(54 days)
The disposable laparoscopic electrodes are intended for use in minimally invasive surgical procedures where monopolar electrosurgical cutting and coagulation are desired.
The disposable laparoscopic electrodes are classified by FDA as an "Electrosurgical, Cutting & Coagulation Device and Accessories", under the General & Plastic Surgery Panel, Product Code GEI, Regulation number 878.4400, Class II, panel 79. The devices are provided to healthcare professional only.
The New Deantronics disposable laparoscopic electrodes are used in conjunction with monopolar electrosurgical pencils that accept 2.36 mm connectors, trocars or cannulas with appropriate 5 mm adapters, electrosurgical generator, and patient return electrode. During the operation, the electrode and the insulated shaft are to be inserted through a trocar and the conductive shaft end is inserted into the nose of the electrosurgical pencil from which it receives the high frequency current while contacting target tissue for cutting and coagulation in laparoscopic procedure. The New Deantronics laparoscopic electrodes are single use.
The New Deantronics laparoscopic electrodes consists of four distinct sections, including a conduction insulated shaft, a conductive shaft end, and an electrode tip and a shaft end protector.
There are two groups of laparoscopic electrodes, including non-coated and coated laparoscopic electrodes. The coated laparoscopic electrodes have the same configuration but the electrode tips are coated with non-sticking coating material. The devices are available in five electrode tip configurations and two different shaft lengths.
There are sixteen models of New Deantronics laparoscopic electrodes available.
The provided text describes the New Deantronics Disposable Laparoscopic Electrodes, non-coated and coated, and refers to non-clinical testing to demonstrate its performance and substantial equivalence to predicate devices. However, the document does not contain information about acceptance criteria and reported device performance in the format of a table, nor does it detail a study that proves the device meets specific acceptance criteria as you've requested.
The document primarily focuses on establishing substantial equivalence through comparison of technological characteristics, intended use, and adherence to various recognized standards. It states that "All the test results demonstrate the performance of monopolar laparoscopic accessories meet the requirements of its pre-defined acceptance criteria and intended uses." and "A side by side study comparing the ND electrode to the predicate devices demonstrates substantial equivalence. A thermal Effect Study productions the New Deantronics electrode performs equivalent or better than the predicates. The device is safe and effective based on the non-clinical studies."
However, it does not explicitly list the "pre-defined acceptance criteria" or specific performance metrics in a structured table. Additionally, information regarding sample size, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, standalone performance data, or training set details is not present within this document.
The document mentions that the device "Passes test of 6.3 kV, according to IEC 60601-2-2, 201.8.8.3.104 Capacitive coupled HF current not exceed 50 mA" for electrical safety and "Wire electrode can survive 4 bends with no crack or failure" for mechanical safety. These could be considered acceptance criteria, but they are not presented in a comprehensive table with reported performance.
Therefore, I cannot fulfill your request for the comprehensive table and study details as the information is not provided in the input text.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.