(88 days)
The DePuy Mitek VAPR Electrodes for use with the VAPR System are intended for resection, , ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue in patients requiring arthroscpic surgery of the knee, shoulder, hip, ankle, elbow and wrist.
The VAPR system is electrosurgical system that utilizes bipolar technology specifically designed to provide a range of arthroscopic surgical treatments including soft tissue ablation, cutting and coagulation and temperature control. The VAPR system includes a generator, electrodes which facilitate access and control the delivery of energy to the joint space, and accessories such as a footswitch and electrodes.
The provided document is a 510(k) Premarket Notification for the DePuy Mitek VAPR Electrodes, specifically seeking to add hip arthroscopy to the indications for use. This document outlines the safety and performance testing conducted to support this change.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated as "Testing") | Reported Device Performance ("Results") |
|---|---|
| Device Insertion | Pass: No visible cracks or missing portions at the distal tip of the electrodes. |
| Shaft Bending | Pass: No visible splitting of heatshrink after one cycle of bending and straightening of the electrode handle and shaft. |
| Active Tip Engagement | Pass: The electrodes withstood with no breakage at the active tip. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set (number of electrodes tested for each criterion). It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective). However, given that this is a 510(k) submission for an electrosurgical device, the testing would typically be conducted in a laboratory setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The provided text does not mention the use of experts to establish a ground truth for the mechanical and physical tests performed (Device Insertion, Shaft Bending, Active Tip Engagement). These are objective engineering tests with pass/fail criteria.
4. Adjudication Method for the Test Set
No adjudication method is described, as the tests performed are objective and do not require expert adjudication.
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: "No clinical studies are required to demonstrate safety and efficacy of the device in support of an application for premarket clearance."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
This question is not applicable to this device. The VAPR Electrode is a physical medical device, not an algorithm or AI system. Therefore, standalone algorithm performance is not a relevant concept here.
7. The Type of Ground Truth Used
For the safety and performance testing described (Device Insertion, Shaft Bending, Active Tip Engagement), the "ground truth" is based on objective engineering and material science pass/fail criteria. For example, "no visible cracks" or "no breakage at the active tip" are directly observable and measurable outcomes against predefined standards. There is no concept of "expert consensus," "pathology," or "outcomes data" for these specific engineering tests.
8. The Sample Size for the Training Set
This question is not applicable. The VAPR Electrode is a physical medical device, not an AI or machine learning system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as point 8.
§ 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.