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The Apyx Helium Plasma Generators (owned by Apyx Medical) are indicated for delivery of radiofrequency energy and/ or helium plasma to cut, coagulate and ablate soft tissue during open and laparoscopic surgical procedures. The helium plasma portion of the generator can be used only with dedicated Renuvion/ J-Plasma handpieces.

The Apyx Helium Plasma Generator is an electrosurqical device that delivers radiofrequency (RF) energy to cut and coaqulate soft tissue. It can also deliver Helium plasma energy for cutting, coagulation, and ablation of soft tissue. Like the predicate, the Apyx Helium Plasma Generator provides standard electrosurgical energy and Helium Plasma energy, and there are no changes to the intended use, performance specifications, electrosurgical modes, output power waveforms or maximum power settings. Essentially, the Apyx Helium Plasma Generator is a combination of a standard electrosurgical generator and a Helium Plasma generator.

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

1. Table of Acceptance Criteria and Reported Device Performance

Summary of the Study:

The provided document describes a 510(k) premarket notification for the Apyx Helium Plasma Generator. This notification seeks to demonstrate substantial equivalence to a previously cleared predicate device (K170188, Bovie Ultimate® Gen 2 Electrosurgical Generator). The study involved bench and software verification and validation testing to confirm the modified device's safety and effectiveness.

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

The document does not specify a numerical sample size for the test set. The tests describe "Electrical Verification," "Software Verification & Validation," and "Mechanical Verification," which are typically performed on a limited number of manufactured units or system components, rather than a large clinical "test set" in the sense of patient data.

The data provenance is retrospective, as the study primarily compares the modified device to a previously cleared predicate and leverages existing regulatory standards. The testing itself would have been conducted in a controlled laboratory or engineering environment, rather than using patient data from a specific country of origin.

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. The type of testing described (electrical, software, mechanical verification) typically relies on engineering and regulatory standards rather than expert clinical consensus to establish "ground truth" for the device's functional and safety characteristics.

4. Adjudication Method for the Test Set

This information is not applicable/not provided for the type of testing described. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where expert consensus is needed to establish ground truth for diagnostic decisions. Here, the "truth" is determined by adherence to established engineering and safety standards.

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

No, an MRMC comparative effectiveness study was not done. The study described is not a clinical trial evaluating human reader performance with or without AI assistance. It's a regulatory submission demonstrating the substantial equivalence of an electrosurgical device through engineering and software verification.

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

This concept is not directly applicable to this device. The Apyx Helium Plasma Generator is a physical medical device that delivers energy for surgical procedures. It does not operate as an "algorithm only" or an AI system that provides diagnostic output without human intervention in the loop. Its performance is evaluated based on its technical specifications and safety conformity, regardless of human interaction methods.

7. Type of Ground Truth Used

The "ground truth" used in this submission is implicitly based on established international and national standards for medical electrical equipment (e.g., IEC 60601 series). Compliance with these standards, along with the device's documented performance against its own product specifications, forms the basis of its "truth" for safety and effectiveness in the context of substantial equivalence. There is no mention of pathology, expert consensus (in a clinical sense), or outcomes data being used to establish ground truth for the device itself in this specific regulatory context.

8. Sample Size for the Training Set

This information is not applicable/not provided. The device in question is an electrosurgical generator, which is a hardware device with embedded software. It is not an artificial intelligence (AI) or machine learning (ML) algorithm that requires a "training set" of data in the conventional sense. The software verification and validation are against predefined specifications, not learned from a dataset.

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

This information is not applicable/not provided for the same reasons mentioned in point 8.

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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.

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).

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.

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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