(338 days)
The devices are used to cut and cauterize soft tissue.
Not Found
The provided text is a U.S. FDA 510(k) clearance letter for the "Mini Lap Electrocautery Instruments." This document primarily indicates that the device has been found substantially equivalent to a predicate device, allowing it to be marketed.
However, the document does NOT contain information about acceptance criteria, specific device performance metrics, clinical studies, sample sizes for testing or training sets, expert qualifications, or adjudication methods.
The FDA clearance process for a 510(k) submission generally relies on demonstrating substantial equivalence to a legally marketed predicate device. This often involves comparing device features, intended use, technological characteristics, and performance data (which may include bench testing, non-clinical studies, and sometimes limited clinical data, but not always a full-scale clinical trial with the detailed information you're asking for).
Therefore, based solely on the provided text, I cannot complete the requested information. The document focuses on the regulatory clearance aspect rather than detailed performance study results.
To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data (often submitted as part of the 510(k) but not fully reproduced in this clearance letter) or a clinical study report.
§ 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.