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Instruments insulated for optional monopolar coagulation which enable a surgeon to grasp, manipulate, dissect, retrieve, biopsy, cut or coagulate internal tissue or organs while performing laparoscopic procedures.

The Paiunk GmbH Modular Handle Instruments are identical in terms of materials, modes of construction, to the Richard Wolf Medical Modular Forcep and Scissor System.

PAJUNK GmbH Modular Handled Instruments consist of three basic parts: Handles, Guidance Tubes and Instrument Inserts.

Three handles constitute the basis of the system. While the free-moving handle opens and closes without locking into place, the handle with ratchet is especially suitable for securing and holding in place. The combination handle incorporates the advantages of these two handles.

The Guidance Tubes have insulated shafts and include diameter of 3mm (Shaft + Insert = One Unit), 5mm and 10mm.

The instrument inserts consist of four basic types: Grasping Forceps, Scissors, Biopsy Punches and Clamps / Needle Holders.

All handles can be combined with all insulated shafts and instrument inserts, regardless of their size and shape.

The shaft screws onto the handle tightly, and it ensures the safe and secure connection of the two elements. Every module of the handle-instrument is kept in place in its bracing fixture, secured against distortion. A snap-on mechanism locks the instrument insert in the shaft (exception: 3mm tube): This whole clement can then in turn be latched onto the handle by a special locking device. This latching of the connecting rod and the shaft minimizes the torsion stress exerted upon the instrument insert; the double security against distortion transfers the torque also to the entire shaft.

Jacketed with glass fiber-reinforced plastic, the precise mechanical construction of the PAJUNK handle ensures maximum stability.

Designed for left and right handed use, the ergonomically shaped handles are simple and comfortable to operate. The rotary wheel can be adjusted with a little pressure applied by the index finger. A built-in rotation stop secures the desired position when grasping.

The provided documentation does not contain any information regarding acceptance criteria or a study proving that the device meets specific acceptance criteria.

The document is a 510(k) submission for the PAJUNK Modular Handle Instruments, focused on demonstrating substantial equivalence to a predicate device (Richard Wolf Medical, Modular Forcep and Scissor System, K935270).

Here's why the requested information is absent:

• Substantial Equivalence: The primary goal of a 510(k) submission is to demonstrate that a new device is as safe and effective as a legally marketed predicate device. This often involves comparing device characteristics (design, materials, intended use, etc.) and demonstrating that any differences do not raise new questions of safety or effectiveness. It typically does not require the establishment of new, quantitative acceptance criteria or a dedicated study to prove performance against such criteria beyond what was established for the predicate device.
• Focus on Bench Testing and Standards: The "Testing conducted or standards applied to assure safety and effectiveness" section (page 2 of 3) lists compliance with general medical device standards like ISO 11134 (sterilization), ISO 11135 (ethylene oxide sterilization), and ISO 10993 (biocompatibility). These are general safety and performance standards for medical devices, not specific performance criteria for the function of grasping, cutting, or coagulating.
• No Performance Standards Developed: The document explicitly states: "No performance standards have been developed Performance Standards: for this device." This confirms that formal, quantitative performance metrics were not established or tested against for this 510(k).
• No Clinical Trial Information: There is no mention of a clinical trial or even a non-clinical performance study (other than the listed standards compliance) that would involve a test set, ground truth, experts, or statistical analysis of performance outcomes.

Therefore, since the document does not include information on acceptance criteria or a study to meet them, I cannot populate the requested table or answer the specific questions about sample size, data provenance, ground truth, MRMC studies, or standalone performance.

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