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The U Deliver Bolink ENFit Enteral Feeding Sets are intended for over-the-counter use to deliver liquid nutritional formulas or water to a patient's enteral access device (feeding tube).

The U Deliver Bolink ENFit Enteral Feeding Sets consist of two configurations:

• U Deliver Bolink Small Cap Gravity Feeding Set with Cross Spike and ENFit Connector (ref. BK-2085) .
• U Deliver Bolink Large Cap Gravity Feeding Set with ENFit Connector (ref: BK-2405)
  The U Deliver Bolink Small Cap Gravity Feeding Set with Cross Spike and ENFit Connector uses the free flow of gravity to dispense enteral feeding solutions from a distal reservoir (not supplied) which connects via a safety screw connection meeting the requirements of clauses 4 "General requirement" and 5 "Dimensional requirements for enteral feed reservoir connectors" of ISO18250-3, "Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral applications', to a PVC tube with external clamp, to a distal ENFit connector, meeting the requirements of ISO 80369-3, 'Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications'.
  The U Deliver Bolink Large Cap Gravity Feeding Set with ENFit Connector uses the free flow of gravity to dispense enteral feeding solutions from a distal reservoir (not supplied) which connects via a screw cap with a 40 mm thread, to a PVC tube with external clamp, to a distal ENFit connector, meeting the requirements of ISO 80369-3
  Both sets are constructed from medical grade, biocompatible materials, and are supplied non-sterile for single patient use only.

The provided document is an FDA 510(k) clearance letter for a medical device: "U Deliver Bolink ENFit Enteral Feeding Sets." It describes the device, its intended use, and the basis for its substantial equivalence to a predicate device.

However, the document does not contain any information about an AI/ML-driven medical device. Specifically, it does not describe:

• An AI algorithm or its performance.
• Acceptance criteria for an AI model.
• A study that proves an AI device meets acceptance criteria, including details on sample size, data provenance, expert ground truth establishment, adjudication, MRMC studies, standalone performance, or training set details.

The "Performance Data" section explicitly states: "No new device testing was necessary as no changes have been been made to the device design, materials or packaging. The testing necessary for this submission was usability testing to demonstrate that both laypersons with no prior tube feeding experience and caregivers/tubefeeders were able to perform the essential tasks using only the proposed instructions for use. The results of usability testing demonstrate that the subject device(s) are appropriate for over-the-counter use." This confirms that the critical study mentioned was a usability test for a physical device, not an AI performance study.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI device based on this document.

The document pertains to the clearance of a physical medical device (enteral feeding sets) and its change in indications for use from prescription-only to over-the-counter, based on usability testing and substantial equivalence to a cleared predicate device.

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