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The Bovie Ultimate® Electrosurgical Generators are indicated for delivery of radiofrequency energy and/or helium gas plasma to cut, coagulate and ablate soft tissue during open and laparascopic surgical procedures. The J-plasma portion of the generator can be used only with dedicated Bovie J-Plasma handpieces.

The Bovie J-Plasma Precise Open® Handpiece is intended to be used in conjunction with the Bovie Ultimate® electrosurgical generator for the delivery of radiofrequency energy and/or a helium gas plasma for electrosurgical cutting, coagulation and ablation of soft tissue during open surgical procedures. The Bovie J-Plasma Precise Open® Handpiece is compatible with Bovie Ultimate® Electrosurgical Generators BVX-200H, and BVX-200P.

Bovie Ultimate® Gen 2 Electrosurgical Generator is a multipurpose electrosurgical device that delivers high frequency electrical energy to cut and coagulate soft tissue. It can also deliver Helium gas plasma energy (J-Plasma) for the cutting, coagulation, and ablation of soft tissue.

The Ultimate Gen 2 electrosurgical generator is the next generation of the original Bovie Ultimate®. The Ultimate Gen 2 has offers the same electrosurgical modes and has the same performance specifications as the original Bovie Ultimate, but the Ultimate Gen 2 will be compatible with the new Bovie J-Plasma Precise Open handpiece passive accessory.

The Bovie J-Plasma Precise Open Handpiece is a sterile, single use electrosurgical accessory intended to be used in conjunction with the Bovie Ultimate Gen 2 electrosurgical generator for the delivery of radiofrequency energy and/or a helium plasma gas for electrosurgical cutting, coagulation and ablation of soft tissue during open surgical procedures. The handpiece utilizes a retractable blade or needle electrode to ignite the helium gas to create the plasma.

This document is a 510(k) premarket notification for electrosurgical devices, primarily comparing a new generation device to a predicate device. It does not contain information typically found in an AI/ML device study.

Therefore, the requested information cannot be fully provided from this document as it relates to clinical performance studies for AI/ML devices. I will extract the information that is present, or state its absence.

Acceptance Criteria and Study for an AI/ML Device:

This document describes an electrosurgical device (Bovie J-Plasma Precise Open Handpieces & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator), not an AI/ML device. Therefore, the requested information regarding AI/ML device performance and studies is not applicable.

However, I can provide a summary of the performance testing performed for this electrosurgical device, as detailed in the document.

1. Table of Acceptance Criteria and Reported Device Performance (for Electrosurgical Device):

The document lists performance tests but does not present specific quantitative acceptance criteria or reported performance values in a table format that allows for direct comparison against pre-defined thresholds. Instead, it indicates that testing was performed to "assure that the Bovie J-Plasma Precise Open Handpiece and the Ultimate Gen 2 meet performance requirements." The "Objective" column in the provided table serves as a high-level acceptance criterion for each test. The study confirms device performance and demonstrates equivalent tissue effect.

*The document states: "The Bovie J-Plasma Precise® Open Handpiece and Ultimate Gen 2 were subjected to verification testing that confirmed device performance and demonstrated equivalent tissue effect between the J-Plasma passive accessory and active accessory."

Regarding AI/ML specific questions:

2. Sample size used for the test set and the data provenance: Not applicable. This document does not describe an AI/ML device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this electrosurgical device is its ability to perform its intended functions (cutting, coagulation, ablation) and meet safety standards.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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