(14 days)
The Aquamantys™ Bipolar Pump Generator is an electrosurgical generator with a rotary peristaltic pump which is intended for hemostatic sealing of soft tissue and bone at the operative site. It is intended for, but not limited to, use in orthopaedic, spine and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization). For use only by qualified medical personnel properly trained in the use of electrosurgical equipment, technology and techniques.
The Aquamantys Pump Generator is a shelf top unit consisting of a sheet metal housing, front control panel and side mounted pump. Within the housing resides a main circuit board, a display board and a power supply. The software integrates the flow to the desired power setting and flow level selected. The pump generator can be set from 20 to 200 watts and has high, medium and low flow rate settings.
The Aquamantys system includes the pump generator, cart and specified Aquamantys disposable devices. The Aquamantys BPS 6.0 and the Aquamantys BPS 2.3 are hand held "wand" like devices that consist of a plastic handle with two needle electrodes at one end that interface with the operative site. The other end of the handle has a cable that plugs into the pump generator and have a section of pump tubing that clamps into the peristaltic pump.
Compared to most conventional electrosurgical devices and generators, TissueLink bipolar devices are unique in that they provide simultaneous fluid delivery, as well as the treatment of tissue that is based on simultaneous irrigation and low power density RF energy delivery to tissue that is oozing blood at a slow but steady rate.
The provided text is a 510(k) summary for the TissueLink Aquamantys Pump Generator System. It focuses on demonstrating substantial equivalence to predicate devices and describes the device's function and intended use. However, it does not contain the specific information required to answer your questions about acceptance criteria and a study proving the device meets those criteria.
Here's why and what's missing:
- No Acceptance Criteria: The document does not list any specific performance acceptance criteria (e.g., minimum accuracy, sensitivity, specificity, or other quantitative measures).
- No Performance Study Results: While it mentions the device, its function, and comparisons to predicate devices for substantial equivalence, it does not present data from a study designed to measure the device's performance against any set criteria.
- No Details on Test Sets, Ground Truth, Training Sets, or Expert Adjudication: These are all elements typically found in studies evaluating the diagnostic or functional performance of a medical device, especially those involving AI or image analysis. This document is a regulatory submission for substantial equivalence based on device description and intended use, not a clinical or performance study report.
Therefore, I cannot populate the table or answer the specific questions you've posed based on the provided text.
To answer your questions, I would need a document that presents the results of a performance study for the TissueLink Aquamantys Pump Generator System, including details on its evaluation metrics and the methodology used.
§ 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.