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Renuvion® Micro Handpiece is intended for the delivery of radiofrequency energy and/or helium plasma where coagulation/contraction of soft tissue is needed. Soft tissue includes subcutaneous tissue.

The Renuvion® Micro Handpiece is compatible with the Apyx One Console Generator, owned by Apyx Medical.

The Renuvion® Micro System with all components and accessories is show in the picture below. The system is comprised of a compatible electrosurgical generator (Apyx One Console), a sterile, single use handpiece, and a supply of helium gas. Additional accessories include a digital gas regulator, grounding pad and optional footswitch.

The Renuvion® Micro handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with the Apyx One Console Electrosurgical Generator for the percutaneous delivery of radiofrequency and helium plasma energy to soft tissue. When connected to the Apyx One Generator, the device operates at an adjustable power of up to 12 W (expressed as 0 - 30% where 30% is 12 W) and an adjustable helium gas flow of 1 -1.5 L/Min. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue coagulation/contraction.

The handpiece has a non-extendable electrode to generate helium plasma. The handpiece features a low-profile shaft that is 10cm in length. The distal end of the shaft and tip has a 2mm outer diameter that tapers down to 1.5mm for the remaining length of the shaft.

The Renuvion® Micro Handpiece is cleared based on demonstrating substantial equivalence to a predicate device, the Renuvion® APR Handpiece (K223262 and K230272). This type of submission (510(k)) focuses on comparing a new device to an already legally marketed device, rather than proving absolute safety and effectiveness through extensive clinical trials. Therefore, the "acceptance criteria" are primarily based on demonstrating that the new device is as safe and effective as the predicate device by showing similar technological characteristics and performance.

Here's a breakdown of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" in a separate section with specific numerical targets. Instead, it presents various tests performed and states whether the device "met requirements" or demonstrated equivalent/lesser effects compared to the predicate. The overall acceptance criterion is demonstrating that the Renuvion® Micro Handpiece is as safe and effective as the predicate device.

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

• The document does not specify numerical sample sizes for the bench, electrical safety, biocompatibility, or ex-vivo tests. It states that tests were conducted according to protocols.
• Data Provenance:
  • All summarized tests appear to be pre-clinical/bench-top studies and ex-vivo (tissue) tests conducted by the manufacturer, Apyx Medical Corporation.
  • The "Ex-vivo tissue testing" section implies that animal or cadaveric tissue was used, but the specific origin (e.g., species, country) is not mentioned.
  • There is no mention of human subjects or clinical data in this submission.

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

• Since these are primarily bench and ex-vivo tests for a 510(k) submission, the "ground truth" is established by engineering and scientific measurements/observations against predefined specifications and industry standards.
• The document does not mention the involvement of external medical experts (e.g., radiologists) for establishing ground truth in these specific tests. The experts involved would likely be engineers, scientists, and quality assurance personnel from Apyx Medical performing the tests and comparing results to established criteria. There is no mention of "ground truth" in the context of clinical interpretation, as clinical studies were not performed.

4. Adjudication Method for the Test Set:

• Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation by multiple readers.
• Given that this submission relies on bench and ex-vivo testing, such adjudication methods are not applicable and are not mentioned in the document. Performance is measured against physical or biological criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." (Section 6: Clinical Studies).
• Therefore, there is no effect size reported for human readers improving with AI vs. without AI assistance. The device is not an AI-based diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• This question is not applicable as the Renuvion® Micro Handpiece is an electrosurgical device, not an algorithm or AI-based system. It does not perform diagnostic tasks independently.

7. The Type of Ground Truth Used:

• For the bench and ex-vivo tests, the "ground truth" is based on:
  • Defined engineering specifications (e.g., mechanical functionality, system compatibility, electrical safety, packaging integrity).
  • Biological responses to known stimuli (e.g., non-cytotoxic, no sensitization reaction for biocompatibility tests).
  • Physical measurements and comparisons (e.g., thermal effect and tissue temperature measurements in ex-vivo tissue).
• The ground truth is established by the test protocols against established standards and internal design requirements, often compared to the performance of the predicate device.
• No pathology or outcomes data is mentioned as forming the ground truth for this set of studies.

8. The Sample Size for the Training Set:

• This question is not applicable for this device. Training sets are relevant for machine learning or AI-based devices. The Renuvion® Micro Handpiece is a physical surgical tool, and its development involves engineering design and testing, not algorithm training.

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

• This question is not applicable as there is no training set for this device.

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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:

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