The revised Wackers-Liu CQ® Software is a stand-alone software package for quantification of emission computed tomography (ECT) myocardial perfusion images. The data generated by the Wackers-Liu CQ® Software is intended to be used by the physician in addition to other complementary data in the evaluation of cardiac function and blood supply. It is not meant to replace or eliminate the physician's standard visual interpretation of the patient study or the integration of additional clinical and/or diagnostic information (patient history, stress and/or rest EKG, echocardiogram, etc.) prior to making any final clinical diagnostic or treatment decision. The Wackers-Liu CQ® Software also provides for transmission of ECT images over the internet.

Device Description

The revised Wackers-Liu CQ® Software is a stand-alone software package. This original product is the automated commercial version of a totally integrated and manually operated cardiac imaging analysis package developed by Drs. Wackers and Liu, and others at the Yale University Cardiovascular Nuclear Imaging Laboratory and described extensively in the peer-reviewed literature. Modifications to the cleared Wackers-Liu CQ® Software consist of changes to the handling of non-circular left ventricular edges and counting voxels. Changes to the Wackers-Liu CQ® Software are transparent to the user.

AI/ML Overview

ECLIPSE Systems, Inc., Modified Wackers-Liu CQ® Software Acceptance Criteria and Study Details

The provided 510(k) summary for the ECLIPSE Systems, Inc., Modified Wackers-Liu CQ® Software focuses on demonstrating substantial equivalence to its predicate device (Wackers-Liu CQ® Software, K002229) rather than establishing novel safety and effectiveness criteria through extensive clinical trials. Therefore, the "acceptance criteria" discussed here relate to the verification and validation of the modifications made to the software, and the "study" is primarily a performance testing and comparison to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

The submission implicitly establishes its "acceptance criteria" by demonstrating that the revised software performs equivalently to the cleared predicate device and "correlates favorably with clinical judgment." The specific performance metrics are not explicitly quantified in a table of acceptance criteria; instead, the claim is based on the functional equivalence outlined in Table E-1 and general performance validation.

Feature/Metric	Acceptance Criteria (Implied)	Reported Device Performance
Functional Equivalence	Maintains all functionalities of the predicate device (K002229).	"The revised Wackers-Liu CQ® Software fulfills performance specifications, equivalent to those obtained with the original Wackers-Liu CQ® Software." (Table E-1 demonstrates feature-by-feature equivalence).
Clinical Correlation	Correlates favorably with clinical judgment.	"Correlates favorably with clinical judgment." (No specific metrics or statistical values provided in this summary)
Handling of Non-circular LV Edges	Improved or maintained accuracy in handling non-circular left ventricular edges.	The modification specifically addresses "changes to the handling of non-circular left ventricular edges," implying a refinement or correction for this scenario. No specific performance improvement metrics are provided.
Counting Voxels	Improved or maintained accuracy in counting voxels.	The modification includes "counting voxels," implying a refinement or correction for this scenario. No specific performance improvement metrics are provided.

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

Sample Size for Test Set: Not explicitly stated. The summary mentions "Verification and validation testing," but does not provide details on the number of cases or images used for this testing.
Data Provenance: Not explicitly stated. Given the context of a software modification and comparison to a predicate, it is likely that existing datasets, potentially from the Yale University Cardiovascular Nuclear Imaging Laboratory where the original software was developed, were used. The submission does not specify if the data was retrospective or prospective, or its country of origin.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not explicitly stated. The statement "correlates favorably with clinical judgment" implies an assessment by medical professionals. However, the exact number, their roles in establishing ground truth, or their specific qualifications (e.g., radiologist with X years of experience) are not detailed in this summary.
Qualifications of Experts: Not explicitly stated.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified.

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

MRMC Study: No. The summary does not mention an MRMC study comparing human readers with and without AI assistance. The focus is on the performance of the software itself and its equivalence to the predicate.
Effect Size of Human Readers with/without AI: Not applicable, as no MRMC study was reported.

6. Standalone (Algorithm Only) Performance Study

Standalone Study: Yes. The performance testing described (though lacking detail) appears to be a standalone evaluation of the modified software to ensure it functions as intended and is equivalent to the predicate. The device itself is described as "a stand-alone software package for quantification of emission computed tomography (ECT) myocardial perfusion images." The comparison to the predicate and the favorable correlation with clinical judgment would form the basis of this standalone assessment.

7. Type of Ground Truth Used

Type of Ground Truth: The summary refers to "clinical judgment" and the original software being "developed by Drs. Wackers and Liu, and others at the Yale University Cardiovascular Nuclear Imaging Laboratory and described extensively in the peer-reviewed literature." This suggests that the ground truth for the underlying algorithm (and by extension, the validation of the modified software) was established through expert consensus based on clinical interpretation and potentially other diagnostic information (e.g., patient history, EKG, echocardiogram), as the intended use explicitly states, "The data generated by the Wackers-Liu CQ® Software is intended to be used by the physician in addition to other complementary data in the evaluation of cardiac function and blood supply."

8. Sample Size for the Training Set

Sample Size for Training Set: Not explicitly stated. The device is a "modified" version of an existing, cleared software. The original software was "the automated commercial version of a totally integrated and manually operated cardiac imaging analysis package developed by Drs. Wackers and Liu, and others at the Yale University Cardiovascular Nuclear Imaging Laboratory." This implies that the original software's underlying algorithms were developed and "trained" (in a general sense of algorithm development and refinement) using a corpus of data from Yale University, but the specific size of this developmental dataset is not provided in this 510(k) summary.

9. How Ground Truth for the Training Set Was Established

How Ground Truth Was Established for Training Set: The ground truth for the original Wackers-Liu CQ® Software (from which this modified version is derived) would have been established through expert clinical interpretation, potentially informed by follow-up outcomes data, pathology (if applicable for myocardial perfusion), and correlation with other diagnostic modalities as part of the extensive research and publications from the Yale University Cardiovascular Nuclear Imaging Laboratory. The modifications in this submission (handling of non-circular LV edges and counting voxels) suggest refinements based on continued understanding and potentially addressing limitations identified in the original implementation, guided by clinical expertise.

Summary

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K032500
page 1 of 3

AUG 2 5 2003

510(k) Summary for the ECLIPSE Systems, Inc., Modified Wackers-Liu CQ® Software (per 21 CFR 807.92)

1. SPONSOR

ECLIPSE Systems, Inc. 540-15 East Main Street Branford, CT 06405

Mr. William Carroll Contact Person: 203-483-0665 Telephone:

August 5, 2003 2. DATE PREPARED:

3. DEVICE NAME

Proprietary Name:	Wackers-Liu CQ® Software
Common/Usual Name:	ECT Quantitative Analysis and image communicationsoftware
Classification Name:	Emission Computed Tomography System and MedicalImage Digitizer

PREDICATE DEVICE 4.

Wackers-Liu CQ® Software (K002229)

DEVICE DESCRIPTION ട.

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6. INTENDED USE

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TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 7.

The claim of substantial equivalence is based on indications for use, operational principles, and technological characteristics. A side-by-side comparison of the Wackers-Liu CQ® Software to the cleared Wackers-Liu CQ® Software is provided in Table E-1 below.

Characteristic	RevisedECLIPSESystems, Inc.Wackers-Liu CQ®	ECLIPSESystems, Inc.Wackers-Liu CQ®K002229
Used to quantify ECT images	Yes	Yes
Automatic processing	Yes	Yes
Manual processing capability	Yes	Yes
Slice-by-slice viewing	Yes	Yes
3D imaging	Yes	Yes
Computes and displays left ventricular chamber volume	Yes	Yes
Computes and displays ejection fraction	Yes	Yes
Compares data to "normal" database	Yes	Yes
Display left ventricular endocardial/epicardial surfaces	Yes	Yes
Displays polar maps indicating perfusion	Yes	Yes
Displays wall thickening	Yes	Yes
Displays wall motion	Yes	Yes
Displays 3D rendered image of cardiac surfaces	Yes	Yes
Displays short axis, vertical long, and horizontal long slice data	Yes	Yes
Displays single data set or comparison of related data sets	Yes	Yes
Can be executed on most nuclear medical computers	Yes	Yes
Can be executed on PC computers	Yes	Yes
Can be executed on Macintosh computers	No	No

Table E-1. Comparison of the Revised and Original Wackers-Liu CQ® Software

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8. PERFORMANCE TESTING

K032550
page 3/3

Verification and validation testing of the revised Wackers-Liu CQ® Software demonstrates that the ECLIPSE Systems, Inc., Wackers-Liu CQ® Software fulfills performance specifications, equivalent to those obtained with the original Wackers-Liu CQ® Software, and correlates favorably with clinical judgment.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three wavy lines extending from its body, representing the department's mission to protect and promote the health and well-being of Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 5 2003

ECLIPSE Systems, Inc. % Ms. Rosina Robison, RN, Med, RAC Senior Staff Consultant Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760

Re: K032500

Trade/Device Name: Wackers-Liu CQ® Software . Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS Dated: August 11, 2003 Received: August 13, 2003

Dear Ms. Robinson:

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 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. 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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510(k) Number (if known): K د 3 2500

Device Name: ECLIPSE Systems, Inc., Revised Wackers-Liu CQ® Software

Indications for Use:

The revised Wackers-Liu CQ® Software is a stand-alone software package for quantification of emission computed tomography (ECT) myocardial perfusion images. The data generated by the Wackers-Liu CQ® Software is intended to be used by the physician in addition to other complementary data in the evaluation of cardiac function and blood supply. It is not meant to replace or eliminate the physician's standard visual interpretation of the patient study or the integration of additional clinical and/or diagnostic information (patient history, stress and/or rest EKG, echocardiogram, etc.) prior to making any final clinical diagnostic or treatment decision. The Wackers-Liu CO® Software also provides for transmission of ECT images over the internet.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Leymm

eproductive, Abdominal 510(k) Number

Prescription Use u (Per 21 CFR 801.109)

Over-the-Counter Use

ECLIPSE Systems, Inc., Special 510(k) Revised Wackers-Liu CQ® Software

August 11, 2003

Regulation Number and Section

N/A