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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.

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.

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.

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.

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