Search Results

The KSEA Plastic Trocars are intended for making incisions into the patient's body to allow insertion of endoscopes and endoscopic accessories during Ob/Gyn laparoscopic procedures.

The Karl Storz Plastic Trocars are manually operated surgical devices. The body contact portions of the KSEA Plastic Trocars are composed of surgical grade stainless steel and PEEK which are commonly used in medical devices for a wide range of applications and have a long history of biocompatibility for human use.

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) summary for two medical devices:

1. Karl Storz Plastic Trocars (K980694)
2. ENDO FMS® UROLOGY (Fluid Management System - K980808)

These summaries focus on demonstrating substantial equivalence to predicate devices, which is the regulatory pathway for 510(k) notifications. They describe the device's indications for use, device description, and state that the device is substantially equivalent to a predicate device, implying that no new issues of safety or effectiveness are raised. They do not include specific performance metrics, acceptance criteria, or detailed study results that would typically be required to fill out the requested table and answer the study-related questions.

Therefore, I cannot provide the requested information based on the given input.

Ask a specific question about this device

The KSEA Plastic Trocars are intended for use by qualified surgeons during general endoscopic and laparoscopic procedures.
These instruments are manually operated surgical devices intended for making incisions into the patient's body to allow insertion of endoscopes and endoscopic accessories during general endoscopic and laperoscopic procedures.

The Karl Storz Plastic Trocars are manually operated surgical devices. The body contact portions of the KSEA Plastic Trocars are composed of surgical grade stainless steel and PEEK which are commonly used in medical devices for a wide range of applications and have a long history of biocompatibility for human use.

The provided text is related to a 510(k) submission for a medical device (KSEA Plastic Trocars), but it primarily focuses on regulatory approval and substantial equivalence. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the details requested in your prompt.

Specifically, the document states:

• The device is a "Trocar and Cannula" intended for use by qualified surgeons during general endoscopic and laparoscopic procedures.
• It's a "manually operated surgical device."
• The materials are "surgical grade stainless steel and PEEK."
• It claims "Substantial Equivalence" to predicate devices, stating that "minor differences... raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices."

This is a regulatory filing, not a performance study report. Therefore, I cannot extract the requested information as it is not present in the provided text.

Ask a specific question about this device