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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

Summary of the Study:

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

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

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

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

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

This information is not provided in the document. The type of testing described (electrical, software, mechanical verification) typically relies on engineering and regulatory standards rather than expert clinical consensus to establish "ground truth" for the device's functional and safety characteristics.

4. Adjudication Method for the Test Set

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

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

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

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

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

7. Type of Ground Truth Used

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

8. Sample Size for the Training Set

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

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

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

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The Apyx Plasma/RF Handpiece is intended to be used with compatible electrosurgical generators for the delivery of radiofrequency energy and/or helium plasma for cutting, coagulation of soft tissue during open surgical procedures. The Apyx Plasma/RF Handpiece is compatible with the Electrosurgical Generators, BVX-200H and BVX-200P, owned by Apyx Medical.

The Apyx Plasma/RF Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. The compatible Generators operate at an adjustable power of up to 40W (expressed as 0-100% where 100% is 40W) and provide an adjustable helium gas flow of 1-5 LPM. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation.

The Apyx Plasma/RF Handpiece has a non-extendable electrode to generate helium plasma. The handpiece is available in two different lengths: 15cm and 27cm. The 15cm length is available in a single port (APYX-15-SP) as well as a twin port configuration (APYX-15-TP). The 27cm length is only available with a twin port configuration (APYX-27-TP).

The provided text describes the performance data for the Apyx Plasma/RF Handpiece (K191542) to demonstrate its substantial equivalence to predicate devices, focusing on non-clinical testing.

Here's the breakdown of the acceptance criteria and the studies that prove the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

This section synthesizes the various tests and their outcomes as presented in the document.

2. Sample Size for Test Set and Data Provenance

• Sample Size: Not explicitly stated for each individual test. The document mentions "testing involved device activation on porcine skin" for the tissue temperature profile equivalency and "a live porcine model" for the maximum temperature study. For ex-vivo studies, it states "several tissue types (i.e., muscle, liver, kidney)."
• Data Provenance:
  • Country of Origin: Not specified but typically assumed to be conducted in the US or collaborating international laboratories if not stated otherwise for FDA submissions.
  • Retrospective or Prospective: Prospective, as these were specific tests designed and executed to evaluate the new device and its equivalence to predicates.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable: For this device, the "ground truth" is based on objective, quantifiable physical and biological measurements (e.g., temperature, power output, tissue necrosis depth, mechanical integrity, standard safety compliance), not subjective expert interpretation of images or clinical outcomes that would require expert consensus. Therefore, no "experts" in the sense of clinicians establishing ground truth for a diagnostic test were used. The ground truth is defined by established engineering and biological standards and quantitative measurements.

4. Adjudication Method

• None (Not Applicable): As the ground truth is based on objective measurements and compliance with established standards, there is no need for an adjudication method typically used in studies involving subjective interpretation (e.g., by radiologists).

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

• No: No MRMC comparative effectiveness study was performed or described. This type of study is more relevant for diagnostic AI tools where human readers interpret medical images. This submission focuses on the safety and performance equivalence of a surgical electrosurgical handpiece through bench and animal testing.

6. Standalone Performance (Algorithm Only)

• Yes, In essence: The studies described are inherently "standalone" in the sense that they evaluate the device's technical and biological performance directly, rather than its performance in assisting human operators or interpreting data for them. The device itself (the Apyx Plasma/RF Handpiece) is the "system" being tested for its intrinsic capabilities (e.g., cutting, coagulation, ablation effectiveness, and safety). There is no "human-in-the-loop" performance being measured in these specific tests, as they focus on the physical and biological effects generated by the device.

7. Type of Ground Truth Used

• Objective Measurements and Standard Compliance: The ground truth for these studies is based on:
  • Benchmarking against Predicate Devices: Demonstrating equivalent electrical output and tissue effects.
  • Physical Measurements: Calorimetric energy/power output, mechanical functionality, thermal video camera measurements for tissue temperature, depth and lateral spread of thermal effect in tissue.
  • Compliance with Standards: Electrical safety (IEC 60601 series) and Biocompatibility (ISO 10993 series).
  • Biological Outcomes (Animal/Ex-vivo): Observation of tissue heating, coagulation, and ablation effects in porcine models and various tissue types.

8. Sample Size for Training Set

• Not Applicable / Not Provided: This device is a medical instrument, not an AI/ML algorithm that requires a "training set" in the conventional sense. The device's design is based on established engineering principles and iterative development, not data-driven machine learning.

9. How Ground Truth for Training Set Was Established

• Not Applicable: As there is no "training set" for an AI/ML algorithm, the concept of establishing ground truth for it does not apply here. The device's performance is verified against design specifications and established safety and efficacy benchmarks through the testing described.

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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, < 24 hours)	Conducted per FDA Blue Book Memo #G95-1 and ISO 10993-1. Included Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Hemolysis, and Material Mediated Pyrogen. Verification testing for changed patient-contacting components (flow tube coupler and O-ring) was satisfactorily conducted.

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

   The document does not explicitly state the sample sizes for each mechanical, electrical, usability, or biocompatibility test. It mentions "Performance testing" was performed, indicating that multiple units were likely tested for each criterion. The data provenance is internal testing performed by the manufacturer, Bovie Medical Corporation. The tests are prospective as they were performed on the new device models to demonstrate their safety and efficacy.

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. The tests described are primarily engineering, electrical, and biological evaluations, typically not requiring medical experts for "ground truth" establishment in the same way clinical studies would. The "usability evaluation" would have involved users, but their qualifications are not specified beyond being relevant to using the "J-Plasma Pistol Grip Handpiece."

4. Adjudication method for the test set:

   This information is not provided and is not typically relevant for the type of engineering and biocompatibility testing described. The tests would likely have pass/fail criteria based on predefined specifications.

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:

   No, an MRMC comparative effectiveness study was not done. This device is an electrosurgical handpiece, not an AI diagnostic or assistance tool, so such a study would not be applicable.

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

   No, this is an electrosurgical handpiece, a physical medical device, not a software algorithm. Therefore, "standalone" algorithm performance is not applicable.

7. The type of ground truth used:

   The ground truth for the various tests was based on:

   • Engineering Specifications: For mechanical and electrical tests (e.g., connector dielectric strength, cable flexure, integrity of insertion/extraction force).
   • Regulatory Standards: For biocompatibility testing (ISO 10993 guidelines, FDA Blue Book Memorandum #G95-1).
   • Safety and Efficacy Requirements: For usability evaluation, ensuring the device is safe and performs as intended.

8. The sample size for the training set:

   This concept is not applicable as this is a physical medical device, not a machine learning algorithm requiring a training set.

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

   This concept is not applicable as this is a physical medical device, not a machine learning algorithm requiring a training set.

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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.

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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.

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The intended use for the DERM 942 is for removal and destruction of skin lesions and the coagulation of tissue.

The intended use for the Bantam/PRO is for removal and destruction of skin lesions and for electrosurgical cutting, blending, coagulation, fulguration, and bipolar procedures.

The intended use for the DERM 941 and DERM 942 is for removal and destruction of skin lesions and the coagulation of tissue.

The intended use for the Bantam/PRO is for removal and destruction of skin lesions and for electrosurgical cutting, blending, coagulation, fulguration, and bipolar procedures.

The Bantam/PRO performs the following functions:

Cut mode: Allows the user to utilize electrosurgical current to vaporize or cut tissue.

Blend mode: Combines cutting with hemostasis, which achieves a bloodless cut.

Coagulation mode: Is used for the destruction of tissue and hemostasis.

Fulguration mode: Allows the user to coagulate over a broad area with less tissue penetration.

Bipolar mode: Allows coagulation of tissue using forceps.

The DERM 942 has the following functions shared with the Bantam/PRO: Fulguration mode: Allows the user to coagulate over a broad area with less tissue penetration.

Bipolar mode: Allows coagulation of tissue using forceps.

The DERM 941 has only the basic Fulguration mode function.

The DERM 942 and 941 are termed High Frequency Dessicators since they perform treatment of skin lesions. The fulguration and bipolar are termed the dessication modes. The Bantam/PRO performs treatment of skin lesions but also has the basic cut and coagulation functions of a typical electrosurgical generator. All these units are considered low wattage (<50W).

This document is a 510(k) premarket notification for electrosurgical generators and does not describe a study involving an AI device or its acceptance criteria. Therefore, most of the requested information regarding AI device performance, sample sizes, ground truth establishment, or expert evaluation methods is not applicable.

The document focuses on demonstrating substantial equivalence of the new Bovie Bantam/PRO, Bovie Derm 941, and Bovie Derm 942 Electrosurgical Generators to legally marketed predicate devices.

Here's the information that is available from the provided text, adapted to the closest relevant categories:

1. Table of Acceptance Criteria and Reported Device Performance

No specific quantitative acceptance criteria or performance metrics (like sensitivity, specificity, accuracy, etc., for an AI device) are reported in this document beyond verification that the devices pass these tests and meet relevant standards. The conclusion states that "Performance testing demonstrates equivalence between the proposed and predicate devices," implying successful completion of these tests.

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

Not applicable. This is not a study assessing an AI device on a test set of data. The "test set" here refers to the physical devices being tested.

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

Not applicable. Ground truth in the context of an AI device is not relevant here. The "ground truth" for these electrosurgical generators would be their functional specifications and safety standards.

4. Adjudication Method for the Test Set

Not applicable, as this is not a study with expert adjudication of data.

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 document does not describe an AI device or an MRMC study.

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

Not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by adherence to recognized international standards and specifications for electrosurgical equipment. The document explicitly lists:

• IEC-60601-1, Edition 3.1: Medical Electrical Equipment - Part 1: General Requirements For Safety
• IEC 60601-1-2:2007: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
• IEC-60601-2-2 : 2009: Particular requirements for the safety of high frequency surgical equipment

8. The Sample Size for the Training Set

Not applicable. This is not an AI device trained on a dataset.

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

Not applicable.

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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 a shaft diameters of 3.3mm and is available in aspirating and non-aspirating versions. 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 50 degrees. There is a feature on the handle that lets the operator easily determine the orientation of the active electrode face. The wedgeshaped 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 primary difference between the Bovie Disposable Bipolar Ablator and the predicate device is that the Bovie Disposable Bipolar Ablator does not require the use of a dedicated electrosurgical generator but is compatible with standard electrosurgical generators.

The Bovie Disposable Bipolar Ablator has the same intended use and energy type as the predicate device. There are no technological differences, no changes to the principle of operation or the method of application.

The Bovie Disposable Bipolar Ablator is designed for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures. The provided document focuses on demonstrating the substantial equivalence of the Bovie Disposable Bipolar Ablator to legally marketed predicate devices rather than providing a detailed study that proves a specific quantitative acceptance criterion. The performance testing outlined primarily verifies compliance with various safety and performance standards for electrosurgical equipment.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in the format of specific thresholds for metrics like sensitivity, specificity, or accuracy that would be typical for an AI/diagnosis device. Instead, the acceptance criteria are implicitly that the device meets applicable standards and requirements for safety, electrical performance, biocompatibility, and functional integrity.

2. Sample Size for Test Set and Data Provenance

The document does not specify a "test set" in the context of a dataset for an AI algorithm. The performance testing described involves bench-top validation testing of the device's physical and electrical properties, as well as its functional performance. The "sample size" would refer to the number of devices or components tested. This is not explicitly stated but is implicitly sufficient to demonstrate compliance with the referenced standards.

• Sample Size: Not explicitly stated for each test, but typically several units/components would be tested for each verification.
• Data Provenance: The tests are described as bench-top validation testing performed by the manufacturer (Bovie Medical Corporation), indicating they are internal, prospective tests on manufactured devices/components. No country of origin for specific "data" is mentioned beyond the manufacturing location of the company (Clearwater, Florida, USA).

3. Number of Experts and Qualifications for Ground Truth

This question is not applicable in the context of the provided document. The device is a surgical instrument, not an AI diagnostic tool that requires expert-established ground truth from images or data. The "ground truth" for this device's performance is compliance with established engineering, electrical, and safety standards (e.g., IEC, ISO, FDA guidelines for biocompatibility) and its ability to perform its intended function in a simulated environment. The "experts" involved would be engineers, quality assurance personnel, and regulatory affairs specialists within Bovie Medical, along with the independent testing labs that certify compliance to the standards. Their qualifications are inherent in their professional roles and certifications to conduct such tests.

4. Adjudication Method

Not applicable. This is not a study assessing diagnostic performance where adjudication of disagreement among experts would be necessary. The tests are objective measurements against defined standards.

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

Not applicable. This is not a study of an AI-assisted diagnostic tool or an imaging device to compare human reader performance with and without AI assistance. The study described focuses on the standalone performance and safety of a electrosurgical ablator.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical electrosurgical tool, not an algorithm. Its "standalone performance" is what is described in the bench-top testing, demonstrating its functional capabilities without human in-the-loop diagnostic interpretation. The device's "standalone" performance means it performs its intended function (cutting, vaporization, coagulation) when activated.

7. Type of Ground Truth Used

The "ground truth" for the performance testing is based on:

• International Standards: Compliance with specific standards such as IEC-60601-1, IEC 60601-1-2, IEC-60601-2-2, ISO 10993-1, ISO 11135-1, and ISO 10993-7. These standards define acceptable limits and methodologies for testing.
• Bovie Self-Enforced Requirements: Internal specifications set by the manufacturer.
• Functional Verification: Demonstrating the device performs its intended functions (e.g., aspiration flow rate, tissue removal, temperature during use) under specified conditions.

Essentially, the "ground truth" is defined by established engineering and medical device safety requirements.

8. Sample Size for Training Set

Not applicable. The device is not an AI algorithm that requires a training set.

9. How Ground Truth for Training Set was Established

Not applicable, as there is no training set for this type of device.

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The Bovie J-Plasma Precise 360 Handpiece is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparascopic surgical procedures.

The Bovie J-Plasma Precise 360 Handpiece is compatible only with Bovie J-Plasma generators.

The Bovie J-Plasma Precise 360 Handpiece is a sterile, single-use electrosurgical accessory intended to be used in conjunction with Bovie J-Plasma electrosurgical generators for the delivery of helium gas plasma for cutting, coagulating and ablating of soft tissue.

The Bovie J-Plasma Precise 360 Handpiece is available with a retractable needle tip, or with a retractable cutting blade tip for excising tissue. Both tip configurations serve as electrodes to generate helium plasma. A 30 degree angled shaft tip provides improved visibility during use, and a rotating knob is used to orient the angled shaft tip to the optimal position. The device is available with 33cm and 45cm shaft lengths. The device can be used in laparoscopic procedures using a standard 5mm trocar.

The provided text describes performance testing for the Bovie J-Plasma Precise 360 Handpiece. Based on the information given, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly state "acceptance criteria" for each test with specific numerical targets. Instead, it lists objectives for performance tests, implying that meeting these objectives constitutes acceptance. The reported device performance is described as the device fulfilling these objectives, as evidenced by the corresponding test reports.

Additionally, the device was designed in accordance with several international standards (IEC-60601-1, IEC 60601-1-2, IEC-60601-2-2, ANSI/AAMI/ISO 10993-1, ANSI/AAMI/ISO 11135-1, ANSI/AAMI/ISO 10993-7), implying that compliance with these standards (including their safety and performance requirements) served as acceptance criteria.

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

The document does not specify the sample sizes used for each test set (e.g., number of devices tested, number of tissue samples, number of users for usability). It also does not mention the provenance of the data (e.g., country of origin, retrospective or prospective). The testing appears to be primarily bench and laboratory testing.

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

The document does not provide information regarding the number of experts used or their qualifications for establishing ground truth, as the testing described appears to be primarily technical and engineering-focused rather than involving clinical judgment for ground truth.

4. Adjudication method for the test set

The document does not specify any adjudication method. This is consistent with the type of technical performance and safety testing described, which typically relies on objective measurements and established protocols rather than expert adjudication.

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

The document does not describe an MRMC comparative effectiveness study, nor does it mention any AI assistance. The device is an electrosurgical handpiece, not an AI-powered diagnostic or assistive tool for human readers.

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

The device is a medical instrument (electrosurgical handpiece) that requires human operation. Therefore, the concept of "standalone (algorithm only)" performance without human-in-the-loop is not applicable to this device.

7. The type of ground truth used

The ground truth for the performance tests was established through objective measurements and adherence to engineering and safety standards. For example:

• Mechanical and Electrical Verification: Ground truth would be the device meeting specified mechanical tolerances, electrical safety parameters, and functional requirements.
• Plasma Characteristics: Ground truth would involve quantitative measurements of plasma stream properties under various generator settings.
• Performance Evaluation (on tissue): Ground truth would relate to the observed effects on tissue (cutting, coagulation, ablation depth, etc.) as per predefined expectations for safety and efficacy.
• Usability Evaluation: Ground truth would be based on user feedback and demonstrated safe and effective operation by representative users.
• Biocompatibility: Ground truth from standard tests to ensure material safety.
• Shelf Life: Ground truth from measurements demonstrating maintained performance and integrity over time.

8. The sample size for the training set

The document does not mention a training set. This is because the Bovie J-Plasma Precise 360 Handpiece is a physical medical device (electrosurgical instrument) and not an algorithm or AI system that requires a training set.

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

Since there is no training set mentioned or implied for this physical device, this question is not applicable.

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The Bovie J-Plasma Handpiece is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparascopic surgical procedures.

The Bovie J-Plasma Handpiece is compatible only with Bovie J-Plasma generators.

The Bovie J-Plasma Handpiece is a sterile, single use electrosurgical accessory intended to be used in conjunction with Bovie J-Plasma electrosurgical for the delivery of helium gas plasma for cutting, coagulating, and ablating soft tissue.

The Bovie J-Plasma Handpiece is available with a retractable cutting blade tip for excising tissue or a needle tip. Both tip configurations serve as electrodes to generate helium plasma. The device is available in 15cm, 33cm, and 45cm lengths. The device can be used in laparascopic or open surgical procedures.

The provided text describes a 510(k) summary for the Bovie J-Plasma Handpiece (K151325). The document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study with specific acceptance criteria and detailed device performance metrics in a table format.

Therefore, much of the requested information regarding acceptance criteria, reported device performance, sample sizes for test and training sets, data provenance, expert ground truth establishment, MRMC studies, standalone performance, and ground truth types is not explicitly available in the provided document.

However, I can extract the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding reported device performance metrics. Instead, it lists various performance tests and implies their successful completion to demonstrate equivalence.

2. Sample size used for the test set and the data provenance:
This information is not provided in the document. The document mentions "Performance testing" but does not detail the sample sizes for any of the tests. Data provenance (country of origin, retrospective/prospective) is also not stated.

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 are primarily bench tests and engineering assessments, not clinical or diagnostic studies that would typically involve expert ground truth.

4. Adjudication method for the test set:
This information is not provided in the document. As there is no mention of expert ground truth, an adjudication method is not applicable in this context.

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:
This information is not provided in the document. The device in question is an electrosurgical handpiece, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study with human readers and AI assistance would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not provided in the document. The device is a surgical instrument and does not involve an algorithm for standalone performance evaluation in the context of AI.

7. The type of ground truth used:
For the listed performance tests (mechanical, electrical, plasma characteristics, performance evaluation, usability, shipping), the "ground truth" would likely be based on engineering specifications, industry standards (e.g., IEC standards listed), and predefined functional requirements. For "Performance Evaluation on various tissue types," the ground truth would be the observed effect of the device (cutting, coagulation, ablation) on those tissues, assessed against desired outcomes or predicate device performance. However, the specific methodology for establishing this ground truth (e.g., histological analysis, expert observation) is not detailed.

8. The sample size for the training set:
This information is not provided in the document. The document describes a medical device, not an AI model that requires a training set.

9. How the ground truth for the training set was established:
This information is not provided in the document. Not applicable as this is not an AI model.

Summary of what is available:

The document primarily serves as a 510(k) summary for a medical device and describes various performance tests (bench tests) conducted to ensure the device meets requirements and is substantially equivalent to a predicate. It does not provide detailed results or specific acceptance criteria in a quantitative, tabular format beyond the general statement that the device "meets performance requirements." The "study" here refers to the collection of these performance tests. There is no mention of clinical studies, human readers, AI, or large datasets for algorithm training or testing.

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