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

The Renuvion®/J-Plasma® Precise Handpiece is compatible with the Electrosurgical Generators BVX-200H and BVX-200P manufactured by Apyx Medical.

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

The blade can be extended in 2mm increments from 0 to 10mm from the distal tip of the shaft via a ratcheted slider and retracted via a release latch. The device is activated via pressing the purple activation trigger. The handpiece is to be used with compatible electrosurgical generators, BVX-200H or BVX-200P, manufactured by Apyx Medical.

The Renuvion®/J-Plasma® Precise Handpiece is available in a 33 cm length for use in laparoscopic or open surgical procedures. The 33 cm is a standard length for laparoscopic instruments and are compatible with standard 5 mm trocars.

The provided document is a 510(k) Premarket Notification from Apyx Medical Corporation for their Renuvion®/J-Plasma® Precise Handpiece (Model # BVX-330 BPS). This submission describes a modification of an already cleared device and aims to demonstrate substantial equivalence to previously marketed predicate devices. Therefore, the "acceptance criteria" and "device performance" described are focused on proving this equivalence through various tests rather than establishing initial clinical efficacy with novel endpoints.

Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample sizes (e.g., number of units tested) for the individual bench tests. The tests were performed as "bench testing," meaning they were conducted in a laboratory setting, not on human or animal subjects. The data provenance is internal to Apyx Medical Corporation and based on their design and development procedures and risk assessment in accordance with ISO 14971. No geographical provenance (country of origin for data) is specified beyond the company's location in Clearwater, Florida, USA. The tests are retrospective in the sense that they are comparing a modified device to previously cleared predicates, rather than a de novo clinical investigation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. For bench testing related to mechanical functionality, electrical safety, EMC, and biocompatibility, "experts" in the traditional sense of medical specialists establishing ground truth (like radiologists reading images) are not typically involved. Instead, the ground truth is defined by established engineering standards, material science principles, and biological safety guidelines. For tissue effect tests, conclusions are drawn from bench experiments and comparison to predicate devices, where the "ground truth" would be the observed tissue response under controlled conditions, compared to the known response of the predicate. The document doesn't detail the personnel or their qualifications who interpreted these tissue effects.

4. Adjudication Method for the Test Set:

An adjudication method (like 2+1 or 3+1 expert review) is not applicable here. These methods are common for clinical imaging studies where there's subjectivity in interpretation. For the bench tests described (mechanical, electrical, EMC, biocompatibility, and comparing tissue effects), the results are typically objectively measured and evaluated against predefined thresholds or comparative equivalence, not through expert consensus on subjective findings.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC comparative effectiveness study was not performed, nor is it applicable to this submission. MRMC studies are used to evaluate the diagnostic performance of a device (often AI-based) in a clinical setting with multiple human readers and cases, typically to assess how the device aids human interpretation. This submission is for an electrosurgical handpiece, and the performance assessment is based on physical and biological characteristics, not diagnostic interpretation by human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

A standalone performance study is not applicable here. This device is a surgical instrument, not an algorithm or AI system. Its function is directly performed by the device itself, often with a human operator, but its primary performance endpoints are physical effects (cutting, coagulation) and safety, not an algorithmic output that could be independently evaluated.

7. The Type of Ground Truth Used:

The ground truth used for these tests is generally based on:

• Engineering Specifications and Standards: For mechanical performance, electrical safety, and EMC, the ground truth is defined by established industry and international standards (e.g., IEC 60601 series) and the device's own design specifications.
• Predicate Device Performance: For tissue effects, the ground truth for "equivalence" is the documented and cleared performance of the primary predicate device (for J-Plasma mode) and the reference device (for Monopolar Coagulation mode). The results of the subject device are compared to these established performances.
• Biological Safety Guidelines: For biocompatibility, the ground truth is established by international standards like ISO 10993 guidelines, which define acceptable biological responses for device materials.

8. The Sample Size for the Training Set:

This information is not applicable because this is a medical device, not an AI/ML product that requires a training set for algorithm development. The "design controls process" and "verification and validation" mentioned refer to engineering and quality assurance processes for medical devices, not to machine learning training.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as there is no training set for an AI/ML algorithm involved in this device submission.

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