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The BD Nexiva™ Diffusics™ intravascular catheter is inserted into a patient's vascular system to sample blood, monitor blood pressure or administer fluids. The BD Nexiva Diffusics catheters are suitable for use with power injectors when a direct connection is made.

The BD Nexiva Diffusics device is designed to minimize blood exposure. It includes a passive needle-shielding mechanism designed to reduce accidental needlestick injury. The closed system is designed to keep blood contained within the device throughout the insertion process, which may prevent potential exposure for clinicians and patients. The system consists of a radiopaque Vialon® material catheter, a notched needle to enhance flashback visualization, a septum designed to remove visible blood from the needle surface that seals after needle removal, a stabiliization platform, extension tubing, a clamp, a vent plug and a luer connector, The 18-24 gauge catheter systems are capable of withstanding high pressure injection procedures. The stabilization platform and luer adapter are color-coded.

The provided text describes the BD Nexiva™ Diffusics™ Closed IV Catheter System, primarily focusing on its substantial equivalence to predicate devices based on bench testing. It does not contain the specific information requested in the prompt regarding acceptance criteria, a study proving device meets acceptance criteria, sample sizes, expert involvement, adjudication, MRMC studies, or standalone performance. The document explicitly states: "No clinical test results were included in this submission."

Therefore, I cannot fulfill most of your request directly from the provided text. However, I can extract the information that is present concerning the testing done.

Here's a summary of what can be inferred and what is missing:

Summary of Device Performance and Testing (from provided text):

The submission for the BD Nexiva™ Diffusics™ Closed IV Catheter System relies on bench testing to demonstrate performance and substantial equivalence.

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

• Acceptance Criteria: The text states, "Studies were designed and performed to demonstrate that the BD Nexiva Diffusics device met-predetermined product specifications." However, the specific predetermined product specifications (acceptance criteria) are not detailed in the provided document.
• Reported Device Performance: The document generally states, "Nonclinical test results and technological characteristics of like gauge size catheters were shown to be equivalent between the subject device and the predicate device." And "The BD Nexiva Diffusics (subject) device met the minimum requirements and are substantially equivalent in design, materials, sterilization, principles of operations and indications for use to the predicates."
  • Specific performance metrics or numerical outcomes from the bench tests are not provided.
  • The testing performed included:
    • In-vitro testing in accordance with ISO 10555-1 and ISO 10555-5 (which generally cover sterile, single-use intravascular catheters).
    • Flow rate testing.
    • Catheter strength and performance.
    • Clamp performance.
    • Labeling durability.
    • Extension tube and septum integrity.
    • Biocompatibility evaluation in accordance with ISO 10993-1.

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

• Sample Size: The sample sizes used for the bench tests are not specified in the provided text.
• Data Provenance: The data provenance (country of origin, retrospective/prospective) for the bench tests is not specified. Given it's bench testing, it would likely be conducted in a laboratory setting, not tied to a country of patient data, and inherently prospective for that specific test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This question is not applicable as there were no clinical studies or human expert evaluations mentioned for establishing ground truth. The submission relies solely on bench testing and comparison to predicate devices, not on human diagnostic performance.

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

• This question is not applicable as there were no human evaluations or a "test set" in the context of diagnostic interpretation that would require adjudication.

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:

• No MRMC study was done. The document explicitly states: "No clinical test results were included in this submission." The device is a physical medical device (IV catheter), not an AI diagnostic tool.

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

• This question is not applicable as the device is an IV catheter, not an algorithm or AI system.

7. The type of ground truth used:

• For the bench testing, the "ground truth" would be established by the predefined product specifications and performance standards (e.g., ISO 10555, ISO 10993) which the device had to meet. These are objective engineering and material science standards, not expert consensus, pathology, or outcomes data from patients.

8. The sample size for the training set:

• This question is not applicable as the device is not an AI/ML algorithm that requires a "training set."

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

• This question is not applicable as the device is not an AI/ML algorithm.

In summary, the provided document focuses on demonstrating substantial equivalence through bench testing against established industry standards and comparison to predicate devices. It explicitly states that no clinical tests were included, meaning there are no details about human or AI performance, expert involvement, or related statistical measures.

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