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The Monoject™ Enteral Syringe with ENFit Connector is indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids, either orally or enterally, into the gastrointestinal system of a patient. The orallenteral syringes are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to clinicians, in all age groups.

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This document is an FDA 510(k) clearance letter for the Monoject™ Enteral Syringe with ENFit Connector. It does not contain any information regarding acceptance criteria or a study proving that a device meets those criteria for software or AI/ML-enabled devices.

The letter is a regulatory document indicating that the FDA has determined the device to be substantially equivalent to a legally marketed predicate device. This process primarily focuses on comparing the new device's intended use, technological characteristics, and safety and effectiveness to an existing, legally marketed device.

Therefore, I cannot provide the requested information from this document. The document discusses regulatory aspects like:

• Trade/Device Name
• Regulation Number and Name
• Regulatory Class
• Product Code
• Indications for Use
• General controls provisions of the Act (e.g., annual registration, listing of devices, good manufacturing practice, labeling, misbranding, adulteration)
• Quality System (QS) regulation requirements
• Unique Device Identification System (UDI Rule)
• Medical Device Reporting (MDR)
• Contact information for the FDA.

However, none of these sections detail acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert qualifications as typically provided for AI/ML device submissions.

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The Monoject™ Enteral Syringe with ENFit Connector is indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids, either orally or enterally, into the gastrointestinal system of a patient. The oral/enteral syringes are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to clinicians, in all age groups.

The Monoject™ Enteral Syringes with ENFit Connector are provided in sizes of 1mL to 60mL, sterile or non-sterile. The device (sizes 6mL to 60mL) incorporates a female ENFit connector for connection to an enteral access device with male ENFit connector. The device specific for low dose applications (sizes 1mL & 3mL) incorporates a female ENFit Syringe tip with an internal tip lumen for connection to an enteral access device with male ENFit connector.

The provided document is a 510(k) summary for the Monoject™ Enteral Syringe with ENFit Connector. It describes non-clinical testing performed to demonstrate substantial equivalence to predicate devices, rather than a study proving the device meets clinical acceptance criteria for an AI or diagnostic device.

Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, how training set ground truth was established) are not applicable to this type of device and submission.

However, I can extract the relevant acceptance criteria and reported performance from the non-clinical testing described:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:
The document does not specify the exact sample sizes for each non-clinical test.
Data provenance is internal testing performed by Covidien for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a non-clinical device performance study based on engineering and material standards, not expert clinical interpretation of data.

4. Adjudication method for the test set:
Not applicable. This is a non-clinical device performance study based on engineering and material standards.

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 non-AI medical device (syringe).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a non-AI medical device (syringe).

7. The type of ground truth used:
For most tests (Fluid Leakage, Stress Cracking, Resistance to separation, Resistance to overriding, Disconnection by unscrewing, Dimensional Analysis), the "ground truth" is defined by established engineering and material standards (AAMI /CN3 (PS):2014 and ISO 80369-20). For biocompatibility, it's safety standards. For stability, it's product integrity after aging. For dosing accuracy and usability, it's functional performance.

8. The sample size for the training set:
Not applicable. This is a non-AI medical device (syringe).

9. How the ground truth for the training set was established:
Not applicable. This is a non-AI medical device (syringe).

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