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The Enteral Feeding Extension Set (EFES) is intended for use as an extension set for nasogastric/ oralgastric or gastric tube enteral feeding tubes, incorporating safety connectors which help mitigate the risk of accidental misconnection with an I.V. system to the enteral system or the enteral system to an I.V. system.

The Kentec Medical Enteral Feeding Extension Set (EFES) is a sterile disposable device for single patient use only. The device is designed to connect existing feeding tubes (nasogastric, oralgastric, gastric, etc) to various delivery enteral syringes as well as to help minimize the potential for inadvertent delivery of enteral feedings through the intravenous route. i.e., the device cannot be connected to a luer connector.

The device consist of flexible PVC tubing with an orange strip for easy quick identification of enteral feeding lines as well as a "For Enteral Feeding Only" tag and a slide clamp to provide the additional safety assurance for connection errors.

The basic set (OC-ENT-60) consists of tubing with a step connector (catheter tip) and an oral syringe connector not compatible with intravencus (I.V.) tubing or stopcocks. Other variations include:

• The basic set with shorter tubing (OC-ENT-36) t
• The basic set with step connector changed into oral syringe connector . (20C-ENT-60)
• The basic set with the addition of a "Y" site with an oral syringe connector . to allow the clinician to attach other equipment.

The provided documentation describes the Kentec Medical, Inc. Ameritus® Medical Enteral Feeding Extension Set (EFES) and its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria for AI/algorithm performance. The document focuses on regulatory approval (510(k)) based on non-clinical testing for device function and safety.

Therefore, many of the requested categories related to AI/algorithm performance (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, training set details) are not applicable to this type of device and regulatory submission.

However, I can extract information related to the device's functional performance and general non-clinical testing.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists "Specific Tests" performed and states that these tests "demonstrated the EFES met the acceptance criteria." Specific quantitative acceptance criteria or detailed performance results (e.g., exact tensile strength achieved, precise leakage rates) are not provided in this summary. Instead, the document relies on comparison to predicate devices and adherence to relevant standards.

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

The document does not explicitly state the numerical "sample size" for the various engineering tests (e.g., how many units were subjected to tensile testing). It states "EFES" was tested, implying representative samples of the manufactured device.

• Data Provenance: The tests were conducted internally by Kentec Medical, Inc. or contractors on their behalf. The manufacturing facility is in Kunshan, China. These are non-clinical, in-vitro engineering tests, not clinical studies involving human patients or retrospective/prospective data from healthcare settings.

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

Not Applicable. This is an engineering device submission. "Ground truth" in the context of expert consensus or clinical outcomes is not relevant here. The ground truth for these tests is defined by engineering specifications, relevant ISO standards (e.g., ISO 80369-1, ISO 594), and comparison to predicate devices' known characteristics.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for expert consensus, which is not relevant to non-clinical engineering device testing. Test results are compared against predefined engineering specifications and standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. MRMC studies are for evaluating the performance of diagnostic devices or algorithms with human readers. This device is an enteral feeding extension set, not a diagnostic algorithm.

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

Not Applicable. There is no algorithm involved in this device. The "standalone performance" refers to the device's functional performance as an engineered product, which was indeed tested (e.g., Luer connection testing, leakage, tensile strength, flow).

7. The Type of Ground Truth Used

The "ground truth" for these engineering tests is established by:

• Predefined engineering specifications for the device.
• Relevant international standards such as ISO 80369-1 (for small-bore connectors) and ISO 594 (for Luer connectors).
• The known functional and material characteristics of legally marketed predicate devices (NeoMed Enteral Only Extension Set K100288 and CORFLO Anti-I.V. Enteral Feeding Extension Set K083786/K083791).
• Analytical comparison and lab testing to objectively measure physical properties and fit.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" as this is not an AI/ML algorithm.

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

Not Applicable. There is no "training set" as this is not an AI/ML algorithm.

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