(51 days)
The Smoke Evacuation Button Switch Pencil and Telescoping Smoke Evacuation Switch Pencil are intended for general electrosurgical applications, including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The Pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.
The application devices, the Smoke Evacuation Button Switch Pencil and the Telescopic Smoke Evacuation Button Switch Pencil (referred to hereafter as the Smoke Evaluation Pencils), are a collection of electrosurgical electrodes with an integrated smoke collection tube. The flat blade electrode provided in each pencil can be removed and replaced with a compatible electrode.
New Deantronics is requesting clearance two series Smoke Evacuation Pencils.
The simplified series includes two different housing styles (round and oval) of pencil body design. Each housing style has two different lengths of attached tubing at the proximal end of the pencil body, 10ft and 15ft; thus, there are 4 models in this and the premium series. These 4 simplified series models share the same design elements (functional design, technology design, packaging, sterilization method and process, etc.)
The premium series embodies one of two extender mechanisms. There are 2 smoke nozzle extender/fixation mechanism designs in this series; with and without lock mechanism. Each design includes two lengths of spiral tube and cable, while all the other design elements, such as cosmetic appearance, grip characteristics, construction materials, packaging, sterilization method, etc., are identical in this premium series to the simplified series.
The Smoke Evacuation Pencils are designed to be used with a compatible electrosurgical generator and smoke evacuation system.
These devices are single use and are sold sterile.
The provided text is a 510(k) summary for a medical device (Smoke Evacuation Button Switch Pencil) seeking FDA clearance. It focuses on demonstrating substantial equivalence to a predicate device. This type of document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, particularly in the context of an AI/algorithm-driven device.
The document describes the device as an electrosurgical accessory for cutting, coagulation, and smoke evacuation, and its performance is evaluated against engineering standards (e.g., IEC 60601 series, ISO 10993-1) and physical tests (e.g., button activation force, weld integrity). It does not mention any AI or algorithmic components, nor does it describe a study involving human readers or expert consensus for ground truth.
Therefore, I cannot fulfill the request using the provided text. The questions posed in the prompt (regarding acceptance criteria for AI performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone performance) are relevant to the evaluation of AI/ML-based medical devices, which this document is not about.
§ 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.