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The CTS MIDCAB/SVH Bipolar Scissors is intended to cut tissue and control bleeding through coagulation, in general and cardiothoracic surgery, including minimally invasive direct coronary artery bypass ("MIDCAB") and saphenous vein harvesting procedures.

The CTS MIDCAB/SVH Bipolar Scissors is an electrosurgical instrument which consists of a pair of scissor blades which are connected to a handle instrument and an electrosurgical generator. Electric current flows from the electrode to the stainless steel cutting surface of the blades and from the stainless steel cutting surface of one blade to the stainless steel cutting surface of the other blade. The flow of the electric current down the electrode is controlled by the power generator. The overall length of the device, which consists of the handle, tube and blades, is approximately 13 inches. The power cord connecting the handle to the power control unit is approximately 120 inches. The blades are approximately 0.5 inches in length.

The surgeon places the opened scissors across the tissue to be cut and depresses the actuation lever while moving the scissors forward against the tissue. By energizing the power control unit on the actuation lever, the surgeon can simultaneously cut and coagulate the target tissue. Alternately, the power control unit may be controlled via a foot pedal. The surgeon can vary the current flow rate according to the tissue and the amount of bleeding encountered. The power setting used for the CTS Bipolar Scissors is 20-30 watts.

The CTS Bipolar Scissors is provided sterile, nonpyrogenic and for single use.

The provided text is for a 510(k) summary for a medical device (CTS MIDCAB™ /SVH™ Bipolar Scissors) and does not contain information about acceptance criteria or a study proving that the device meets such criteria. Typically, 510(k) summaries for surgical instruments like this focus on demonstrating substantial equivalence to predicate devices rather than presenting performance criteria and detailed study results that would be found for diagnostic devices or AI/ML-driven software.

Therefore, I cannot fulfill your request for the specific sections you've outlined based on the given information.

Here's why and what kind of information would be needed:

• Acceptance Criteria and Reported Device Performance: This would require a clearly defined set of performance metrics (e.g., cutting time, coagulation effectiveness, tissue damage assessment, safety parameters) with specific quantifiable targets and the results from testing to demonstrate achievement of those targets.
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set: These are all components of a clinical or performance study that would establish the efficacy and safety of a diagnostic or AI/ML-enabled device. For a surgical instrument like the bipolar scissors, the "proof" often comes from bench testing, animal studies, and sometimes limited human use studies focused on safety and direct function, rather than large-scale diagnostic accuracy studies.

In the context of the provided 510(k) summary, the "study" is the substantial equivalence comparison to predicate devices, which relies on demonstrating similar intended use, technology, and performance, rather than an independent clinical trial with predefined acceptance criteria for novel performance.

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