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Medline Enteral Feeding Sets are intended to dispense liquid nutrition (feeding solutions) at a user controlled rate. These enteral feeding sets interface with a patient's feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The enteral feeding sets may include a bag to contain the feeding solution and/or spike to connect to a pre-filled container.

Medline Enteral Feeding Sets consist of the following three configurations:

• 1.) Medline Enteral Feeding Pump Bag Set (1000ml)
• 2.) Medline Enteral Feeding Pump Spike Set
• 3.) Medline Enteral Feeding Gravity Bag Set (1000ml)

The Medline Enteral Feeding Pump Bag Set (1000ml) is designed for use with Alcor Sentinel® and Nestle Compat® enteral feeding pump systems and features a 1000ml formula bag with 100ml graduations and a protective closure cap.

The Medline Enteral Feeding Gravity Bag Set (1000ml) uses the free flow of gravity to dispense enteral feeding solutions and features a 1000ml formula bag with 100ml graduations and a protective closure cap.

The Medline Enteral Feeding Pump Spike Set features a piercing spike used to connect the set to a prefilled container of enteral feeding solution. It is designed for use with Alcor Sentinel® and Nestle Compat® enteral feeding pump systems.

Medline Enteral Feeding Sets are single-use, non-sterile and disposable enteral feeding sets consiting of an enteral feeding bag, tubing, drip chamber, piercing spike, roller clamp and Distal Tip ENFit connectors.

The provided text describes a 510(k) premarket notification for Medline Enteral Feeding Sets, comparing them to a predicate device. The core of the submission is the replacement of a 4-step Distal Tip Connector with an ENFit connector, aiming to improve safety by mitigating misconnections.

Here's an analysis of the acceptance criteria and the study information, focusing on what is explicitly stated and what cannot be determined from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with specific quantitative thresholds. Instead, it lists various performance tests conducted and generally states that the results demonstrated the device's function and performance were not altered, and that it met requirements.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified for any of the performance tests. The document only lists the types of tests performed (e.g., "Enteral Connector Misconnection Assessment Study," "Human Factors Validation Study").
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be conducted by Medline Industries, Inc. or their contracted labs.
• Retrospective or Prospective: Not specified. Performance testing is typically prospective, but the document does not confirm this.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided. The document details engineering and performance testing, not a study requiring expert clinical assessment for ground truth. The "Human Factors Validation Study" might involve user evaluation, but the number or qualifications of "experts" are not mentioned.

4. Adjudication Method for the Test Set

This is not applicable as the studies described are performance and engineering tests, not clinical evaluations requiring adjudication of subjective assessments.

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

This is not applicable. This document describes a medical device (enteral feeding sets), not an AI/imaging diagnostic device that would typically undergo an MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable as the device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests would be established by the physical and chemical properties of the materials and component designs, and their adherence to engineering standards (e.g., ISO 80369-1 for ENFit connectors) and device specifications. For biocompatibility, it's defined by the pass/fail criteria of ISO 10993 standards.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical medical device. There is no "training set" in the context of an algorithm or AI model development described here.

9. How the Ground Truth for the Training Set Was Established

This is not applicable (see point 8).

In summary, the provided text is a 510(k) summary for a physical medical device. It focuses on engineering performance, biocompatibility, and functional compatibility testing to demonstrate substantial equivalence to a predicate device, particularly concerning a design change to incorporate an ENFit connector. It does not contain information typically found in studies for AI/software as a medical device (SaMD) or clinical diagnostic studies that would involve "test sets," "training sets," "experts," or "adjudication."

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