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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 VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrodes (S0 and S50) with Integrated Handpiece with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.

The VAPR TC Electrode with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgical System, is intended for coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow, and wrist.

The device description of the VAPR 3.5 mm and 2.3 mm Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) with Integrated Handpiece is as follows. The DePuy Mitek VAPR System is designed for arthroscopic surgical procedures. The System consists of a high frequency Electrosurgical Generator, disposable Electrodes with integrated Handpiece, and a Footswitch. The components are designed and intended to be operated as a single unit. The device description of the VAPR TC Electrode with Integrated Handpiece is as follows. The VAPR Temperature Control Electrode is a soft tissue desiccation device intended for use with the VAPR Systems. Utilization with a VAPR System allows the tip temperature of the electrode to be indicated on the generator display. The device description of the VAPR Suction Electrodes (S00 and S50) is as follows. The VAPR Suction Electrodes are soft tissue ablation and desiccation devices intended for use with the VAPR System. They extend the utility of the system by removing bubbles created during activation from the operating site.

The provided text is a 510(k) summary for DePuy Mitek's VAPR Electrodes. This document is a premarket notification for a medical device that aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing entirely new performance criteria or conducting a comprehensive study to prove novel efficacy or diagnostic performance. Therefore, many of the requested categories for AI/diagnostic device performance studies are not applicable to this type of submission.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission like this, "acceptance criteria" are typically met by demonstrating that the new device performs as safely and effectively as its predicate devices. The performance is "accepted" if it is substantially equivalent to devices already on the market. There aren't specific numerical performance metrics in the way one would see for machine learning models.

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

Not applicable. This is a medical device (electrosurgical electrodes), not a diagnostic or AI device that processes patient data. The "test set" would refer to the physical electrodes themselves and their performance in laboratory or simulated surgical environments, not a dataset of patient information. The document refers to "validation testing (performance testing) for the device modification," but does not specify sample sizes for these tests, which would typically involve testing a specific number of manufactured units according to established test protocols.

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

Not applicable. This is not a diagnostic device. "Ground truth" in this context would relate to the physical performance of the electrodes (e.g., cutting efficacy, coagulation, temperature control), which is measured by engineering and biomechanical tests, not expert interpretation of patient data.

4. Adjudication method for the test set

Not applicable. There is no diagnostic "test set" 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

Not applicable. This is an electrosurgical device, not an AI-assisted diagnostic tool.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used

For a device like this, the "ground truth" for performance would be based on:

• Engineering specifications and standards: Performance criteria derived from industry standards (e.g., electrical safety, material biocompatibility, structural integrity, thermal performance) and internal design specifications.
• Biomechanical studies/bench testing: Measurements of tissue cutting, coagulation, and ablation efficacy using ex vivo or in vitro tissue models.
• Predicate device performance: The established safety and effectiveness profile of the predicate devices.

8. The sample size for the training set

Not applicable. This is not a machine learning device.

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

Not applicable. There is no training set for an algorithm.

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