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The 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 tissues in patients requiring arthroscopic surgery.

The VAPR TRIPOLAR 90 Suction Electrode is a single use, one-piece bipolar RF suction electrode for use in a surgical setting by a surgeon trained in arthroscopic surgery. The VAPR TRIPOLAR 90 Suction Electrode is an RF device which incorporates 3 electrodes in the probe tip: one active electrode and two return electrodes. This configuration optimizes ablation and coagulation in a single device. It has been designed to facilitate access and control the delivery of RF energy to the joint space. The connector plug of the VAPR TRIPOLAR 90 Suction Electrode is designed to interface only with the VAPR VUE Radiofrequency Generator. It has an internal identification code which automatically adjusts the VAPR VUE Generator to the optimal default and accessible powers and waveforms. If required, the settings for the VAPR TRIPOLAR 90 Suction Electrode can be modified within safe pre-determined limits by accessing the generator or footswitch control. It is intended to be only operated with the VAPR VUE generator at pre-determined default settings specific for this device. The VAPR TRIPOLAR 90 Suction Electrode has three sets of buttons to address surgeon preference when holding the electrode. Each pair of buttons offers the same functionality and are ergonomically positioned for surgeon comfort. In addition the VAPR TRIPOLAR 90 Suction Electrode features vacuum fluid extraction which enhances the efficiency of the electrode and assists in the removal of bubbles and debris created during activation within the operating site. The design includes the ability to vary flow rate to allow the surgeon to make adjustments depending on particular procedural requirements.

This document describes the VAPR® Tripolar 90™ Suction Electrode developed by DePuy Mitek Incorporated. The device is a single-use, one-piece bipolar RF suction electrode intended for resection, ablation, and excision of soft tissue, hemostasis of blood vessels, and coagulation of soft tissues in patients requiring arthroscopic surgery.

The acceptance criteria for the VAPR® Tripolar 90™ Suction Electrode and the study that proves the device meets these criteria are summarized below.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the battery of tests conducted. For all tests, the reported device performance was "Acceptable."

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

The document does not specify the sample sizes used for each individual test. The tests were performed to demonstrate substantial equivalence to predicate devices for regulatory clearance. The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data provided, though it can be inferred that the testing was conducted by or on behalf of DePuy Mitek, Inc. (a U.S. company) to meet FDA requirements.

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 tests seem to be primarily engineering and bench-top evaluations, rather than clinical studies requiring expert interpretation of results for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the tests (biocompatibility, electrical safety, performance testing), an adjudication method in the context of expert consensus on medical image interpretation or clinical outcomes is not applicable here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states that "No clinical studies are required to demonstrate safety and efficacy of the device in support of an application for premarket clearance." Therefore, there is no effect size of human readers improving with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This device does not involve an algorithm or AI. It is a physical medical device. Therefore, a standalone performance study in this context is not applicable. The performance tests evaluate the device's physical and electrical characteristics and its interaction with biological tissues in a controlled environment.

7. The Type of Ground Truth Used

The "ground truth" for the various tests appears to be established by:

• Biocompatibility: Conformance to recognized international standards (ISO-10993).
• Electrical Safety: Conformance to recognized international electrical safety standards (IEC 60601-1, IEC 60601-2-2).
• Performance Data: Acceptable outcomes based on internal engineering specifications and testing protocols, designed to demonstrate the device performs as intended and is substantially equivalent to predicate devices.

8. The Sample Size for the Training Set

This information is not applicable. The VAPR® Tripolar 90™ Suction Electrode is a physical medical device, not an AI or machine learning algorithm that requires a training set.

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

This information is not applicable, as there is no training set for this device.

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