(99 days)
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.
| Acceptance Criteria (Implied by 510(k) process for substantial equivalence) | Reported Device Performance |
|---|---|
| Safety and Effectiveness | The VAPR Electrodes underwent "validation testing (performance testing) for the device modification." The specific results are not detailed in this summary document, but the FDA concluded they met requirements. |
| Technological Characteristics | The new VAPR electrodes conform to the same intended use and operating principles as their predicate devices (various existing VAPR electrodes). Differences, if any, are not so significant as to raise new questions of safety or effectiveness. |
| Indications for Use | The stated Indications for Use for the new electrodes are identical or very similar to the predicate devices, specifically for resection, ablation, excision of soft tissue, hemostasis, and coagulation in arthroscopic surgery of various joints. |
| Compliance to Design Control Requirements | Mitek provided "certification of compliance to 21 CFR 820.30 Design Control requirements." |
| Risk Analysis | Mitek provided "descriptions of Mitek's subcontractor Design Control and Risk Analysis procedures." |
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.
§ 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.