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The intended use of the patient cables is identical to previous patient cables.

The proposed patient cables are identical to the commercially-approved Models 5455, 5455L, 5455S, and 5455SL surgical cables, with the exception of a modified connector for heart wires and leads.

The provided text describes a 510(k) summary for patient cable assemblies and does not contain information related to software performance, AI/ML models, or a clinical study that would typically involve acceptance criteria, test sets, ground truth establishment, or expert evaluations as requested.

The document focuses on demonstrating substantial equivalence of a new medical device (patient cable assemblies) to a predicate device, primarily through nonclinical tests (mechanical, electrical, environmental/packaging, and biocompatibility).

Therefore, I cannot extract the requested information as it is not present in the provided text. The submission is for a physical device, not an AI/ML-driven diagnostic or assistive tool.

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