AccuSketch Cardiac Quantitative Analysis System w/ Advanced Analysis Components is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. AccuSketch is intended to provide and document an objective quantification of coronary artery stenosis and measurement and quantification of left ventricular function. Also provided is the ability to digitize and store video images and the ability to interactively annotate and report current and post procedural patient cardiac status.

Device Description

The AccuSketch Cardiac Quantitative Analysis System w/ Advanced Analysis Components is a PC based software system comprised of 4 individual programs used to view, capture/print, analyze and annotate images from cardiac catheterization procedures. AccuSketch is offered as a complete turn-key system or can be ported into other GE cardiac image devices for image analysis. The AccuSketch is a Personal Computer (PC) based software system designed to be permanently installed in a hospital in or near the cardiac catheterization laboratory. AccuSketch is comprised of four individual programs responsible for a specific function. Their purpose is to view, capture/print, analyze and annotate images from cardiac catheterization procedures. The CardioTree is an editable coronary tree tool used to electronically annotate and document the anatomy of the patient's vessels.

AI/ML Overview

The provided text describes a 510(k) submission for the "AccuSketch Cardiac Quantitative Analysis System w/ Advanced Analysis Components." This submission demonstrates substantial equivalence to predicate devices rather than proving specific performance against acceptance criteria in a standalone study. Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, expert involvement, and ground truth establishment from a dedicated performance study is not explicitly available within this document.

However, I can extract information related to the device description, intended use, and the general approach to demonstrating effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

As this is a 510(k) submission focused on substantial equivalence, explicit "acceptance criteria" with numerical targets and reported performance values from a dedicated performance study are not detailed in the provided text. The document states that the device "employs the same functional scientific technology as its predicate devices" and "is as safe, as effective, and performs as well as the predicate devices," implying a comparison to the established performance of those predicates rather than a new set of independent criteria.

Acceptance Criteria (Implied through Substantial Equivalence to Predicate)	Reported Device Performance (Implied)
Same functional scientific technology as predicate devices.	The device employs the same functional scientific technology as its predicate devices.
As safe as predicate devices.	The device is as safe as the predicate devices.
As effective as predicate devices.	The device is as effective as the predicate devices.
Performs as well as predicate devices.	The device performs as well as the predicate devices.
Complies with voluntary standards.	The device complies with voluntary standards as detailed in Section 9 of the submission.

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

Not explicitly mentioned. The document focuses on demonstrating equivalence to predicate devices and describes internal testing phases (unit, integration, final acceptance, performance, safety, environmental testing) but does not provide details on specific clinical test sets, their sizes, or data provenance (e.g., country of origin, retrospective/prospective).

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

Not explicitly mentioned. Given the nature of a 510(k) addressing substantial equivalence, a formal ground truth establishment by external experts for a test set is not detailed. The device is intended to "aid the Cardiologist or trained technician," suggesting clinical professionals are the intended users who would interpret outputs.

4. Adjudication Method for the Test Set:

Not explicitly mentioned.

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

Not explicitly mentioned. The provided text does not describe an MRMC study or any quantitative effect size of human readers improving with AI vs. without AI assistance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):

Not explicitly mentioned. The document refers to "requirements reviews," "design reviews," and various forms of testing (unit, integration, final acceptance, performance, safety, environmental), which are internal development and quality assurance measures. These are not typically standalone clinical performance studies. The device's stated intended use is to "aid the Cardiologist or trained technician," suggesting a human-in-the-loop design.

7. Type of Ground Truth Used:

Not explicitly mentioned for a formal performance study. The device's function involves "objective quantification of a patient's Left Ventricular function" and "objective quantification of coronary artery stenosis." For these types of measurements in the clinical context, the "ground truth" would typically be established by expert interpretation/consensus or potentially by comparison to other established quantitative methods. However, the document doesn't detail how this was specifically handled for a ground truth in a clinical study.

8. Sample Size for the Training Set:

Not applicable or not mentioned. The document describes a traditional software system for analysis rather than a machine learning/AI model that undergoes a "training" phase with a specific dataset. The "advanced analysis components" refer to software features, not a continuously learning algorithm.

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

Not applicable (as it's not described as an AI/ML training set).

Summary of available information from the document:

Device: AccuSketch Cardiac Quantitative Analysis System w/ Advanced Analysis Components.
Intended Use: Aid cardiologists or trained technicians in providing and documenting objective quantification of Left Ventricular function and coronary artery stenosis, digitize/store video images, and annotate/report cardiac status.
Demonstration of Effectiveness: By demonstrating substantial equivalence to predicate devices (CardioTrace K912829; MUSE Cardiovascular Information System with Accusketch K992937). The device employs the same functional scientific technology and is claimed to be as safe, effective, and perform as well as the predicates.
Quality Assurance Measures (Internal Testing): Risk Analysis, Requirements Reviews, Design Reviews, Unit-level testing (Module verification), Integration testing (System verification), Final acceptance testing (Validation), Performance testing, Safety testing, Environmental testing. These are internal development and verification processes, not a formal clinical performance study demonstrating acceptance criteria.

Summary

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KO23100

OCT 1 1 2002

Section 2 Summary and Certification

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... ... .. .. .. ... ... ... ... ... ... ... .......

510(k) Summary of Safety and Effectiveness
Date:	September 17, 2002
Submitter:	GE Medical Systems Information Technologies8200 West Tower AvenueMilwaukee, WI 53223USA
Contact Person:	Lisa Lee MichelsRegulatory Affairs SpecialistGE Medical Systems Information TechnologiesPhone: (262) 293-1609Fax: (414) 918-8203
Trade Name:Device:	AccuSketch Cardiac Quantitative Analysis System w/ AdvancedAnalysis Components
Common/Usual Name:	Cardiac Image Analysis Station
Classification Names:	System, Image Processing Radiological
Predicate Devices:	CardioTrace K912829; *MUSE Cardiovascular Information System withAccusketch K992937
	*NOTE: AccuSketch Cardiac Quantitative Analysis System w/ Advanced AnalysisComponents is being compared to AccuSketch, classification code LLZ, integrated intoMUSE in K#992637. MUSE classification codes of DQK Programmable DiagnosticComputer (Class II) and DSI Detector & Alarm, Arrhythmia (Class III) are not applicable toAccuSketch component of MUSE.
Device Description:	The AccuSketch Cardiac Quantitative Analysis System w/ AdvancedAnalysis Components is a PC based software system comprised of 4individual programs used to view, capture/print, analyze and annotateimages from cardiac catheterization procedures. AccuSketch is offeredas a complete turn-key system or can be ported into other GE cardiacimage devices for image analysis. The AccuSketch is a PersonalComputer (PC) based software system designed to be permanentlyinstalled in a hospital in or near the cardiac catheterization laboratory.AccuSketch is comprised of four individual programs responsible for aspecific function. Their purpose is to view, capture/print, analyze andannotate images from cardiac catheterization procedures.
Intended Use:	The AccuSketch LV HL is intended to aid the Cardiologist or trainedtechnician in providing and documenting an objective quantification of apatient's Left Ventricular function. The AccuSketch STN HL is intendedto aid the Cardiologist or trained technician in providing anddocumenting an objective quantification of coronary artery stenosis (theamount of vessel closure due to coronary artery disease). The ImageCapture system provides image capture and printing.

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The CardioTree is an editable coronary tree tool used to electronically annotate and document the anatomy of the patient's vessels.

The AccuSketch Cardiac Quantitative Analysis System w/ Advanced Technology: Analysis Components employs the same functional scientific technology as its predicate devices.
The AccuSketch Cardiac Quantitative Analysis System w/ Advanced Test Summary: Analysis Components complies with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the AccuSketch Cardiac Quantitative Analysis System w/ Advanced Analysis Components:
- Risk Analysis

Requirements Reviews .
Design Reviews .
Testing on unit level (Module verification) .
Integration testing (System verification) ●
. Final acceptance testing (Validation)
Performance testing .
Safety testing .
. Environmental testing
The results of these measurements demonstrated that the AccuSketch Conclusion: Cardiac Quantitative Analysis System w/ Advanced Analysis Components is as safe, as effective, and performs as well as the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the top half of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lisa Lee Michels Regulatory Affairs Specialist GE Medical Systems Information Technologies 8200 West Tower Avenue MILWAUKEE WI 53223

Re: K023100

Trade/Device Name: AccuSketch Cardiac Quantitative Analysis System "/Advanced Analysis Components Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system

Regulatory Class: II Product Code: 90 LLZ Dated: September 17, 2002 Received: September 18, 2002

Dear Ms. Michels:

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 adultcration.

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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Page 2

This letter will allow you to begin marketing your device as described in your 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 this 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). 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. Brogdon

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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Page 1 of 1

K D.23/00

510(k) Number (if known):

Haknown, 510(k) filed on September 17, 2002

AccuSketch Cardiac Quantitative Analysis System w/Advanced Analysis Device Name: Components.

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

David A. Lyman

(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 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).