"Vascular Tools 5" software program has been developed to aid in quantitative analysis of longitudinal vascular ultrasound images, particularly to determine vascular diameter and intima-media thickness, as well as their changes as depicted in brachial and carotid arterial ultrasound images.

Device Description

"Vascular Tools 5" quantification software system is a state-of-the-art product for computer-aided assessment of vascular diameter, intima-media thickness derived from existing ultrasound images. Based on computer-aided detection of vessel wall borders within a region of interest of a single longitudinal ultrasound image or a sequence of longitudinal ultrasound images, vascular diameter and/or IMT are reported for each ultrasound image frame or a user-defined subset of image frames.

"Vascular Tools 5" is a proprietary software program for vascular ultrasound image quantification designed for installation on an IBM-PC-compatible personal computer and use with Windows 2000 r XP operating platform. It provides tools for display, selection, evaluation, and storage of multiple loops of vascular ultrasound image data. Furthermore, "Vascular Tools 5" facilitate impge on namprt of complete studies in "Vascular Tools 5" format, and the export of results into general spread sheets, databases, or in ASCII formats for further statistical analysis of study results by the users,

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Vascular Tools 5" device:

Important Note: The provided document is a 510(k) summary, which often provides a high-level overview. It states that "Detailed assessment of "Vascular Tools 5" performance is given in Appendix D." However, Appendix D is not included in the provided text. Therefore, several of the specific details requested below (especially regarding the test set, ground truth methods, and expert qualifications) are not explicitly present in the provided document.

Acceptance Criteria and Reported Device Performance

The document states that "Actual device performance as tested internally conforms to the system performance specifications." However, specific numerical acceptance criteria or performance metrics (e.g., accuracy, precision, sensitivity, specificity) for target diameter or IMT measurements are not provided in the supplied text. The 510(k) summary focuses more on the equivalence to a predicate device and the general intent of the software to aid human experts.

Given the information, a table of acceptance criteria and reported device performance cannot be fully constructed with quantitative values from the provided text. The general "acceptance criteria" can be inferred as "satisfies the design intent" and "conforms to system performance specifications."

Acceptance Criteria (Inferred from text)	Reported Device Performance (Inferred from text)
Satisfies the design intent	Meets the design intent
Conforms to system performance specifications	Conforms to system performance specifications
Aids the human expert in obtaining quantitative information	Aids the human expert

Study Details

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The provided document does not specify the sample size for the test set.
- Data provenance (country of origin, retrospective/prospective): This information is not provided in the text.
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):
- This information is not provided in the text. The document repeatedly refers to the human expert for inspection and editing, but does not detail how ground truth for a test set was established.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This detail is not provided in the text.
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:
- A formal MRMC comparative effectiveness study, specifically measuring the improvement of human readers with AI assistance versus without, is not explicitly mentioned or detailed. The document states that the software "aids the human expert to obtain quantitative information" and that the "human expert analyst is responsible for inspection and - if needed - editing of the identified vessel wall borders prior to their approval." This implies a human-in-the-loop workflow, but not a study designed to quantify the effect size of improvement.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies a human-in-the-loop system where the human expert is responsible for final approval and editing. It does not explicitly state whether a standalone (algorithm only) performance assessment was conducted for the purpose of regulatory substantial equivalence. The language "aids the human expert" and "human expert analyst is responsible for inspection and - if needed - editing" strongly suggests the device is not intended for standalone use.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- This information is not explicitly stated in the provided text. Given the clinical context of ultrasound image analysis, it is most likely based on expert measurements, possibly through manual tracing or consensus readings, but this is not confirmed.
The sample size for the training set:
- The sample size for the training set is not provided in the text. The document mentions internal testing and validation but doesn't detail the data used for training.
How the ground truth for the training set was established:
- This information is not provided in the text.

Summary of what is known from the provided text:

Device Purpose: "Vascular Tools 5" is software for computer-aided assessment of vascular diameter and intima-media thickness (IMT) from ultrasound images. It includes "Brachial Analyzer 5" and "Carotid Analyzer 5" modules.
Intended Use: To determine brachial artery diameter, carotid artery diameter, and carotid artery IMT. It "aids the human expert to obtain quantitative information."
Human-in-the-loop: The human expert is responsible for inspecting and editing the identified vessel wall borders before approval.
Validation: "Test and validation results support the conclusion that the actual device performance satisfies the design intent. Actual device performance as tested internally conforms to the system performance specifications."
Missing Details: The document lacks specific quantitative acceptance criteria, test set size, data provenance, ground truth establishment methods, expert qualifications, adjudication methods, and details on standalone or comparative effectiveness studies. These are likely present in the "Detailed assessment... in Appendix D," which is not included.

Summary

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K033266 p.1/2

Medical Imaging Applications, LLC 832 Forest Hill Dr., Coralville IA 52241 phone: (319) 358-1529, fax: (319) 688-5296 e-mail: mia-llc@mia-llc.com URL: http://www.mia-llc.com

Medical Imaging Applications

DEC 1 € 2004

510(k) SUMMARY

Submission in accordance with the requirements of 21 CFR Part 807.87(h)

1) Submitter	Medical Imaging Applications LLC832 Forest Hill Dr.Coralville IA 52241phone: (319) 358-1529fax: (319) 688-5296e-mail: mia-llc@mia-llc.com
Contact personPrepared	Milan SonkaOctober 10, 2004
2) Device Name:	"Vascular Tools 5" consisting of modules: "Brachial Analyzer 5""Carotid Analyzer 5"
Common name	Picture Archival and Communications System

3) Predicate Device: QLAB - Philips Ultrasound, Inc.

892.2050

4) Description of the device:

Classification name:

Regulation Number:

Picture Archival and Communications System, Class II

5) Intended use:

"Vascular Tools 5" have been developed for the objective and reproducible analysis of vascular ultrasound images. The "Vascular Tools 5" data analysis program package components are intended to:

Brachial Analyzer: Determine brachial artery diameter .
Carotid Analyzer: Determine carotid artery diameter .
Carotid Analyzer: Determine carotid artery intima-media thickness .

In each of the above listed intended use items, the Vascular Tools software aids the human expert to obtain quantitative information about the vascular morphology. Same as when using standard clinical

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methods, the human expert analyst is responsible for inspection and - if needed - editing of the identified vessel wall borders prior to their approval.

6) Substantial equivalence Information:

The "Vascular Tools 5" software is believed substantially equivalent to the predicate devices of Philips Medical Systems' K040227"QLAB QUANTIFICATION SOFTWARE" by using the same technological characteristics and identical intended use.

Technological differences between the subject and predicate devices are minor and presented above. lt is concluded that the differences in technical characteristics between the two products are not significant in that there are no features in the subject device that raise new questions regarding safety nor that could result in a decrease of effectiveness as compared to the predicate device.

7) Conclusions respecting safety and performance - Level of Concern:

It is the opinion of Medical Imaging Applications LLC that "Vascular Tools 5" is a safe image quantification software and potential hazards are controlled by a risk management plan for the software development process (see Appendix B), including hazard analysis (see Appendix C), verification and validation tests (see Appendix D). In Medical Imaging Applications LLC's opinion, the level of concern for the stand-alone software to view images is moderate. The use of "Vascular Tools 5" quantification software neither changes the intended use of ultrasound scanners in practice, nor does the use of software result in any new potential hazards.

8) Validation and test conclusions

Test and validation results support the conclusion that the actual device performance satisfies the design intent. Actual device performance as tested internally conforms to the system performance specifications. Detailed assessment of "Vascular Tools 5" performance is given in Appendix D.

9) Release version number

The software release described in this document has a release version number: Version 5.1.1, release date June 1, 2004

Revision Level History No revisions were recorded to date.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle or bird with three curved lines representing its wings or body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 6 2004

Medical Imaging Applications, LLC c/o Mr. Milan Sonka 832 Forest Hill Dr. Coralville, IA 52241

Re: K033266

Trade Name: Vascular Tools 5 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable diagnostic computer Regulatory Class: II (two) Product Code: DQK Dated: October 10, 2004 Received: October 13, 2004

Dear Mr. Sonka:

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 10 mmerce 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

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Page 2 - Mr. Milan Sonka

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. 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 proficated 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 (301) 594-4648. 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 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,

Brimmer for

Bram D. Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):	K033266
Device Name:	"Vascular Tools 5" consisting of modules:"Brachial Analyzer 5", "Carotid Analyzer 5"
Indications For Use:	"Vascular Tools 5" software program has beendeveloped to aid in quantitative analysis oflongitudinal vascular ultrasound images,particularly to determine vascular diameter andintima-media thickness, as well as theirchanges as depicted in brachial and carotidarterial ultrasound images.

X _ AND/OR Over-The-Counter Use ______________________________________________________________________________________________________________________________________________ Prescription Use __ (Part 21 CFR 801 Subpart D) (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 Cardiovascular Devices
510(k) Number K23326

Page 1 of

Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).