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The joimax® Endovapor®2 RF device is intended for the generation of electrical power for monopolar and bipolar cutting and coagulation on tissue structures in surgical operations.

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This document is a FDA 510(k) clearance letter for the joimax Endovapor 2, an electrosurgical device. It primarily focuses on regulatory approval and does not contain specific details about acceptance criteria, study data, or performance metrics in the way a clinical study report or a more detailed technical submission would.

Therefore, most of the requested information regarding acceptance criteria and performance studies cannot be extracted from this document.

Here's what can be stated based on the provided text:

• Device Name: joimax® Endovapor®2
• Regulation Number: 21 CFR 878.4400
• Regulation Name: Electrosurgical cutting and coagulation device and accessories
• Regulatory Class: Class II
• Product Code: GEI
• 510(k) Number: K170358
• Indications for Use: The joimax® Endovapor®2 RF device is intended for the generation of electrical power for monopolar and bipolar cutting and coagulation on tissue structures in surgical operations.

The letter states that the device has been determined to be "substantially equivalent" to legally marketed predicate devices. This implies that the device met the necessary criteria for substantial equivalence, which typically involves demonstrating that the new device is as safe and effective as the predicate device. However, the specific technical or clinical performance data used to support this determination are not detailed in this clearance letter.

Therefore, I cannot provide the requested information for the following points as they are not present in the provided document:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improve with AI vs without AI assistance (This device is an electrosurgical tool, not an AI diagnostic device, so this is unlikely to apply in the traditional sense).
6. If a standalone performance study (algorithm only without human-in-the-loop performance) was done (Again, this is not an AI diagnostic device).
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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