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The REGER Nebulizer Irrigation Cannula is indicated for use in patients undergoing a laparoscopic procedure. It is designed to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to lavage blood and tissue debris from the surgical site.

The REGER Medizintechnik Nebulizer Irrigation Cannula is a sterile, single use stainless steel cannula with a polymer handle that is intended to nebulize irrigation fluids into the body during laparoscopic procedures. The sterile irrigation fluid is delivered from an injection pump (not provided) through the polymer tubing and into the stainless-steel shaft. The shaft has internal mechanics that deliver the fluid as microscopic droplets in a fine mist. The REGER Medizintechnik Nebulizer Irrigation Cannula is designed with a precision orifice at the tip for the deployment of a precise nebulized spray of irrigation solution into the laparoscopic cavity.

The REGER Medizintechnik Nebulizer Irrigation Cannula is straight and measures between 243-245 mm from Tip to the end of the handle with a shaft diameter ranging from 3.0 - 8.0 mm. The orifice at the head of the cannula shaft ranges in diameter of 0.17mm to 0.2mm. The REGER Medizintechnik Nebulizer Irrigation Cannula also contains a 10' flexible 3.15mm outer diameter polymer tube at the handle end for attachment to attached to irrigation fluid injection pump (not provided) via a luer fitting.

The provided document is a 510(k) summary for the REGER Nebulizer Irrigation Cannula, which is a medical device and not an AI/ML (Artificial Intelligence/Machine Learning) powered device. Therefore, the information requested regarding acceptance criteria, study details, human-in-the-loop performance, and training data for an AI/ML model is not applicable to this document.

This document describes a medical device seeking 510(k) clearance based on substantial equivalence to a predicate device. The "performance data" section it refers to are for functional and biocompatibility testing of the physical cannula device, not for the performance of an AI/ML algorithm.

Here's why the requested information cannot be extracted from this document:

• No AI/ML Component: The device is a physical cannula intended to deliver irrigation fluids during laparoscopic procedures. There is no mention of any software, AI, or machine learning component.
• Device Performance vs. Algorithm Performance: The document discusses the performance of the physical device (e.g., irrigation flow rate, spray angle, droplet size) and its biocompatibility. It does not discuss the performance of an AI algorithm, such as sensitivity, specificity, or AUC.
• No Test Set/Training Set: Since there's no AI/ML model, there are no test sets, training sets, ground truth established by experts, or adjudication methods for AI performance.
• No MRMC Study: A Multi-Reader Multi-Case (MRMC) study is relevant for evaluating the impact of AI assistance on human readers, which is not applicable here.
• No Standalone Algorithm Performance: There is no algorithm to be evaluated in a standalone manner.

In summary, the provided text describes the regulatory clearance process for a physical medical device and does not contain any information related to the acceptance criteria or performance study of an AI/ML device.

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