The Emory Cardiac Tool Box™ (CEqual®, EGS™) 2.1 software program should be used for the quantification of left-ventricular function parameters and for the display of wall motion and quantification of the results of the SPECT & PET myocardial perfusion studies (EGS™).

Device Description

The Emory Cardiac Tool Box™ 2.1 is used to display gated wall motion and for quantifying parameters of left-ventricular perfusion and function from gated SPECT & PET myocardial perfusion studies. These parameters are: perfusion, ejection fraction, end-diastolic volume, end-systolic volume, myocardial mass and transient ischemic dilatation (TID). In addition, the program offers the capability of providing the following diagnostic information: computer assisted visual scoring, prognostic information, expert system image interpretation, and patient specific 3D coronary overlay. This program was developed to run in the IDL operating system environment which can be executed on any nuclear medicine computer systems which supports IDL and the Aladdin (General Electric) software development environment. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.

AI/ML Overview

The provided text offers details about the Emory Cardiac Tool Box™ 2.1, but it does not explicitly state specific acceptance criteria or present a detailed study comparing device performance against such criteria in a table format. It primarily focuses on demonstrating substantial equivalence to its prior version.

However, based on the information provided, we can infer some aspects related to its validation and the types of studies performed.

Here's a breakdown of the available information structured to answer your questions, with inferences made where direct statements are lacking:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria. It mentions "expected accuracy" for the prior version (Vansant et al.) and states that accuracy for version 2.1 can be found in "Item F (Testing & Validation)" of the 510(k) submission, which is not fully included here.

Instead, the document focuses on validation studies for different features, implying that the successful completion of these studies demonstrated the device's effectiveness.

Feature/Parameter Tested	Performance/Validation Result	Indirect Acceptance Implication
Left Ventricular Functional Parameter Calculations	Evaluated in 217 patients	Successful calculation of parameters in a significant patient cohort.
Multicenter Trial Validation (overall device function)	80 patients	Demonstrated effectiveness in a broader clinical setting.
Computer Assisted Visual Scoring	Successfully evaluated in 20 patients	Ability to assist in visual scoring.
Prognostic Information	Successfully evaluated in 504 patients	Capability to provide prognostic data.
Expert System Image Interpretation	Successfully evaluated in 461 patients	Functionality of the expert system for image interpretation.
Patient Specific 3D Coronary Overlay	Successfully evaluated in 9 patients	Effectiveness of the 3D overlay feature.
Rb-82 Normal Limits Development & Validation	176 patients	Development and validation of normal limits for specific imaging agent.
PET Tools for Perfusion-Metabolism Match-Mismatch	90 patients	Validation of PET tools for specific assessments.
Safety	Determined through software development stages (design, coding, debugging, testing, validation)	Implies software robustness and reliability.

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

The document describes several validation activities rather than a single unified "test set."

Left ventricular functional parameters: 217 patients (retrospective/prospective not specified, country not specified).
Multicenter trial: 80 patients (retrospective/prospective not specified, country not specified).
Computer assisted visual scoring: 20 patients (retrospective/prospective not specified, country not specified).
Prognostic information: 504 patients (retrospective/prospective not specified, country not specified).
Expert system image interpretation: 461 patients (retrospective/prospective not specified, country not specified).
Coronary fusion algorithms (3D overlay): 9 patients (retrospective/prospective not specified, country not specified).
Rb-82 normal limits: 176 patients (retrospective/prospective not specified, country not specified).
PET tools for perfusion-metabolism match-mismatch: 90 patients (retrospective/prospective not specified, country not specified).

The data provenance (country of origin, retrospective/prospective) is not explicitly stated for any of these patient cohorts.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth for any of the validation cohorts. It mentions "physician will utilize for his final interpretation" and "standard visual analysis," implying qualitative assessment by medical professionals, but details are absent.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test sets mentioned in the validation studies.

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

A multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is not explicitly described in the provided text. The document states the program "serves merely as a display and processing program to aid in the diagnostic interpretation" and is "not meant to replace... visual analysis," suggesting an assistive role. However, no study measuring the improvement of human readers with AI assistance is detailed.

6. Standalone (Algorithm Only) Performance

The document does not explicitly describe a standalone performance study where the algorithm's performance is tested without human-in-the-loop. The statement "user verification of output is required" and "manual processing capability is provided" reinforces the idea of human oversight, rather than a purely standalone AI performance. The various "successful evaluations" of parameters and algorithms imply some form of standalone capability for those specific functions, but a comprehensive standalone performance study is not presented.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for the various validation studies. However, given the context of myocardial perfusion studies and functional parameters, it's highly probable that ground truth would have been established through a combination of:

Expert consensus: For visual scoring, interpretation, and potentially defining "normal limits."
Clinical outcomes data: Potentially for prognostic information algorithms.
Corroboration with other diagnostic modalities: Although not explicitly stated, this is common in cardiology.
Known "truth" from phantom/computer simulations: Mentioned as part of the overall effectiveness determination, suggesting a controlled environment for some initial testing.

8. Sample Size for the Training Set

The document does not explicitly state the sample size used for the training set. The patient numbers provided are for "evaluations," "validations," or "trials," which typically refer to test or validation sets rather than pure training sets.

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

Since a training set size or methodology is not explicitly mentioned, the method for establishing ground truth for a training set is not described in the provided text.

Summary

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KO/40 33

ITEM G

FEB 2 2 2002

510(k) SUMMARY

Safety and Effectiveness

1. Medical Device Establishment:

Syntermed, Inc. Registration No. 1066019 Owner Operator I.D. 9041128 Voice/FAX: (714) 281-1256 Contact person: Kenneth F. Van Train Date Summary Prepared: December 4, 2001

2. Medical Device:

Emory Cardiac Tool Box™ 2.1 - Display and Processing program for gated SPECT & PET myocardial perfusion studies executing on nuclear medicine computer systems.

3. Medical Device Equivalence:

Emory Cardiac Tool Box™ (CEqual®, EGS™) Version 2.0, Ref. 510(k) #: K992450,

4. Device Description:

5. Intended Use and Potential Adverse Effect on Health:

The intended use of this program was to provide the physician with a program which would allow him to determine quantitative analysis of the myocardial perfusion, display wall motion and determine measurements of ejection fraction and ventricular volumes from his

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patients gated SPECT & PET myocardial perfusion study, obtain visual interpretation scores, prognostic information, expert system interpretation, and coronary overlay onto 3D perfusion images. This program serves merely as a display and processing program to aid in the diagnostic interpretation of a patients' study. It was not meant to replace or in the days standard visual analysis of the gated SPECT & PET study. The physician should integrate all of the patients' clinical and diagnostic information, i.e. patients' history, stress and/or rest EKG, quality control images, visual interpretation of the gated tomographic images, and quantitative results, prior to making his final interpretation. This tomographic integroe as with all diagnostic imaging) is not perfect, and will be associated with some false positive and false negative results. The expected accuracy of the initial program can be found in the multicenter trial results listed in the article by Vansant et al (See Item F, Testing & Validation for Emory Cardiac Tool Box™ (CEqual®) EGS™) Version 2.0, Ref. 510(k) #: K992450) and the accuracy for version 2.1 can be found in Item F (Testing & Validation) of this 510(k) submission. The physician should be aware of the accuracy when integrating the quantitative results for his final interpretation. Therefore, this program has no direct adverse effect on health since the results represent only a part of the information which the physician will utilize for his final interpretation. The final responsibility for interpretation of the study lies with the physician.

6. Marketing History:

There have been several medical device gated SPECT programs marketed in the past which perform similar functions to those performed by the Emory Cardiac Tool Box™ 2.0. These programs are all used for the purpose of displaying wall motion and deriving functional parameters for the diagnostic interpretation by a physician. The Emory Cardiac Tool Box™ 2.1 provides a program which executes in the IDL operating system environment and we believe is substantially equivalent to our previous version of the Emory Cardiac Tool Box™ 2.0 (CEqual®, EGS™), K992450. To our knowledge there have been no safety problems with the Emory Cardiac Tool Box™ 2.0 (CEqual®, EGS™) program which has been in the marketplace for twentynine months.

7. Conclusions:

The safety of this program has been determined through the various stages of software development which included the initial design, coding, debugging, testing, and validation. The effectiveness of the program has been established in phantom and computer simulations studies, in-house trial validations which included an evaluation of left ventricular functional parameter calculations in 217 patients, and in a multicenter trial validation consisting of 80 patients. In addition, the computer assisted visual scoring, prognosis, expert system, and coronary fusion algorithms were successfully evaluated in 20, 504, 461, and 9 patients respectively. Specific details and results concerning the validation of the Emory Cardiac Tool Box™ 2.1 program for development and validation of Rb-82 normal limits (n=176) and validation of PET tools for assessment of perfusion - metabolism match-mismatch (n=90) are listed in Item F, Testing & Validation. We contend that the method employed for the development and validation of the Rb-82 and PET tools for analysis of

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metabolism and perfusion of this medical display software program, Emory Cardiac Tool Box™ 2.1, have proven its safety and effectiveness. In our opinion the Emory Cardiac Tool Box™ 2.1 is substantially equivalent to our previous version of the Emory Cardiac Tool Box™ 2.0 (CEqual®, EGS™) which has been cleared for marketing. The Emory Cardiac Tool Box™ 2.1 is intended for the same purpose and raises no new issues of safety or effectiveness.

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Image /page/3/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an emblem. The emblem is a stylized representation of a bird or a wing-like shape, composed of three curved lines that suggest movement or flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 2 2002

Mr. Kenneth F. Van Train President Syntermed, Inc. 245 Owens Drive ANAHEIM CA 92808

Re: K014033

Trade/Device Name: Emory Cardiac Toolbox™ 2.1 Executing on Nuclear Medicine Computers Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS Dated: December 4, 2001 Received: December 7, 2001

Dear Mr. Van Train:

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 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 described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nredicate 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 vours.

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

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:____Emory Cardiac-Toolbox 2.1-Executing on Nuclear Medicine Computers

Indications For Use:

The Emory Cardiac Tool Box™ (CEquar®, EGS™) 2.1 software program should be The Emory Cardiac Tool Box = (OEqual + EUG = and for the display of wall motion and used for the quantification of left-ventricular (Ocquar ) and really of the results of the results of the SPECT & PET
quantification of left-ventricular function parameters f myocardial perfusion studies (EGS™): .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number	K017033
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Prescription Use (Per 21 CFR 801.109)	✓	OR	Over-The-Counter Use ______
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Regulation Number and Section

§ 892.1200 Emission computed tomography system.

(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.