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NUTRICAIR™ enteral feeding syringes with ENFit® are disposable, sterile medical devices that are intended for the measurement, the preparation and enteral administration of solutions (hydration, feeding) or medications for neonatal, pediatric and adult patient populations. These devices are intended to be used in clinics and home care settings by: - health care professionals - adult laypersons (instructed by/or under the supervision of health care professionals).

The Nutricair™ enteral syringe with ENFit is sterile, single use device. It is provided in size 10 ml. It consists in a body with ENfit connector in polypropylene, a plunger in polypropylene and a piston seal in isoprene. This device incorporates a female ENFit connection to enteral access device with a male ENFit connector that is compliant to ISO 80369-3. Graduations from 1 to 10 ml are printed on the body. The 10 mL syringe model number is NCE10SE.

The provided text describes a 510(k) premarket notification for a medical device called "Nutricair Enteral Syringe with ENFit," which functions as an enteral feeding syringe. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness or conducting clinical trials.

As such, the information you're requesting regarding acceptance criteria and studies demonstrating a device meets acceptance criteria, an AI-driven system, ground truth establishment, sample sizes for training/test sets, expert adjudication, MRMC studies, or standalone algorithm performance, is not applicable to this document.

This submission focuses on engineering and performance criteria to show the new device performs as safely and effectively as an existing one, usually through non-clinical bench testing and comparative analysis of design features.

Here's a breakdown of why your specific questions generally don't apply to a 510(k) for a physical medical device like a syringe, based on the provided text:

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

  • The document largely relies on meeting established international standards (e.g., ISO) for medical devices, particularly those related to syringes and enteral connectors. The "acceptance criteria" are these standard requirements, and the "reported device performance" is that the device met these standards.
  • The table on pages 6-7 ("Table 5-1: Device comparison table") highlights comparisons to the predicate device and states "Equivalent" or "Similar" and "No impact on safety or performance" as the outcome, indicating that existing standards and comparative performance are the basis for acceptance.
  • Section VIII, "Performance Testing," lists the types of tests performed (biocompatibility, visual inspections, enteral device performance tests, enteral connector performance tests, risk analysis, usability analysis) and the standards they comply with (e.g., ISO 10993, ISO 20695, ISO 7886-1, ISO 80369-20, ISO 80369-3, ISO 14971, ISO 62366-1). The acceptance criteria for each of these would be the specific quantitative or qualitative limits defined within those ISO standards. The document states that the device "met updated standard ISO 20695:2020" or "met the standards of 80369-3." However, specific numeric performance results are not typically included in these public 510(k) summaries unless a deviation from a standard is justified or an equivalence needs quantitative proof for a specific parameter.

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

  • For physical product testing as described (e.g., fluid leakage, stress cracking, barrel dimensions), sample sizes are typically defined by the test protocols within the relevant ISO standards (e.g., a certain number of syringes tested per batch). This information is generally not included in the 510(k) summary itself, as it's part of the detailed test reports provided to the FDA.
  • Data provenance for such physical device testing is typically the manufacturer's internal testing labs or third-party accredited labs. Country of origin for testing is not specified, but the manufacturer is based in France. The testing is retrospective in the sense that it was completed before the submission to demonstrate compliance.

• 3. Number of experts used to establish the ground truth... and their qualifications:

  • This is not applicable. There is no "ground truth" in the diagnostic AI or clinical outcome sense for a basic physical device like a syringe. The "truth" is whether it meets engineering specifications and safety standards defined by regulatory bodies and consensus standards. These are established through engineering principles, laboratory testing, and risk assessment by qualified engineers and scientists.

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

  • Not applicable. This concept pertains to human review of diagnostic imaging or clinical findings for establishing ground truth, which is 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 not an AI/software device that would involve human readers or diagnostic interpretation.

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

  • Not applicable. This is not an AI/software device.

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

  • As explained in #3, "ground truth" in the diagnostic sense is not applicable. The "truth" is whether the physical device meets its specified engineering performance parameters and safety requirements, as verified through standard laboratory tests and adherence to ISO standards.

• 8. The sample size for the training set:

  • Not applicable. This device does not involve machine learning or a "training set."

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

  • Not applicable. No training set is involved.

In summary: The provided document is an FDA 510(k) clearance summary for a disposable medical syringe. The "acceptance criteria" are the relevant ISO standards for medical device safety and performance, and the "study" is a series of non-clinical, bench-top engineering tests demonstrating compliance with these standards and substantial equivalence to a predicate device. Concepts related to AI/ML performance, diagnostic ground truth, or multi-reader studies are entirely outside the scope of this particular device and its regulatory submission.

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