Search Results

The Rüsch Blakemore Tube - 4 Lumen (Minnesota Type), sterile is a single use, sterile, naso-gastric double balloon tube that can be passed nasally or orally into the stomach suitable for use in the management of bleeding esophageal varices.

The Rüsch Blakemore Tube - 4 Lumen (Minnesota Type), sterile consists of a radiopaque (BaSO2) soft red rubber tube which is rounded and sealed at the distal end and belled out to form a funnel at the proximal end. Four elongated eyes are cut in the tube between the distal end and the cuffs. Two SILKOLATEX™ cuffs are inflated via separate color identified funnels using any Luer syringe; pilot balloons are provided to indicate cuff inflation. A fourth lumen is provided for suctioning of saliva from just above the esophageal cuff.

I am sorry, but the provided text describes a 510(k) premarket notification for a medical device (Rüsch Blakemore Tube - 4 Lumen), and it primarily focuses on establishing substantial equivalence to a predicate device. This type of submission, popular prior to the mid-2010s, does not typically include detailed information on acceptance criteria, a standalone study, or the comprehensive data provenance and expert adjudication methods that would be present in a submission for an AI/ML-powered device.

Therefore, I cannot extract the following information from the provided text:

• A table of acceptance criteria and reported device performance: This document does not specify any performance acceptance criteria or report results of a performance study. Its focus is on demonstrating equivalence based on materials, manufacturing, and intended use.
• Sample size and data provenance for the test set: No information on a test set, sample size, or data origin is provided as no performance study is described.
• Number of experts and their qualifications for ground truth: No ground truth establishment is described.
• Adjudication method for the test set: Not applicable as no test set or adjudication is described.
• Multi-reader multi-case (MRMC) comparative effectiveness study: There is no mention of such a study. This is a traditional medical device, not an AI/ML product where such studies are common.
• Standalone algorithm-only performance: The device is a physical tube, not an algorithm.
• Type of ground truth used: Not applicable as no ground truth is established or discussed.
• Sample size for the training set: Not applicable as no training set is relevant to this device.
• How the ground truth for the training set was established: Not applicable as no training set is relevant to this device.

The document is a regulatory submission for a physical medical device, not software or an AI/ML product. The regulatory pathway in 1998 was based on demonstrating substantial equivalence to a predicate device, which did not typically involve the type of performance studies and detailed data analysis commonly required for AI/ML devices today.

Ask a specific question about this device