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The Medline ENFit OTC Feeding Syringe is intended for Over-The-Counter use to measure and administer enteral nutrition.

The device that is the subject of this submission is the same device as the Medline ENFit Syringe cleared under K160642, but rather than being intended for prescription use only, is instead intended for over-the-counter use. The Medline ENFit OTC Feeding Syringe (the subject device) is a standard piston syringe which incorporates a female ENFit connector designed to interal access devices (i.e. feeding tubes) and ENFit compatible enteral feeding extension sets. The design consists of a polypropylene barrel and plunger rod, a polyisoprene plunger seal or stopper, an ISO 80369-3 compliant female ENFit connector, and a threaded cap. The Medline ENFit OTC Feeding Syringe is available in one size (60mL) and will be sold as a single use, non-sterile device.

The provided document pertains to a 510(k) premarket notification for a medical device, the "Medline ENFit OTC Feeding Syringe." This submission focuses on expanding the intended use of an already cleared device (Medline ENFit Syringe, K160642) to include Over-The-Counter (OTC) use.

The document does not describe an AI/ML-based medical device and therefore does not contain information related to acceptance criteria, study design, ground truth establishment, or performance for such a device. The tests performed are standard for physical medical devices like syringes (biocompatibility, mechanical performance, stability, and usability for OTC labeling).

Therefore, I cannot extract the requested information about acceptance criteria, study that proves the device meets acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth types and establishment methods, as these details are not relevant or present in the context of this traditional medical device submission.

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