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The Adeor Medical Non-stick Bipolar Forceps are intended for use by a physician familiar with electrosurgery in bipolar coagulation for general open surgery where coagulation of soft tissue is needed. Adeor bipolar forceps must be operated with the following parameters: Frequency range between 300 kHz and 1,000 kHZ; maximum generator operating voltage 600Vp.

The Adeor Medical Non-stick Bipolar Forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.

The types of surgery intended include:

• ENT
• Gynecology (except for use in female sterilization)
• Urology
• General surgery
• Neurosurgery
• Laryngeal Surgery
• Orthopedic Surgery
• Thoracic Surgery

The Adeor Medical AG Bipolar Forceps are electrosurgical instruments used to grasp, manipulate, cut or coagulate tissue. Bipolar forceps have various lengths and tip configurations, as well as irrigation and suction technologies. Both reusable and single-use forceps are available, with flat plug or two pin plug configurations. Bipolar forceps are connected through a suitable bipolar cable with the bipolar output of a high frequency generator and may be used only with bipolar coagulation current. Adeor bipolar forceps must be operated with the following parameters: Frequency range between 300 kHz and 1,000 kHz: maximum generator operating voltage 600Vn.

This FDA 510(k) summary for the "Adeor Medical nxt Non-stick Bipolar Forceps" focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific performance acceptance criteria for an AI/ML medical device.

Therefore, I cannot create a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details, as this document does not contain data related to these aspects for an AI/ML product.

The document primarily discusses the physical characteristics, intended use, and non-clinical testing (electrical safety, wear, function (drop testing)) of surgical forceps, comparing them to legally marketed predicate devices to establish substantial equivalence.

The information provided in the document is about a traditional medical device (bipolar forceps), not an AI/ML device.

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