(85 days)
The DePuy Mitek VAPR Electrodes for use with the VAPR 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 Electrodes with Handcontrol are similar in technological characteristics, geometry and materials, as their predicated except they will now be available with integrated handcontrol capabilities via three buttons mounted on the existing one-piece handles. These buttons control ablation, coagulation and the generator mode functions. The plug of the electrode is designed to fit the VAPR VUE generator (K100638: June 18, 2010) socket only and houses the components for ID recognition. They are intended to be run only off the VAPR VUE platform at pre-determined default settings specific for the device. If required, the settings for the device can be modified within safe pre-determined limits by accessing the generator or footswitch control in addition to the buttons on the handpiece. There are no changes being made to the fundamental technology of the electrode with the exception of the addition of handcontrol functionality.
The provided document describes the predicate device and the new features of the VAPR Electrodes with Handcontrols, primarily the addition of integrated handcontrols. The study conducted to demonstrate the device's conformance to acceptance criteria is detailed as performance testing, summarized in Table 1 on page 2.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Name | Acceptance Criteria (Implied "Pass") | Reported Device Performance |
|---|---|---|
| One Piece Cantilever Handle Separation Test | The handle must remain intact and functional under specified cantilever forces. | Pass |
| One Piece Handle Retention Test | The handle must remain securely attached to the electrode under specified retention forces. | Pass |
| Fluid Ingress Test for Finger switches | The finger switches must prevent fluid ingress to maintain functionality and safety. | Pass |
| System Compatibility Test | The device must function correctly and safely when integrated with the VAPR VUE generator. | Pass |
| Capacitance Test | The device's capacitance must fall within specified safety and performance ranges. | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample size for each test conducted. It only reports "Pass" for each test.
- Data Provenance: The document does not provide details on the country of origin of the data. The data is retrospective in the sense that the testing was performed on the modified electrodes before submission, but it's not a clinical study involving patients or real-world data collection in a longitudinal manner. It's laboratory-based performance testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The tests performed are engineering and performance validation tests, not clinical evaluations requiring expert interpretation for ground truth establishment in the traditional sense (e.g., image analysis, disease diagnosis). The "ground truth" for these tests would be the pre-defined engineering specifications and safety requirements the device must meet to function as intended.
4. Adjudication Method for the Test Set:
Not applicable. The tests are pass/fail based on objective measurements against engineering specifications, not subjective interpretation requiring an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. 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. The VAPR Electrodes with handcontrols do not differ from the predicate device in fundamental scientific technology or intended use." Therefore, there is no mention of "human readers" or "AI assistance" in this context, nor an "effect size."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. This device is an electrosurgical electrode with integrated handcontrols, not an AI algorithm. The performance described is the standalone function of the physical device and its integrated electronic controls, without an AI component or a human-in-the-loop performance study in the context of diagnostic AI.
7. The Type of Ground Truth Used:
The "ground truth" for these tests is based on engineering specifications, safety standards, and predefined performance criteria for the electrosurgical device. These are objective, measurable outcomes (e.g., does the handle separate at a certain force? Is there fluid ingress?). It is not expert consensus, pathology, or outcomes data related to disease.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI algorithm or a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
§ 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.