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Manually operated surgical device intended for making incisions into the patient's body to allow insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures.

Manually operated surgical device intended for creating a surgical space by dissecting layers of connective tissue along natural planes to allow insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures.

Manually operated surgical device intended for providing a well anchored and gas tight instrument channel to allow insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures.

The Pajunk Trocars together with the Trocar Sleeves, the Pajunk Balloon Systems and the according accessories are manually operated surgical devices used by physicians for making incisions into the patient's body to allow insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures.

The Paiunk Trocar Sleeves are rigid tubes placed with the help of Trocars or Obturators into the patient's body to allow insertion of endoscopes and endoscopic accessories.

The trocars are used together with the trocar sleeves for puncture of the patient's body. The trocar is then removed to allow insertion of endoscopes and endoscopic accessories.

The Pajunk Safety-Trocar features a sharp, beveled tip that is covered by an inside, spring loaded, blunt obturator (Veress-concept). During puncture, the obturator is pushed into the shaft against the force of the spring and thus releases the cutting tip which can now penetrate the skin layers. As soon as the abdominal space is reached, the blunt obturator is moved forward by the spring, covers the cutting tip and prevents injuries in the abdomen.

The PAJUNK distension balloon system is indicated for laparoscopic procedures specially in extraperitoneal surgery, where dissection of tissue in the extraperitoneal space under direct view is essential.

The PAJUNK structural balloon system is indicated for laparoscopic procedures specially in extraperitoneal surgery, where a solid anchored and gas-tight entry port with an instrument channel together with a mechanical support of the extraperitoneal work space is needed. The inflation of the balloon causes a continuing dissection and anchoring in the extraperitoneal work space.

The PAJUNK Ring-Anchor balloon system is indicated for laparoscopic procedures specially in extraperitoneal surgery, where a solid anchored and gas-tight entry port with an instrument channel is needed.

The disposable valve top is used with the Pajunk trocar sleeves and provides the same intended use. The valve is used instead of the trap door valve. The top is made out of polymer instead out of chromated brass. The metal tube is reusable and identical to the ones of the Paiunk trocar sleeves. The advantage is the easier cleaning, sterilization and assembling procedure.

The Pajunk fixable slide cones with or without a fixation thread and with suture holders on both sides have been designed for first puncture technique according to Hasson in laparoscopic applications.

The reducer sleeve is inserted into the actually used trocar sleeve to reduce the diameter for improved quide and gas-tight insertion of endoscopic surgical instruments with outer diameters smaller than the nominal inner diameter of the trocar sleeve.

If the actually applied trocar sleeve does not provide sufficient space for needed endoscopes and endoscopic accessories or endoscopic surgical instrument it can be replaced with a larger trocar sleeve.

The trocar stop with fixation thread is used to fixate the insertion of the trocar sleeve. The trocar sleeve is fixed by hand with a screw.

This document is a 510(k) Summary of Safety and Effectiveness for Pajunk GmbH's Trocars, Trocar Sleeves, Distension System, and Anchoring System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the way a clinical trial might.

Therefore, many of the requested categories for describing a study proving acceptance criteria cannot be directly extracted from this type of regulatory submission. This document primarily asserts that the new devices are substantially equivalent to existing, legally marketed predicate devices, meaning they have similar features, intended uses, and do not raise new issues of safety or effectiveness.

Here's an analysis based on the provided text, highlighting where information is available and where it is not:

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

This document does not present a table of specific acceptance criteria (e.g., performance metrics like penetration force, sealing integrity, or specific clinical outcomes) nor does it report detailed device performance data against such criteria. The "acceptance criteria" here is met through the demonstration of substantial equivalence to predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This submission relies on an equivalency claim rather than new clinical data from a dedicated test set. The data provenance would be a comparison to existing predicate devices already on the market.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth, in the context of device performance, would typically be established through clinical observation or objective measurements. This document does not describe such a process for a new clinical trial. The "ground truth" for substantial equivalence is the safety and effectiveness profile of the predicate devices.

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

Not applicable. No test set requiring adjudication in the clinical study sense is described.

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. This device is a surgical tool, not an AI diagnostic/interpretive system. Therefore, an MRMC study related to AI assistance is irrelevant.

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

Not applicable. This is not an algorithm-only device. It is a manually operated surgical device used by physicians.

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

The "ground truth" for the regulatory submission is based on the established safety and effectiveness of the predicate devices already on the market. The submission asserts that the new device has "similar basic features and intended uses" to these predicates and "raise no new issues of safety and effectiveness."

8. The sample size for the training set

Not applicable. There is no concept of a "training set" in the context of this 510(k) submission for a surgical instrument.

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

Not applicable. See point 8.

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