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Pajunks disposable inserts are 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 Pajunk MIS-System contains but is not limited to electrode-inserts for comfortable and safe coagulation. PAJUNK has extended its range of instruments for MIS by a reuseable, modular system with disposeable inserts, which permits the economic replacement of the sensitive inserts. 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 its bracing future, secured against distortion. A snap-on mechanism locks the instrument insert in the shaft: This whole element 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. For the 1293- and 1292- Combination Handle an ergonomically placed switch allows the ratchet to be easily switched on or off during usage. 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. And with that, PAJUNK® has created the option to always work and also to coagulate with new, guaranteed sharp scissors at every intervention. Three different sizes are available: micro, medium and large. They are packed individually, sterile, and they can be replaced very easily. The fast and easy assembly is based on the ingenious locking mechanism. The scissor-insert is clicked into the connecting rod and tightly screwed together with the guidance tube. Please observe, that the replacement can only be carried out if the scissors are closed.

The provided document is a 510(k) Premarket Notification for "Pajunks disposable inserts for Handle instruments and HF Electrodes." This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting new clinical trials with acceptance criteria and formal studies as described in the request.

Therefore, many of the specific details requested regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not present in this document because they are generally not required for a 510(k) submission that relies on demonstrating substantial equivalence to a previously cleared device.

However, I can extract the relevant information from the document to address the user's request as much as possible:

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

The document does not specify quantitative acceptance criteria or report performance data derived from a formal study against such criteria. Instead, it makes a qualitative claim of "Substantial Equivalence" to a predicate device (Pajunk's monopolar electrodes marketed under K033249).

The "performance" claimed is that the proposed device is "at least as safe and effective as, as well as substantially equivalent to Pajunks predicate device."

Therefore, a table cannot be constructed as requested.

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

No test set or associated data provenance (country of origin, retrospective/prospective) is described in the document. The submission relies on a comparison to a predicate device, not empirical testing data.

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

Not applicable. No ground truth establishment by experts for a test set is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set or adjudication method is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. An MRMC study is not mentioned as this device is a surgical instrument, not an AI-assisted diagnostic tool for "human readers."

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

Not applicable. This device is a surgical instrument, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable. Ground truth for a study is not mentioned. The regulatory decision is based on a demonstration of substantial equivalence.

8. The sample size for the training set

Not applicable. No training set is mentioned as this is not an AI/machine learning device.

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

Not applicable. No training set is mentioned.

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