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The subject device is indicated for use as a dispenser, a measuring device and a fluid transfer device. It is used to deliver fluids into the body orally or enterally. It is intended to be used in clinical or home care settings by users ranging from clinicians to laypersons (under the supervision of a clinician) in all age groups.

Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) are basically enteral syringes that can also be used for oral uses. There are two different types of models of the syringes, which are Type A and Type B. The Type A syringes of a polypropylene barrel and plunger rod and a synthetic rubber gasket stopper manufactured from polyisoprene. The Type B syringes consist of a polypropylene barrel and plunger rod and a silicone O-ring. The 10 to 60 mL syringes come with the standard female ENFit connector and the 1 to 5 mL syringes come with a female ENFit connector incorporating a low dose tip design.

The provided text focuses on establishing substantial equivalence for an Oral/Enteral Syringe, primarily through comparison to a predicate device and adherence to recognized standards. It does not contain information about an AI/ML powered medical device, or the kind of acceptance criteria and study designs that would be typical for such a device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, including specifics like sample size for test and training sets, expert ground truth establishment, MRMC studies, or standalone performance, as this information is not present in the provided document for this particular medical device.

The document discusses non-clinical tests performed to ensure the device's effectiveness and safety, primarily focusing on:

• Biocompatibility: Adherence to ISO 10993 series standards (in vitro cytotoxicity, irritation, skin sensitization, systemic toxicity).
• Performance safety and effectiveness (according to ISO 7886-1): Cleanliness, lubricant, limits of extractable metals, limits for acidity/alkalinity, tolerance on graduated capacity, graduated scale, dead space, barrel configuration, nozzle design verification, piston/plunger assembly, freedom from air and liquid leakage, force to operate the piston.
• Performance safety and effectiveness (according to ISO 80369-3 for connectors): Fluid leakage, stress cracking, resistance to separation from axial load, resistance to unscrewing, resistance to overriding, disconnection by unscrewing.
• Additional Performance tests: Dimensional verification (to ISO 80369-3, low dose tips, syringes), risk management report, dosing accuracy testing (for low dose tips and oral administration).

The conclusion states that the "subject device will be as safe and effective for usage as the listed predicate device," based on these non-clinical tests and the comparison of technological characteristics. No clinical tests were performed for this submission.

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