(11 days)
The ArthroCare 8000S Coblator Surgery System is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurological procedures.
The ArthroCare 8000S Coblator Surgery System is a bipolar, high frequency electrosurgical system consisting of three components: an electrosurgical generator called the Controller; a family of disposable, bipolar, single use Wands; and a reusable Patient Cable.
The provided document is a 510(k) summary for the ArthroCare 8000S Coblator Surgery System, describing its substantial equivalence to a predicate device, the ArthroCare® System 2000 (K001588). It is not a study report that details acceptance criteria and device performance based on a specific study.
Therefore, I cannot extract the information required to populate the table of acceptance criteria and reported device performance or other study-specific details such as sample sizes, ground truth establishment, expert information, or MRMC study results because this information is not present in the provided text.
The document states that the new device's substantial equivalence is based on:
"The proposed modifications in performance specifications, dimensional specifications, and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the System."
This implies that the device meets the same performance standards as the predicate device, but specific acceptance criteria and a study demonstrating this are not detailed in this 510(k) summary. Further documentation (e.g., test reports referenced in the original 510(k) submission) would be needed to answer these questions.
§ 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.