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The Mitek VAPR VUE Radiofrequency System is intended for resection, ablation and excision of soft tissue, and hemostasis of blood vessels in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.

The P50 and P90 Electrodes when used with Mitek VAPR Electrosurgical Systems are intended for resection, ablation and excision of soft tissue, and hemostasis of blood vessels in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.

The VAPR CP90 Electrodes when used with Mitek VAPR VUE Electrosurgical System is intended for resection, ablation and excision of soft tissue, and hemostasis of blood vessels in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.

The DePuy Mitek VAPR Electrodes for use with all VAPR Electrosurgical Systems are intended for resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow, and wrist.

The DePuy Mitek VAPR Electrodes for use with the VAPR VUE Radiofrequency System are intended for resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow, and wrist.

The VAPR VUE Radiofrequency System is DePuy Mitek's next generation of VAPR Radiofrequency Systems. The system consists of a generator, wired or wireless footswitch and electrodes. The VAPR VUE generator was designed to provide comparable RF performance with legacy VAPR electrodes.

As with its predicate devices including the VAPR 3 generator, this electrosurgical system utilizes bipolar technology specifically designed to provide a range of arthroscopic surgical treatments including soft tissue ablation, contouring, cutting and coagulation and temperature control.

The VAPR VUE system offers five output types of operation: Vaporization (ablation), Coagulation, CP Vaporization (ablation), Blended Vaporization (ablation and coagulation) and temperature control coagulation. All types are present in the predicate device (VAPR3 generator) except the CP Vaporization (ablation).

The VAPR P50 and P90 Electrodes are an addition to the family of LPS Electrodes. These Suction Electrodes are soft tissue ablation and coagulation devices intended for use with the VAPR Electrosurgical Systems. They extend the utility of the system by removing bubbles created during activation from the operating site.

The VAPR CP90 Electrodes are identical in technological characteristics as the P90 electrode only it is intended to be run only off the VAPR VUE platform at pre-determined default settings specific for the device. The CP90 with Handcontrols offers the integration of handcontrol capabilities via three buttons molded on the existing one-piece handles. Those buttons control ablation, coagulation and the generator mode functions.

The information provided describes the DePuy Mitek VAPR VUE Radiofrequency System and associated electrodes, which is a medical device for electrosurgical cutting and coagulation. The submission is a 510(k) premarket notification, aiming to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide specific quantitative acceptance criteria or detailed reported device performance in terms of clinical metrics (e.g., success rates, complication rates, accuracy). Instead, it relies on demonstrating compliance with recognized electrical safety and software standards and asserting comparable RF performance.

The device's performance is generally stated as:

• RF Performance: "The VAPR VUE generator was designed to provide comparable RF performance with legacy VAPR electrodes."
• Safety and Performance Testing: "In addition safety and performance testing have been done to validate the performance and safety of the device. It has been demonstrated that these device modifications will not affect safety and effectiveness of the subject devices."
• Verification Testing: "Verification of the VAPR VUE System and Electrodes includes electrical, Safety and software and performance tests to show that the device meets its product Performance specifications over a range of operating conditions."

Acceptance Criteria (Implied by Standards & Equivalence):

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

The document does not specify sample sizes for "test sets" in the context of clinical performance or accuracy in a medical imaging or diagnostic sense. The testing mentioned (electrical, safety, software, performance) would typically involve engineering verification and validation on the device itself and its components, rather than patient data test sets.

• Test Set Sample Size: Not applicable/not specified in the provided text for clinical performance. The testing mentioned is for engineering verification and validation.
• Data Provenance: Not applicable, as no clinical/patient data test sets are described. The testing is device-centric.

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 because the submission explicitly states:

• "No clinical studies are required to demonstrate safety and efficacy of the device in support of an application for premarket clearance."
• Therefore, there were no "ground truth" derived from expert review of clinical cases.

4. Adjudication Method for the Test Set

This information is not applicable as there were no clinical test sets requiring adjudication by experts.

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 MRMC study was done. This device is an electrosurgical tool, not an AI-assisted diagnostic or imaging device. The concept of "human readers improve with AI vs without AI assistance" is not relevant to this type of device.

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

• Not applicable. This is a hardware-based electrosurgical system, not an algorithm, and does not operate in a standalone diagnostic capacity.

7. The Type of Ground Truth Used

• No clinical grand truth was used. The "ground truth" for the device's performance is its compliance with engineering specifications, electrical safety standards, software standards, and its ability to achieve its intended physical effects (resection, ablation, coagulation) in laboratory or simulated environments, as demonstrated through non-clinical performance and safety testing.

8. The Sample Size for the Training Set

• Not applicable. This device does not employ machine learning or AI that would require a "training set" of data.

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

• Not applicable. As no training set was used, no ground truth needed to be established for it.

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The ConMed/Linvatec LightWave™ Integrated Electrode Ablators are intended to be used for electrosurgical cutting and coagulation in shoulder, ankle, wrist, elbow, and knee arthroscopic procedures in a conductive fluid environment. Additionally, the suction/aspiration version also has capability for suctioning irrigation fluids.

The ConMed/Linvatec LightWave" Integrated Electrode Ablators are a modification of the currently marketed 3.2 mm UltrAblator electrode (Linvatec, K030720) and a Switch Pencil control handle (Linvatec, K983652) integrated into one device. One version incorporates handcontrolled buttons to actuate the "cut" and "coag" functions of the electrosurgical generator. Another version is actuated by foot-control to control "cut" and "coag" functions of the electrosurgical generator. The hand-controlled and foot controlled version consists of an electrical insulation coated electrode and ceramic insulator attached to an integrated handle and cord set, allowing attachment to commonly available electrosurgical generators in distribution.

A third version of the ConMedILinvatec LightWave™ Integrated Electrode Ablators incorporates a suction/aspiration feature and is a modification of the currently marketed 3.2 mm Ult Ablator electrode (Linvatec, K993885) and a Switch Pencil control handle (Linvatec, K983652) integrated into one device, and is similar in technology to Heatwave Hand-Controlled Electrode (Conmed, K021299) and the VAPR™ 3.5mm 90° Suction Electrode (Mitek, K002422), which incorporate aspiration or suction. The device is similar to the hand-controlled device and will also have suction capability and attach to commonly available suction equipment. This electrode will be hollow allowing for the removal of irrigating fluids during surgical procedures.

The front switch contained in the hand-controlled devices provide the surgeon with electrosurgical cut (ablate) capability when depressed. The rear button activates electrosurgical coagulating (coag) current.

The provided text is a 510(k) submission for the LightWave™ Integrated Electrode Ablator and LightWave™ Integrated Electrode Suction Ablator. It aims to demonstrate substantial equivalence to previously marketed devices. However, this document does not contain information about specific acceptance criteria or a study proving that the device meets those criteria, as typically understood in the context of performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic or AI-driven device.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices based on:

• Intended Use: "ConMed/Linvatec LightWave™ Integrated Electrode Ablators are intended to be used for electrosurgical cutting and coagulation in shoulder, ankle, wrist, elbow, and knee arthroscopic procedures in a conductive fluid environment. Additionally, the suction/aspiration version also has capability for suctioning irrigation fluids."
• Surgical Effect, Function, Materials of Construction, Patient Population, Compliance with Recognized Standards and Published FDA Guidance, and Manufacturing Methods.

The "study" in this context is the 510(k) submission process itself, which asserts that the new device is substantially equivalent to existing predicate devices, implying that its performance is implicitly acceptable because the predicates are already approved.

Therefore, many of the requested details about acceptance criteria for performance, sample sizes for test and training sets, ground truth establishment, expert qualifications, and MRMC studies are not applicable or not present in this type of regulatory submission for a Class II electrosurgical device relying on substantial equivalence to establish safety and effectiveness.

Here's a breakdown of what can be gathered from the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable / Not Provided. This document describes a new electrosurgical electrode and relies on demonstrating substantial equivalence to existing devices. It does not present a "test set" in the sense of clinical data points used to evaluate an AI or diagnostic device's performance.

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

• Not Applicable / Not Provided. Ground truth establishment by experts is not a component of this 510(k) filing for an electrosurgical device.

4. Adjudication method for the test set

• Not Applicable / Not Provided. No test set or adjudication method is described.

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 / Not Provided. This is not an AI-driven device or one that involves human readers interpreting results.

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

• Not Applicable / Not Provided. This is an electrosurgical tool, not an algorithm.

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

• Not Applicable / Not Provided. The "ground truth" for this device's acceptance is its substantial equivalence to legally marketed predicate devices, which are presumed safe and effective based on their established clinical use. Testing typically involves bench testing (e.g., power output, insulation integrity, fluid flow for suction), electrical safety, and biocompatibility, not clinical "ground truth" for performance in the same way a diagnostic device would.

8. The sample size for the training set

• Not Applicable / Not Provided. This is not an AI/machine learning device that requires a training set.

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

• Not Applicable / Not Provided. As per point 8, there is no training set mentioned.

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