(150 days)
The ENT Biotech Solutions Tissue Removal Device (Elasso™) is intended to be used for the cutting and coagulation of soft tissue during otolaryngology (ENT) surgery including adenoid and tonsil tissue (Pharyngeal, Tubal, and Palatine).
The ENT Biotech Solutions tissue removal device (also referred to as the "Elasso™") is a single-use, surgical accessory, used with a recommended electrosurgical generator (not supplied by ENT Biotech Solutions, INC) and associated equipment (monopolar cord and patient return electrode). The Elasso device configuration is similar to a standard forceps geometry (patterned after the commercially available reference device, St. Clair Forceps), but with an integrated loop electrode at the distal tip of one of the forceps. The proximal end contains a single banana pluq. for connection to the generator. The hand piece is operated by the generator's footswitch controller. The Elasso™ is a single-use, sterile packaged device.
The provided document does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of AI/ML performance. The document is a 510(k) premarket notification for a medical device (ENT Biotech Solutions Tissue Removal Device (Elasso™)), which focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics, intended use, and performance testing (mechanical, electrical safety, operational, in-vivo, ex-vivo thermal effects, etc.).
There is no mention of artificial intelligence, machine learning, or any form of algorithm that would require acceptance criteria related to classification, detection, or other AI performance metrics. Therefore, the information requested in the prompt, such as reported device performance against acceptance criteria, sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone AI performance, type of ground truth, and training set details, is not available in the provided text.
§ 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.