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The I.V. Administration Set intended use is to deliver sterile, infusion fluid from a container to the patient with or without flow control features.

The I.V. Extension Set may act as an extension of other infusion tubing in delivering intravenous fluids from a container to patient.

The subject device is a single use device. It has ten models and their features are listed in Table 1. The ten models have differences in configurations. The differences are provided in Table 2.

The I.V. Administration Set is used to deliver sterile, infusion fluid from a container to the patient with or without flow control features. The I.V. Extension Set may act as an extension of other infusion tubing in delivering intravenous fluids from a container to patient.

There are ten different models, each configuration containing various components which may include: Spike Protector, Vented Air Cap, Air Filter, Spike, Drip Chamber, 10 Drops, Tubing, Back Check Valve, Needle Free TYPE Y, Clamp, Roller, Precision Filter, Robert Clamp, Male Luer Slip, Luer Lock Ring, Protective Cap, 15um Filter, Flow Regulator, Female Luer Connector. The devices are provided sterile and single use.

This document generally describes the submission of an I.V. Administration Set and I.V. Extension Set for FDA 510(k) clearance, asserting substantial equivalence to a predicate device. However, it does NOT contain the type of acceptance criteria and performance study data typically found for AI/ML-based medical devices.

The acceptance criteria and performance data provided in this document are based on bench testing and adherence to established medical device standards for physical and mechanical properties, not on the performance of a software algorithm or AI model in a clinical diagnostic setting.

Therefore, the following information, which is relevant to AI/ML device performance, is NOT available in the provided text:

• A table of acceptance criteria and the reported device performance (for AI/ML): The tables provided compare technological characteristics (e.g., product code, regulation, indications, configuration, materials, physical specifications) and note adherence to standards (e.g., ISO 8536-4 for infusion set performance). There's no AI/ML specific performance metrics like sensitivity, specificity, AUC, etc.
• Sample size used for the test set and the data provenance: Not applicable as this is not an AI/ML study. The "test sets" mentioned refer to physical samples of the IV sets for bench testing.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these devices is established by physical measurements and compliance with engineering standards.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI/ML context. Ground truth for this type of device involves measurements and physical properties.
• The sample size for the training set: Not applicable as this is not an AI/ML device.
• How the ground truth for the training set was established: Not applicable.

Based on the provided text, here is the information that is available regarding the device's acceptance criteria and the study proving it meets them:

The document describes the requirements for a traditional medical device (I.V. Administration Set, I.V. Extension Set) based on substantial equivalence to a predicate device, rather than an AI/ML-driven device.

1. Table of Acceptance Criteria and Reported Device Performance (as pertains to this type of device)

The acceptance criteria here are based on meeting design specifications and complying with recognized national and international standards. The "reported device performance" is the demonstration of compliance through non-clinical testing.

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

The document describes non-clinical (bench) testing rather than clinical study data. Specific sample sizes for each test (e.g., how many devices were tested for seal strength or biocompatibility) are not detailed in this summary. The data provenance is implied to be from the manufacturer's internal testing (BQ PLUS Medical Co., Ltd, China), as is typical for 510(k) submissions based on non-clinical testing. This is retrospective data from device manufacturing and testing processes.

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

Not applicable in the context of an AI/ML device. For a traditional medical device like an IV administration set, the "ground truth" for performance is established by adherence to engineering standards, validated test methods, and quantitative measurements (e.g., flow rate, seal strength, material properties). This is typically performed by qualified engineers, technicians, and potentially third-party labs specializing in medical device testing, not "experts" in the sense of clinical reviewers for diagnostic accuracy.

4. Adjudication Method for the Test Set:

Not applicable. This concept is relevant for establishing ground truth in clinical data (e.g., expert consensus on image reads), not for bench testing of physical properties.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC study was not done. This type of study is specifically designed for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not relevant to an IV administration set.

6. If a Standalone Performance Study was done:

No, an AI "standalone" performance study was not done. The performance studies conducted were non-clinical bench tests (e.g., flow rate, material biocompatibility, sterility) to demonstrate that the device meets its design specifications and complies with relevant international standards.

7. The Type of Ground Truth Used:

The "ground truth" for this device is based on quantifiable physical and chemical properties measured against established international and national standards (e.g., ISO, ASTM, USP). It is verified through laboratory testing and engineering principles to ensure the device functions as intended, is safe for patient contact, and is sterile.

8. The Sample Size for the Training Set:

Not applicable. This device does not involve an AI model, so there is no "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable.

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