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The GUARDIAN CONNECTION™ is designed to be used with standard adult tapered feeding tube connectors to secure the connection.

The Guardian Connection is a non-sterile, reusable, plastic "Ushaped" clip designed to hold the connectors of an enteric feeding tube and an enteric feeding set together to help prevent inadvertent disconnection. The product is specifically designed to accommodate the non-IV tapered male conical stepped connectors and mating non-IV tapered female connectors commonly found on standard adult enteric feeding tubes and sets. The Guardian Connection clips around the outside of these connectors, and helps to prevent them from being pulled apart by tensile force.

The provided FDA 510(k) summary for the Guardian Connection™ device focuses on its substantial equivalence to a predicate device based on technological characteristics and bench testing. It does not contain information about acceptance criteria and a study in the context of diagnostic performance metrics like sensitivity, specificity, or AUC, as it is a physical medical device (a clip for feeding tubes), not a diagnostic algorithm.

Therefore, many of the requested categories are not applicable to this particular device submission.

Here's a breakdown of the relevant information from the document in relation to your request, and where information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit from testing description):

• The device should secure the connection between an enteric feeding tube and a nutrient delivery set.
• The device should "break away" at a tensile force of approximately two pounds.

Reported Device Performance:

Regarding the study proving the device meets the acceptance criteria:

The document states: "Bench testing was performed on the Guardian Connector to show that the device performs as intended. No clinical testing was performed on this device."

The following questions are not applicable to this 510(k) submission as it is for a physical medical device (a clip) and not an AI/diagnostic algorithm:

• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc)
• The sample size for the training set
• How the ground truth for the training set was established

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