(18 days)
The Wands are intended for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurological procedures.
The Wands are bipolar, single use, high frequency electrosurgical devices.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the ArthroCare® SpineWand®, which focuses on establishing substantial equivalence to predicate devices for modifications to its packaging. It explicitly states that "The indications for use, materials, technology, sterilization, principle of operation, and performance specifications of the Wands remain the same as in the predicate cleared 510(k)." This suggests that performance testing information would be found in the predicate 510(k)s (K070851, K060823, K001588), which are not provided here.
Therefore, I cannot provide the requested table or any of the detailed study information regarding acceptance criteria, sample sizes, ground truth, or MRMC studies.
§ 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.