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The Enteral Feeding Sets are intended to dispense liguid nutrients (feeding solutions) at a user controlled rate. These enteral feeding sets interface with the passess feeding tube and may asse gravity or an enteral feeding pump to dispense feeding solution. The enteral feeding sets may include a hag to contain the feeding solution and/or spike to a pre-filled container.

The Generica Medical International's line of Enteral Feeding Sets consists of the following:

• Generica Medical Enteral Delivery Pump Bag Set, 1.
• Generica Medical Enteral Delivery Pump Spike Set, 2.
• ે. Generica Medical Enteral Delivery Gravity Bag Set

The Generica Medical Enteral Delivery Pump Spike Set with the Cross Spike Connector is compatible with SpikeRight® and SpikeRight® enteral feeding systems.

The Generica Medical Enteral Delivery Pump Bag Set has a twist cap. The vinyl bag features a rigid wide-mouth angled funnel opening that makes pouring easv and helps prevent spills and waste. The 1000 mL formula vinvi bag has 50 mL graduations to make it easier for reading and better accuracy when filling.

The Generica Medical Enteral Delivery Gravity Bag Set has a twist cap. The vinyl bag features a rigid wide-mouth angled funnel opening that makes pouring easy and helps prevent spills and waste. Bag graduations are in 50 mL increments for easier readings and allow for better accuracy when filling

Here's a breakdown of the requested information based on the provided document:

This document describes a 510(k) submission for Enteral Feeding Sets, which are devices intended to dispense liquid nutrients. 510(k) submissions typically demonstrate substantial equivalence to a predicate device rather than undergoing extensive clinical trials for de novo approval. Therefore, the "study" proving the device meets acceptance criteria is primarily non-clinical performance testing to demonstrate equivalence to the predicate, not a clinical study involving human patients or complex AI model evaluation.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are based on demonstrating substantial equivalence to the predicate device (Dynarex Enteral Feeding Sets) through similar technological characteristics and comparable performance in specific tests.

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

• Sample Size: The document does not specify the exact sample size (e.g., number of bags, spikes, sets tested) for the non-clinical performance tests. It states that the "Generica Medical Enteral Feedings Sets were tested." This implies an adequate number were tested to support the claims of compatibility and accuracy, but the precise count is not provided.
• Data Provenance: The testing was conducted by or on behalf of Generica Medical International (located in La Verne, CA, USA) and their manufacturer Conod Medical Co., Limited (located in Jiangsu, China). The testing is implicitly prospective in the sense that it was conducted specifically for this premarket notification rather than being a retrospective analysis of existing data. It's a non-clinical, in-vitro/benchtop type of testing.

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

This section is Not Applicable (N/A).
For a non-clinical device like an enteral feeding set, the "ground truth" is defined by the objective performance parameters (e.g., flow rate variance, compatibility) measured against engineering specifications or the predicate device's performance. There are no human "experts" establishing a "ground truth" in the way one would for image interpretation or diagnosis. It's about engineering and performance validation.

4. Adjudication Method for the Test Set

This section is Not Applicable (N/A).
Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers are interpreting complex data (e.g., medical images) and need a consensus mechanism to establish ground truth or handle disagreements. Since this is a non-clinical device performance test, no human adjudication was involved.

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 section is Not Applicable (N/A).
This submission is for a basic medical device (enteral feeding sets), not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed.

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

This section is Not Applicable (N/A).
This device is not an algorithm; it's a physical medical device. Performance was evaluated as a standalone product (i.e., the feeding set itself), but not as an "algorithm only".

7. The Type of Ground Truth Used

The "ground truth" for this device's performance testing was established by:

• Engineering Specifications / Predicate Device Performance: The primary ground truth was defined by meeting the performance characteristics (e.g., flow rate variance <10%, "Spike Right" compatibility) demonstrated by the predicate device and the inherent functional requirements of an enteral feeding set.
• Objective Measurements: The tests involved objective measurements of flow rates and physical compatibility with pumps.

8. The Sample Size for the Training Set

This section is Not Applicable (N/A).
This is not an AI/machine learning device, so there is no "training set."

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

This section is Not Applicable (N/A).
As there is no training set, there is no ground truth for it.

In summary: The "study" for this device was a series of non-clinical, benchtop performance tests designed to demonstrate that the Generica Medical Enteral Feeding Sets perform comparably to their predicate device and meet essential functional requirements, thereby establishing substantial equivalence for 510(k) clearance. Clinical trials or complex AI performance evaluations were not applicable to this type of device.

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