(90 days)
The Oratec TAC-C™ Monopolar Cautery Probe is a single-use electrosurgical device intended to be used to create controlled coagulative lesions in tissues. It is intended to be used only in conjunction with the Oratec Electrothermal Generator.
The Oratec TAC-C™ Monopolar Cautery Probe is a disposable electrosurgical device designed to create controlled coagulative lesions in tissues.
The Oratec TAC-C™ Monopolar Cautery Probe has a tip electrode oriented at a right angle from the axis of the shaft in the shape of a half dome. This tip configuration provides the ability to coagulate tissues that lie in the same plane as the angle of the shaft. The probe shaft is made of stainless steel which is malleable and may be bent to any shape that is necessary. Only the tip is heated; the adjacent/rest of the tube is insulated with a protective insulative coating. The proximal end of the shaft is attached to a plastic handle.
The provided text is related to a 510(k) premarket notification for a medical device called the Oratec TAC-C™ Monopolar Cautery Probe. This document describes the device, its intended use, and its substantial equivalence to a predicate device (Oratec TAC-S™ Monopolar Cautery Probe).
However, the provided text does not contain any information about acceptance criteria, device performance metrics, study design (sample sizes, data provenance, ground truth establishment, expert involvement, adjudication methods), or any comparative effectiveness study (MRMC) or standalone algorithm performance data.
The document is purely a regulatory submission, focusing on establishing substantial equivalence based on device characteristics rather than clinical performance data with specific metrics.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The requested information (Table of acceptance criteria, sample sizes, data provenance, number of experts, adjudication method, MRMC study details, standalone performance, ground truth type, training set size, and how training ground truth was established) is not present in the given document.
§ 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.