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ENFit Nutrifit™ enteral syringes deliver enteral fluids to the gastrointestinal system of a patient who is physically unable to eat and swallow. The 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 to administer enteral fluids. ENFit Nutrifit™ enteral syringes are single use devices. ENFit Nutrifit™ enteral syringes are intended for pediatric and adult use.

An enteral syringe consists of a syringe barrel with integral tip (ENFit), plunger, gasket, barrel lubricant and can be supplied with or without a syringe tip cap. Only the 5mL single use syringe can be connected with compatible enteral syringe-driver pumps; the other syringes are for manual use.

The provided document is a 510(k) Premarket Notification for ENFit enteral syringes, which are medical devices used for delivering enteral fluids. It outlines the regulatory process for clearance, not a study proving the device meets acceptance criteria for an AI/ML powered medical device. The document primarily focuses on establishing substantial equivalence to a predicate device through bench testing and conformance to established standards, rather than clinical studies with human participants.

Therefore, I cannot provide the information requested in the prompt's structured format (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, ground truth types, training set details) because this document does not describe such a study for an AI/ML powered device.

The document details the following about the device's testing and intended performance:

• Device Type: ENFit enteral syringes (NUTRIFIT™)
• Intended Use: Delivering enteral fluids to the gastrointestinal system of patients unable to eat and swallow. Intended for use in clinical or home care settings by laypersons (under supervision) and clinicians, for pediatric and adult use.
• Regulatory Class: Class II (Product Code: PNR, Regulation Number: 21 CFR 876.5980 - Gastrointestinal tube and accessories).
• Predicate Device: ENFit enteral pump syringes PENTA™/ENFit enteral pump syringes NUTRIFIT™ (K161141).
• Testing and Evaluation:
  • Performance test: According to ISO 7886-1/-2 & ISO 80369-3/-20, including testing after simulated clinical use and cleaning.
  • Biocompatibility tests: According to ISO 10993 series requirements.
  • Sterility validation and tests: According to ISO 11135.
  • Packaging validation and tests: According to ISO 11607-1/-2.
  • Labeling requirements: According to ISO 15223-1 and FDA Guidance "Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications."
• Conclusion: The tests demonstrated that the ENFit enteral syringes NUTRIFIT™ are safe and effective, meet their intended use, and are similar to the predicate device in terms of intended use, indications for use, and medical technique.

The document emphasizes compliance with international standards (ISO) and FDA guidance for medical devices, specifically for physical characteristics, sterility, biocompatibility, and packaging, rather than performance metrics related to diagnostic accuracy, image interpretation, or other tasks that would involve AI/ML algorithms and require the types of studies outlined in your request.

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The proposed device is indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral syringes are intended to be used in clinical or home care setting by users ranging from laypersons (under the supervision of a clinician) to clinicians, in all age groups.

The proposed device is a disposable enteral feeding syringe provided in a variety of sizes from 1ml~60ml. This device incorporates a female ENFit connection to an enteral access device with male ENFit connector.

The propsoed syringe is sterilized by Ethylene Oxide Gas to achieve a SAL of 10 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years.

This document describes the non-clinical testing performed to demonstrate that the ENFit Enteral Syringe meets its acceptance criteria and is substantially equivalent to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is demonstrated by compliance with several international standards. The specific acceptance criteria are defined within these standards. Below is a table summarizing the tests described and the reported outcome of compliance.

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

The document does not explicitly state the specific sample sizes (number of units tested) for each non-clinical test. However, it indicates that "Non clinical tests were conducted to verify that the proposed device met all design specifications" and that "Connector testing performed on the proposed device included the items listed below, in accordance with ISO 80369-3:2016... using the test methods provided in ISO 80369-20..." and similarly for syringe testing. These standards often specify minimum sample sizes for different tests.

The data provenance is from non-clinical (bench) testing performed on the proposed device. The device manufacturer is Jiangsu Caina Medical Co., Ltd. located in Jiangyin, Jiangsu, China. The report is a summary of these tests. This is retrospective in the sense that the tests were completed prior to this submission.

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

This section is not applicable as the information provided pertains to non-clinical (bench) testing of a medical device (enteral syringe). "Ground truth" and "experts" typically refer to human interpretation or pathology results in diagnostic or clinical studies. For physical device testing, the "ground truth" is defined by the technical specifications and requirements within the cited international standards (e.g., ISO, ASTM, USP).

4. Adjudication method for the test set

This section is not applicable as adjacency methods are used in clinical studies with human readers, not in non-clinical bench testing. The compliance is determined by whether the device's physical and performance characteristics meet the quantitative and qualitative requirements of the listed 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

This section is not applicable. An MRMC comparative effectiveness study is used for evaluating diagnostic or screening tools, often involving artificial intelligence. This document describes the non-clinical testing of a physical medical device (enteral syringe).

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

This section is not applicable. "Standalone performance" in this context refers to the performance of an algorithm without human intervention, typically in AI/software as a medical device. This document is about a physical medical device.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is compliance with established international and national standards and their specified test methods and acceptance criteria. This includes:

• Performance Specifications: Defined by standards like ISO 80369-3, ISO 7886-1 for connector and syringe function (e.g., fluid leakage, tolerance on graduated capacity).
• Biocompatibility Standards: Defined by ISO 10993 series for biological safety (e.g., cytotoxicity, irritation, sensitization).
• Sterilization and Packaging Standards: Defined by ISO 10993-7, ASTM F 88/F88M-09, ASTM F1140/F1140-13, USP37-NF32 .

8. The sample size for the training set

This section is not applicable. "Training set" refers to data used to train machine learning models. This document describes the non-clinical testing of a physical medical device.

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

This section is not applicable.

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