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The devices in this product family are used to dispense liquid nutrients (feeding solutions) at a user controlled rate. These enteral feeding sets interface with the patients feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The devices may include a bag to contain the feeding solution and/or a spike to connect to a pre-filled container. These devices are food contacting.

Dynarex is substantially equivalent in safety and effectiveness to the Zevex, Inc. Enteral Feeding Sets for Gravity and Pump Use in that both products have the same principles of operation, form and function and meet the same safety requirements under Class VI testing and functional Luer taper testing as required by the referenced standard.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a separate "test set" in the sense of a clinical or image-based dataset. The testing described focuses on material properties and physical conformance.

• Sample Size for testing: Not explicitly stated for each test (e.g., number of devices tested for Luer taper inspection). However, it implies testing was conducted on samples of the Dynarex Enteral Feeding Sets.
• Data Provenance: The testing was conducted by Dynarex Corporation to demonstrate substantial equivalence to the predicate device. The document does not specify a country of origin for the data beyond Dynarex being a US-based company, and the nature of the tests suggests laboratory or bench testing rather than patient data. It is therefore prospective with respect to the device's design and testing.

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

Not applicable. This is a medical device clearance based on substantial equivalence to a predicate device, primarily through material and functional characteristic comparison, and safety testing (biocompatibility, physical standards). It does not involve expert interpretation of medical images or patient outcomes in the way an AI/ML device would.

4. Adjudication Method for the Test Set

Not applicable. See point 3.

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 an AI/ML device, nor does it involve human readers interpreting cases.

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

Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on established industry standards and validated test methods for material biocompatibility (Class VI USP) and physical performance (AAMI/ANSI ID54.1996/(R)2005). The comparison is also made against the specifications and performance of the legally marketed predicate device (Zevex, Inc. Enteral Feeding Sets for Gravity and Pump Use K012147), which serves as a benchmark for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device; there is no "training set."

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

Not applicable. See point 8.

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