M'Ath® software is a Windows based application program running on a personal computer that is intended to aid the physician in the organisation of patient data relating to the ultrasound images or video acquired during vascular examination by sonography, and including patient characteristics. Additionally the software allows making measurements to determine the intima media thickness of the carotid artery from the accurate image and store them with the patient file.

Device Description

M'Ath®Std is a software running on a stand alone computer under Microsoft Windows operating system. Images are captured from any ultrasound device. Proprietary algorithms are used to measure Intima Media Thickness ( IMT).Storage of patient measurements values can be performed during the examination. These measurements help to detect early atherosclerosis in the carotid vascular bed.

AI/ML Overview

The provided text reports a 510(k) summary for the M'Ath® Std software, which is intended to aid physicians in measuring Intima Media Thickness (IMT) from ultrasound images. However, the document explicitly states that no performance standards are required for this device class for determining substantial equivalence, and therefore, no specific acceptance criteria or detailed study data proving the device meets acceptance criteria are provided.

The submission focuses on establishing substantial equivalence to predicate devices (K021966, Q Lab Software; K030223, Sonocalc) based on similar intended use, technological characteristics, features, specifications, and mode of operation, rather than presenting a performance study with defined acceptance criteria.

The relevant sections state:

"Performance data: There are no section 514 performance standards for this class of device for assisting in the determination of its substantial equivalence."
"Conclusions drawn from clinical and non clinical test data: Not required for determination of substantial equivalence for this class of device, though publication of some clinical data are contained in this premarket submission."

Therefore, based solely on the provided text, it's not possible to populate all the requested information columns regarding acceptance criteria and study details.

However, I can extract the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified/Not required for substantial equivalence	Substantially equivalent to predicate devices (Q Lab Software and Sonocalc) in intended use, technological characteristics, features, specifications, and mode of operation.

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

Sample size: Not specified.
Data provenance: Not specified (the document mentions "publication of some clinical data are contained in this premarket submission" but does not detail the nature or origin of this data, nor does it link it to a specific test set for performance).

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

Not specified.

4. Adjudication method for the test set

Not specified.

5. 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

Not specified. The document does not describe a comparative effectiveness study of this nature.

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

Not specified. The device is described as "intended to aid the physician," implying human-in-the-loop, but no standalone performance metrics are provided.

7. The type of ground truth used

Not specified.

8. The sample size for the training set

Not specified.

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

Not specified.

Summary

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KOUOSLO

JUL 30 2004

Intelligence in medical Technologies 510K Pr

510K Summary of Safety and Effectiveness

(Completed on July 2004)

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

1. Submitter's Name

Intelligence in Medical Technologies 18-24 Rue Tiphaine Paris 75015 France + 33 (0)1 45 78 11 66 Contact person : Scott Pease PO Box 222 Hartland WI 53029 Tel :414-704-6979 Fax : 414-327-1417

Summary's Date preparation: Submitted March 1, 2004 (completed July 7th 2004)

Device trade name: M'Ath® Std

Common name: Ultrasound Medical Image Measurement Software

Classification Name: 892.2050-System, Image processing, Radiological.

3. Predicate substantially equivalent devices:

K021966, Q Lab Software, Advanced Technology Laboratories, Inc. (dba Philips Ultrasound); -
K030223, Sonocalc, SonoMetric Health, LLC.

Device description : M'Ath®Std is a software running on a stand alone computer under Microsoft Windows operating system. Images are captured from any ultrasound device. Proprietary algorithms are used to measure Intima Media Thickness ( IMT).Storage of patient measurements values can be performed during the examination. These measurements help to detect early atherosclerosis in the carotid vascular bed. Predicate device specifications comparison

	PRINCIPAL DEVICE	PREDICATE DEVICE 1	PREDICATE DEVICE 2
	Intelligence in MedicalTechnologies (IMT)	Advanced TechnologyLaboratories (ATL)	SonoMetric Health ,LLC
	M'Ath Std	Q Lab Software(K021966)	Sonocalc (K030223)
Computer/Operating System	PC Based Hardware andMicrosoft Windowsoperating system.	PC Based Hardware andMicrosoft Windowsoperating system.	PC Based Hardware andMicrosoft Windowsoperating system.
User Interface	PC Keyboard mouse ( 2buttons)	PC Keyboard Mouse	PC Keyboard Mouse
Image Source	Ultrasound	Ultrasound	Ultrasound
Image Format	AVI, JPEG, GIF, TIFF,BMP, PCX, PCD, TGA,EPS, IMG.	AVI,BMP	JPEG and BMP
Data Storage(image and Video)	Yes	Yes	Yes
Report Generation	Yes	Yes	Yes
Measurement ofIntima MediaThickness	Yes	Yes	Yes
Semi AutomaticDetection (Userpoints out where todetect)	Yes	Yes	Yes
Edge Detection	Yes	Yes	Yes
Quality Index	Yes	No	Unknown

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5.Intended use

Performance data: There are no section 514 performance standards for this class of device for assisting in the determination of its substantial equivalence.

Conclusions drawn from clinical and non clinical test data:

Not required for determination of substantial equivalence for this class of device, though publication of some clinical data are contained in this premarket submission.

Substantial equivalence summary: The Intelligence in Medical Technologies (IMT), M'Ath Software is comparable and substantially equivalent to a legally marketed predicate device. The intended use of the Intelligence in Medical Technologies (IMT) software is the same as that of the of the predicate devices "Q Lab Software" marketed by Advanced Technologies Laboratories (d.b.a Philips Ultrasound) and "Sonocalo" marketed by Sonometrics Health ,LLC" . No new safety or effectiveness issues are raised with M'Ath™ Std.The subject device has substantially equivalent technological characteristics, features, specifications, mode of operation, and intended use as a legally marketed predicate device.

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Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized emblem consisting of three curved lines that resemble a bird in flight. The emblem is positioned in the center of the seal.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 0 2004

Intelligence in Medical Technologies % Mr. Scott J. Pease, ASQ CQA-HACCP Consultant, Regulatory/QS PEASE Consulting P.O. Box 222 HARTLAND WI 53029

Re: K040686 Trade/Device Name: M'Ath® Std Regulatory Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: July 12, 2004

Received: July 19, 2004

Dear Mr. Pease:

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 such 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 (OS) 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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Page 2

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 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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,

Nancy C. Bugden

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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er/ 3 - 4/24/96
Applicant:	Intelligence in Medical Technologies
510(k) Number (if known):	K040686
Device Name:	M'Ath Std Software

Indications For Use: M'Ath Std software is a Windows-based application program running on a personal
computer that is intended to aid the physician in the organization of patient data relating to the
ultrasound images or video acquired during echo-cardiology exams of the cardiovascular system,
including the patient's characteristics. Additionally, the software allows the physician to makes
measurements to determine the intima-media thickness of the carotoid artery from the acquired images
and stores them with the patient file.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Prescription Use
------------------	--

(Division Sign-Off)

Division of Reproductive, Abdominal,

and Radiological Devices

510(k) Number	K040686
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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).