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The IV Administration Sets are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.

IV Administration Sets are gravity, single use, disposable, intravenous administration sets used to deliver fluids from a container into a patient's vascular system. These sets may be comprised of various components which are broadly used throughout industry including insertion spike, drip chamber, clamp, needleless luer access device, injection site, check valve, tubing, clamp, and luer connection (connector, adaptor). IV Administration sets are configured to ensure the intended use of the device is met.

The provided document is a 510(k) summary for an IV Administration Set, not an AI-powered medical device. Therefore, the information required to answer your query (acceptance criteria and study details for an AI/algorithm-based device) is not present in the given text.

The document focuses on demonstrating substantial equivalence of a conventional medical device (IV administration set) to a predicate device, based on:

• Similar indications for use and intended use.
• Similar principle of operation and fundamental scientific technology.
• Similar component types and materials (with specific testing for material differences).
• Compliance with recognized performance standards (e.g., ISO 8536-4, ISO 10993-1).
• Successful completion of non-clinical performance and biocompatibility testing.

The concept of "acceptance criteria" in this context refers to meeting the performance specifications outlined in the relevant ISO standards and the functional and performance tests listed. There is no mention of an algorithm, AI, or comparative effectiveness studies involving human readers and AI assistance.

To summarize why I cannot provide the requested information:

1. Nature of the Device: The device is a physical medical administration set, not a software or AI-based diagnostic/assistive tool.
2. Type of Submission: This is a 510(k) premarket notification for substantial equivalence, not a de novo or PMA submission that would typically involve extensive clinical performance data for novel AI devices.
3. No AI/Algorithm Mentioned: The document does not describe any AI component, algorithm, or software functionality.
4. No Human-in-the-Loop Study: Since there's no AI, there's no MRMC study, no human reader improvement data, and no standalone algorithm performance.
5. No Ground Truth Establishment: The concept of "ground truth" for diagnostic accuracy is not applicable to a physical IV administration set.

Therefore, I cannot populate the table or answer the specific questions related to AI device evaluation based on the provided text.

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Sterile, single-use plastic cannula used to penetrate pre-slit septums covering injection sites as well as, vials designed for penetration with needleless IV access cannula. The cannula is pre-lubricated to reduce septum insertion forces.

The B-D® Blunt Plastic Cannula replaces hypodermic needles currently used to access injection sites, as well as, vials designed for penetration with needleless IV access cannula. The B-D Blunt Plastic Cannula provides access to the fluid path and prevents accidental needlesticks in this application.

Sterile, single-use plastic cannula used to penetrate pre-slit septums covering injection sites as well as, vials designed for penetration with needleless IV access cannula. The cannula is pre-lubricated to reduce septum insertion forces.

B-D® Blunt Plastic Cannula is a molded plastic blunt tipped cannula for use in preslit IV safety systems, (i.e. Baxter InterLink® , Abbott LifeShield®, and McGaw SafeLine™). The B-D Blunt Plastic Cannula is intended for penetration of pre-slit IV port septums or vials designed for penetration with needleless IV access cannula (i.e. Abbott LifeShield® Single Dose Vials). B-D® Blunt Plastic Cannula, InterLink® Syringe Cannula, and McGaw SafeLine™ Blunt Cannula are all plastic devices. LifeShield® Blunt Cannulas is a two (2) piece design which has a plastic hub with a blunt steel cannula attached.

B-D® Blunt Plastic Cannula is molded from copolyester resin.

Here's a breakdown of the acceptance criteria and supporting studies for the B-D® Blunt Plastic Cannula, based on the provided document:

Acceptance Criteria and Device Performance for B-D® Blunt Plastic Cannula

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the total number of individual devices or injection sites/vials included in each test. However, it mentions specific quantities for certain test procedures:

• Microbial Ingress Testing (6.1.4): Injection sites were penetrated two hundred (200) times with various cannulas. Six combinations of cannula and injection sites were challenged.
• Leakage Testing (6.1.5): Injection sites were penetrated two hundred (200) times with various cannulas.
• Particulate Matter Generation (6.1.7): Injection sites were penetrated two hundred (200) times with cannula.

Data Provenance: The studies appear to be retrospective in the sense that they are laboratory tests conducted on existing materials and designs, comparing a new device to already marketed predicate devices. The country of origin of the data is not specified but is implicitly from the manufacturer's testing facilities (Becton Dickinson).

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

The document does not mention the use of human experts or their qualifications to establish ground truth for the test set. These are largely engineering and performance tests based on measurable physical and biological parameters, rather than human interpretation.

4. Adjudication Method for the Test Set:

No adjudication method is mentioned, as the tests are objective laboratory measurements (e.g., force, flow rate, presence of microbes/particles, leakage).

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 typically used for diagnostic devices that involve human interpretation of images or other data, where the AI assists the human reader. The current device is a sterile medical accessory, and its performance is evaluated through physical, mechanical, and biological compatibility tests.

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

This question is not applicable to the B-D® Blunt Plastic Cannula. The device itself is a physical medical accessory, not an AI algorithm. Its performance is inherent to its design and material properties.

7. The type of ground truth used:

The "ground truth" for these tests is established by:

• Physical measurements: E.g., peak penetration force, flow rate (ml/min), pressure (psi), volume (cc/ml), particle size (>10 µm, >100 µm).
• Absence/Presence criteria: E.g., absence of microbial ingress, absence of leakage, absence of visible particulates.
• Comparisons to predicate devices: Performance is deemed acceptable if it is equivalent, superior, or within an acceptable range compared to established, legally marketed predicate devices.
• Material analysis: Fourier Transform Infrared (FTIR) analysis for particle characterization.

8. The sample size for the training set:

This concept is not applicable. The device is a physical product, not a machine learning model, so there is no "training set" in the context of AI. The development process would have involved design, prototyping, and iterative testing, but not machine learning training.

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

Not applicable, as there is no training set for an AI model.

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