(53 days)
This device is intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures. This device is intended to be used with a standard electrosurgical generator with footswitch control and a standard return electrode connection, and the electrode is to be activated only when immersed in a conductive media such as standard saline solution.
The device is comprised of the following major components: an insulated handle, an active electrode, a length of aspiration tubing, a standard foot-switch RF connector, and a standard return connector. The hand piece is designed to connect to electrosurgical generators that feature a standard foot switch controlled monopolar connector and a standard return connector. A stainless steel electrode tip is surrounded by a ceramic thermal insulator. The product is available in shaft diameters of 3.3mm, 2.4mm, and 1.8mm. The larger size is available in aspirating and non-aspirating version. The aspirating versions use suction to remove saline irrigant during the surgical procedure for the dissipation of heat and improved vision. The device is available in electrode face angles of 55 degrees, and 90 degrees. There is a feature on the handle that lets the operator easily determine the orientation of the active electrode face. The wedge-shaped tapered tip allows access to difficult to reach locations. The working length is 160mm. The cable from the handle is 126" +/- 6" in length. The device operates in bipolar mode. The return electrode is located on the device and does not require the use of an external grounding pad or return electrode. The device has a simple user interface that uses a footswitch to activate the device.
The provided text is a 510(k) Pre-market Notification for a medical device (Bovie Disposable Bipolar Ablator). It describes the device, its intended use, and the testing conducted to demonstrate substantial equivalence to predicate devices. However, it does not contain any information about an AI/ML-driven device or its performance characteristics.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving an AI/ML device meets them, nor can I provide information on sample sizes, expert involvement, MRMC studies, or ground truth establishment relevant to an AI/ML system.
The document primarily focuses on:
- Device description: Electrosurgical cutting and coagulation device for arthroscopic procedures.
- Intended Use: Cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.
- Performance Testing: Mechanical, electrical, electromagnetic compatibility, biocompatibility, INE (insertion/navigation/extraction), and various bench-top validation tests (visual inspection, mold stress relief, cable strain/impulse/flexure, drop testing, connector verification, temperature measurements, rigidity testing, compatibility, aspiration flow, thermal performance & clogging).
- Substantial Equivalence Comparison: A table comparing features of the Bovie Disposable Bipolar Ablator to predicate devices (ArthroCare SuperTurbo Vac, TurboVac 90, Arthrocare ArthroWand®, and a previous Bovie Disposable Bipolar Ablator model).
To answer your request, I would need a document that describes the development and validation of an AI/ML device, including details about its performance evaluation against defined acceptance criteria.
§ 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.