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Renuvion® APR 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® APR Handpiece is intended for the coagulation of subcutaneous soft tissues following liposuction for aesthetic body contouring.

The Renuvion® APR Handpiece is indicated for use in subcutaneous dermatological and aesthetic procedures to improve the appearance of lax (loose) skin in the neck and submental region.

The Renuvion® APR Handpiece is intended for the delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures.

The Renuvion® APR Handpiece is intended to be used with compatible electrosurgical generators owned by Apyx Medical.

The Renuvion® APR (Apyx Plasma/RF) handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with a compatible generator for the delivery of radiofrequency energy and helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. 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 cutting, coagulation or ablation of soft tissue during open surgical procedures. The compatible generators operate at an adjustable power of up to 40 W (expressed as 0 - 100% where 100% is 40 W) and provide an adjustable helium gas flow of 1 - 5 L/Min. APR Handpiece has a non-extendable electrode to generate helium plasma. The handpiece is available in two different lengths: 15 cm and 27 cm. The 15 cm 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 device can also be used for percutaneous delivery of radiofrequency and helium plasma energy to coagulate subcutaneous soft tissue.

The provided document is a 510(k) summary for the Renuvion® APR Handpiece. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. The primary change for this submission is an addition to the indications for use.

Crucially, this document describes a determination of substantial equivalence, not a study proving adherence to specific acceptance criteria for performance, particularly not for an AI/algorithm-based device as the prompt's structure implies. The device in question is an electrosurgical handpiece, a hardware device, not an AI/software device.

Therefore, many of the requested fields related to AI/algorithm performance (e.g., sample size for test set, data provenance, ground truth establishment, MRMC studies, standalone performance, training set details) are not applicable in the context of this 510(k) submission. The "Performance Data" section explicitly states "N/A" for bench testing, electrical safety, EMC, and biocompatibility because "no modifications were made to the commercially available handpiece cleared under K220970."

However, I can extract information related to the clinical justification for the expanded indications for use.

Here's an analysis based on the provided text, addressing the prompt's points where applicable, and stating "Not Applicable" or "Not Provided" where the information is not present or relevant to this type of device submission:

Device Name: Renuvion® APR Handpiece
Regulation Name: Electrosurgical cutting and coagulation device and accessories
Product Code: GEI

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present explicit "acceptance criteria" in the format one would typically see for an AI performance study (e.g., minimum AUC, sensitivity, specificity). Instead, the assessment for substantial equivalence relies on:

• Technological equivalence to predicate devices.
• Demonstration of safety and effectiveness for the additional proposed indication.

The "performance" is assessed in terms of comparable safety profiles rather than specific quantitative metrics against a defined threshold.

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

• Test Set (for the new indication): The document refers to "real-world evidence gathered from 6 studies in which all procedures used Renuvion APR following liposuction."
  • This data set includes retrospective chart reviews in 1,184 body areas across 483 subjects.
  • Data Provenance: The document does not explicitly state the country of origin for the retrospective chart reviews. It is implied to be clinical data, likely from the US, given the FDA submission.
  • Retrospective or Prospective: Primarily retrospective chart reviews for the liposuction indication. There is also a mention of an IDE study (G190152, VP-1902) for the neck and submental region (which was already an indicated use for the predicate device, not new for this submission).

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

• Not Applicable in the context of an AI ground truth. For this device (an electrosurgical handpiece), "ground truth" relates to clinical outcomes and safety profiles, typically established by treating physicians and follow-up. The data relies on clinical records and published meta-analyses. No specific "experts" were convened to "establish ground truth" for a test set in the way one would for an AI study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. This is not an AI performance study requiring image or data annotation adjudication. Clinical outcomes are typically recorded by the treating physician or study staff, and adverse events are reported as per standard clinical practice.

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

• Not Applicable. This is not an AI device. The study described compares adverse event rates of Renuvion APR following liposuction to liposuction alone, based on a meta-analysis. It does not involve human readers interpreting images, assisted or unassisted by AI.

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

• Not Applicable. This is not an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" in this context is clinical outcomes and adverse event rates derived from:
  • Retrospective chart reviews (for the new liposuction-related indication).
  • Data from a previously conducted IDE study (for the neck and submental region indication, which was already on the predicate).
  • Comparative data from a published meta-analysis (for liposuction alone adverse event rates).

8. The sample size for the training set

• Not Applicable. This is not an AI device that requires a training set. The clinical data mentioned (1,184 body areas across 483 subjects) serves as the evidence for safety and effectiveness for the new indication.

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

• Not Applicable. As this is not an AI device, there is no "training set" or "ground truth for the training set" in the context of machine learning. Clinical data collection follows established medical record-keeping and study protocols.

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The Renuvion® APR 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® APR Handpiece is indicated for use in subcutaneous dermatological and aesthetic procedures to improve the appearance of lax (loose) skin in the neck and submental region.

The Renuvion® APR Handpiece is intended to be used with compatible electrosurgical generators owned by Apyx Medical.

The Renuvion® APR Handpiece is a sterile, single-use electrosurgical (monopolar) device intended to be used in conjunction with compatible electrosurgical generators. 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 passes over the energized electrode, a helium plasma is generated which delivers thermal energy to soft tissue for the purposes of cutting, coagulation/contraction, or ablation.

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).

This document is an FDA 510(k) premarket notification for the Renuvion® APR Handpiece. It discusses the device's substantial equivalence to previously cleared devices based on bench testing, electrical safety, biocompatibility, and pre-clinical/ex-vivo studies. Crucially, it states that "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." Therefore, there is no information in this document regarding acceptance criteria, human reader studies (MRMC), or specific expert consensus for establishing ground truth as these types of studies were not conducted for this specific submission to demonstrate substantial equivalence.

However, the document does contain information about performance testing to support expanded indications for use. I will address the relevant points based on the provided text.

Acceptance Criteria and Device Performance (as inferred from the pre-clinical/ex-vivo studies to support expanded indications)

Since the submission did not rely on clinical performance data for substantial equivalence, formal acceptance criteria in the typical sense for a clinical study are not provided. Instead, the document describes the types of pre-clinical and ex-vivo studies conducted and the data they demonstrated to support the expanded indications.

The expanded indication required demonstrating the ability of the device to achieve "coagulation/contraction of soft tissue" including "subcutaneous tissue."

1. Table of Acceptance Criteria and Reported Device Performance

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

• Ex-Vivo Tissue Testing: The document mentions "liver, kidney, and muscle tissues" were used. A specific sample size (number of tissue samples or replicates) is not provided.
• In-Vivo Acute Porcine Study: The document refers to "an in vivo acute porcine study" but does not specify the number of animals used.
• Data Provenance: The document does not explicitly state the country of origin for the data. The studies were conducted by Apyx Medical, a US-based company. The nature of the studies (ex-vivo and acute in-vivo) suggests they are prospective laboratory and animal studies, not retrospective or prospective human clinical data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Ground Truth for Ex-Vivo and In-Vivo Studies: Ground truth for these studies was established through "histological examination" to characterize lateral spread and depth of thermal effect. The document does not specify the number of experts or their exact qualifications (e.g., pathologist with X years of experience) who performed this histological analysis. It's implied this was done by qualified personnel in a lab setting, but specifics are missing from this FDA letter.

4. Adjudication Method for the Test Set

• Given the nature of the ground truth (histological examination), a multi-reader adjudication method like "2+1" or "3+1" is typically not applicable in the same way as for diagnostic imaging studies. Histological analysis would involve expert pathological review. The document does not describe any specific adjudication method, such as multiple pathologists reviewing and finding consensus, for the histological examinations.

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

• No. The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." An MRMC human reader study would fall under clinical performance data. Therefore, no information on human reader improvement with or without AI assistance is provided.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done

• Not applicable. This device is an electrosurgical handpiece, not an AI algorithm. Its performance is measured by its physical effect on tissue, not by an algorithm's diagnostic capabilities.

7. The Type of Ground Truth Used

• For the ex-vivo and in-vivo studies supporting the expanded indications, the ground truth was established through histological examination of treated tissues (liver, kidney, muscle, and subcutaneous tissue) to measure thermal effects, specifically lateral spread and depth of thermal effect. This is a form of pathology-based ground truth.

8. The Sample Size for the Training Set

• Not applicable. This submission is for a physical medical device (electrosurgical handpiece), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

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

• Not applicable, as there is no training set for an AI/ML algorithm.

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