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The Apyx Plasma/RF Handpiece is intended to be used with compatible electrosurgical generators for the delivery of radiofrequency energy and/or helium plasma for cutting, coagulation of soft tissue during open surgical procedures. The Apyx Plasma/RF Handpiece is compatible with the Electrosurgical Generators, BVX-200H and BVX-200P, owned by Apyx Medical.

Device Description

The Apyx Plasma/RF Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of 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. 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 cutting, coagulation or ablation.

The Apyx Plasma/RF Handpiece has a non-extendable electrode to generate helium plasma. The handpiece is available in two different lengths: 15cm and 27cm. The 15cm length is available in a single port (APYX-15-SP) as well as a twin port configuration (APYX-15-TP). The 27cm length is only available with a twin port configuration (APYX-27-TP).

AI/ML Overview

The provided text describes the performance data for the Apyx Plasma/RF Handpiece (K191542) to demonstrate its substantial equivalence to predicate devices, focusing on non-clinical testing.

Here's the breakdown of the acceptance criteria and the studies that prove the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

This section synthesizes the various tests and their outcomes as presented in the document.

Test Category	Acceptance Criteria/Objective	Reported Device Performance/Result
Bench Testing
Mechanical Verification & Functionality	Verify mechanical functionality of the Apyx Plasma/RF Handpiece.	Mechanical functionality requirements met.
Energy & Power Output	Verify via calorimetric testing that the tissue effects are equivalent between the subject device (Apyx Plasma/RF Handpiece), primary predicate device (Renuvion/J-Plasma® Precise Open Handpiece - K183610 & K170188), and predicate device (Renuvion/J-Plasma® Precise Handpiece - K183610 & K151325). Aim to show all deliver the same amount of energy to tissue at equivalent generator settings.	There are no significant differences in energy and power outputs between the subject device, Primary Predicate devices owned by Apyx Medical; all 3 devices will deliver the same amount of energy to tissue at equivalent generator settings.
Electrical Safety & EMC
Standards Compliance	Complies with ANSI/AAMI/IEC 60601-1:2015/(R)2012 and A1:2012, AAMI/ANSI/IEC 60601-2-2:2017 for safety, and AAMI/ANSI/IEC 60601-1-2:2014 (4th Edition) for EMC.	The Apyx Plasma/RF System was determined to be in conformance with these standards.
Biocompatibility Testing
ISO 10993 Compliance	Evaluation in accordance with FDA Guidance "Use of International Standard ISO 10993-1" and AAMI/ANSI/ISO 10993-1:2009/(R2013). Focus on cytotoxicity, sensitization, systemic toxicity, irritation, hemolysis, and material-mediated pyrogen/pyrogenicity for an external communicating device with an indirect blood path contact for <24 hours.	Biocompatibility has been established per ISO 10993 guidelines for this category. Biocompatibility verification testing was satisfactorily conducted for the subject device.
Pre-Clinical & Ex-Vivo Studies
Tissue Temperature Profile Equivalency	Compare tissue temperature profiles of the subject device and predicate devices (Renuvion/J-Plasma® Precise Open Handpiece and Renuvion/J-Plasma® Precise Handpiece) via device activation on porcine skin. Objective: demonstrate equivalent heating of tissue.	The subject device (Apyx Plasma/RF Handpiece) and predicate devices (Renuvion/J-Plasma® Precise Open Handpiece & Renuvion/J-Plasma® Precise Handpiece) all heat tissue in an equivalent manner and are substantially equivalent in terms of tissue effect for the coagulation of soft tissue.
Maximum Internal & External Temperature Study	Quantify internal and external tissue temperatures (via thermal video camera) resulting from Renuvion/J-Plasma® technology for soft tissue coagulation in a live porcine model. Determine effect of multiple variables and worst-case scenario (six consecutive passes in the same area). Acceptance (implied): epidermal surface temperature remains below 41°C and safe limits (below 47°C).	The porcine skin epidermal surface temperature remained below 41°C and within safe limits (below 47°C) even with 6 passes in the same area. The results demonstrate that safe skin temperatures are maintained with Renuvion/J-Plasma® Technology, and skin temperature monitoring is not indicated due to its unique mechanism of action.
Thermal Tissue Effect Comparison (Ex-vivo)	Verify that the Apyx Plasma/RF Handpiece produces an equivalent ex-vivo tissue effect (depth and lateral spread of thermal effect) when compared to the predicate device across a range of power and flow settings, including worst-case clinical scenarios.	The depth and lateral spread (i.e., average of length and width) of thermal effect measured for the Apyx Plasma/RF handpiece were equivalent to the predicate device's thermal effect as measured over a range of power and flow settings which include worst-case clinical scenarios. The quantitative results demonstrated that the tissue effects of all subject device models (APYX-27-TP, APYX-15-TP and APYX-15-SP) are equivalent to the predicate device's effect.

2. Sample Size for Test Set and Data Provenance

Sample Size: Not explicitly stated for each individual test. The document mentions "testing involved device activation on porcine skin" for the tissue temperature profile equivalency and "a live porcine model" for the maximum temperature study. For ex-vivo studies, it states "several tissue types (i.e., muscle, liver, kidney)."
Data Provenance:
- Country of Origin: Not specified but typically assumed to be conducted in the US or collaborating international laboratories if not stated otherwise for FDA submissions.
- Retrospective or Prospective: Prospective, as these were specific tests designed and executed to evaluate the new device and its equivalence to predicates.

3. Number of Experts and Qualifications for Ground Truth

Not Applicable: For this device, the "ground truth" is based on objective, quantifiable physical and biological measurements (e.g., temperature, power output, tissue necrosis depth, mechanical integrity, standard safety compliance), not subjective expert interpretation of images or clinical outcomes that would require expert consensus. Therefore, no "experts" in the sense of clinicians establishing ground truth for a diagnostic test were used. The ground truth is defined by established engineering and biological standards and quantitative measurements.

4. Adjudication Method

None (Not Applicable): As the ground truth is based on objective measurements and compliance with established standards, there is no need for an adjudication method typically used in studies involving subjective interpretation (e.g., by radiologists).

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

No: No MRMC comparative effectiveness study was performed or described. This type of study is more relevant for diagnostic AI tools where human readers interpret medical images. This submission focuses on the safety and performance equivalence of a surgical electrosurgical handpiece through bench and animal testing.

6. Standalone Performance (Algorithm Only)

Yes, In essence: The studies described are inherently "standalone" in the sense that they evaluate the device's technical and biological performance directly, rather than its performance in assisting human operators or interpreting data for them. The device itself (the Apyx Plasma/RF Handpiece) is the "system" being tested for its intrinsic capabilities (e.g., cutting, coagulation, ablation effectiveness, and safety). There is no "human-in-the-loop" performance being measured in these specific tests, as they focus on the physical and biological effects generated by the device.

7. Type of Ground Truth Used

Objective Measurements and Standard Compliance: The ground truth for these studies is based on:
- Benchmarking against Predicate Devices: Demonstrating equivalent electrical output and tissue effects.
- Physical Measurements: Calorimetric energy/power output, mechanical functionality, thermal video camera measurements for tissue temperature, depth and lateral spread of thermal effect in tissue.
- Compliance with Standards: Electrical safety (IEC 60601 series) and Biocompatibility (ISO 10993 series).
- Biological Outcomes (Animal/Ex-vivo): Observation of tissue heating, coagulation, and ablation effects in porcine models and various tissue types.

8. Sample Size for Training Set

Not Applicable / Not Provided: This device is a medical instrument, not an AI/ML algorithm that requires a "training set" in the conventional sense. The device's design is based on established engineering principles and iterative development, not data-driven machine learning.

9. How Ground Truth for Training Set Was Established

Not Applicable: As there is no "training set" for an AI/ML algorithm, the concept of establishing ground truth for it does not apply here. The device's performance is verified against design specifications and established safety and efficacy benchmarks through the testing described.

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