(56 days)
The VNUS Vessel and Tissue Coagulation System (proprietary name: TBD) is intended for use in vessel and tissue coagulation.
The VNUS Vessel and Tissue Coagulation System is a bipolar, high frequency electrosurgical system designed for use in general surgical procedures where lood vessel and tissue coagulation is desired. It consist of three main components The VNUS Vessel and Tissue Coagulation Device (proprietary name; TBD), the Radiofrequency (RF) Generator, and the Instrument Cable.
The VNUS Vessel and Tissue Coagulation Device is sterile disposable device intended for a single-use only. The device's function is to deliver bipolar RF energy to the intenired treatment site and relay temperature and other feedback to the RF General The disposable device is available in three bipolar configurations for selection by the physician based on preference for method of vessel access.
The RF Generator is a high frequency electronic, bipolar, microprocessor / software controlled instrument. It allows the user to set Power, Temperature and Time viruals, and provides user displays of Power, Temperature and Time (set-noints and meanured values) as well as measured Impedance and user messages. The RF Generator remains out of the sterile field during use, and is provided non-sterile.
The instrument cable connects the disposable device to the RF generator. The Instrument Cable is provided non-sterile, and is user sterilizable by autoclave. It has been validated to multiple steam sterilization cycles. Both ends of the cable are identical to eliminate connection errors.
The provided document describes the "VNUS Vessel and Tissue Coagulation System" and details its substantial equivalence to predicate devices, but it does not contain the specific information required to complete the detailed table and answer the questions about acceptance criteria and a study proving device performance.
Here's why and what information is missing:
- Acceptance Criteria & Reported Performance: The document states, "Results of in-vitro testing demonstrate that the VNUS Vessel and Tissue Coagulation System (proprietary name: TBD) is safe and effective for its intended function." However, it does not provide a table of specific quantitative acceptance criteria (e.g., coagulation time, tissue penetration depth, temperature thresholds) or the reported device performance metrics against those criteria.
- Sample Size and Data Provenance: This information is not provided. The document generally mentions "in-vitro testing" but gives no details about the sample sizes used, whether it was animal or human tissue, or the origin of any data.
- Number of Experts & Qualifications: Not mentioned.
- Adjudication Method: Not mentioned.
- Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not mentioned, and highly unlikely for this type of electrosurgical device. MRMC studies are typically for diagnostic imaging interpretation.
- Standalone Performance: While "in-vitro testing" implies standalone performance, no specific metrics or study details are provided.
- Type of Ground Truth: Not explicitly stated, although for in-vitro coagulation tests, the ground truth would likely be based on direct measurement of tissue coagulation effects.
- Training Set Sample Size & Ground Truth Establishment: This device is a hardware system, not an AI/ML algorithm. Therefore, there wouldn't typically be a "training set" in the sense of machine learning. The "training" would be related to device validation against engineering specifications and predicate device performance.
Conclusion:
The provided document is a 510(k) summary for a medical device that establishes substantial equivalence based on technological characteristics and general safety/effectiveness. It does not contain the detailed, quantitative performance study data or acceptance criteria typically found in reports for AI/ML devices or more complex clinical trials.
If this were a document about an AI device, the missing information would be critical for evaluating its performance. As it pertains to an electrosurgical device, the 510(k) focuses on demonstrating equivalence to existing, legally marketed devices.
§ 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.