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The Renuvion®/J-Plasma® Precise Handpiece is intended to be used with compatible J-Plasma electrosurgical generators for the delivery of helium plasma for cutting, coagulation of soft tissue during open and laparoscopic surgical procedures.

The Renuvion®/J-Plasma® Precise Open Handpiece is intended to be used with compatible J-Plasma electrosurgical generators for the delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. The Renuvion®/J-Plasma® Precise Open® Handpieces are compatible with electrosurgical Generators BVX-200H, and BVX-200P.

The Renuvion/J-Plasma Handpieces are sterile, single use electrosurgical accessories intended to be used in conjunction with compatible electrosurgical generators for the delivery of helium gas plasma for cutting, coagulating soft tissue. The compatible Generators operate at an adjustable power of up to 40W (expressed as 0-100% is 40W) and provide an adjustable helium gas flow of 1-5 LPM. The Renuvion/J-Plasma Handpieces are available with a retractable cutting blade tip for excising tissue. The blade tip serves as an electrode to generate helium plasma.

The Renuvion/J-Plasma Precise devices are available in 15cm, 27cm and 33cm lengths for use in laparoscopic or open surgical procedures. The 27cm are standard lengths for laparoscopic instruments and are compatible with standard 5mm trocars.

The Renuvion/J-Plasma Precise Open devices are available in 44mm and 150mm for used in open surgical procedures.

This document describes the Renuvion/J-Plasma Precise Handpiece and Renuvion/J-Plasma Precise Open Handpiece, intended for use with compatible electrosurgical generators for soft tissue cutting, coagulation, and ablation during open and laparoscopic surgical procedures.

Here's an analysis of the acceptance criteria and the supporting studies:

1. Table of acceptance criteria and the reported device performance:

   Test / Acceptance Criteria	Reported Device Performance
   Mechanical & Electrical Verification and Functionality
   Pneumatic Testing	Verified
   Electrical Continuity Test	Verified
   Cable Flexure / Tension Test	Verified
   Connector Dielectric Strength Test	Verified
   Mold Stress Test	Verified
   Free-fall Drop Test	Verified
   Insertion/Extraction Integrity (Reduced insertion/extraction force to plug/unplug)	Verified (The document specifically notes a reduction in insertion/extraction force compared to predicate devices, indicating this was a design change tested and met)
   Usability Evaluation	Protocol executed to verify and validate usability "as it relates to safety." (Satisfactorily conducted)
   Biocompatibility Testing (for external communicating device with indirect blood path, < 24 hours)	Conducted per FDA Blue Book Memo #G95-1 and ISO 10993-1. Included Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Hemolysis, and Material Mediated Pyrogen. Verification testing for changed patient-contacting components (flow tube coupler and O-ring) was satisfactorily conducted.

2. Sample size used for the test set and the data provenance:

   The document does not explicitly state the sample sizes for each mechanical, electrical, usability, or biocompatibility test. It mentions "Performance testing" was performed, indicating that multiple units were likely tested for each criterion. The data provenance is internal testing performed by the manufacturer, Bovie Medical Corporation. The tests are prospective as they were performed on the new device models to demonstrate their safety and efficacy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   This information is not provided. The tests described are primarily engineering, electrical, and biological evaluations, typically not requiring medical experts for "ground truth" establishment in the same way clinical studies would. The "usability evaluation" would have involved users, but their qualifications are not specified beyond being relevant to using the "J-Plasma Pistol Grip Handpiece."

4. Adjudication method for the test set:

   This information is not provided and is not typically relevant for the type of engineering and biocompatibility testing described. The tests would likely have pass/fail criteria based on predefined specifications.

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:

   No, an MRMC comparative effectiveness study was not done. This device is an electrosurgical handpiece, not an AI diagnostic or assistance tool, so such a study would not be applicable.

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

   No, this is an electrosurgical handpiece, a physical medical device, not a software algorithm. Therefore, "standalone" algorithm performance is not applicable.

7. The type of ground truth used:

   The ground truth for the various tests was based on:

   • Engineering Specifications: For mechanical and electrical tests (e.g., connector dielectric strength, cable flexure, integrity of insertion/extraction force).
   • Regulatory Standards: For biocompatibility testing (ISO 10993 guidelines, FDA Blue Book Memorandum #G95-1).
   • Safety and Efficacy Requirements: For usability evaluation, ensuring the device is safe and performs as intended.

8. The sample size for the training set:

   This concept is not applicable as this is a physical medical device, not a machine learning algorithm requiring a training set.

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

   This concept is not applicable as this is a physical medical device, not a machine learning algorithm requiring a training set.

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