The AtheroEdge™ software is a Window's-based application program used on a personal computer for an automatic measurement of the Intima-Media Thickness (IMT) of the carotid artery from images obtained from ultrasound systems.

Device Description

AtheroEdge™ is a software package that runs on a stand-alone computer running a Microsoft Windows™ XP or Microsoft Windows™ 7.0 Operating System. There is no dedicated medical equipment required for operation of this software application except for an ultrasound machine that is the source of images of the carotid artery. These images are digitally transferred from the ultrasound machine to the computer containing the software application. AtheroEdge™ software provides a means of opening and displaying images in DICOM, ISO Joint Photographic Experts Group (JPEG) Image Compression Standard and Microsoft Windows's BMP formats. AtheroEdge™ then uses proprietary techniques and algorithms to automatically measure the Intima-Media Thickness (IMT) and its variability of the distal (far) wall of the carotid artery in ultrasound image. AtheroEdge™ software provides a means for creating a region of interest on the distal (far) wall image and display by the software. AtheroEdge™ software provides a means of analyzing the content of the image data contained within the region of interest (ROI) and compute the IMT and its variability. AtheroEdge™ can generate, view and print a report indicating what the patient's IMT and its variability values. This information is used adjunctively with other medical data by a physician to help assess the cardiovascular health of a patient. AtheroEdge™ is also capable of storing patient measurement values in the database management system along with the images for future reference.

AI/ML Overview

Acceptance Criteria and Study for AtheroEdge™

This response summarizes the acceptance criteria and the study conducted to demonstrate that the AtheroEdge™ device meets those criteria, based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Device performance within 5% tolerance of the mean manual caliper measurements of IMT values.	AtheroEdge™ software performed within 5% tolerance of the mean manual caliper measurements of IMT values taken from a commercially available ultrasound system.
Device performance within 5% tolerance of the mean expert reader's measurement of IMT values.	AtheroEdge™ software performed within 5% tolerance of the mean expert reader's measurements of IMT values taken from two radiological expert ultrasound tracers.

Note: The acceptance criteria were implicitly defined by the chosen benchmarking methods and the 'within 5% tolerance' goal stated for the performance.

2. Sample Size and Data Provenance

Sample Size for Test Set: 200 carotid ultrasound images from 50 subjects.
Data Provenance: Retrospective, from a longitudinal study. The specific country of origin is not mentioned, but the ultrasound scanner used was a Sonoline Antares from Siemens, USA. The images were "laboratory tested off-line."

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Two radiological expert ultrasound tracers.
Qualifications of Experts: Described as "radiological expert ultrasound tracers." Specific experience levels (e.g., years of experience) are not provided.

4. Adjudication Method for the Test Set

The adjudication method involved "taking its average" of the measurements from the two radiological expert ultrasound tracers. This implies a simple averaging method, rather than a formal consensus or 2+1/3+1 approach.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. The study focused on benchmarking the device's performance against two forms of ground truth (manual caliper and averaged expert readings), not on how human readers improve with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was conducted. The AtheroEdge™ algorithm's performance (without human-in-the-loop assistance) was evaluated by comparing its IMT measurements to:
* Manual caliper measurements.
* Averaged measurements from two expert readers.

7. Type of Ground Truth Used

Two types of ground truth were used:

Manual Caliper Measurements: Taken from a commercially available ultrasound system.
Expert Consensus (Averaged): Mean measurements from two radiological expert ultrasound tracers.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set. It only describes the validation study (test set).

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

Since the training set size and details are not provided, information on how its ground truth was established is also not available in the provided text.

Summary

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K122022

SEP 2 6 2012

510(k) Summary

Submitter's Name: Submitter's Address: Submitter's Telephone: Contact Name:

Date Summary Prepared: Trade or Proprietary: Common or Usual Name: Classification Name:

AtheroPoint™ LLC 208 Otter Glen CT, Roseville, CA, 95661 916-749-5628 Jasjit S. Suri June 21, 2012 AtheroEdge™ Medical Image Processing Workstation System, Image Processing, Radiological, LLZ

Picture Archiving and Communications, 21CFR 892.2050

Device Name	510(k) Number
SonoCalc	K030223
IMT.LAB	K043360

Predicate Devices:

Device Description, Indications of Use and Technology 5.0

5.0.1 Device Description and Its Technology

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measure the Intima-Media Thickness (IMT) and its variability of the distal (far) wall of the carotid artery in ultrasound image. AtheroEdge™ software provides a means for creating a region of interest on the distal (far) wall image and display by the software. AtheroEdge™ software provides a means of analyzing the content of the image data contained within the region of interest (ROI) and compute the IMT and its variability. AtheroEdge™ can generate, view and print a report indicating what the patient's IMT and its variability values. This information is used adjunctively with other medical

data by a physician to help assess the cardiovascular health of a patient. AtheroEdge™ is also capable of storing patient measurement values in the database management system along with the images for future reference.

5.0.2 Device - Indications of Use

Device Comparison Table 5.1

AtheroEdge™ is substantially equivalent to other legally marketed products, specifically, the SonoCalc product (K030223) developed by SonoMetric Health, LLC and Esaote's IMT.LAB product (K043360), when SonoCalc and Esaote IMT.Lab is used for automated measurement of the IMT of the carotid artery. The technological characteristics comparison table is shown below:

CompanyName	AtheroPoint™	Sono Metric Health	ESAOTE IMT.LAB
Product Name	AtheroEdge™	SonoCalc	IMT.LAB
510(k) no	Via this submission	K030223	K043360
Intended Use	The AtheroEdge™software is a Windows-based applicationprogram used on a	The SonoCalc softwareis a Windows-basedapplication programused on a personalcomputer for theautomaticmeasurement of theIntima-Mediathickness (IMT) of thecarotidArtery from imagesobtained fromultrasound systems.	The IMT.LAB softwareis a Windows 2000/XPsoftware applicationpackage to be used on apersonal computer forthe automaticmeasurement of theIntima-Media thickness(IMT) of the carotidartery from videoimages obtained fromEsaote Pie ultrasoundsystems.
Image Source	Ultrasound images.	Ultrasound images.	Ultrasound images.
Operatingenvironment,system andhardware	Stand-alone applicationprogram for use on apersonal computer withMicrosoft Windows.	Stand-aloneapplication programfor use on a personalcomputer withMicrosoft Windows.	Stand-alone applicationprogram for use on apersonal computer withMicrosoft Windows.
Image Format	DICOM, JPEG andWindows's BMP	JPEG and WindowsBMP	DICOM, JPEG andWindows BMP
Image storageand reportgeneration	Yes	Yes	Yes
Automaticdistancemeasurementof the Intima-Mediathickness ofcarotid artery	Yes	Yes	Yes
Classification	90 LLZ892.2050	90 LLZ892.2050	90 LLZ892.2050
ImageCompression	JPEG Loss-less	JPEG Loss-less	JPEG Loss-less

AtheroPoint™ LLC Confidential PreMarket Notification - AtheroEdge™ June 21, 2012

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5.2 Performance Testing and benchmarking

There are no Section 514 performance standards for this class of device. The AtheroEdge™ software has been designed to comply with the following voluntary Standards: .

. Digital Imaging and Communications in Medicine (DICOM).
. ISO Joint Photographic Experts Group (JPEG) Image.
. Microsoft Windows Bitmap (BMP) Image Encoding.
. Two types of clinical validation and performance testing were performed:
(i) Benchmarking against the manual caliper measurements of IMT values taken from commercially available ultrasound system.
(ii) Benchmarking against expert reader's measurement of IMT values taken from two radiological expert ultrasound tracers and taking its average.

The validation study consisted of 200 carotid ultrasound images corresponding to 50 subjects, retrospectively taken from a longitudinal study and laboratory tested off-line. The carotid ultrasound images were scanned with a commercially available ultrasound system using a 13-5 MHz linear transducer of Sonoline Antares ultrasound scanner (Siemens, USA). The acquisition followed echo cardiology standards. The benchmarking results for both validation methods showed that AtheroEdge™ software performed within 5% tolerance of the (i) mean manual caliper measurements of IMT values taken from commercially available ultrasound system and (ii) mean expert reader's measurement of IMT values taken from two radiological expert ultrasound tracers.

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5.3 Conclusion

The results of comparing the intended use, function, technological characteristics, mode of operation and specifications of the AtheroEdge™ with those predicate devices demonstrate that the AtheroEdge™ is substantially equivalent to existing products in the market today.

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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

SEP 26 2012

Jasjit S. Suri, PhD Chief Executive Officer (CEO) AtheroPoint™ LLC 208 Otter Gen Court ROSEVILLE CA 95661

Re: K122022

Trade/Device Name: AtheroEdge Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 21, 2012 Received: July 10, 2012

Dear Dr. Suri:

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 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 comply with an the rece orequirements 801 and 809); medical device reporting (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 nothleate 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 11 July 11 Specific and refice 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 I va may ocain other generational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

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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Indications for Use (IFU)

510(k) Number (if known): Pending

Device Name: AtheroEdge™

Prescription Use _____________________________________________________________________________________________________________________________________________________________ OR (Part 21 CFR 801 Subpart D)

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 of Radiological Devices
510k K122282 OIVD

AtheroPoint™ LLC Confidential PreMarket Notification - AtheroEdge™ June 21, 2012

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).