(75 days)
The Habib 4X is intended to be used to assist in coagulation of tissue during intraoperative surgical procedures.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the Habib 4X device, an electrosurgical cutting and coagulation device. This type of document does not typically contain the detailed study information required to answer your specific questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert qualifications for AI/ML device studies.
The letter focuses on:
- Confirming substantial equivalence to a predicate device.
- Indicating that the device can be marketed subject to general controls.
- Outlining relevant regulations.
- Providing the stated Indications for Use.
Therefore, based solely on the provided text, I cannot reconstruct the specific information you requested. The document does not describe a study, acceptance criteria, or performance metrics in the way your questions demand for an AI/ML device.
§ 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.