(148 days)
MEDISISS Reprocessed ENT Ablation Wands (Coblators) are indicated for coagulation, ablation, resection, of soft tissue and hemostasis of blood vessels in otoloaryngology (ENT) procedures including: tonsillectomy/adenoidectomy and soft tissue reduction.
The device is a high frequency, bipolar ablation wand with suction capability that contains an integrated electrical cable and integrated saline delivery system.
The provided text is a 510(k) notification for MEDISISS Reprocessed ENT Ablation Wands (Coblators). This document is for a medical device (an ablation wand) and not for an AI/ML powered medical device. Therefore, the information requested such as "acceptance criteria and the study that proves the device meets the acceptance criteria", "sample size used for the test set and the data provenance", "number of experts used to establish the ground truth", "adjudication method", "multi reader multi case (MRMC) comparative effectiveness study", "standalone (i.e. algorithm only without human-in-the-loop performance)", "type of ground truth used", "sample size for the training set", and "how the ground truth for the training set was established" are not applicable to this document. These questions are typically relevant for discussing studies related to the performance of AI/ML algorithms.
The document focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and performance specifications for regulatory clearance, rather than presenting a study with acceptance criteria in the manner requested 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.