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Intended for use in patients with any condition requiring enteral feeding and/or enteral hydration, which can be accomplished by means of an enteral feeding, pump and pump set. The pump and feeding sets are intended to be used in alternate, acute and home care settings by users ranging from laypersons to clinicians. The purpose of this device is to deliver enteral nutrition at a controlled rate to a patients gastrointestinal system.

The ePump "" platform is a new enteral feeding system comprised of an enteral feeding pump and disposable Enteral Feeding Sets. This Class II device is an enteral feeding pump that delivers formula via rotary peristaltic tension loop pumping to provide nutrition for those who do not have the ability to orally ingest food. This enteral feeding pump is an attitude independent pump offering a streamlined graphical user interface that walks the user through the ePump" setup and operation with many new features to allow the ability to both feed nutrition and flush when required.

The ePump™ Enteral Feeding Pump Sets are compatible with standard prefilled formula containers presently available on the market. The ePump" enteral feeding pump sets are also designed to be compatible with present marketed enteral access devices and accessories (extension sets).

The provided text describes the Kendall ePump™ Enteral Feeding Pump and Enteral Feeding Sets, submitted for 510(k) clearance in 2004. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics, especially in the context of AI/ML or diagnostic performance studies.

Instead, this document focuses on:

• Device Description: What the device is and how it works.
• Intended Use: For whom and in what settings the device is to be used.
• Predicate Device Comparison: Establishing substantial equivalence to an already marketed device (Kangaroo 524 Enteral Feeding Pump & Administration Sets).
• Nonclinical Testing (Biocompatibility): Mention of biocompatibility testing according to ISO Standard 10993, Part 1. This is a safety test, not a performance study as typically understood for AI/ML devices.
• FDA Clearance Letter: Official communication from the FDA granting 510(k) clearance based on substantial equivalence.

Therefore, I cannot provide the requested table and study details because the information is not present in the provided text. The document is for a medical device approval that predates the common application of AI/ML in medical diagnostics and does not include the type of performance study details you are asking for.

If you have a different document that describes such acceptance criteria and a study for an AI-powered device, please provide that text.

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