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For use in achieving simultaneous access to the stomach and duodenum to allow fluid sampling in procedures such as pancreatic exocrine function testing.

The PEF Tube consists of a soft, dual-lumen tube with a proximal Y-connector that allows separate access to each of the 2 lumens. One lumen opens distally in the stomach; the second lumen opens into the duodenum.

The N.M. Beale Company, Inc. PEF Tube is a gastrointestinal tube designed for simultaneous access to the stomach and duodenum for fluid sampling, particularly in pancreatic exocrine function testing. The performance testing for this device focused on demonstrating substantial equivalence to a predicate device and/or meeting pre-determined acceptance criteria for safety and effectiveness.

Here's an analysis of the provided information:

Acceptance Criteria and Reported Device Performance

Note: The provided document states that "tensile testing" was performed, but it does not specify the exact numerical acceptance criteria for this testing (e.g., minimum tensile strength in Newtons, or maximum elongation). It only indicates that the device "met pre-determined acceptance criteria."

Study Information

1. Sample size used for the test set and the data provenance:

   • The document does not specify the sample size for the tensile testing or its
     provenance (e.g., country of origin, retrospective/prospective).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This is not applicable as the performance testing for the PEF Tube
     involved physical tensile testing, not interpretation of data requiring expert
     ground truth.

3. Adjudication method for the test set:

   • This is not applicable for tensile testing.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No MRMC or AI-related study was indicated for this medical device. The
     device is a physical gastrointestinal tube, not an AI or imaging device.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • This is not applicable. The device is a physical gastrointestinal tube,
     not an algorithm.

6. The type of ground truth used:

   • For tensile testing, the "ground truth" would be established by
     engineering standards and specifications for the material and design of
     gastrointestinal tubes, verified through calibrated testing equipment. The
     document does not explicitly state the specific standards or
     specifications used but implies that predefined criteria were met.

7. The sample size for the training set:

   • This is not applicable. The device undergoes physical performance
     testing, not machine learning training.

8. How the ground truth for the training set was established:

   • This is not applicable.

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