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NeoConnectTM Enteral Syringe with ENFit™ Connector:
The device is indicated for use as a dispenser, a measuring device. It is used to deliver fluids into the body 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.

NeoConnect™ NeoSecure™ Tip Cap:
A NeoConnect™ Enteral Syringe with ENFit™ connector accessory used to prevent fluid loss and contamination of syringe contents until ready for use.

The NeoMed NeoConnect™ Enteral Syringes with ENFit™ connector are standard piston style syringes consisting of a syringe barrel with an integral ENFit™ syringe tip, syringe plunger, syringe gasket, and supplied with or without a syringe tip cap. They are provided in varying sizes ranging from 0.5 mL to 100 mL nominal capacity. The integral syringe tip is a female ENFit™ connector which is compatible only with enteral access devices having ENFit™ male connectors to form a dedicated system that prevents wrong-route administration of fluids. They possess translucent barrels to provide visualization of fluid contents and volume.

The NeoConnect™ NeoSecure™ Tip Cap is supplied with the NeoConnect™ Enteral Syringe with ENFit™ connector or sold separately (sterile or non-sterile). It is an ENFit™ compatible closure cap for the tip of the syringe.

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) premarket notification letter and a summary for an enteral syringe and tip caps. It discusses substantial equivalence to predicate devices and lists various performance tests conducted. However, it does not provide acceptance criteria, reported device performance in a comparative table, details about specific study designs (like sample sizes for test/training sets, data provenance, expert qualifications, or adjudication methods), or information about MRMC comparative effectiveness studies or standalone algorithm performance.

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The 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 via extension sets and feeding tubes in neonatal and small pediatric patients.

The NeoMed NeoConnect™ Enteral Syringes are standard piston style syringes consisting of a syringe barrel with integral ENFit syringe tip, syringe plunger, syringe gasket, and supplied with a syringe tip cap. They are provided in varying sizes ranging from 0.5ml to 100ml nominal capacity. The integral syringe tip is a female ENFit connector which is compatible only with feeding tubes and extension sets that have ENFit male connectors to form a dedicated system that prevents wrong-route administration of fluids. They possess translucent barrels to provide visualization of fluid contents and volume.

The provided document is a 510(k) premarket notification for a medical device (NeoMed NeoConnect™ Enteral Syringes with ENFit Connector). It does not contain information about a study proving device performance against acceptance criteria in the context of an AI/ML powered device, which typically involves metrics like sensitivity, specificity, AUC, or reader performance.

The document describes bench testing for the physical properties and safety of the syringe. These are acceptance criteria for a physical medical device, not an AI algorithm.

Therefore, many of the requested categories (e.g., sample size for test set, ground truth experts, MRMC study, standalone performance) are not applicable to the information provided in this regulatory submission.

However, I can extract the acceptance criteria and related "performance" from the document based on the provided bench testing section.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified in the document. The document refers to "Finished Device Verification Testing" and various specific tests but does not disclose the number of units tested.
• Data Provenance: Not explicitly stated, but based on the context of a 510(k) submission, this would be prospective bench testing conducted by the manufacturer, NeoMed, Inc. The document implies the tests were performed as part of the device's design validation prior to market submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. This document describes testing for a physical medical device (syringe), not an AI/ML algorithm that requires expert-established ground truth for diagnostic or prognostic performance. The "ground truth" for these tests would be the measured physical properties or compliance with engineering standards.

4. Adjudication method for the test set:

• Not Applicable. As above, this is not an AI/ML diagnostic or prognostic test. Adjudication methods like 2+1 or 3+1 are used for expert consensus in image interpretation or similar tasks, which are not relevant here.

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 for a physical medical device; no AI component is mentioned, and therefore, no MRMC study involving AI assistance would have been performed or reported here.

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

• Not Applicable. There is no algorithm or software component described in this device submission.

7. The type of ground truth used:

• Direct Measurement / Standard Compliance. The ground truth for this device's performance is established by direct physical measurements against defined engineering standards (e.g., critical dimensions, leakage rates, strength of connections, biocompatibility testing against ISO standards). This is typical for traditional hardware medical devices.

8. The sample size for the training set:

• Not Applicable. This device does not have a "training set" as it is not an AI/ML product. The design and manufacturing processes are developed based on engineering principles and regulatory standards, not trained on data.

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

• Not Applicable. As there is no training set, there is no ground truth for a training set.

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