(88 days)
The Mitek VAPR VUE Radiofrequency System is intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery.
The Mitek VAPR II Electrode System, when used with a VAPR™ Electrode, is intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery.
The VAPR 3 Electrode System, when used with a VAPR™ Electrode, is intended for resection, ablation, excision of soft tissues, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery.
The DePuy Mitek VAPR Electrodes for use with the VAPR VUE Radiofrequency System are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue in patients requiring arthroscopic surgery of the knee, shoulder, hip, ankle, elbow and wrist.
The DePuy Mitek VAPR Electrodes for use with all VAPR Electrosurgical Systems are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue in patients requiring arthroscopic surgery of the knee, shoulder, hip, ankle, elbow and wrist.
The VAPR LD and LP Suction Electrodes, when used with the VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissues, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic 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, contouring, 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 describes a 510(k) premarket notification for the DePuy Mitek VAPR® VUE™ Radiofrequency System, VAPR III Electrode Surgical System, VAPR II Electrode Surgical System, and various VAPR electrodes (P90, CP90, CP90 with Handcontrol, LDS, LPS Electrode). The purpose of the submission is to add hip arthroscopy to the existing indications for use.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Device Insertion | No visible cracks or missing portions at the distal tip of the electrodes after insertion. | Pass: No visible cracks or missing portions at the distal tip of the electrodes. |
| Shaft Bending | No visible splitting of heatshrink after one cycle of bending and straightening of the electrode handle and shaft. | Pass: No visible splitting of heatshrink after one cycle of bending and straightening of the electrode handle and shaft. |
| Active Tip Engagement | Electrodes withstand use without breakage at the active tip. | Pass: The electrodes withstood with no breakage at the active tip. |
Study Description:
The document states: "Safety and Performance Verification and Validation of the VAPR Electrodes included performance testing to demonstrate that the device is appropriate for hip arthroscopy. A summary of testing is provided in Table 1."
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the exact number of devices tested for each performance test (Device Insertion, Shaft Bending, Active Tip Engagement). It only states "performance testing."
- Data Provenance: The data provenance is not explicitly stated. However, given that this is a premarket notification to the FDA, the testing was presumably conducted by the manufacturer, DePuy Mitek, a Johnson & Johnson company, in a controlled laboratory environment. It is not clinical data; it's device performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This type of information is not applicable to the provided study. The study involves engineering performance tests (e.g., physical integrity of the electrodes) rather than assessments requiring expert medical interpretation of images or patient outcomes. The "ground truth" for these tests is based on objective pass/fail criteria for physical characteristics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for resolving discrepancies in expert interpretations (e.g., radiographic readings). The disclosed study involves objective engineering performance tests with clear pass/fail criteria, not subjective interpretations.
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
- An MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, particularly in diagnostic imaging. The current submission is for electrosurgical devices and does not involve AI or human reading tasks.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- A standalone performance study of an algorithm was not done. The VAPR system and electrodes are electrosurgical devices, not AI algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for this performance testing is based on objective engineering and physical integrity criteria. For example, for "Device Insertion," "Pass" means "No visible cracks or missing portions at the distal tip of the electrodes." This is a directly observable and measurable physical attribute, not requiring expert consensus, pathology, or outcomes data.
8. The sample size for the training set
- This information is not applicable. This is not an AI/machine learning study, so there is no training set mentioned or implied.
9. How the ground truth for the training set was established
- This information is not applicable for the same reason as point 8. There is no training set in this context.
In summary, the provided document describes a premarket notification for electrosurgical devices, specifically seeking to add hip arthroscopy to their indications. The "study" described involves engineering-based performance verification and validation of the device's physical integrity and functionality, rather than clinical trials or AI performance evaluations.
§ 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.