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The monopolar forceps and clamps are designed to grasp, dissect and coagulate tissue. They must be connected to the monopolar output of an electrosurgical generator and must only be used with parameters for monopolar coagulation.

Do not exceed a maximum output of 2000 Vp of your generator.

Cables for electrosurgery are designed to conduct electrical power from the output of a high-frequency electrosurgical generator to the electrosurgical instrument.

Do not exceed a maximum output of 6250 Vp of your generator.

Bissinger's Monopolar Forceps are used in various surgical applications. Therefore they are varying in size and build-up, though the general principle remains unchanged.

By using the firmly attached connecting cable, the monopolar forceps can be connected to high-frequency electrosurgical generators.

Monopolar Forceps are used for grasping, dressing and coagulating of tissue. They must be connected to a monopolar output of a high frequency generator by using the attached monopolar cable. The application of monopolar current and connection with a neutral electrode is mandatory.

Bissinger's monopolar forceps either have a straight or bayonet-shaped handle. They are equipped with a firmly attached connecting cable with dual spring connector.

Bissinger Cables are a line of non-sterile, reusable Monopolar Cables fitting Erbe, Martin, Berchtold, Bovie, Valleylab, Codmann Electrosurgical units. They are designed to conduct electrical power from the output of a high frequency generator to the instrument.

This document is a 510(k) Pre-Market Notification for Medagent Incorporated's Bissinger Monopolar Forceps and Cables. It is not an AI/ML device, and therefore the requested information regarding acceptance criteria and study details for AI/ML performance is not present in the provided text.

Specifically, the document discusses:

• The FDA's decision of substantial equivalence to predicate devices (K101080, K072124, K111262, K073450).
• The intended use of the devices (grasp, dissect, and coagulate tissue using a monopolar electrosurgical generator).
• Technological characteristics and safety testing (electrical safety per EN 6061-1:2006 and EN 60601-2-2:2009, sterilization validation, reprocessability validation, manual cleaning validation, and biocompatibility per ISO 10993-1).

Since this is not an AI/ML device, the following categories of information cannot be extracted from the text:

1. A table of acceptance criteria and the reported device performance for an AI/ML model.
2. Sample size used for the test set and data provenance for an AI/ML model.
3. Number of experts used to establish the ground truth for an AI/ML model.
4. Adjudication method for an AI/ML model test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study for AI assistance.
6. Standalone (algorithm only) performance for an AI/ML model.
7. Type of ground truth used for an AI/ML model.
8. Sample size for the training set of an AI/ML model.
9. How the ground truth for the training set was established for an AI/ML model.

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