(135 days)
The Stryker Disposable Laparoscopic Scissors are intended for cutting, dissecting and performing monopolar electrosurgery during any laparoscopic procedure.
The Stryker Disposable Laparoscopic Scissors are composed of an ABS plastic handle, 304 and 420 grade stainless steel, silicon, and medical grade PPSU (Radel). All materials are tested for biocompatibility as any of these materials may come into contact with both the patient and surgeon. The device is distributed sterile and intended for single use only.
The provided text is a 510(k) summary for the Stryker Disposable Laparoscopic Scissors. It states the device's intended use and claims substantial equivalence to a predicate device (Stryker Multi Cut Scissors, K935237).
However, the document does not contain information regarding an AI medical device, performance criteria, or any study involving AI or human readers. The information requested in the prompt, such as acceptance criteria table, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, is not present in the provided text, as this is a regulatory submission for a conventional surgical instrument, not an AI-powered diagnostic or assistive tool.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the document pertains to a physical surgical tool and lacks any relevant data for an AI-based system.
§ 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.