(26 days)
The ClosureRFG generator is used with radiofrequency catheters intended for vessel and tissue coagulation.
The ClosureRFG Radiofrequency Generator (RFG3) is designed to provide controlled delivery of radiofrequency (RF) energy to RF catheters marketed by Covidien. The RFG3 is for use with the ClosureFast™ endovenous radiofrequency catheters and ClosureRFSTM endovenous radiofrequency stylet, intended for vessel and tissue coagulation.
The RFG3 supplies, measures, and displays RF output power, load impedance (displayed for ClosureRFS only), and elapsed time of RF delivery. The RFG3 also interfaces with a sensor in the catheter to provide a continuous display of measured temperature during RF delivery.
This document is a 510(k) premarket notification for the ClosureRFG Radiofrequency Generator, a medical device. It does not contain information about acceptance criteria or a study proving device meets acceptance criteria in the format requested. The document describes the device, its intended use, and states that performance testing was conducted to demonstrate substantial equivalence to a predicate device. However, it does not provide specific acceptance criteria values, reported device performance metrics, sample sizes, ground truth establishment, or details about comparative effectiveness studies (MRMC) or standalone algorithm performance.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about the specific studies.
However, I can extract the following information that is present in the document:
- Device Name: ClosureRFG Radiofrequency Generator
- Intended Use: The ClosureRFG generator is used with radiofrequency catheters intended for vessel and tissue coagulation.
- Type of Testing Performed (as listed in Section 7):
- Mechanical
- Mechanical Strength
- Electrical
- Thermal
- Environmental
- Electromagnetic Compatibility and Electrical Safety
- Packaging Integrity
- Software Verification and Validation
- Simulated Use
- Tissue Model
- Conclusion of Testing (Section 7 and 8): "The results of the testing demonstrate that the RFG3 meets all requirements and has comparable performance to the predicate device." and "Covidien considers the proposed RFG3 to be substantially equivalent to the currently marketed VNUS Radio Frequency Generator - RFGPlus Model RFG2 (K040638)."
Missing Information (not found in the provided document):
- Table of acceptance criteria and reported device performance: Specific values are not provided.
- Sample sizes used for the test set and data provenance: No details on the number of units tested, the source of data, or whether it was retrospective/prospective.
- Number of experts used to establish ground truth for the test set and their qualifications: Not applicable for this type of device (an electrosurgical generator). Ground truth in this context would likely be based on technical specifications and engineering standards, not expert clinical consensus.
- Adjudication method for the test set: Not applicable for this type of device.
- MRMC comparative effectiveness study: Not conducted as this is an energy generator and not an AI-assisted diagnostic or prognostic device.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Not explicitly stated but would be based on engineering specifications, regulatory standards, and established physical principles for electrosurgical devices.
- Sample size for the training set: Not applicable, as this is hardware with software, not a machine learning algorithm that is "trained" in the typical sense.
- How the ground truth for the training set was established: Not applicable.
§ 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.