(161 days)
The DeRoyal Cautery Pencil is indicated for use whenever an electrosurgical procedure requires the removal of tissue or the control of bleeding by either cutting or coagulation.
The DeRoyal Industries, Inc. Electrosurgical Cautery Pencil functions in the same manner as predicate devices in that it is intended to be used in electrosurgical procedures to remove tissue and control bleeding. The device can be used for both cutting and coagulating. Device Design/Materials Used/Physical Properties: The DeRoyal Industries, Inc. Electrosurgical Cautery Pencil is made of materials commonly used for their purpose. The concept of use is intended to remove tissue and control bleeding by use of high frequency electrical current.
This document describes a 510(k) summary for the DeRoyal Industries, Inc. Electrosurgical Cautery Pencil, which appears to be a traditional medical device and not an AI/ML-driven device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment, which are typically relevant for AI/ML device evaluations, are not applicable to this submission.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (DeBusk Technology Corporation) based on design, materials, intended use, and technological characteristics. The "predicate or legally marketed devices" section and the "technological comparison with predicate or legally marketed device(s)" table confirm this approach.
In summary, as this is a traditional electrosurgical cautery pencil and not an AI/ML device, the specific types of acceptance criteria and performance study details asked for in the prompt (e.g., related to accuracy, sensitivity, specificity, expert consensus, training sets, etc.) are not present in the provided text and are not typically required for this class of device submission.
§ 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.