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The B-D® Blunt Plastic Cannula replaces hypodermic needles currently used to access injection sites, as well as, vials designed for penefration with needleless IV access cannula. The B-D@ Blunt Plastic Cannula provides access to fluid path for Injection/aspiration of fluids. Use of this device prevents accidental hypodermic needlesticks in this application. These devices can also be used to flush pre-slit injection sites.

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 with medical grade silicone to reduce septum insertion forces.

The provided text is related to a 510(k) submission for a medical device, the Becton Dickinson Blunt Plastic Cannula. The primary claim supported by data is the effective flushing of pre-slit injection sites.

However, the document does not contain information about:

• Specific acceptance criteria in the form of numerical targets for performance metrics. Instead, the acceptance criterion seems to be "superior flushing effectiveness" compared to competitive cannulas, which is a comparative claim.
• A "device performance" table with quantitative results directly linked to acceptance criteria.
• Sample sizes for the test set in terms of the number of injection sites or repetitions for each cannula type.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• MRMC comparative effectiveness study or related effect sizes.
• Standalone performance (algorithm only without human-in-the-loop) because this is a physical medical device, not an AI/software device.
• Ground truth type for the flushing effectiveness (while red blood cell count is mentioned, it's the outcome of the test, not an externally established ground truth for a diagnostic claim).
• Sample size for the training set (not applicable for this type of device and study).
• How ground truth for the training set was established (not applicable).

Therefore, based only on the provided text, a comprehensive answer for all requested points cannot be generated. I will provide the information that is present and indicate where information is missing.

Acceptance Criteria and Study Details for B-D® Blunt Plastic Cannula

1. Table of Acceptance Criteria and Reported Device Performance

Flushing effectiveness was assessed by counting the remaining red blood cells in the injection site after flushing under controlled test conditions. |

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

The document does not explicitly state the sample size (e.g., number of injection sites, number of trials) for the test set. It mentions four experiments were developed.

• Test Set Sample Size: Not explicitly stated (e.g., number of replicates for each condition).
• Data Provenance: The study was conducted internally by Becton Dickinson ("Becton Dickinson Test Protocol"). The country of origin and whether it was retrospective or prospective data are not specified, but typically, such testing is prospective and conducted in a lab environment.

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

This information is not applicable and not provided. The "ground truth" here is the physical outcome of flushing (number of remaining red blood cells), which is a measurable quantity, not an expert opinion or diagnosis.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication typically applies to expert review of diagnostic information, not to the direct measurement of a physical phenomenon in a laboratory test.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study applies to diagnostic imaging or AI devices involving human interpretation, not to the functional performance of a physical medical device like a cannula.

6. If a Standalone Performance Study Was Done

Yes, a standalone study of the device's flushing performance was done. The "Injection Site Flushing Evaluation" was a controlled laboratory test assessing the B-D® Blunt Plastic Cannula's flushing effectiveness independently and compared to competitor devices. This is a standalone study of the device itself. (Note: "Standalone" in the context of AI often refers to algorithm-only performance, which is not relevant here).

7. The Type of Ground Truth Used

The ground truth for flushing effectiveness was established by direct measurement of the outcome: the "number of red blood cells remaining in the injection site measured flushing effectiveness." This is a quantifiable, objective outcome data, not expert consensus or pathology in the traditional sense.

8. The Sample Size for the Training Set

This information is not applicable and not provided. This device is not an AI/machine learning model, so there is no concept of a "training set" for an algorithm. The data presented is for validation testing of the physical device.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided, as there is no training set for this type of device.

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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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