(44 days)
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.
| Test | Objective | Reported Device Performance |
|---|---|---|
| Mechanical Verification and Functionality | Verify the mechanical functionality of the handpiece | Confirmed, no issues mentioned |
| Electrical Verification (Handpiece) | Verify the electrical functionality and safety of the handpiece | Confirmed, no issues mentioned |
| Electrical Verification (Ultimate Gen 2 Gen) | Verify the electrical functionality and safety of the Ultimate Gen 2 Generator. | Confirmed, no issues mentioned |
| Inspectional Verification | Document parameters that can be verified through inspection for the Ultimate Gen 2 gen. | Confirmed, no issues mentioned |
| Plasma Characteristics | Measure effect of generator settings on the plasma stream, plasma stream characterization | Confirmed, no issues mentioned |
| FPGA Validation for the Main Board | Perform testing required to verify Main Board FPGA. | Confirmed, no issues mentioned |
| FPGA Validation for the Display Board | Perform testing required to verify Display Board FPGA. | Confirmed, no issues mentioned |
| Performance Evaluation | Confirm device performance on various tissue types | Confirmed device performance and 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:
- Sample size used for the test set and the data provenance: Not applicable. This document does not describe an AI/ML device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 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.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.