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The AYON Body Contouring System is intended for the fragmentation, emulsification, and aspiration of subcutaneous fatty tissue for the purpose of aesthetic body contouring.

• The AYON Ultrasound Sub-System is used for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring.
• The AYON Infiltration and Aspiration Sub-System(s) are used for the infiltration and suction / aspiration of fluids and tissue during surgical procedures. Infiltration and Suction is designed to operate as a stand-alone function.

The AYON Body Contouring System includes an Ultrasound Sub-system, an Infiltration Sub-system, and an Aspiration Sub-system. The Ultrasound Sub-system includes an ultrasound amplifier, an ultrasound handpiece, and ultrasound probes which are to be used with compatible skin ports and plugs. The Infiltration Sub-system includes a peristaltic pump and weighing scale and utilizes sterile infiltration tubing, handles and cannulas to infiltrate tissue with fluids. The Aspiration Sub-system includes two suction units that have the capability to function separately or together in series, such that it can be used as two separate suction units by two operators, or as a single suction unit (in series) by a single operator. The Aspiration Sub-system utilizes sterile suction tubing, handles and cannulas to aspirate fluids and soft tissue. The Infiltration and Aspiration Sub-systems are designed to operate independent of the Ultrasound Sub-system such that the system may be offered with only Infiltration and Aspiration to support standard suction-assisted liposuction (SAL) or with Ultrasound enabled to support ultrasound-assisted liposuction (UAL).

Apyx Medical devices/accessories for the system include the following:

• Infiltration and aspiration handles
• Ultrasound handpiece
• Ultrasound handpiece cables
• Ultrasound probes
• Footswitches: Two (2) wireless footswitches to control ultrasound and infiltration
• Skin ports and skin port tool
• AYON Base Tower mounting poles and canister mounts
• Power cords

Additional commercially available devices/accessories include the following:

• Infiltration and aspiration cannulas
• Aspiration filters
• Sterile, single-use infiltration and aspiration tubing
• Wrench
• Sterilization tray and cleaning brushes
• Collection canisters and liners
• Infiltration fluid warming unit(s)

The AYON Body Contouring System may also accommodate other equipment, including commercially available electrosurgical generators owned by Apyx Medical, such as the Apyx One Console.

The provided FDA 510(k) clearance letter for the AYON Body Contouring System does not contain acceptance criteria or a study proving the device meets those criteria in the way typically expected for an AI/software-driven medical device for diagnosis or prognosis.

Instead, this document describes a traditional medical device clearance process for a hardware-based system (liposuction system), which relies on substantial equivalence to a predicate device rather than performance against defined metrics.

Therefore, many of the requested sections about acceptance criteria, study details, sample sizes, ground truth, experts, and MRMC studies are not applicable or cannot be extracted from this document.

However, I can still extract information related to the performance data provided, even if it's not structured around explicit acceptance criteria and corresponding performance metrics for an AI algorithm.

Non-Applicable Sections for this Device Type:

• Acceptance Criteria for AI Performance: No explicit acceptance criteria (e.g., sensitivity, specificity, F1-score thresholds) for AI performance are stated because the device is not an AI/software diagnostic or prognostic tool.
• Study Proving Acceptance Criteria: No such study is described.
• Sample size used for the test set and the data provenance: No test set for AI/software performance is mentioned. The "testing" refers to mechanical, electrical, software, biocompatibility, and reprocessing validation.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for AI performance is established.
• Adjudication method for the test set: Not applicable.
• 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-assisted diagnostic device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI performance.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Extracted Relevant Information (related to device performance and testing):

While not in the requested format of AI acceptance criteria, here's a summary of the performance testing conducted and the "reported device performance" as described in the 510(k) summary for the AYON Body Contouring System:

1. Table of "Acceptance Criteria" (interpreted as performance characteristics compared to predicate) and Reported Device Performance:

Notes for Table:

• ¹ Suction vacuum for the Subject Device falls within the vacuum range of 0 to 29.9 in Hg included in the Product Code description and falls below the maximum vacuum range for other FDA cleared devices. Vitruvian Ultimate Aspirator (K161722), PSI-TEC Aspirator (K981215).
• ² The infiltration flow rates for the Subject Device are identical or fall below the maximum flow rates for other FDA cleared infiltration and infusion pumps. Reference devices; Klein Surgical Infiltration pump (K031432) and the Wells Johnson Infusion pump (K991437).

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

• Test Set (for AI/software performance): Not applicable.
• Data Provenance: Not applicable.

However, the document lists various non-clinical performance tests:

• Mechanical and Physical Bench Testing: Each subsystem (ultrasound, infiltration, aspiration) was tested separately and as a combined system for overall performance, tip vibrational amplitude, thermal effects on tissue, voltage/current outputs, and compatibility. Aspiration testing was in accordance with ISO 10079-1 and ISO 10079-4.
• Electrical Safety and EMC: Testing performed per IEC 60601-1-1, IEC 60601-1-2, and 60601-4-2. Wireless emissions testing for footswitch.
• Software and Cybersecurity: Verification and Validation (V&V) performed in accordance with ISO 62304.
• Biocompatibility Testing: Conducted per ISO 10993-1 on patient-contacting materials.
• Reprocessing: Tested in accordance with ISO 17665.

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

• Not applicable. This device does not use an expert-established ground truth for performance evaluation in the context of AI. The performance is assessed through engineering and bench testing, and comparison of specifications to a predicate device.

4. Adjudication method for the test set:

• Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No, an MRMC study was not done. The device is not a diagnostic imaging or AI-assisted diagnostic tool. No clinical studies were required or performed.

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

• Not applicable. This is not an algorithm-only device. The product is a physical electro-mechanical system.

7. The type of ground truth used:

• For the non-clinical tests, the "ground truth" is derived from established engineering standards (e.g., ISO, IEC), physical measurements, and direct comparison of specifications to the legally marketed predicate device. There is no biological or expert consensus "ground truth" in the AI sense.

8. The sample size for the training set:

• Not applicable. The device is a hardware system, not an AI model that requires a training set.

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

• Not applicable.

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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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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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The Apyx One Console is 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 One Console is an electrosurgical generator that delivers radiofrequency (RF) energy to cut and coagulate soft tissue. It can also deliver Helium plasma energy for cutting, coagulation, and ablation of soft tissue. Like the predicate, the Apyx One Console provides standard electrosurgical energy and Helium Plasma energy, with no changes to the intended use, electrosurgical modes, output power waveforms, or maximum power settings. The Apyx One Console is a modified version of the primary predicate device that was cleared under K192867 (Apyx Helium Plasma Generator), with a no change to the intended use.

The Apyx One Console has a Graphical User Interface (GUI). Remote Services will be available using an attached cellular module to assist in troubleshooting the generator in the field, a helium Gas Pressure Transmitter, and two monopolar ports.

The Remote Service module will also provide non-HIPPA data to a cloud data system which will log the various settings of the generator throughout its use.

The Apyx One Console is an electrosurgical generator intended for the 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 only be used with dedicated Renuvion/J-Plasma handpieces.

Here's a breakdown of the acceptance criteria and the study proving the device meets them:

1. A table of acceptance criteria and the reported device performance

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

The document does not specify a separate "test set" in the context of clinical data for performance evaluation. Instead, the performance testing described focuses on engineering verification and validation. Therefore, information regarding sample size and data provenance for a test set (e.g., patient data) is not applicable here as it is not a clinical study in that sense.

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

Not applicable. This evaluation focuses on engineering performance rather than clinical endpoints requiring expert ground truth establishment.

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

Not applicable. This was not a study requiring adjudication of interpretations.

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. The device is an electrosurgical generator, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not relevant.

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

Not applicable. The device is a physical medical instrument, not an algorithm, so the concept of "standalone algorithm performance" is not relevant. The performance evaluation focuses on the engineering safety and effectiveness of the hardware and software in its intended operational context.

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

The "ground truth" for this device's acceptance criteria primarily involved:

• Compliance with established international electrical safety, electromagnetic compatibility, and usability standards.
• Verification against product and performance specifications for electrical functionality, software/firmware operation, and mechanical design.

8. The sample size for the training set

Not applicable. This device, being an electrosurgical generator, does not utilize a "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 this type of medical device evaluation.

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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 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 (specifically BVX-200H, BVX-200P, APYX-200H, APYX-200P, APYX-RS3, and APYX-JS3).

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 for soft tissue cutting, coaqulation or ablation.

The Renuvion® APR 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 document describes the K220970 Premarket Notification for the Renuvion APR Handpiece. The focus of this submission is not on a new device but on an expanded indication for use for an existing, previously cleared device (Renuvion APR Handpiece, cleared under K191542). Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are specifically related to proving the safety and effectiveness of the device for this new indication, rather than the core functionality of the electrosurgical device itself, as no modifications were made to the hardware.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are effectively the primary and safety endpoints defined for the clinical study.

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The Renuvion® Dermal System is an electrosurgical device for dermatological procedures for the treatment of moderate to severe wrinkles and rhytides, limited to patients with Fitzpatrick skin types I, II or III. The treatment is achieved through controlled heating of the outer layers of the skin so that part or all of the epidermis becomes non-viable and there is controlled thermal modification to the underlying dermis.

The Renuvion® Dermal Handpiece is only compatible with Apyx Medical Electrosurgical Generators.

The Renuvion® Dermal Handpiece is a sterile single use electrosurgical (monopolar) device intended to be used in conjunction with a compatible Apyx Helium Plasma Generator (APYX-200P, APYX-RS3 - cleared under 510(k) K170188 & K192867) for the delivery of radiofrequency energy and/or helium plasma for the delivery of helium plasma for the noninvasive treatment of facial wrinkles and rhytides, in patients with Fitzpatrick skin types I, II or III.

The Renuvion Dermal handpiece is part of the Renuvion System composed of the compatible Apyx generator, Foot switch, helium source, and patient grounding pad.

The tip of the Renuvion® Dermal Handpiece is used to deliver thermal energy to tissue through a precise helium plasma beam. The device connects to the electrosurgical generator which is also connected to a helium gas tank and regulator. The device requires the use of a grounding pad plugged into the generator to complete the circuit. The device is offered only in one size, 44mm, catalog number APYX-044-DERM. The handpiece is activated by pressing the activation button on the handpiece or by pressing the purple foot pedal on the foot control accessory. The device is rated at 4.0kVpeak.

The provided text describes the acceptance criteria and the study that proves the Renuvion® Dermal Handpiece meets the criteria, as part of a 510(k) premarket notification.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes both bench testing and human clinical trial results.

Bench Testing Acceptance Criteria & Results:

Human Clinical Trial Acceptance Criteria & Results:

• 25.5% scored at least a two-point improvement.
• 5.5% scored at least a three-point improvement.
  The primary effectiveness endpoint was achieved. The effectiveness outcomes were described as "as good or better" than the predicate device. |
  | Primary Safety Endpoint | Evaluation of adverse events up to the 3-month visit following the procedure. | - No serious adverse events (SAEs) related to the study device or procedure were reported.
• Adverse events (AEs) were in line with expectations for dermatological wrinkle reduction procedures involving controlled heat to the epidermis.
• Common AEs: edema, erythema, and post-inflammatory hyperpigmentation.
• The rate of AEs was consistent with the expected range for the predicate device, as reported in literature. |

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Bench Testing: Not explicitly stated as a numerical sample size but "all acceptance criteria were met" for the various tests.
  • Pre-clinical Animal Studies: Not specified, but conducted on "live porcine skin tissue."
  • Human Clinical Trial: 55 study subjects.
• Data Provenance:
  • Bench Testing: Likely conducted in a lab environment by the manufacturer.
  • Pre-clinical Animal Studies: Conducted in a lab environment.
  • Human Clinical Trial: Prospective, multicenter, single-arm clinical study evaluating the use of the Renuvion® Dermal System. Conducted at 3 investigational centers in the United States. The study was an evaluator-blinded prospective study.

3. Number of Experts and Qualifications for Ground Truth

• Human Clinical Trial: Ground truth for the primary effectiveness endpoint (FWS improvement) was established by 3 blinded Independent Photographic Reviewers (IPR). Their specific qualifications (e.g., radiologist, years of experience) are not explicitly stated in the provided text. However, their role as "Independent Photographic Reviewers" suggests expertise in evaluating aesthetic outcomes from medical photographs.

4. Adjudication Method for the Test Set

• Human Clinical Trial Adjudication: For the primary effectiveness endpoint, an improvement was determined when 2 out of 3 blinded Independent Photographic Reviewers (IPR) agreed. This is a form of consensus-based adjudication, specifically a "majority rule" (2/3).

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

• A formal MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted, as this device is an energy-based surgical device, not an AI diagnostic tool.
• The clinical study did compare the device's safety and effectiveness profile (AEs, improvement rates) to the predicate device's data from existing literature. This is a comparison of device performance, not a human reader study.

6. Standalone Performance (Algorithm Only)

• This device is an electrosurgical system, not an algorithm. Therefore, a standalone (algorithm-only) performance evaluation does not apply in this context. The performance evaluated was that of the physical device and its interaction with tissue.

7. Type of Ground Truth Used

• Bench Testing: Engineering specifications, functional requirements, and established physical/electrical properties served as ground truth.
• Pre-clinical Animal Studies: Ground truth for thermal damage zone (coagulation necrosis) was established by histology under magnification on porcine skin tissue.
• Human Clinical Trial:
  • Effectiveness: Ground truth for wrinkle and rhytide improvement was based on a consensus of 3 blinded Independent Photographic Reviewers using the Fitzpatrick Wrinkle and Elastosis Scale (FWS) applied to photographs.
  • Safety: Ground truth for adverse events was based on clinical observation and reporting by investigators and subjects during the study.

8. Sample Size for the Training Set

• The provided document describes a premarket notification (510(k)) for a medical device that involves physical interaction with tissue, not an AI/Machine Learning device that requires a "training set" in the computational sense. Therefore, "training set" sample size is not applicable to this type of device submission. The clinical study of 55 subjects serves as the clinical validation dataset.

9. How Ground Truth for Training Set was Established

• As noted above, the concept of a "training set" in the context of an AI/ML algorithm does not apply to this device. The clinical study served as a validation study for the device's performance in humans. The ground truth for this clinical validation was established as described in section 7.

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The J-Plasma Precise® FLEX is used for the delivery of radiofrequency energy and/or helium gas plasma (J-Plasma energy) for electrosurgical cutting, coagulation of soft tissue. It is intended for use with a grasper during minimally invasive surgical procedures.

The J-Plasma Precise® FLEX is compatible with Apyx Medical electrosurgical generators.

The J-Plasma Precise® Flex Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the delivery of radiofrequency ("RF") energy and/or helium gas plasma for electrosurgical cutting, coaqulation, and ablation of soft tissue. It is intended for use with a grasper during minimally invasive surgical procedures. The handpiece has one configuration, model # APYX-500BF. 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 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 J-Plasma Precise® Flex Handpiece has an extendable electrode (blade) in the tip to generate helium plasma. The tip is controlled by the user via graspers to actuate (extend and retract) the blade. The handpiece comes with an Introducer that allows for more control of the tip when introducing and removing the distal end to and from the cannula. The handpiece has a flexible, seamless cable that can be advanced with graspers through the cannula during minimally invasive surgical procedures. The handpiece is activated by the footswitch.

The provided text describes a 510(k) premarket notification for a medical device, the J-Plasma Precise® FLEX Handpiece. The core of the submission is to demonstrate that the modified device is substantially equivalent to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantitative manner (e.g., a specific percentage or value to be met). Instead, the studies aim to demonstrate equivalence to the predicate device. The performance is reported qualitatively as "equivalent" or that requirements were "met."

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

• Sample Size for Test Set: The document states that an "ex-vivo study was conducted on several tissue types (i.e., muscle, liver, kidney)" for the tissue thermal effect equivalency testing. However, the specific number of samples or replicates for each tissue type is not provided.
• Data Provenance: The study was "ex-vivo," meaning performed on tissue outside of a living organism. The country of origin for the tissue or the testing location is not specified, but the applicant is Apyx Medical Corporation, located in Clearwater, Florida, USA. The study design appears to be retrospective in the sense that it's comparing a modified device to an existing predicate, rather than a prospective clinical trial.

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

This document describes bench testing and ex-vivo studies. There is no mention of human experts establishing ground truth for a test set in the context of diagnostic performance or interpretation. The "ground truth" for the performance tests (e.g., tissue effect, electrical safety) would be established by the physical measurements and compliance with engineering standards by qualified technical personnel.

4. Adjudication Method for the Test Set

As there's no mention of a human expert-based assessment or diagnostic interpretation requiring adjudication, there is no adjudication method described. The tests are directly measuring physical and electrical properties.

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

No, an MRMC comparative effectiveness study was not done. This device is an electrosurgical handpiece, not an AI diagnostic tool. The performance evaluation focuses on the safety and effectiveness of the device itself and its equivalence to a predicate, not on how it assists human readers in making diagnoses.

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

This question is not applicable in the context of this device. The J-Plasma Precise® FLEX Handpiece is a physical surgical tool, not an algorithm. Its "performance" is its ability to cut, coagulate, and ablate tissue, and to meet safety standards. The ex-vivo tissue effect studies are "standalone" in the sense that they assess the device's direct effect on tissue, independent of a human operator's skill, but it's not an algorithm's performance.

7. The Type of Ground Truth Used

The ground truth for the performance studies is based on:

• Physical Measurements and Engineering Standards: For electrical safety and mechanical functionality, the ground truth is defined by compliance with established international standards (e.g., IEC 60601 series, ISO 14971) and meeting predefined operational requirements.
• Quantitative Tissue Effect Data: For tissue thermal effect, the ground truth is derived from measurements of depth and lateral spread of thermal effects in the ex-vivo tissue samples. The "truth" is established by direct scientific measurement and comparison to the predicate device's measured effects.
• ISO Standards for Biocompatibility: For biocompatibility, the ground truth is established by demonstrating compliance with ISO 10993 guidelines.

8. The Sample Size for the Training Set

This document describes a medical device, not an AI/ML algorithm. Therefore, there is no concept of a "training set" as would be used for machine learning. The device's design, manufacturing, and testing follow established engineering and quality system procedures.

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

As there is no training set for an AI/ML algorithm, this question is not applicable. The "ground truth" for the device's development and verification relies on engineering specifications, risk assessments (ISO 14971), and established laboratory testing protocols in compliance with design and development procedures (21 CFR 820.30).

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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

• ANSI/AAMI/IEC ES60601-1:2005/(R)2012 and A1:2012 (Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance)
• AAMI/ANSI/IEC 60601-1-2:2014 (4th Edition) (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests)
• AAMI/ANSI/IEC-60601-2-2:2017 (Medical electrical equipment - Part 2-2: Particular requirements of basic safety and essential performance of high-frequency surgical equipment) |
  | Electromagnetic Compatibility (EMC) | Complies with:
• AAMI/ANSI/IEC 60601-1-2:2014 (4th Edition) (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests)
• IEC60601-1-2 (electromagnetic compatibility) |
  | Electrical Performance | The electrical functionality of the generator was verified to meet performance specification requirements. |
  | Software Functionality | The system and Field Programmable Gate Array (FPGA) perform as intended and according to the product specifications. |
  | Mechanical Design | The mechanical design meets the product and performance requirements. |

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.

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