The Emory Cardiac Tool Box™ (CEqual®,EGS™) software program should be used for the quantification of perfusion (CEqual®) and for the display of wall motion and quantification of left-ventricular function parameters from gated TC99m SPECT myocardial perfusion studies (EGSTM).

Device Description

The Emory Cardiac Tool Box™ (CEqual®, EGS™) is used to display gated wall motion and for quantifying parameters of left-ventricular from gated SPECT myocardial perfusion studies. These parameters are: ejection fraction, end-diastolic volume, end-systolic volume, myocardial mass and transient ischemic dilatation (TID). This program was developed to run in the IDL operating system environment and can be executed on any nuclear medicine computer systems which supports IDL. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the "Emory Cardiac Tool Box" device, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes the device's functionality and its intended use but does not explicitly state numerical acceptance criteria for its performance. Instead, it refers to the "expected accuracy of the program" being found in a multicenter trial. The "reported device performance" is thus interpreted as the success in demonstrating equivalence to a predicate device through these studies.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Inferred)	Reported Device Performance
Substantial Equivalence to Predicate Device (SPECTEF Protocol, K954874)	Demonstrated through various stages of software development (design, coding, debugging, testing, validation), phantom and computer simulations, in-house trial validations, and a multicenter trial validation. The FDA concluded substantial equivalence.
Quantification of Left-Ventricular Parameters:	Parameters quantified by the device: Ejection Fraction, End-Diastolic Volume, End-Systolic Volume, Myocardial Mass, Transient Ischemic Dilatation (TID).
Accuracy of Ventricular Parameter Calculation:	Evaluated in an in-house trial of 217 patients and a multicenter trial of 80 patients. (Specific accuracy metrics are not provided in this document).
Display of Gated Wall Motion:	Device successfully displays gated wall motion.
User Verification and Manual Processing Capability	Provided for user verification of output and manual processing.

Study Details

The document refers to two main types of studies: in-house trial validations and a multicenter trial validation.

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

In-house trial validations: 217 patients
- Provenance: Not explicitly stated, but "in-house" suggests data likely from Emory University or affiliated institutions. The temporal nature (retrospective/prospective) is not specified.
Multicenter trial validation: 80 patients
- Provenance: "Multicenter trial" implies data from multiple institutions, but specific countries of origin are not mentioned. The temporal nature (retrospective/prospective) is not specified.

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

The document does not specify the number of experts used to establish ground truth or their qualifications for either the in-house or multicenter trials. It mentions that the physician should integrate all clinical and diagnostic information for a final interpretation, but this is about clinical use, not the ground truth establishment for the validation studies.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done to measure the effect size of how much human readers improve with AI vs. without AI assistance. The device is described as a "display and processing program to aid in the diagnostic interpretation," not as an AI-assisted diagnostic tool in the sense of directly impacting reader performance metrics. It's a quantitative tool for the physician.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the device performs "automatically" and provides quantitative parameters such as ejection fraction and ventricular volumes. Therefore, standalone algorithm-only performance is implied in the calculation of these parameters. However, the document also states, "user verification of output is required and manual processing capability is provided," indicating that it's designed for use with a human in the loop for final interpretation. The validation studies focused on the accuracy of these automatically generated parameters.

7. The Type of Ground Truth Used

The document does not explicitly state the method used to establish ground truth (e.g., expert consensus, pathology, outcomes data). For parameters like ejection fraction and ventricular volumes in nuclear medicine, ground truth is often established through:

Correlation with other imaging modalities (e.g., echocardiography, cardiac MRI - though less common in 1998 for routine validation)
Expert interpretation with manual or semi-automated analysis of raw images (potentially considered "expert consensus" in a practical sense).
It is highly unlikely pathology or outcomes data would be used directly for these specific functional parameters.

8. The Sample Size for the Training Set

The document does not specify the sample size for the training set. It mentions "various stages of software development which included the initial design, coding, debugging, testing, and validation" and "phantom and computer simulations studies," which would likely involve data for development and internal testing/training, but specific numbers are not provided.

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

The document does not specify how the ground truth for the training set was established. Given the device's function (quantification of ventricular parameters), it's highly probable that training data ground truth would have been derived from independently validated measurements, potentially from other imaging modalities or highly experienced manual analysis, but this is not confirmed in the text.

Summary

{0}------------------------------------------------

K980914

JUN 4 1998

ITEM I

510(k) SUMMARY

Safety and Effectiveness

1. Medical Device Establishment:

Emory University Voice: (404) 712-7422 FAX: (404) 712-7961 Contact person: Ernest Garcia, Ph.D. Date Summary Prepared: March 9, 1998

2. Medical Device:

Emory Cardiac Tool Box™ (CEqual®, EGS™) - Display and Processing program for gated SPECT myocardial perfusion studies executing on nuclear medicine computer systems.

3. Medical Device Equivalence:

SPECTEF Protocol developed by GE Medical Systems, Ref. 510(k) #: K954874.

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 display wall motion and determine measurements of ejection fraction and ventricular volumes from his patients

{1}------------------------------------------------

gated SPECT myocardial perfusion study. This program serves merely as a display and processing program to aid in the diagnostic interpretation of a It was not meant to replace or eliminate the standard visual patients' study. analysis of the gated SPECT 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 This comprehensive processing technique (as with all interpretation. In diagnostic imaging) is not perfect, and will be associated with some false positive and false negative results. The expected accuracy of the program can be found in the multicenter trial results listed in the article by Vansant et al (See Item H, Testing & Validation) and 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 The final responsibility for interpretation utilize for his final interpretation. of the study lies with the physician.

6. Marketing History:

several medical device gated SPECT programs There been have the past which perform similar functions to those marketed in the Emory Cardiac Tool Box™ (CEqual®, EGS™). These performed by 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™ (CEqual®, EGS™) provides a program which executes in the IDL operating system environment and we believe is substantially equivalent to the SPECTEF Protocol developed by GE Medical Systems K954874. To our knowledge there have been no safety problems with the SPECTEF Protocol program which has been in the marketplace for over two years.

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 (See Item H, Testing & We contend that the method employed for the Validation). development and the final in-house and multicenter trial validation results of this medical display software program, Emory Cardiac Tool

{2}------------------------------------------------

Box™ (CEqual®, EGS™), have proven its safety and effectiveness. In our opinion the Emory Cardiac Tool Box™ (CEqual®, EGS™) is substantially equivalent to the GE Medical Systems SPECTEF Protocol which has been cleared for marketing. The Emory Cardiac Tool Box™ (CEqual®, EGS™) is intended for the same purpose and raises no new issues of safety or effectiveness.

{3}------------------------------------------------

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 1998

Ernest V. Garcia, Ph.D. Emory University School of Medicine Emory Center For Positron Emission Tomography Emory University Hospital 1364 Clifton Rd., N.E. Atlanta, Georgia 30322

Dear Dr. Garcia:

K980914 Re:

Emory Cardiac Tool Box Dated: March 9, 1998 Received: March 11, 1998 Regulatory class: II 21 CFR 892.1200/Procode: 90 KPS

We have reviewed your Section 510%) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 Federal Food, Drug, and Cosmetic Act (Act). 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 problibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivaliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. This response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/odri/dsmaldsmamain.html".

Sincerely yours,

Kiliai Yin

Lillian Yin. Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

510 (k) NUMBER (IF KNOWN): _ K980914

DEVICE NAME: Emory Cardiac Tool Box™ (CEqual ®, EGS TM)

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)

Jamil A. Severson

(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devi 510(k) Number _

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.