(112 days)
The VFS1 Bipolar Electrosurgical Generator is indicated for use in micro, macro, and endoscopic bipolar irrigation, cutting and coagulating of tissue and the coagulation of blood vessels in all types of surgery.
The VFS1 Bipolar Electrosurgical Generator (referred to as generator or VFS1 Generator) is designed to cut and coagulate living human tissue during surgical procedures. The system provides 1 MHz Radio Frequency (RF) energy that is user/operator selectable based on the surgical procedure undertaken. The generator is configured for bipolar output and is earth isolated, to minimize leakage current, thus providing increased patient comfort and safety. The system will be provided with safety features that are continuously monitored and will provide warnings and/ or alerts when critical parameters exceed specified limits.
The VFS1 Generator is designed to cut and coagulate living tissue during surgical procedures. The system includes a bipedal footswitch. The generator is equipped with a tone generator to provide audible feedback each time cutting, or coagulation is performed. The generator incorporates a variable-rate irrigation pump to provide saline flow during procedures.
The VFS1 Generator is compatible with a variety of reusable bipolar products; i.e., insulated mirror finish bipolar forceps, disposable nonstick bipolar instruments as well as disposable bipolar cords and tubing products.
Items that are included in the system are:
- VFS1 generator -CO 840
- . Footpedal- CO 841
The provided text describes the 510(k) premarket notification for the "VFS1 Bipolar Electrosurgical Generator." This document outlines the device's technical specifications, intended use, and comparison to predicate devices, along with summaries of non-clinical performance testing.
However, the nature of this document (a 510(k) summary for an electrosurgical generator) means that the types of "acceptance criteria" and "study" details requested in your prompt (which relate to AI/Machine Learning models for diagnostic purposes, involving concepts like sample size for test/training sets, expert ground truth, MRMC studies, etc.) are not applicable to this medical device.
Electrosurgical generators are physical devices that perform cutting and coagulation using electrical energy. Their performance is evaluated through engineering tests, electrical safety standards compliance, and bench/ex vivo testing on tissue, rather than the statistical performance metrics used for AI diagnostic tools.
Therefore, I cannot extract the information you've requested about acceptance criteria and studies (as defined by your prompt's context) from this document.
For clarity, here's why each point in your request is not present or applicable:
- Table of acceptance criteria and reported device performance: The document implicitly states that tests "met specifications" or were "acceptable." There isn't a table comparing a specific performance metric against a quantitative acceptance threshold in the way an AI diagnostic model would have (e.g., "sensitivity > 90%"). Instead, it confirms functional compliance.
- Sample size for the test set and data provenance: Not applicable. The "test set" here refers to hardware components and ex vivo tissue samples, not patient data for an AI model.
- Number of experts and their qualifications for ground truth: Not applicable. Ground truth for an electrosurgical device is about its physical effects on tissue, assessed typically by engineers and potentially surgeons, not by interpretation of images/data by multiple experts.
- Adjudication method for the test set: Not applicable. There's no subjective interpretation requiring adjudication.
- MRMC comparative effectiveness study: Not applicable. This is for evaluating changes in human reader performance with AI assistance, which is irrelevant for an electrosurgical generator.
- Stand-alone (algorithm only) performance: Not applicable. This is a hardware device, not a standalone algorithm.
- Type of ground truth used: Ex vivo testing on tissue samples to demonstrate cutting and coagulation effect. This is a physical outcome, not a diagnostic classification.
- Sample size for the training set: Not applicable. There is no AI model being trained.
- How ground truth for the training set was established: Not applicable for the same reason as above.
In summary, the provided document describes a traditional medical device (electrosurgical generator), and the requested information about acceptance criteria and studies are phrased in the context of AI/Machine Learning diagnostic devices. These frameworks are fundamentally different.
§ 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.