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suction/irrigation
Systems for irrigation and aspiration of rinsing liquid in the operating area.

Oenchal modular multifunction suction/irrigation system with pistol handle, maintenance i he Fajant modular many different adaptable tubes and lockable instrument channel for iree & way varro, marry af rinsing liquid in the laparoscopic operating area. The instrument imgation and aspliation of this instruments are inserted and closes when they are channel adomatioally opene would the instrument channel can be opened manually by removed. Allemativery "are xample to remove a hook-type instrument or a biopsy. The prossing a pachbutter.inted/ assembled for cleaning without any tools needed.

Modular Turve fiction handles with trumpet valves or maintenance-free 2-way valves The T ajurit Suchon inigation hardison her in the dismounted without any tools. Each handle can be used with any tube having a M8x1 mm connector; i.e. all handles of the series 1298-XX-00 are completely interchangeable.

The Pajunk adaptable suction/irrigation tubes with connector M8x1 mm can be used with any handle having a M8x1 mm connector. Adaptable suction/irrigation tubes with large LuerLock connector female can be used with any handles of series 1295-XX-00.

Modular multifunction suction/irrigation system with pistol handle, maintenance-free 2-way walve, many different adaptable tubes and lockable instrument channel Ø 5mm for irrigation valve, many direront adaptable the laparoscopic operating area. The instrument channel automatically opens when instruments are inserted and closes when they are removed. automativally the closure of the instrument channel can be opened manually by pressing a Akerhutton for example to repove a hook-type instrument or a biopsy. The system can be dismounted/assembled for feaning without any tools need

This is a 510(k) premarket notification for a medical device, not a study report. Therefore, most of the requested information regarding acceptance criteria, study design, ground truth, and sample sizes for a performance study is not present in the provided text.

The document describes the device, its indications for use, and confirms that the FDA has found it substantially equivalent to legally marketed predicate devices. It does not contain a study demonstrating how the device meets specific acceptance criteria based on performance metrics.

Here's an attempt to answer the questions based on the available information, noting what cannot be extracted:

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

This information is not available in the provided document. The 510(k) submission is about demonstrating substantial equivalence to a predicate device, not typically about reporting specific performance metrics against pre-defined acceptance criteria in the format of a clinical or technical study.

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

This information is not available. The document focuses on the description of the device itself and its equivalence to other devices, not on a performance study with a test set.

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)

This information is not available. No test set or ground truth establishment process is described.

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

This information is not available. No test set or adjudication process 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

This information is not available. The device is a "modular valve handles for adaptable tubes" and an "adaptable suction/irrigation system." It is a surgical instrument, not an AI-assisted diagnostic tool, so an MRMC study or AI-related effectiveness is irrelevant and not applicable.

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

This information is not available and is not applicable. The device is a physical surgical instrument, not an algorithm.

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

This information is not available. No ground truth for performance evaluation is mentioned.

8. The sample size for the training set

This information is not available. The document is not about a machine learning or AI device that would require a training set.

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

This information is not available. Not applicable to this type of device.

Summary of what is present:

• Indications for Use: "suction/irrigation Systems for irrigation and aspiration of rinsing liquid in the operating area."
• Device Description: Modular valve handles, adaptable suction/irrigation tubes, and a modular multifunction suction/irrigation system with a pistol handle, 2-way valve, and lockable instrument channel.
• Regulatory Classification: Class II, Product Code GCJ, Regulation Number 876.1500.
• Outcome: The FDA found the device "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed.

This document serves as an FDA clearance letter based on substantial equivalence, which is a different type of submission than a detailed performance study with defined acceptance criteria and experimental results.

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