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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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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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The Renuvion®/J-Plasma® Precise Handpiece is intended to be used with compatible J-Plasma electrosurgical generators for the delivery of helium plasma for cutting, coagulation of soft tissue during open and laparoscopic surgical procedures.

The Renuvion®/J-Plasma® Precise Open Handpiece is intended to be used with compatible J-Plasma electrosurgical generators for the delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. The Renuvion®/J-Plasma® Precise Open® Handpieces are compatible with electrosurgical Generators BVX-200H, and BVX-200P.

The Renuvion/J-Plasma Handpieces are sterile, single use electrosurgical accessories intended to be used in conjunction with compatible electrosurgical generators for the delivery of helium gas plasma for cutting, coagulating soft tissue. The compatible Generators operate at an adjustable power of up to 40W (expressed as 0-100% is 40W) and provide an adjustable helium gas flow of 1-5 LPM. The Renuvion/J-Plasma Handpieces are available with a retractable cutting blade tip for excising tissue. The blade tip serves as an electrode to generate helium plasma.

The Renuvion/J-Plasma Precise devices are available in 15cm, 27cm and 33cm lengths for use in laparoscopic or open surgical procedures. The 27cm are standard lengths for laparoscopic instruments and are compatible with standard 5mm trocars.

The Renuvion/J-Plasma Precise Open devices are available in 44mm and 150mm for used in open surgical procedures.

This document describes the Renuvion/J-Plasma Precise Handpiece and Renuvion/J-Plasma Precise Open Handpiece, intended for use with compatible electrosurgical generators for soft tissue cutting, coagulation, and ablation during open and laparoscopic surgical procedures.

Here's an analysis of the acceptance criteria and the supporting studies:

1. Table of acceptance criteria and the reported device performance:

   Test / Acceptance Criteria	Reported Device Performance
   Mechanical & Electrical Verification and Functionality
   Pneumatic Testing	Verified
   Electrical Continuity Test	Verified
   Cable Flexure / Tension Test	Verified
   Connector Dielectric Strength Test	Verified
   Mold Stress Test	Verified
   Free-fall Drop Test	Verified
   Insertion/Extraction Integrity (Reduced insertion/extraction force to plug/unplug)	Verified (The document specifically notes a reduction in insertion/extraction force compared to predicate devices, indicating this was a design change tested and met)
   Usability Evaluation	Protocol executed to verify and validate usability "as it relates to safety." (Satisfactorily conducted)
   Biocompatibility Testing (for external communicating device with indirect blood path,

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

The Bovie J-Plasma Precise Flex Handpiece is compatible with Bovie Ultimate Electrosurgical Generators BVX-200H, and BVX-200P.

The Bovie J-Plasma Precise Flex handpiece, is an electrosurgical accessory that is connected to a Bovie Ultimate Electrosurgical Generator and used to deliver helium gas plasma (J-Plasma) and standard electrosurgical monopolar coagulation during surgical procedures. The accessory has a flexible shaft that can be advanced through a cannula during minimally invasive surgical procedures. The handpiece is activated by the generator footswitch.

The primary difference between the Bovie J-Plasma Precise Flex handpiece and currently available Bovie J-Plasma handpieces is that the Bovie J-Plasma Precise Flex handpiece has a flexible shaft that can be controlled with graspers, forceps, or grasping instruments during minimally invasive surgical procedures.

The Bovie J-Plasma Precise Flex handpiece uses the same basic technology and delivers the same J-Plasma helium plasma energy as currently available J-Plasma handpieces (K151325, K152570, K170188) and are compatible only with Bovie Ultimate electrosurgical generators.

The provided text describes the Bovie J-Plasma Precise Flex Handpiece, an electrosurgical accessory. However, it does not contain the specific details required to answer all parts of your request regarding acceptance criteria and a study that proves the device meets those criteria. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results with acceptance criteria.

Here's an analysis based on the information available:

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

The document provides a table of tests performed but does not explicitly state specific acceptance criteria in measurable terms. It describes the objective of each test and the protocols used, but not the pass/fail thresholds.

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

The document does not specify the sample size for any of the performance tests. It also does not mention the data provenance (e.g., country of origin, retrospective/prospective). The tests listed are primarily bench and electrical verification, which typically do not involve human patient data.

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

This information is not provided in the document. The tests described (electrical, bench, mechanical, EMC) are primarily engineering and technical verifications, not typically requiring expert interpretation of clinical data for ground truth.

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

This information is not provided. Given the nature of the tests (bench, electrical, mechanical), an adjudication method like 2+1 or 3+1, which is common in clinical imaging studies for ground truth establishment, would not be applicable.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the document. This type of study is typically associated with AI-powered diagnostic devices, not electrosurgical handpieces. The device described is a surgical instrument, not an AI diagnostic tool.

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

This information is not applicable as the device is an electrosurgical handpiece, not an AI algorithm. It's a hand-held tool used by a surgeon.

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

For the bench equivalency testing, the "ground truth" for tissue effect was established by comparison to the predicate J-Plasma handpiece. This would likely involve observable and measurable tissue effects (e.g., coagulation depth, cutting efficiency) under controlled bench conditions. For electrical, mechanical, and EMC tests, the ground truth is simply meeting predefined engineering specifications and regulatory standards.

8. The sample size for the training set

This information is not provided. The device is not an AI/ML product, so the concept of a "training set" in the context of machine learning does not apply.

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

This information is not applicable as the device is not an AI/ML product.

In summary, the provided document is a 510(k) summary for an electrosurgical handpiece, focusing on substantial equivalence. It outlines technical performance tests but lacks the detailed clinical study data, acceptance criteria, ground truth establishment methods, and sample sizes that would be found in a clinical trial report or for AI/ML device submissions.

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The Bovie Ultimate® Electrosurgical Generators are indicated for delivery of radiofrequency energy and/or helium gas plasma to cut, coagulate and ablate soft tissue during open and laparascopic surgical procedures. The J-plasma portion of the generator can be used only with dedicated Bovie J-Plasma handpieces.

The Bovie J-Plasma Precise Open® Handpiece is intended to be used in conjunction with the Bovie Ultimate® electrosurgical generator for the delivery of radiofrequency energy and/or a helium gas plasma for electrosurgical cutting, coagulation and ablation of soft tissue during open surgical procedures. The Bovie J-Plasma Precise Open® Handpiece is compatible with Bovie Ultimate® Electrosurgical Generators BVX-200H, and BVX-200P.

Bovie Ultimate® Gen 2 Electrosurgical Generator is a multipurpose electrosurgical device that delivers high frequency electrical energy to cut and coagulate soft tissue. It can also deliver Helium gas plasma energy (J-Plasma) for the cutting, coagulation, and ablation of soft tissue.

The Ultimate Gen 2 electrosurgical generator is the next generation of the original Bovie Ultimate®. The Ultimate Gen 2 has offers the same electrosurgical modes and has the same performance specifications as the original Bovie Ultimate, but the Ultimate Gen 2 will be compatible with the new Bovie J-Plasma Precise Open handpiece passive accessory.

The Bovie J-Plasma Precise Open Handpiece is a sterile, single use electrosurgical accessory intended to be used in conjunction with the Bovie Ultimate Gen 2 electrosurgical generator for the delivery of radiofrequency energy and/or a helium plasma gas for electrosurgical cutting, coagulation and ablation of soft tissue during open surgical procedures. The handpiece utilizes a retractable blade or needle electrode to ignite the helium gas to create the plasma.

This document is a 510(k) premarket notification for electrosurgical devices, primarily comparing a new generation device to a predicate device. It does not contain information typically found in an AI/ML device study.

Therefore, the requested information cannot be fully provided from this document as it relates to clinical performance studies for AI/ML devices. I will extract the information that is present, or state its absence.

Acceptance Criteria and Study for an AI/ML Device:

This document describes an electrosurgical device (Bovie J-Plasma Precise Open Handpieces & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator), not an AI/ML device. Therefore, the requested information regarding AI/ML device performance and studies is not applicable.

However, I can provide a summary of the performance testing performed for this electrosurgical device, as detailed in the document.

1. Table of Acceptance Criteria and Reported Device Performance (for Electrosurgical Device):

The document lists performance tests but does not present specific quantitative acceptance criteria or reported performance values in a table format that allows for direct comparison against pre-defined thresholds. Instead, it indicates that testing was performed to "assure that the Bovie J-Plasma Precise Open Handpiece and the Ultimate Gen 2 meet performance requirements." The "Objective" column in the provided table serves as a high-level acceptance criterion for each test. The study confirms device performance and demonstrates equivalent tissue effect.

*The document states: "The Bovie J-Plasma Precise® Open Handpiece and Ultimate Gen 2 were subjected to verification testing that confirmed device performance and demonstrated equivalent tissue effect between the J-Plasma passive accessory and active accessory."

Regarding AI/ML specific questions:

2. Sample size used for the test set and the data provenance: Not applicable. This document does not describe an AI/ML device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this electrosurgical device is its ability to perform its intended functions (cutting, coagulation, ablation) and meet safety standards.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

This device is intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures. This device is intended to be used with a standard electrosurgical generator with footswitch control and a standard return electrode connection, and the electrode is to be activated only when immersed in a conductive media such as standard saline solution.

The device is comprised of the following major components: an insulated handle, an active electrode, a length of aspiration tubing, a standard foot-switch RF connector, and a standard return connector. The hand piece is designed to connect to electrosurgical generators that feature a standard foot switch controlled monopolar connector and a standard return connector. A stainless steel electrode tip is surrounded by a ceramic thermal insulator. The product is available in shaft diameters of 3.3mm, 2.4mm, and 1.8mm. The larger size is available in aspirating and non-aspirating version. The aspirating versions use suction to remove saline irrigant during the surgical procedure for the dissipation of heat and improved vision. The device is available in electrode face angles of 55 degrees, and 90 degrees. There is a feature on the handle that lets the operator easily determine the orientation of the active electrode face. The wedge-shaped tapered tip allows access to difficult to reach locations. The working length is 160mm. The cable from the handle is 126" +/- 6" in length. The device operates in bipolar mode. The return electrode is located on the device and does not require the use of an external grounding pad or return electrode. The device has a simple user interface that uses a footswitch to activate the device.

The provided text is a 510(k) Pre-market Notification for a medical device (Bovie Disposable Bipolar Ablator). It describes the device, its intended use, and the testing conducted to demonstrate substantial equivalence to predicate devices. However, it does not contain any information about an AI/ML-driven device or its performance characteristics.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving an AI/ML device meets them, nor can I provide information on sample sizes, expert involvement, MRMC studies, or ground truth establishment relevant to an AI/ML system.

The document primarily focuses on:

• Device description: Electrosurgical cutting and coagulation device for arthroscopic procedures.
• Intended Use: Cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.
• Performance Testing: Mechanical, electrical, electromagnetic compatibility, biocompatibility, INE (insertion/navigation/extraction), and various bench-top validation tests (visual inspection, mold stress relief, cable strain/impulse/flexure, drop testing, connector verification, temperature measurements, rigidity testing, compatibility, aspiration flow, thermal performance & clogging).
• Substantial Equivalence Comparison: A table comparing features of the Bovie Disposable Bipolar Ablator to predicate devices (ArthroCare SuperTurbo Vac, TurboVac 90, Arthrocare ArthroWand®, and a previous Bovie Disposable Bipolar Ablator model).

To answer your request, I would need a document that describes the development and validation of an AI/ML device, including details about its performance evaluation against defined acceptance criteria.

Ask a specific question about this device