(145 days)
The ArthroSteer Ablator and Coagulator are intended for general surgical use, including orthopedic and arthroscopic applications for resection, ablation, excision of soft tissue, hemostasis of blood vessels and in coagulating soft tissue in joints including, but not limited to, the knee, shoulder, wrist and hip.
Not Found
This K093086 document is an FDA 510(k) clearance letter for the ArthroSteer Ablator & Coagulator. It does not contain information about acceptance criteria or a study proving device performance against such criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory compliance requirements.
Therefore, the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC study, standalone performance, ground truth types, training set size, and ground truth establishment for training set) cannot be extracted from this document as it is not present.
§ 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.