ct42 is intended to be used for viewing, post-processing and quantitative evaluation of cardiovascular computed tomography (CT) images in a Digital Imaging and Communications in Medicine (DICOM) Standard format. It enables; Importing Cardiac CT Images in DICOM format Supporting clinical diagnostics by qualitative analysis of the cardiac CT images using display functionality such as panning, windowing, zooming, navigation through series/slices and phases, 3D reconstruction of images including multi-planner reconstructions of the images. Supporting clinical diagnostics by quantitative measurement of the heart and adjacent vessels in cardiac CT images, specifically distance, area, volume and mass Supporting clinical diagnostics by using area and volume measurements for measuring LV function and derived parameters cardiac output and cardiac index in long axis and short axis cardiac CT images. Supporting clinical diagnostics by quantitative measurements of calcified plaques in the coronary arteries (calcium scoring), specifically Agatston and volume and mass calcium scores. It shall be used by qualified medical professionals, experienced in examining and evaluating cardiovascular CT images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process. ct42 is a software application that can be used as a stand-alone product or in a networked environment. The target population for the ct42 is not restricted, however the image acquisition by a cardiac CT scanner may limit the use of the device for certain sectors of the general public. ct42 shall not be used to view or analyze images of any part of the body except the cardiac CT images acquired from a cardiovascular CT scanner.

Device Description

ct42 is a dedicated software application for evaluating cardiovascular images in a DICOM Standard format. The software can be used as a stand-alone product that can be integrated into a hospital or private practice environment. ct42 has a graphical user interface which allows users to qualitatively and quantitatively analyze cardiac CT images for volume/mass, and calcium scoring. It provides a comprehensive set of tools for the analysis of Cardiovascular Computed Tomography (CT) images.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the ct42 Cardiac Computed Tomography (CT) Software:

Note: The provided document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed performance study with acceptance criteria in the manner one might find in a clinical trial report. As such, some requested information (like specific numerical acceptance criteria and a detailed study proving the device meets those criteria) is not explicitly present in the provided text. The document states that "The successful non-clinical testing demonstrates the safety and effectiveness of the ct42 when used for the defined indications for use and demonstrates that the device for which the 510(k) is submitted performs as well as or better than the legally marketed predicate device."

Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format with corresponding reported performance for the ct42 software. Instead, it relies on demonstrating equivalence to a predicate device (Ziosoft - Cardiac Function Analysis & Calcium Scoring, K083446) by possessing similar features and functionalities. The "Conclusion" section indirectly serves as the statement of meeting acceptance, asserting that "ct42... demonstrates that the device... performs as well as or better than the legally marketed predicate device."

Here's a table based on the "Device Comparison Table" provided, highlighting the features where equivalence is drawn, which implicitly serve as the "acceptance criteria" for functionality:

Acceptance Criteria (Feature/Functionality)	Reported Device Performance (ct42)
Post processes ECG gated - Cardiac CT images	YES
Image viewer functionality	YES
Left ventricular ejection fraction	YES
End diastolic volume	YES
End systolic volume	YES
Stroke volume	YES
Cardiac output	YES
Cardiac Index	YES
Wall thickness	YES
Wall thickness ratio	YES
Wall movement	YES
Volume Curve	YES
Calcium Scoring	YES
Evaluates calcified plaque in the coronary arteries	YES
Agatston calcium score	YES
Volume calcium score	YES
Calcium mass/density calculations	YES (calculates mass)
DICOM compliant	YES

Additional Information on the Study:

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided 510(k) summary. The document mentions "non-clinical testing" and testing "according to the specifications that are documented in a Master Software Test Plan," but specific details about the number of cases or images in the test set are absent.
- Data Provenance: Not specified. It's unclear if the data was retrospective or prospective, or its country of origin.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document does not detail how ground truth was established for any testing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified.
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. The document presents a substantial equivalence claim based on feature comparison and non-clinical software testing. It does not describe a MRMC comparative effectiveness study involving human readers and AI assistance. The device itself is a software application for viewing, post-processing, and quantitative evaluation, implying it's a tool for human professionals, but no study on human performance improvement is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The submission focuses on "non-clinical testing" to demonstrate safety and effectiveness and equivalence to a predicate device. This implies testing the algorithm's functionality and accuracy in various measurements (distance, area, volume, mass, calcium scoring) in a standalone manner, but the specifics of how this was done (e.g., comparing algorithm outputs to known truths or another software's output) are not detailed. The term "standalone" performance in the context of an FDA submission for this type of device usually refers to the accuracy of its quantitative measurements rather than a human-like diagnostic output.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not explicitly stated. Given the nature of the device (quantitative measurements for cardiac CT), ground truth for accuracy testing would typically involve comparisons to:
  - Manual measurements by experts (expert consensus)
  - Measurements from another validated software/method
  - Perhaps in some cases, correlation with pathology or invasive measurements, though this is less common for software functionality claims.
- The document does not detail which of these, if any, were used.
The sample size for the training set:
- Not applicable/Not mentioned. The provided document is for a traditional 510(k) submission for ct42. It describes a software application for quantitative analysis of CT images. It does not indicate that this device utilizes machine learning or AI models that would require a distinct "training set" in the modern sense. The "testing" mentioned refers to traditional software validation and verification.
How the ground truth for the training set was established:
- Not applicable, as no training set (for machine learning) is implied or mentioned for this device.

Summary

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K111373

AUG 2 3 2011

510(K) SUMMARY

Image /page/0/Picture/3 description: The image shows a logo with the word "circle" in lowercase letters, with a broken circle above it. Below the word "circle" is the text "CARDIOVASCULAR IMAGING" in all caps. The font appears to be sans-serif and slightly distressed, giving it a textured look.

Submitter's Name	Circle Cardiovascular Imaging Inc.
Address	Suite 12, 3535 Research Road NW, Calgary, AB, Canada T2L 2K8
EstablishmentRegistration Number	3007301305
Date of Summary	May 12, 2011
Telephone NumberFax Number	1 403 338 18701 403 338 1895
Email	shirantha@circlecvi.com
Contact Person	Shirantha Samarappuli
Name of the Device	ct42 Cardiac Computed Tomography (CT) Software
Common or Usual Name	Image Processing System
Classification Name	Classification Name: Picture Archiving and CommunicationsSystemDevice Class: IIProduct Code: LLZRegulation Number: 21 CFR 892.2050
Indications for Use	ct42 is intended to be used for viewing, post-processing andquantitative evaluation of cardiovascular computedtomography (CT) images in a Digital Imaging andCommunications in Medicine (DICOM) Standard format.It enables;● Importing Cardiac CT Images in DICOM format● Supporting clinical diagnostics by qualitative analysisof the cardiac CT images using display functionalitysuch as panning, windowing, zooming, navigationthrough series/slices and phases, 3D reconstruction of

images including multi-planner reconstructions of the

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CIRCLE Cardiovascular Imaging Inc.	ct 42Traditional 510(k)
	images.Supporting clinical diagnostics by quantitative measurement of the heart and adjacent vessels in cardiac CT images, specifically distance, area, volume and massSupporting clinical diagnostics by using area and volume measurements for measuring LV function and derived parameters cardiac output and cardiac index in long axis and short axis cardiac CT images.Supporting clinical diagnostics by quantitative measurements of calcified plaques in the coronary arteries (calcium scoring), specifically Agatston and volume and mass calcium scores
	It shall be used by qualified medical professionals, experienced in examining and evaluating cardiovascular CT images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process. ct 42 is a software application that can be used as a stand-alone product or in a networked environment.
	The target population for the ct 42 is not restricted, however the image acquisition by a cardiac CT scanner may limit the use of the device for certain sectors of the general public.
	ct 42 shall not be used to view or analyze images of any part of the body except the cardiac CT images acquired from a cardiovascular CT scanner.
Device Description	ct 42 is a dedicated software application for evaluating cardiovascular images in a DICOM Standard format. The software can be used as a stand-alone product that can be integrated into a hospital or private practice environment. ct 42 has a graphical user interface which allows users to qualitatively and quantitatively analyze cardiac CT images for volume/mass, and calcium scoring. It provides a comprehensive set of tools for the analysis of Cardiovascular Computed Tomography (CT) images.

and the country of the country of the county of

Document No.	Rev	File name:	Sheet
N/A	00	ct42 Traditional 510k Submission	Page 23 of 78
This document contains information, which is the property of CIRCLE Cardiovascular Imaging, Inc. Thisdocument may not, in whole or in part, be duplicated, disclosed, or used for design or manufacturing purposeswithout the prior written permission of CIRCLE Cardiovascular Imaging, Inc.

and the comments of the comments of the comments of

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CIRCLE Cardiovascular Imaging Inc.

· Craditional 510(k)

510(k) SUMMARY, continued

Indications for Use Comparison

DEVICE	INDICATIONS FOR USE
ct42	ct42 is intended to be used for viewing, post-processing andquantitative evaluation of cardiovascular computed tomography (CT)images in a Digital Imaging and Communications in Medicine(DICOM) Standard format.It enables;Importing Cardiac CT Images in DICOM format
	Supporting clinical diagnostics by qualitative analysis of thecardiac CT images using display functionality such aspanning, windowing, zooming, navigation throughseries/slices and phases, 3D reconstruction of imagesincluding multi-planner reconstructions of the images.Supporting clinical diagnostics by quantitative measurementof the heart and adjacent vessels in cardiac CT images,specifically distance, area, volume and massSupporting clinical diagnostics by using area and volumemeasurements for measuring LV function and derivedparameters cardiac output and cardiac index in long axis andshort axis cardiac CT images.Supporting clinical diagnostics by quantitative measurementsof calcified plaques in the coronary arteries (calciumscoring), specifically Agatston and volume and mass calciumscores
	It shall be used by qualified medical professionals, experienced inexamining and evaluating cardiovascular CT images, for the purposeof obtaining diagnostic information as part of a comprehensivediagnostic decision-making process. ct42 is a software application thatcan be used as a stand-alone product or in a networked environment.
	The target population for the ct42 is not restricted, however the imageacquisition by a cardiac CT scanner may limit the use of the devicefor certain sectors of the general public.
	ct42 shall not be used to view or analyze images of any part of thebody except the cardiac CT images acquired from a cardiovascularCT scanner.

Document No.	Rev	File name:	Sheet
N/A	00	ct42 Traditional 510k Submission	Page 24 of 78

This document contains information, which is the property of CIRCLE Cardiovascular Imaging, Inc. This document may not, in whole or in part, be duplicated, disclosed, or used for design or manufacturing purposes without the prior written permission of CIRCLE Cardiovascular Imaging, Inc.

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CIRCLE Cardiovascular Imaging Inc.

and the same of the same of the same of the same of the same of the same

い ct42 Traditional 510(k)

DEVICE	INDICATIONS FOR USE
K083446	The Cardiac Function Analysis software option for use with Ziostation is intended
Cardiac Function	for noninvasive post-processing of DICOM compliant cardiac CT images to semi-
Analysis	automatically calculate and display various functional parameters, such as left
Calcium Scoring	ventricular ejection fraction, end diastolic volume, end systolic volume, strokevolume, cardiac output, cardiac index, wallthickness, wall thickness ratio and regional wall motion display. Thesemeasurements can be used to assist the clinician in a cardiac evaluation.The Calcium Scoring software option for use with Ziostation is a non-invasivepost processing software tool that can be used with CT images to evaluatecalcified plaques in the coronary arteries, which may be a risk factor for coronaryartery disease.

Device Comparison Table

Feature	Ziosoft - Cardiac Function Analysis & Calcium Scoring	ct42	Remarks
510k #	K083446	TBD
Device Class	II	II
Device Classification	LLZ	LLZ
Regulation Name	Picture Archiving and communications systems	Picture Archiving and communications systems
Regulation Number	21 CFR 892.2050	21 CFR 892.2050
Post processes ECG gated - Cardiac CT images	YES	YES
Image viewer functionality	YES	YES
Left ventricular ejection fraction	YES	YES
End diastolic volume	YES	YES
End systolic volume	YES	YES
Stroke volume	YES	YES
Cardiac output	YES	YES
Cardiac Index	YES	YES
Wall thickness	YES	YES
Wall thickness ratio	YES	YES
Wall movement	YES	YES
Volume Curve	YES	YES
Calcium Scoring	YES	YES
Evaluates calcified plaque in the coronary arteries,	YES	YES
Agatston calcium score	YES	YES
Volume calcium score	YES	YES
Calcium mass/density calculations	YES	YES	Ziosoft calculate density and ct42 calculate mass
DICOM complaint	YES	YES

Document No.	Rev	File name:	Sheet
N/A	00	ct42 Traditional 510k Submission	Page 25 of 78
This document contains information, which is the property of CIRCLE Gardiovascular Imaging, Inc. This
document may not, in whole or in part, be duplicated, disclosed, or used for design or manufacturing purposeswithout the prior written permission of CIRCLE Cardiovascular Imaging, Inc.

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ct42 Traditional 510(k)

510(k) SUMMARY, continued

Description and Conclusion of Testing

Testing:

ct 4 have been tested according to the specifications that are documented in a Master Software Test Plan. Testing is an integral part of Circle Cardiovascular Imaging Inc software development process as described in the company's product development process.

Conclusion:

The successful non-clinical testing demonstrates the safety and effectiveness of the ct22 when used for the defined indications for use and demonstrates that the device for which the 510(k) is submitted performs as well as or better than the legally marketed predicate device.

Document No.	Rev	File name:	Sheet
N/A	00	ct42 Traditional 510k Submission	Page 26 of 78
This document contains information, which is the property of CIRCLE Cardiovascular Imaging, Inc. Thisdocument may not, in whole or in part, be duplicated, disclosed, or used for design or manufacturing purposeswithout the prior written permission of CIRCLE Cardiovascular Imaging, Inc.

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Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

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

Shirantha Samarappuli, Ph.D. Vice President-Regulatory Affairs and Quality Assurance Circle Cardiovascular Imaging 12, 3535 Research Road NW Calgary, AB. T2L 2K8 CANADA

AUG 2 3 2011

Re: K111373

Trade/Device Name: ct12 Cardiac Computed Tomography (CT) Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ. Dated: August 10, 2011 Received: August 12, 2011

Dear Dr. Samarappuli:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 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/cdrl/industry/support/index.html.

Sincerely Yours.

Mary Patel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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CIRCLE Cardiovascular Imaging Inc.

Ct42 Traditional 510(k)

INDICATIONS FOR USE

510(k) Number (if known): K ( 1 ( 37 3

Device: ct22 Cardiac Computed Tomography (CT) Software

Indications for Use:

ct 2 is intended to be used for viewing, post-processing and quantitative evaluation of cardiovascular computed tomography (CT) images in a Digital Imaging and Communications in Medicine (DICOM) Standard format. It enables;

. Importing Cardiac CT Images in DICOM format
. Supporting clinical diagnostics by qualitative analysis of the cardiac CT images using display functionality such as panning, windowing, zooming, navigation through series/slices and phases, 3D reconstruction of images including multiplanner reconstructions of the images.
. Supporting clinical diagnostics by quantitative measurement of the heart and adjacent vessels in cardiac CT images, specifically distance, area, volume and mass
. Supporting clinical diagnostics by using area and volume measurements for measuring LV function and derived parameters cardiac output and cardiac index in long axis and short axis cardiac CT images.
Supporting clinical diagnostics by quantitative measurements of calcified plaques . in the coronary arteries (calcium scoring), specifically Agatston and volume and mass calcium scores

It shall be used by qualified medical professionals, experienced in examining and evaluating cardiovascular CT images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process. ct3 is a software application that can be used as a stand-alone product or in a networked environment.

The target population for the ct3 is not restricted, however the image acquisition by a cardiac CT scanner may limit the use of the device for certain sectors of the general public.

ct ' shall not be used to view or analyze images of any part of the body except the cardiac CT images acquired from a cardiovascular CT scanner.

Over-The-Counter Use Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary Spatd
(Division Sign-On)

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).