Search Results

The Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars) is used to puncture the abdominal wall of human body during laparoscopy and operation to establish the working channel for abdominal surgery.

The Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars) are available in total of eight (8) sizes. The Disposable Abdominal Trocars (Bladed Trocars), knows as Auto-Locking Trocar, has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Disposable Abdominal Trocars (Bladed Trocars) is available in three (3) sizes: 5mm, 10mm and 12mm. The cannula assembly has a universal seal, a valve, and a stopcock. This device has a bladed tip with an internal shield, which is designed to cover the cutting edges once the body cavity has been entered. The Disposable Abdominal Trocars (Bladeless Trocars) has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Disposable Abdominal Trocars (Bladeless Trocars) is available in one (1) size: 5mm. The Disposable Abdominal Trocars (Optical Trocars), knows as Visible Trocar, has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. This device has a blunt tip, which is designed for open Laparoscopy. The Disposable Abdominal Trocars (Optical Trocars) is available in four (4) sizes: 5mm, 10mm, 12mm. This device allows direct visualization of the abdominal wall layers when the trocar is traversed, which offers a safe and rapid option of primary trocar. The cannula assembly has a universal seal, a valve and a stopcock. Based on the filter valve, the Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars) are divided into two (2) product series: CNTCI series without smoke evacuation function and CNTCII series with smoke evacuation. The cannula consists of sleeve, stopcock valve, valve lever, gas check valve and lip seal. The obturator consists of fixed base, obturator tube and obturator tip. There are various specifications available depending on the inner diameter and length of sleeve.

The provided text describes a 510(k) premarket notification for "Disposable Abdominal Trocars." It details the device's classification, intended use, description, and comparison to predicate devices. It also mentions non-clinical testing performed to assess safety and effectiveness.

However, this document does not contain any information about an AI/ML powered device, its acceptance criteria, or a study proving its performance. The device in question is a physical medical device (trocars) used in laparoscopic surgery.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details, or how ground truth was established, as these concepts are not relevant to the content of the provided document.

The document explicitly states in section H: "No clinical study is included in this submission." This further confirms that no performance study of the type requested was performed or is detailed in this filing.

Ask a specific question about this device