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Enteral feeding set is intended to use gravity to deliver liquid nutritional formulas or water to patient's enteral access device (feeding tube). The device includes a bag to contain the feeding solution.

The proposed device is provided non-sterile and single use. It has two types (Type A and Type B). Type A has more component (ENFit transition adapter) than Type B.

The Type A includes 5 models, ENF02G-1000R-T, ENF02G-1000B-T, ENF02G-1200R-T, ENF02G-1200B-T and ENF02-500R-T, which have the same components including 1) filling port, 2) bag, 3) tube, 4) drip chamber, 5) roller clamp, 6) ENFit female connector, 7) ENFit transition adaptor and 8) protecting cover. The difference between the 5 models is the specification of bag and tube.

The Type B includes 5 models, ENF02G-1000R, ENF02G-1000B, ENF02G-1200R, ENF02G-1200B and ENF02-500R, which have the same components including 1) filling port, 2) bag, 3) tube, 4) drip chamber, 5) roller clamp, 6) ENFit female connector and 7) protecting cover. The difference between the 5 models is the specification of bag and tube.

The provided document is a 510(k) summary for an Enteral Feeding Set. It describes non-clinical tests performed to demonstrate substantial equivalence to a predicate device, but it does not include any information about clinical studies or the performance of a device based on expert reviewer adjudication for a test set. This device is an "Enteral Feeding Set" which is a physical medical device, not a software-driven diagnostic or AI-powered system that would typically involve acceptance criteria related to diagnostic accuracy, sensitivity, or specificity, adjudicated by experts.

Therefore, many of the requested items (2, 3, 4, 5, 6, 7, 8, 9) are not applicable to the content of this document.

Here's an analysis of the provided information based on the request:

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

The document provides a summary of non-clinical test conclusions and a comparison to a predicate device (K142539). These demonstrate compliance with relevant standards rather than specific performance metrics against pre-defined acceptance criteria in the typical sense of a diagnostic device.

Study that proves the device meets the acceptance criteria:

The device meets its "acceptance criteria" through a series of non-clinical tests and compliance with recognized international standards for medical devices. The document explicitly states: "Non clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards." The study described is essentially a compilation of these non-clinical tests.

The following information is not available in the provided text as it pertains to clinical studies often associated with diagnostic or AI-powered devices, which is not the nature of this enteral feeding set's submission.

2. Sample size used for the test set and the data provenance: Not applicable; no clinical test set for diagnostic performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; no clinical test set requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable; no clinical test set requiring adjudication.
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 a physical medical device, not an AI software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable; this is a physical medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable; the "ground truth" for this device is compliance with engineering specifications, material biocompatibility, and functional performance as per standards, rather than a diagnostic 'truth'.
8. The sample size for the training set: Not applicable; no training set mentioned, as this is a physical device, not a machine learning model.
9. How the ground truth for the training set was established: Not applicable.

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