(198 days)
HI-880DG Plus Electrocoagulator unit is to be used in order to cut and coagulate (burn) the skin in and during minor and general surgery.
HM-880DG Plus Electrocoagulator
The provided document is a 510(k) clearance letter from the FDA for a device called "HM-880DG Plus Electrocoagulator." This letter indicates that the device has been found substantially equivalent to a predicate device already on the market.
However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
The information provided is purely administrative, confirming the device's clearance for marketing based on substantial equivalence. Therefore, I cannot fulfill your request for a table of acceptance criteria and study details using only the provided text. This type of information is typically found in the 510(k) submission itself, or in a separate clinical or performance study report, not in the FDA's clearance letter.
§ 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.