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The device is indicated for use as a dispenser, measuring device, and 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) to in all age groups.

The device is an enteral feeding syringe for single use. The devices are piston-style syringes consisting of a syringe barrel, syringe plunger, syringe gasket, and syringe cap. The device incorporates a female ENFit connector designed to be compatible only with enteral access devices or accessories. It has ENFit compliant or compatible male connectors to form a dedicated system that prevents wrong-route administration of fluids.

The device is a disposable syringe made of the following components:

1. Plunger: The Plunger is a piston having a longitudinal shaft that is mechanically received into the proximal syringe barrel aperture. It is made of polypropylene and uncoated. The proximal end of the plunger is flat to allow the device user to apply uniform pressure to the plunger shaft, thereby initiating the plunger into the syringe barrel.
2. Barrel: The Barrel is a single, clear molded plastic hollow barrel made of polypropylene. This is the identical material used to manufacture the barrel of the predicate device. The distal end of the barrel possesses an integrally molded syringe tip. The barrel is marked on the exterior with non-toxic, biocompatible ink to create gradient volume graduation markings. The barrel is translucent to allow visualization of fluid contents and volume. The barrel is designed at an appropriate length to accommodate the nominal volume of each syringe size as labeled.
3. Gasket: The gasket is attached to the distal end of the syringe plunger in an o-ring orientation. It is attached to the plunger via a mechanical interference fit. The purpose of the gasket is to engage the syringe barrel to form a low-pressure seal, which is impervious to fluids.
4. Tip cap: The tip cap is an ENFit compatible closure cap for the syringe. The syringe tip cap is designed to be compatible with the ENFit female syringe tip of the syringe. The syringe tip cap is made of polypropylene and purple colorant.

This document primarily discusses the substantial equivalence of a medical device (Enteral Feeding Syringes with ENFit connector) to a predicate device, focusing on non-clinical performance testing, biocompatibility, and sterility. It does not present a study proving a device meets acceptance criteria in the context of an AI/ML medical device, clinical efficacy, or human reader performance. The document explicitly states "No clinical study is included in this submission."

Therefore, based on the provided text, I cannot answer the questions related to clinical studies, human readers, AI assistance, ground truth establishment for AI/ML models, or sample sizes for training sets.

However, I can extract the acceptance criteria and performance data for the non-clinical aspects of the device.

Here's the information gleaned from the document regarding the acceptance criteria and device performance for the physical device itself:

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

The document defines acceptance criteria by referencing compliance with specific international standards and then states that the device "met all requirements" or that "All of the pre-determined acceptance criteria were met." Specific numerical performance data is provided for sterility residuals and bioburden.

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

The document does not explicitly state the sample sizes for the performance, biocompatibility, sterility, or packaging tests. It describes "bench testing" and "verification tests" which are typically done on a defined number of units, but the specific count is not provided. The data provenance is not specified in terms of country of origin, but it is implied to be from the manufacturer's testing facilities (Jiangsu Shenli Medical Production Co., Ltd in China). These tests are typically prospective for regulatory submission.

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 not applicable as the document describes non-clinical performance and safety testing of a physical device, not an AI/ML system requiring expert interpretation of medical images or data.

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

Not applicable for tests of a physical medical device.

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. The document explicitly states: "No clinical study is included in this submission."

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

Not applicable. This is not an AI/ML device.

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

For the physical device testing:

• Performance: Ground truth is defined by the technical specifications and requirements outlined in the referenced ISO standards (e.g., specific force required, leak integrity, volume accuracy).
• Biocompatibility: Ground truth is adherence to the toxicological and biological safety requirements in ISO 10993 series.
• Sterility: Ground truth is 10^-6 SAL, absence of growth in sterility tests, compliance with residual limits, and pyrogenicity/endotoxin limits.
• Packaging & Shelf Life: Ground truth is maintaining integrity and sterility over the claimed shelf life as per referenced ASTM and ISO packing standards.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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