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The Solution Infusion Sets are intended to be used for the administration of intravenous fluid solution into the body. They are also intended for use in administering intravenous fluids to a dialysis set in conjunction with hemodialysis.

Intravascular administration sets are described in 21 CFR §880.5440. The Disposable Solution Infusion Sets that we intend to market include 4 types of designs. The sets consist of a length of polyvinylchloride tubing with a clamp roller along it and a male luer lock at one end and a nonvented infusion subassembly without filter at the other end. Model number NNC-3L has a male luer-lock conector (without injection site) and NNC-3CL has the male luer-lock connector and Y-connector with injection site. Model NNC-3CS has the cone luer slip and Y-connector with injection site and NNC-3C has the cone slip connector (without injection site). The materials used for the components include polyethylene (PE), polyvinylchloride (PVC) (contains DEHP), polypropylene (PP) and acrylonitrile butadiene styrene (ABS). Cyclohexanone and adhesive bond are used and are present in trace amounts.

The provided document is a 510(k) summary for the Nipro Disposable Solution Infusion Set. This type of submission is for demonstrating substantial equivalence to a legally marketed device, rather than proving device performance against specific acceptance criteria through a clinical study in the way typically seen for novel or high-risk devices.

Therefore, many of the requested elements (e.g., acceptance criteria, detailed study results, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types for AI/ML) are not applicable or not provided in this type of regulatory submission because the device is a standard, well-understood medical product that has a predicate.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent due to the nature of the submission:

Acceptance Criteria and Device Performance Study for Nipro® Disposable Solution Infusion Set

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not specify quantitative or qualitative acceptance criteria typical of performance studies (e.g., specific flow rates, burst pressures, material biocompatibility thresholds) because it relies on the predicate device's established safety and effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable. There was no specific "test set" in the context of a prospective performance study as would be conducted for an AI/ML device. The claim of equivalence is based on the technical characteristics being identical to the predicate device and historical clinical use.
• Data Provenance: The "data" provenance refers to "years of clinical use" of similar devices, implying real-world usage data, likely from various geographies where such devices are used. The specific country of origin or whether it was retrospective/prospective is not detailed.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not applicable. There was no "ground truth" establishment in the context of expert review for a performance study. Clinical experience with the predicate device and similar infusion sets forms the basis of the safety and effectiveness claim.

4. Adjudication Method for the Test Set

• Not applicable. No adjudication method was described as there was no test set requiring expert consensus.

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 device is a disposable solution infusion set, not an AI/ML diagnostic or assistive technology. Therefore, an MRMC study related to human readers and AI is irrelevant to this submission.

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

• Not applicable. This device is a physical medical device, not an algorithm, so standalone performance in that context is not relevant.

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

• Historical Clinical Outcomes: The "ground truth" for the safety and effectiveness claim relies on "years of clinical use" and the absence of reported problems for similar, legally marketed devices. This implicitly refers to real-world outcomes and user experience, rather than specific diagnostic ground truth like pathology or expert consensus on individual cases.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML model, so the concept of a "training set" is not relevant.

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

• Not applicable. See #8.

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The Solution Infusion Sets are intended to be used for the administration of intravenous fluid solution into the body.

Intravascular administration sets are described in 21 CFR 5880.5440. The Disposable Solution Infusion Sets that we intend to market include 4 types of designs. The sets consist of a length of polyvinylchloride tubing with a clamp roller along it and a male luer lock at one end and a nonvented infusion subassembly without filter at the other end. Model number NNC-3L has a maie luer-lock conector (without injection site) and NNC-3CL has the male luer lock connector and Y-connector with injection site. Model NNC-3CS has the cone luer slip and Y-connector with injection site and NNC-3C has the cone slip connector (without injection site). The materials used for the components include polyethylene (PE), polyvinylchloride (PVC) (contains DEHP), polypropylene (PP) and acrylonitrile butadiene styrene (ABS). Cyclohexanone and adhesive bond are used and are present in trace amounts.

This document, a 510(k) summary for the Nipro® Disposable Solution Infusion Set, does not contain the detailed information required to answer your request.

Here's why and what information is missing:

Missing Information:

• Acceptance Criteria and Device Performance Table: The document describes the device and its intended use, but it does not provide any specific performance metrics (e.g., flow rate accuracy, drip chamber clarity, material degradation) or corresponding acceptance criteria. There is no table detailing these.
• Study That Proves the Device Meets Acceptance Criteria: The document explicitly states: "As these sets have been marketed for several years, safety and effectiveness has been established through years of clinical use. There have not been problems reported during use of the sets." This indicates that no formal study, as you've described, was performed or presented in this document to prove the device meets specific acceptance criteria. Instead, reliance is placed on historical clinical use and the substantial equivalence to a predicate device.
• Sample Size (Test Set, Training Set), Data Provenance, Number of Experts, Adjudication Method, MRMC Study, Standalone Performance, Type of Ground Truth, How Ground Truth was Established: All of these data points are related to a formal performance study (e.g., clinical trial, bench test with predefined metrics). Since no such study is detailed in this 510(k) summary, none of this information is present.

In summary, the provided text is a regulatory submission focused on demonstrating substantial equivalence to a legally marketed predicate device rather than detailing a specific performance study with acceptance criteria. The claim of safety and effectiveness is based on historical market use, not a novel study with measurable outcomes against specific criteria.

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