(111 days)
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.
§ 870.2900 Patient transducer and electrode cable (including connector).
(a)
Identification. A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.(b)
Classification. Class II (performance standards).