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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 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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