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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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The U Deliver Bolink ENFit Enteral Feeding Sets are intended 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-1085)
• U Deliver Bolink Large Cap Gravity Feeding Set with ENFit Connector (ref: BK-1405) .
  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 ISO/DIS 18250-3. '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.

This document is a 510(k) premarket notification for the U Deliver Bolink ENFit Enteral Feeding Sets, establishing substantial equivalence to a predicate device. As such, it does not contain a detailed study proving the device meets specific acceptance criteria in the manner of a clinical trial or a performance study with human subjects or medical imaging analysis.

Instead, the document focuses on bench testing to demonstrate physical and functional equivalence of the U Deliver Bolink ENFit Enteral Feeding Sets to the predicate device and compliance with recognized standards.

Here's an analysis of the information provided, addressing the requested points where applicable, and noting where the information is not present in this type of submission:

1. A table of acceptance criteria and the reported device performance

The document does not provide a formal table of acceptance criteria with reported performance in a quantitative manner for specific benchmarks. Instead, it lists the types of bench tests conducted, implying that the acceptance criteria for these tests are met by conforming to recognized standards (ISO 80369-3, ISO 80369-20, ISO/DIS 18250-3, ISO 10993) or by demonstrating equivalence to the predicate device.

Bench Tests Performed (Implied performance met as per standards/equivalence):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: The document does not specify the exact sample sizes used for each bench test. It generally states that "Bench tests have been carried out on samples of the U Deliver Bolink ENFit Enteral Feeding Sets."
• Data Provenance: The document implies that the testing was performed by or for the manufacturer (Cedic S.r.l., Italy, a contract manufacturer). The submission itself is from U Deliver Medical, LLC (USA). The testing is prospective (conducted specifically for this submission).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable to this type of device and submission. This is a medical device for delivering nutritional formulas, not an imaging or diagnostic device that requires expert interpretation to establish a 'ground truth'. The "ground truth" here is compliance with technical standards and functional performance metrics, verified through engineering bench tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human interpretation (e.g., radiology reads) to resolve discrepancies in expert opinions. This submission relies on objective engineering measurements and compliance with recognized standards.

5. 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

Not applicable. This is not a software device, an AI-powered diagnostic tool, or a device that involves "human readers." It's a physical enteral feeding set.

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

Not applicable. This device does not involve algorithms or AI. It is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device is established by:

• Technical Standards: Compliance with FDA-recognized international standards such as ISO 80369-3, ISO 80369-20, ISO/DIS 18250-3, and ISO 10993. These standards define the required physical dimensions, mechanical properties, and biocompatibility.
• Predicate Device Equivalence: Demonstrating that the subject device performs similarly to or better than the legally marketed predicate device (Metrixcare Enteral Feeding Sets, K132424) in relevant functional aspects (e.g., flow rate).

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. There is no training set for this device.

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