The SonoCalc software is a Windows-based application program used on a personal computer for the automatic measurement of the intima media thickness of the carotid artery from images obtained from ultrasound systems.

Device Description

SonoCalc is a software package that runs on a stand-alone computer running a Microsoft Windows™ 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. SonoCalc then uses proprietary techniques and algorithms to measure the Intima-Media Thickness (IMT) of either or both of the near or far wall(s) of the carotid artery. SonoCalc can generate a report indicating what the patient's IMT value is. This information is used adjunctively with other medical data by a physician to help assess the cardiovascular health of a patient.

SonoCalc also is capable of storing patient measurement values on the hard disk along with the images for future reference.

AI/ML Overview

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Phantom Study: SonoCalc measuring the distance of targets in an ultrasound phantom from images obtained from a commercially available ultrasound system should perform equivalently to the commercial ultrasound system's caliper measurements.	The results of this test showed that the SonoCalc software performed equivalently to the commercial ultrasound system's caliper measurements of the same phantom.
Clinical Validation Comparison: SonoCalc software measurements of IMT values should perform equal to or better than manual measurements with respect to accuracy and reproducibility.	The results of this study showed that the SonoCalc software performed equal to or better than the manual measurements with respect to accuracy and reproducibility.
Standards Compliance: The SonoCalc software has been designed to comply with the following voluntary standards: ISO Joint Photographic Experts Group (JPEG) Image, Microsoft Windows Bitmap (BMP) Image Encoding.	The SonoCalc software has been designed to comply with the following voluntary standards: ISO Joint Photographic Experts Group (JPEG) Image, Microsoft Windows Bitmap (BMP) Image Encoding. (Compliance of the actual device is implied through the statement rather than explicitly tested as a performance metric.)

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

Sample Size: 120 ultrasound images obtained from 20 different subjects.
Data Provenance: The document does not explicitly state the country of origin. The study appears to be prospective in nature, as it involved scanning subjects with a commercially available ultrasound system specifically for this comparison.

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

Number of Experts: 3 trained sonographers.
Qualifications: "trained sonographers" is the only qualification mentioned. No details on years of experience or certification are provided.

4. Adjudication Method for the Test Set

The document describes "Manual caliper measurements of IMT values from the ultrasound system performed by 3 trained sonographers were compared to measurements of the same images performed by SonoCalc." This suggests a direct comparison method rather than a formal adjudication process (like 2+1 or 3+1). The specific method for reconciling differences between the three sonographers' measurements (if any were present) is not described.

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

The study described is a comparison between SonocCalc and manual measurements performed by 3 sonographers. It does not appear to be an MRMC comparative effectiveness study in the sense of evaluating how much human readers improve with AI assistance versus without. It's a direct comparison of the software's performance against human readers. The document does not provide an effect size for human reader improvement with AI assistance.

6. Standalone Performance

Yes, a standalone study was done. The "clinical validation comparison" directly compares the SonoCalc software's measurements against manual measurements, indicating its performance as an algorithm-only without human-in-the-loop performance calculation. The phantom study also represents a standalone performance evaluation.

7. Type of Ground Truth Used

Expert Consensus/Manual Measurement: The ground truth for the clinical validation was established through "Manual caliper measurements of IMT values from the ultrasound system performed by 3 trained sonographers." This indicates a form of expert-derived ground truth.

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 data.

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

The document does not provide information on how the ground truth for the training set was established, as details about the training set itself are absent.

Summary

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510(k) Summary of Safety and Effectiveness

K030223

This summary of safety and effectiveness is provided in accordance with 21 CFR 807.92.

Date of preparation: 12/31/02

1. Submitter SonoMetric Health, LLC 1373 E. Skyline Dr. Bountiful, UT 84010
  FEB 0 6 2003

2. Contact

Helmuth Fritz, MD, RVT SonoMetric Health, LLC 1373 E. Skyline Dr. Bountiful, UT 84010 Phone: (909) 553-2650 Fax: (909) 790-5284 hsfritz@hotmail.com

3. Device Identification

Tradename: SonoCalc Common name: Medical image measurement software Classification: 892.2050 - Radiology - System, Image Processing

4. Indications for use

5. Device Description

SonoCalc also is capable of storing patient measurement values on the hard disk along with the images for future reference.

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6. Substantial Equivalence

SonoMetric Health believes that SonoCalc is substantially equivalent to other legally marketed products, specifically the Q LAB software package (K021966) developed by ATL Ultrasound (d/b/a Philips Ultrasound) a Philips Medical System Company, when O LAB is used for the automatic measurement of the IMT of the carotid artery.

Characteristic	SonoMetric HealthSonoCalc	QLAB (K021966)
Intended use	Automatic measurementof intima media thicknessof carotid arteries.	Automatic measurementof intima media thicknessof carotid and otherarteries.
Image source	Ultrasound images	Ultrasound images
Operatingenvironment, systemand hardware	Stand-alone applicationprogram for use on apersonal computeroperating with MicrosoftWindows	Stand-alone applicationprogram for use on apersonal computeroperating with MicrosoftWindows
Image format	JPEG and Windows BMP	AVI and BMP
Image storage andreport generation	Yes	Yes

7. Performance standards

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

트 ISO Joint Photographic Experts Group (JPEG) Image
. Microsoft Windows Bitmap (BMP) Image Encoding
트 A ultrasound phantom and image calibration markings verification study for the SonoCalc software was performed. This test consisted of SonoCalc measuring the distance of targets in an ultrasound phantom from images obtained from a commercially available ultrasound system. The results of this test showed that the SonoCalc software performed equivalently to the commercial ultrasound system's caliper measurements of the same phantom
트 A clinical validation comparison was performed using the SonoCalc software and manual measurements of subjects' IMT values. The study consisted of 120 ultrasound images obtained from 20 different subjects who were scanned with a commercially available ultrasound system. Manual caliper measurements of IMT values from the ultrasound system performed by 3 trained sonographers were compared to measurements of the same images performed by SonoCalc. The results of this study showed that the SonoCalc software performed equal to or better than the manual measurements with respect to accuracy and reproducibility

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing health, human services, and well-being. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

FEB 2 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SonoMetric Health, LLC % Mr. N. E. Devine, Jr. Responsible Third Party Entela, Inc. Madison Ave. SE GRAND RAPIDS MI 49548 Re: K030223 Trade/Device Name: SonoCalc Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving 3033 and communications system Regulatory Class: II Product Code: 90 LLZ Dated: January 10, 2003 Received: January 22, 2003

Dear Mr. Devine:

This letter corrects our substantially equivalent letter of February 6, 2003 regarding the date.

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 on 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. Ilsting 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); 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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This letter will allow you to begin marketing your device as describe 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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained form the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

David A. Ingram
Nancy C. Brogdon

for

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SonoMetric Health, LLC

Indications for Use Statement

510(k) Number (if known): _ Ko 30 223

SonoCalc Device Name: _________________________________________________________________________________________________________________________________________________________________

Indication for Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-the-counter Use _________________________________________________________________________________________________________________________________________________________

David h. Seznmm

(Division Sign-Off) Division of Reproductive, and Radiological Devic 510(k) Number _

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).