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The ENFit® Reusable Enteral Syringe 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 multiple times in non-clinical settings by users ranging from clinicians to laypersons in all age groups. The device is indicated for single patient use only.

The proposed device with Enfit® connector (1ml-60ml) are standard piston style syringes consisting of syringe barrel with integral EnFit syringe tip, syringe plunger and ring type piston. The proposed device are supplied non-sterile, and reusable. The sizes rang from 1ml to 60ml nominal capacity. The integral syringe tip is a female ENFit connector which is compatible only with enteral access devices or accessories having ENFit compliant or compatible male connectors to form a dedicated system that prevents wrong-route administration of fluids.

This is a 510(k) summary for a medical device (ENFit Reusable Enteral Syringe). 510(k) submissions typically demonstrate substantial equivalence to a predicate device through non-clinical testing, rather than extensive clinical efficacy studies with acceptance criteria in the manner of AI/software devices. Therefore, the information requested in the prompt, especially related to AI-specific metrics, reader studies, and ground truth establishment, is not applicable or present in this document.

However, I can extract the non-clinical tests performed and mention that these tests serve as the "acceptance criteria" for demonstrating substantial equivalence for this type of device.

1. A table of acceptance criteria and the reported device performance

The document lists various non-clinical tests performed to verify that the proposed device met design specifications and was substantially equivalent to the predicate device. These tests, and the implication that the device met their requirements, serve as the "reported device performance" and "acceptance criteria" for a 510(k) submission. No specific numerical thresholds are provided in this summary, but the successful completion of these tests indicates compliance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes for each non-clinical test conducted. It states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications." The data provenance (country of origin, retrospective/prospective) is not mentioned, as these are material performance tests rather than clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is a physical medical device (syringe), not an AI/software device that requires expert ground truth for classification or diagnosis. Therefore, this information is not applicable and not present in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this is not an AI/software device or a study involving human interpretation with adjudication.

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

Not applicable. This is a physical medical device. No MRMC study was conducted or reported.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For these physical device tests, the "ground truth" is defined by the established industry standards (e.g., ISO 14971, ISO 7886-2, ISO 10993 series, ISO 80369-3) and pre-defined specifications for device performance (e.g., freedom from leakage, specific dimensions, resistance to force). The device's performance against these verifiable physical and chemical metrics serves as the ground truth.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/software device requiring a training set.

9. How the ground truth for the training set was established

Not applicable.

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