(105 days)
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):
| Acceptance Criteria Category | Specifics (Implied by Standards/Assertions) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with EN 60601-1: 1995 (General requirements for safety), EN60601-2-2:2007 (Particular requirements for the safety of high-frequency surgical equipment), EN60601-1-2: 2006 (Electromagnetic compatibility). | "Verification of the VAPR VUE System and Electrodes includes electrical, Safety... tests to show that the device meets its product Performance specifications over a range of operating conditions." "Results of performance and safety testing have demonstrated that the modified device is suitable for its intended use." |
| Software Safety/Quality | Compliance with EN 60601-1-4/A1:2005 (Programmable electrical medical systems), ISO 62304 (Medical device software-software life cycle process), FDA Guidance for Premarket Submission for Software, General Principals of Software Validation, Guidance Off-The-Shelf Software Use. | "Verification of the VAPR VUE System and Electrodes includes ... software and performance tests to show that the device meets its product Performance specifications over a range of operating conditions." "Results of performance and safety testing have demonstrated that the modified device is suitable for its intended use." |
| RF Performance Comparability | Expected to provide comparable RF performance to predicate devices (VAPR IIITM). | "The VAPR VUE generator was designed to provide comparable RF performance with legacy VAPR electrodes." |
| Functional Performance | Device meets product performance specifications over a range of operating conditions. | "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." "Validation testing for the VAPR VUE includes testing to show the device meets user needs." |
| Substantial Equivalence | Demonstrates equivalence in intended use, essential components, materials, performance specifications, and technology characteristics to predicate devices. | The conclusion states: "Results of performance and safety testing have demonstrated that the modified device is suitable for its intended use. Based on the indications for use, fundamental scientific technology, and comparison to the predicate devices, the VAPR VUE Radiofrequency System, along with the Premiere50, Premiere90 and CP90 Electrodes are shown to be substantially equivalent to the predicate devices..." |
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.
§ 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.