comprehensive Cardiac Analysis (CCA) Plaque Assessment tool" is manufactured in accordance with the Quality System Regulations (QSR), 21 CFR Part 820 and to International Standards ISO 13485:2003. Potential hazards are identified in a hazard analysis and controlled in the following manner:

Software safety is assured by the company procedures that conform to accepted practices. Quality assurance procedures are adhered to, and meeting the specifications and functional requirements is demonstrated via testing.

Electrical and Mechanical safety is assured by adherence to IEC 60601-1 Standards.

Comprehensive Cardiac Analysis (CCA) - Plaque Assessment tool

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Radiation safety is assured by compliance with 21 CFR, Subchapter J Performance Standards.

Based on the above considerations, it is Philips's opinion that the "Philips' Comprehensive Cardiac Analysis (CCA) Plaque Assessment tool" CT scanner is substantially equivalent in safety and effectiveness to the predicate devices identified in paragraph 3 above.

Comprehensive Cardiac Analysis (CCA) - Plaque Assessment tool

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

UL International Germany GmbH % Mr. Casey Conry Senior Project Engineer Underwriters Laboratories, Inc. 1285 Walt Whitman Road MELVILLE NY 11747

OCT = 9 2009

Re: K092747

Trade/Device Name: Philips Comprehensive Cardiac Analysis (CCA)

Plaque Assessment Tool

Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: September 23, 2009 Received: September 25, 2009

Dear Mr. Conry:

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 (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

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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1092747 510(k) Number (if known):

Page 1 of 1

Device Name:

Philips Comprehensive Cardiac Analysis (CCA) - Plaque Assessment tool

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign. Off.

(Division Sigh-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.