The "Brilliance iCT" is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components, and accessories.

Device Description

The Brilliance iCT is a Whole Body Computed Tomography (CT) X-Ray System featuring a continuously rotating x-ray tube and detectors gantry and multi-slice capability. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. This device also includes signal analysis and display equipment; patient and equipment supports; components; and accessories.

AI/ML Overview

The submitted text describes a 510(k) summary for the Brilliance iCT, a Computed Tomography (CT) X-Ray System. The summary focuses on demonstrating the substantial equivalence of a modified version of the Brilliance iCT to its predicate device, "Brilliance Volume," by highlighting technical characteristics and performance data.

Here's an analysis of the provided information, structured to address your specific questions. It's important to note that the document is a 510(k) summary for a CT scanner, not necessarily an AI-powered diagnostic device in the modern sense. Therefore, many of your questions related to AI-specific studies (like MRMC, training sets, ground truth for AI, etc.) are not directly applicable or detailed in this type of submission for a CT hardware modification.

Acceptance Criteria and Device Performance

The study primarily focuses on demonstrating that the modified Brilliance iCT continues to meet established performance standards for CT systems, particularly IEC 61223-3-5:2004. The acceptance criteria are implicit in compliance with this standard, which outlines specific acceptance tests for the imaging performance of CT X-ray equipment.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implicit from IEC 61223-3-5:2004)	Reported Device Performance (Demonstrated by Bench Tests)
CT Number Accuracy and Consistency	"Demonstrated that the modified Brilliance iCT system continues to conform to IEC 61223-3-5:2004: CT Number Measurements"
Image Uniformity	"Demonstrated that the modified Brilliance iCT system continues to conform to IEC 61223-3-5:2004: Uniformity Measurements"
Image Noise Levels	"Demonstrated that the modified Brilliance iCT system continues to conform to IEC 61223-3-5:2004: Noise Measurements"
Tomographic Section Thickness Accuracy	"Demonstrated that the modified Brilliance iCT system continues to conform to IEC 61223-3-5:2004: Tomographic Section Thickness Measurements"
CTDI Dose Accuracy	"Demonstrated that the modified Brilliance iCT system continues to conform to IEC 61223-3-5:2004: CTDI Dose Measurements"
Air Dose Accuracy	"Demonstrated that the modified Brilliance iCT system continues to conform to IEC 61223-3-5:2004: Air Dose Measurements"
Spatial Resolution	"Demonstrated that the modified Brilliance iCT system continues to conform to IEC 61223-3-5:2004: Spatial Resolution Measurements"
Low Contrast Detectability	"Demonstrated that the modified Brilliance iCT system continues to conform to IEC 61223-3-5:2004: Low Contrast Detectability Measurements"
Diagnostic Image Quality	"Clinical evaluation demonstrated that images... have been evaluated by a radiologist as being of diagnostic quality."

Detailed Responses to Specific Questions:

A table of acceptance criteria and the reported device performance:
- See the table above. The acceptance criteria are based on compliance with IEC 61223-3-5:2004, and the performance is stated as meeting this standard for each listed measurement. A clinical evaluation also confirmed diagnostic image quality.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document mentions "bench tests" for the technical performance measurements. These typically involve phantoms and laboratory setups, not human patient data in the sense of a clinical trial.
- For the "Clinical evaluation," the sample size of cases/images is not specified.
- The data provenance (country of origin, retrospective/prospective) is not mentioned for either bench tests or clinical evaluation.
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):
- For the technical performance measurements (CT Number, Noise, Resolution, etc.), the "ground truth" is established by physical measurement standards and the test methodology dictated by IEC 61223-3-5:2004, not by human experts.
- For the "Clinical evaluation," it states "images... have been evaluated by a radiologist as being of diagnostic quality." The number is one radiologist, and their specific qualifications (e.g., years of experience) are not provided.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Given that only "a radiologist" is mentioned for the clinical evaluation, it implies no multi-reader adjudication method was used. For the technical bench tests, adjudication by human experts is not applicable.
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 MRMC study was done or reported. This submission pertains to a modification of a CT scanner's hardware (detection array and supporting software), not an AI-powered diagnostic tool in the sense of one that assists human readers. The clinical evaluation mentioned is a basic check for diagnostic quality of the reconstructed images.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable in the context of this device. The Brilliance iCT is a CT scanner, which provides images for human interpretation, not an algorithm providing a standalone diagnostic output. The "algorithm only" performance refers to the image reconstruction algorithm's output, which is then clinically evaluated by a radiologist. The technical bench tests assess the fundamental image quality parameters, which are (in a way) "standalone" performance metrics of the hardware and reconstruction.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the technical performance measurements, the "ground truth" is based on the physical properties of phantoms and measurement standards defined by IEC 61223-3-5:2004.
- For the clinical evaluation, the ground truth for "diagnostic quality" appears to be the subjective assessment of a single radiologist. This is not equivalent to pathology or outcomes data.
The sample size for the training set:
- Not applicable / Not mentioned. This document describes the modification of a CT scanner hardware and its performance, not an AI algorithm that would typically require a training set in the sense of machine learning. The "supporting software" mentioned would be for image reconstruction and system control, not a learned model.
How the ground truth for the training set was established:
- Not applicable / Not mentioned for the same reasons as point 8.

Summary

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510(k) Summary

Brilliance iCT

510(k) Number K131773

Applicant's Name:

Philips Medical Systems (Cleveland), Inc. 595 Miner Road Cleveland, Ohio 44143

SEP 2 4 2013

Contact Person:

Catherine M. Connell Requlatory Affairs Specialist Philips Medical Systems (Cleveland), Inc. 595 Miner Road, Cleveland, OH 44143 USA +1 440 483 5581 Tel: +1 440 483 4918 Fax: E-mail: catherine.connell@philips.com

Trade Name:

Brilliance iCT

Preparation Date:

July 09, 2013

Classification:

Name: System, X-Ray, Tomography, Computed Product Code: JAK Regulation No: 21 CFR 892.1750 Class: !! Panel: Radiology

Device Description:

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Intended Use Statement:

The Brilliance iCT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment; patient and equipment supports; components; and accessories.

Predicate Device:

Substantial equivalence to the following predicate device is claimed:

Device Name	510(k) No.	Date of Clearance
Brilliance Volume	K060937------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	June 5, 2006

Compliance with Standards:

Brilliance iCT complies with the following standards:

AAMI / ANSI ES 60601-1:2005/C1:2009 (R)2012, Medical . electrical equipment - Part 1: General requirements for basic safety and essential performance.
. IEC 60601-1-2:2007 (Ed. 3), Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
IEC 60601-1-3:2008 (Ed. 2), Medical electrical equipment -. Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment.
IEC 60601-2-44:2009 (Ed. 3), Medical electrical equipment. . Particular requirements for the basic safety and essential performance of X-rav equipment for computed tomography.
. IEC 61223-3-5:2004 (Ed. 1), Evaluation and routine testing in medical imaging departments – Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment.

The system complies with performance standards for Computed Tomography (CT) Equipment and Laser products (21 CFR 1020.33 and 21 CFR 1040.10, respectively).

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Technical characteristics in comparison to predicate:

Both the cleared Brilliance iCT and its predicate device consist of :

Operator station .
Gantry .
Patient table .
Patient supports (positioning aids) .

The difference between the modified Brilliance iCT and its previously cleared predicate is:

Modified detection array that maintains the same structure of t . 672 x 128 detectors

Substantial Equivalence:

The modified Brilliance iCT is a modification of its predicate device, the "Brilliance Volume". Both are Whole Body Computed Tomography (CT) X-Ray Systems, featuring a continuously rotating x-ray tube and detectors gantry and multi-slice capability, to reconstruct cross-sectional images from the acquired x-ray transmission data.

The modified Brilliance iCT and the legally marketed Brilliance iCT have the same intended use and use the same technology as the predicate device. The modifications that were made are to the detection array and in the supporting software. .

The safe and effective performance of the modified Brilliance iCT has been clearly demonstrated by bench tests.

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Performance Data:

The following tests demonstrated that the modified Brilliance iCT system continues to conform to IEC 61223-3-5:2004:

. CT Number, Uniformity, Noise and Tomographic Section Thickness Measurements
. CTD! Dose Measurements
Air Dose Measurements .
Spatial Resolution Measurements .
Low Contrast Detectability Measurements .

Clinical evaluation demonstrated that images, which are reconstructed by the modified system, have been evaluated by a radiologist as being of diagnostic quality.

Conclusion:

Philips Medical Systems (Cleveland), Inc. believes that, based on the information provided in this submission, the modified Brilliance iCT is substantially equivalent to its predicate device without raising any new safety and/or effectiveness concerns.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure with outstretched arms, rendered in black lines. The figure is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Public Health Service

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

September 24, 2013

Philips Medical Systems (Cleveland) Inc. % Ms. Catherine M. Connell Regulatory Affairs Specialist 595 Miner Road CLEVELAND OH 44143

Re: K131773

Trade/Device Name: Brilliance iCT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: August 22, 2013 Received: August 27, 2013

Dear Ms. Connell:

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

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Page 2 - Ms. Catherine M. Connell

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" (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/dcfault.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.h.7).

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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510(k) Number (if known): K 131773

Device Name: Brilliance iCT

Indications for Use:

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

Over-the-Counter Use (Part 21CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

$(m,n,7)$

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

K131773 510(k)

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Section 4, Page 1 of 1

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.