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The Irrigation Tubing Bipolar Cord Sets are intended to provide irrigation and energy simultaneously to bipolar forceps specifically designed for irrigation.

The Irrigation Tubing Bipolar Cord Se is designed to connect to both an electrical generator and bipolar forceps via an electrically conducting cord and to a saline source for irrigation via a catheter to provide simultaneous coagulation capabilities and irrigation capabilities. A co-extrusion manufacturing process is applied to integrate a bipolar cord with irrigation tubing into one unit. This integrated Irrigation Tubing Bipolar Cord set are helpful to keep the bipolar electrosurgery organized. The electrically conducting cord is formed with a pair of copper wires each coaxially surrounded by an outer insulation sheath. The insulated bipolar cord (24 AWG) provides safety protection to patients and surgical staff. The fluid catheter is formed of PVC and silicone tubing connected by connectors and is defined as fluid passage pathway.

This is a 510(k) premarket notification for a medical device called "Irrigation Tubing Bipolar Cord Sets." As per the provided document, the device's acceptance criteria are demonstrated through non-clinical testing, specifically electrical safety testing and bench testing.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document states: "Electrical safety testing and bench testing has demonstrated that the performance of New Deantronics Irrigation Tubing Bipolar Cord Sets meet the requirements of its pre-defined acceptance criteria and intended uses."

The specific acceptance criteria and detailed performance metrics are not explicitly laid out in a table format in the provided text. However, the document lists the standards the testing was performed in accordance with:

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for the electrical safety testing and bench testing, nor does it explicitly state the data provenance (e.g., country of origin or retrospective/prospective nature). The testing appears to be non-clinical.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. Electrical safety and bench testing typically rely on established engineering standards and test protocols rather than expert consensus on a "ground truth" derived from human interpretation.

4. Adjudication method for the test set

This information is not applicable and is not provided in the document. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes, which is not the nature of the electrical safety and bench testing described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes non-clinical electrical safety and bench testing, not a clinical study involving human readers or cases.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable to the device described. The device is hardware (irrigation tubing bipolar cord sets) and does not involve an algorithm or AI. The testing described is for the physical and electrical performance of the hardware.

7. The type of ground truth used

For electrical safety and bench testing, the "ground truth" is typically defined by established engineering standards and specifications (e.g., IEC standards for electrical safety and performance parameters for fluid flow, cable length, etc.). The device's performance is measured against these objective, predefined criteria.

8. The sample size for the training set

This information is not applicable and is not provided in the document. The device is hardware, not an AI or machine learning model that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable, as there is no training set for this hardware device.

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