(119 days)
The VAPR® ARCTIC™ Suction Electrode for use with the VAPR VUE® RF System is 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 hip.
The VAPR® ARCTIC™ Electrode is a single use, one-piece bipolar suction articulating electrode for use in arthroscopic surgery of the hip. The electrode has a hand-controlled articulating tip to improve access and suction capabilities. This will enhance the efficiency of the electrode and extend the utility of the system by assisting in the removal of bubbles and debris created during activation within the operating site.
The ARCTIC Electrode has been designed to facilitate access and control the delivery of RF energy to the joint space. The plug of the ARCTIC Electrode is designed to fit the VAPR VUE® generator socket only. It has an internal identification capacitor code which automatically adjusts the VAPR VUE Generator to the optimal default and accessible powers and waveforms. If required, the settings for the device can be modified within safe pre-determined limits by accessing the generator or footswitch control. It is intended to be run only off the VAPR VUE electrosurgical generator at pre-determined default settings specific for the device.
The provided text describes a 510(k) premarket notification for the VAPR® ARCTIC™ Suction Electrode. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information about acceptance criteria, detailed study design, and AI performance is not explicitly available in the provided text.
However, I can extract information about the types of tests performed to ensure safety and performance, which can be seen as meeting product specifications and user needs.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of quantitative acceptance criteria and their corresponding reported performance values. Instead, it lists various verification and validation tests performed to ensure the device meets its specifications and user needs. The conclusion states that the "Results of performance and safety testing have demonstrated that the modified device is suitable for its intended use."
Here's a summary of the types of tests conducted:
| Test Category | Specific Tests Mentioned |
|---|---|
| Verification | Electrical and performance tests (to meet product specifications over a range of operating conditions). Conformity to standards: EN 60601-1:2010 (General safety), EN 60601-2-2:2009 (Safety of HF surgical equipment), EN 60601-1-2:2007 (EMC), ISO 10993-1:2009 (Biological evaluation), ISO 11137-1:2013 (Gamma radiation and shelf life), and Software Guidance Document (for moderate level of concern software). |
| Validation | Tests to show the device meets user needs, including: Shaft bending, Articulation durability, Hipot (High Potential Test), Activation, Polyurethane durability, Cable tensile, Suction tube pull, Fluid ingress, Distal tip and suction tube sealing, Active tip and shroud retention, Lever actuation force, Articulation angle measurement, System compatibility, Dielectric strength, Suction flow, Articulation wire pull force, Lever strength, Thermal shock, Thermal margin assessment, Temperature rise, Clogging frequency. |
| Overall Outcome | "Results of performance and safety testing have demonstrated that the modified device is suitable for its intended use." (Implied acceptance that it meets unspecified criteria from these tests). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size for individual tests, nor does it provide details about data provenance (e.g., country of origin, retrospective/prospective nature). The tests appear to be laboratory or bench-top tests of the device components and functionality.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. The device is an electrosurgical tool, and its performance is evaluated against engineering specifications and functional requirements, not through expert-labeled diagnostic data. Therefore, there's no "ground truth" in the clinical imaging or diagnostic sense being established by experts for a test set in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are typically used in clinical studies or studies involving expert interpretation of data (e.g., medical images). This document describes device performance and safety testing, not diagnostic performance.
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 is not applicable. The VAPR® ARCTIC™ Suction Electrode is an electrosurgical device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-related effectiveness metrics are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. As stated above, this device is a surgical instrument, not an algorithm, and the concept of "standalone" performance for an algorithm is not relevant here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by engineering specifications, industry standards (listed in Table 2), and functional requirements for surgical tools. This includes measurements of physical properties (e.g., articulation angle, tensile strength), electrical properties, biological compatibility, and demonstration of proper function (e.g., activation, suction flow, non-clogging). It does not involve clinical "ground truth" in the diagnostic sense.
8. The sample size for the training set
This is not applicable. This device is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable. This device is not an AI algorithm that requires a training set or ground truth establishment for a training set.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.